WO2023033683A1

WO2023033683A1 - Antiviral pharmaceutical composition containing favipiravir and amino acid

Info

Publication number: WO2023033683A1
Application number: PCT/RU2022/050274
Authority: WO
Inventors: Петр Александрович Белый; Эдуард Юрьевич Лопатухин; Владимир Львович КОРОЛЕВ; Кира Яковлевна ЗАСЛАВСКАЯ; Татьяна Владимировна ЛЮТОВА
Original assignee: Общество С Ограниченной Ответственностью "Промомед Рус"
Priority date: 2021-09-06
Filing date: 2022-09-02
Publication date: 2023-03-09

Abstract

The invention relates to the field of the chemical and pharmaceutical industry and medicine, and is a novel pharmaceutical composition of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof and one or more amino acids and/or pharmaceutically acceptable salts, hydrates or solvates thereof, and/or hydrates or solvates of amino acids and/or pharmaceutically acceptable slats thereof. Further claimed is a drug containing said pharmaceutical composition. The invention makes it possible to improve the properties of the pharmaceutical composition and the drug in terms of, for example, bioavailability, stability and safety.

Description

ANTIVIRAL PHARMACEUTICAL COMPOSITION CONTAINING FAVIPIRAVIR AND AMINO ACID

FIELD OF TECHNOLOGY TO WHICH THE INVENTION RELATES

The invention relates to the field of pharmaceutical industry and medicine, and is a new pharmaceutical composition of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate with one or more amino acids and / or their pharmaceutically acceptable salts or hydrates, and / or hydrates or solvates of their pharmaceutically acceptable salts, as well as a medicinal product containing the specified pharmaceutical composition.

BACKGROUND OF THE INVENTION

The worldwide outbreak of SARS-CoV-2 and its associated consequences are a threat to the public health and economies of many countries. The lack of specific therapy against the new virus and its high variability require the creation of new drugs.

As part of the fight against a new infection, a number of preventive vaccines have been developed, as well as non-specific therapies that alleviate the course of the disease. However, in addition to existing therapies, specific drugs are needed that have a direct effect on the virus, leading to symptomatic relief, accelerated resolution of the disease, blocking transmission, and reducing the risk of clinical complications.

Nucleoside analogues directly target blocking the activity of RNA-dependent RNA polymerase and block the synthesis of the viral RNA chain for a wide range of RNA viruses, including the human coronavirus family. Favipiravir (6-fluoro-3-hydroxy-2-pyrazinecarboxamide), a guanine analogue approved in clinical practice for the treatment of influenza, has been proven to effectively block the RNA-dependent RNA polymerase of influenza viruses (various types), Ebola virus, yellow fever, chikungunya , noroviruses, enteroviruses [De Clercq, E. New nucleoside analogues for the treatment of hemorrhagic fever virus infections. Chem. Asian J. 14, 3962-3968, 2019].

A recent study showed the efficacy of favipiravir against SARS-CoV-2 (EC50 = 61.88 mM in Vero E6 cell culture) [Wang, M. et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res.- 2020,- 30, p. 269-271]. The study tested the co-administration of favipiravir with interferon-a (ChiCTR2000029600) and favipiravir with baloquavir marboxil (an influenza-approved cap-dependent endonuclease inhibitor) (ChiCTR2000029544) in patients with SARS-CoV-2.

The universal mechanism of action of favipiravir, which specifically acts on the fundamental enzyme of the viral replication apparatus, suggests a wide spectrum of antiviral activity of this substance, which has been demonstrated in many studies listed below.

Antiviral activity of favipiravir.

According to the Global Substances Report, favipiravir has now entered clinical trials against COVID-19 disease based on its proven mechanism of action against viral RsRp. In a clinical study by the National Center for Clinical Research on Infectious Diseases in Shenzhen, favipiravir was administered to 340 patients (age groups and comorbidities not specified) in two doses (2 doses) of 1600 mg on the first day and two doses of 600 mg for the next 13 days in addition to an inhalation aerosol of interferon-alpha (5 million units * 2 / day). This dosage resulted in more rapid disappearance of the virus to undetectable values in the blood) than in the group of patients taking the combination of anti-HIV proteases - lopinavir / ritonavir, with a median clearance of viral particles of 4 days, versus 11, respectively, and was assessed by control CT chest section. According to the current study, the use of favipiravir reduces the number of detectable viral particles in the blood, which means that it effectively inhibits viral replication, delays the development of an aggressive course of COVID-19 or even prevents it.

The effect of favipiravir against the influenza virus

Influenza epidemics happen all over the world every year. The disease is caused by influenza virus strains of varying virulence. The highly pathogenic avian influenza A(H5N1) virus caused the first outbreak in Hong Kong in 1997. and continues to cause local outbreaks of this type of influenza every year. Avian influenza A(H7N9) epidemic in China in 2013 and the influenza A(H1N1) pandemic in 2009 resulted in 17,700 deaths, and influenza is still one of the major public health problems worldwide, not only in terms of incidence but also in the critical health complications it causes [Writing Committee of the WHO Consultation on Clinical Aspects of Pandemic (H1N1) 2009 Influenza. Clinical aspects of pandemic 2009 influenza A (H1N1) virus infection.- 2010,- N. Engl. J. Med.]. The A(H1N1) epidemic showed that this strain resistant to ocetalmivir (Tamiflu), a neuramidase inhibitor, and to amantadine, an inhibitor of the nonstructural M2 protein. In this regard, in medical practice, a drug with a different mechanism of action is urgently needed.

Favipiravir (T-705; 6-fluoro-3-hydroxy-2-pyrazinecarboxamide) is effective against a wide range of influenza virus strains, including A(H1N1) (pandemic 2009), A(H5N1) and A(H7N9), due to the fact that that the viral RsRn mistakenly takes the favipirovir-RTF metabolite for a purine nucleotide. Favipiravir has completed phase III trials in Japan and Poi in the US for the treatment of influenza.

In addition to antiviral activity against influenza, favipiravir inhibits the replication of arenaviruses, phleboviruses (Rift Valley fever, phlebotomic fever virus and Punta Toro fever), hantaviruses (Maporal, Dobrava and Prospect Hill); flaviviruses (yellow fever and West Nile fever); enteroviruses (full and rhinoviruses); respiratory syncytium paramyxovirus and norovirus [Yousuke Furuta, Brian B. Gowen, Kazumi Takahashi, Kimiyasu Shiraki, Donald F. Smee, Dale L. Bamard. Favipiravir (T-705), a novel viral RNA polymerase inhibitor. antiviral research. -2013, - Volume 100, Issue 2].

Use of favipiravir in in vitro models of influenza

In in vitro studies, favipiravir showed high antiviral activity against all strains of the influenza virus, A, B and C. Based on the calculation of plaque-forming units (PFU) in MDCK cell culture, the effective concentration index (hereinafter referred to as EC50) ranged from 0.014 to 0.55 cg /ml [Furuta Y., Takahashi K., Fukuda Y., Kuno M., Kamiyama T., Kozaki K., Nomura N., Egawa H., Minami S., Watanabe Y., Narita H., Shiraki K. In vitro and in vivo activities of anti-influenza virus compound T-705. -2002, Antimicrob Agents Chemother; 46(4), p. 977-981].

Favipiravir is known to be active against 53 strains of the influenza virus, including seasonal strains A(H1N1), A(H3N2), and strains of influenza type B; A(HlNl)pdmO9 pandemic virus, highly pathogenic avian influenza A(H5N1) isolated from humans, strains A(H1N1) and A(H1N2) isolated from pigs, and A(H2N2), A(H4N2), A(H7N2) .

Use of favipiravir in in vivo models of influenza

In vivo, in mouse models of viral infection with lethal doses of H3N2 (A/Victoria/3/75), H3N2 (A/Osaka/5/70), or H5N1 (A/Duck/MN/1525/81) strains, favipiravir was administered one hour after infection. . Survival of mice at doses of 30 mg/kg/day 2 or 4 times a day was significant, while all infected mice in the control group died.

When administered at 60 to 300 mg/kg/day, favipiravir has been shown to be effective in reducing the viral load in the lungs of H1N1-infected mice (A/ Califomia/04/09), as well as delayed use, up to 96 hours after infection [Takahashi K ., Furuta Y., Fukuda Y., Kuno M., Kamiyama T., Kozaki K., Nomura N., Egawa H., Minami S., Shiraki K. In vitro and in vivo activities of T-705 and oseltamivir against influenza virus. antivirus. Chem. Chemother.- 2003; Sidwell R.W., Barnard D.L., Day C.W., Smee D.F., Bailey K.W., Wong M.H., Morrey J.D., Furuta Y. Efficacy of orally administered T-705 on lethal avian influenza A (H5N1) virus infections in mice.- 2007,- Antimicrob Agents Chemother], Favipiravir showed a significant therapeutic effect compared to ocetalmivir in mice that were injected with a dose of the virus 100 times more, and the treatment itself was delayed by 96 hours post-infection [Takahashi K, Furuta Y, Fukuda Y, Kuno M, Kamiyama T, Kozaki K, Nomura N, Egawa H, Minami S, Shiraki K. Antivir Chem Chemother. In vitro and in vivo activities of T-705 and oseltamivir against influenza virus. 2003].

Efficacy of favipiravir for other families of RNA viruses in in vitro and in vivo studies.

Arenaviridae

Arenaviruses cause fatal human diseases [Moraz M.L., Kunz S. Pathogenesis of arenavirus hemorrhagic fevers. - 2011, - Expert Rev. Anti infection. Ther.-9(1), p. 49-59], for which there are no antiviral drugs, except for ribavirin, which has a pronounced toxic effect.

Use of favipiravir in in vivo models of arenaviruses

In vitro, favipiravir showed greater selectivity than ribavirin. When measuring the cytopathic effect in cell culture, the EC50 values for the drug were 0.79-0.94 cg/ml for Yunin, Pichinde and Takaribe viruses. Also, the viral load during the use of favipiravir significantly decreased by the third day. In the study by the method of counting hemolysis foci, 3K90s against the highly pathogenic Romero strain of the Guanarito virus JUNV (Romero) and the Machupo virus was 3.3-8.4 cg / ml (21-53 cM) [Mendenhall M, Russell A, Juelich T, Messina EL, Smee DF, Freiberg AN, Holbrook MR, Furuta Y, de la Torre JC, Nunberg JH, Gowen BB. Antimicrobial Agents Chemother. T-705 (favipiravir) inhibition of arenavirus replication in cell culture.- 2011,- Antimicrob Agents Chemother.- 55(2), p. 782-787]. When favipiravir was administered orally in a model line of hamsters infected with the Pichinde virus, the drug prevented death, reduced the number of viral titers in the blood and tissues, at dosages of bOmg / kg / day, it prevented liver destruction twice when used for 7 days, starting from 4 hours post-infection [Gowen V.V., Wong M.N., Jung K.N., Sanders A.B., Mendenhall M., Bailey KW, Furuta Y., Sidwell RW In vitro and in vivo activities of T-705 against arenavirus and bunyavirus infections. Antimicrob. Agents Chemother.- 2007,- 51(9), p. 3168-3176]. Viral load was also significantly reduced at the start of treatment from days 4, 5 and 6 post-infection. When used in dosages of 100 mg / kg / day, the survival of animals significantly increased [Gowen V.V., Smee DF, Wong M.N., Hall J.O., Jung KH, Bailey KW, Stevens JR, Furuta Y., Morrey JD Treatment of late stage disease in a model of arenaviral hemorrhagic fever: T-705 efficacy and reduced toxicity suggests an alternative to ribavirin. - 2008, - PLoS One 3, e3725].

In a guinea pig infection model, favipiravir demonstrated its effectiveness even after the onset of acute symptoms of the disease [Mendenhall M., Russell A., Smee D.F., Hall J.O., Skirpstunas R., Furuta Y., Gowen B.B. Effective oral favipiravir (T-705) therapy initiated after the onset of clinical disease in a model of arenavirus hemorrhagic fever. -2011,- PLoS Negl. Trop. Dis. 5, el342].

When using favpiravir at a dose of 300 mg/kg/day, it showed significant effects on survival: 100% of the animals participating in the experiment survived, at a dose of 150 mg/kg/day, the indicators decreased to 50 and 25%, the animals maintained body weight, their temperature dropped to normal and all indicators were generally better than those for ribavirin at a dosage of 50 mg/kg/day. The concentration of aspartate aminotransferase (AST), a prognostic marker of the severity of the disease with Lassa fever in the blood, decreased significantly in a dose-dependent manner by the tenth day of the disease in the treatment with favipiravir. Mean infectious dose viremia per ml of eluate decreased to an average of 2.1, 1.3, and 1.6 logIO SS50/ml in the high and medium dose favipiravir and ribavirin groups, respectively.

The efficacy of oral administration of favipiravir has also been shown in models infected with the lethal Lassa virus in guinea pigs and mice [Safronetz D., et al. The broad-spectrum antiviral favipiravir protects guinea pigs from lethal Lassa virus infection post-disease onset.- 2015,- Sci. Rep. 5, 14775]. The therapeutic effect was observed on the 2nd day after infection. Subcutaneous administration of favipiravir at doses of 300 mg/kg/day once a day lowered the temperature, prevented weight loss, and increased the survival rate of the animals. The effects of the use of favipiravir many times over outperformed ribavirin 50 mg/kg/day. A significant improvement in the survival of Lassa virus-infected guinea pigs was observed even on days 5, 7 and 9 post-infection [Safronetz D., et al. The broadspectrum antiviral favipiravir protects guinea pigs from lethal Lassa virus infection post-disease onset.- 2015,- Sci. Rep. 5, 14775].

Bunyaviridae

Viruses of the Bunyaviride family, including La Croce virus (LACV), Rift Valley fever virus (RVFV), Crimean-Congo hemorrhagic fever virus (CCHFV), acute fever with thrombocytopenia syndrome virus (SFTSV), and hantavirus, cause severe hemorrhagic fevers with concomitant pulmonary and renal complications.

In vitro studies have shown the superiority of favipiravir over other drugs in the direction, efficacy and speed of action against a number of such viruses [Yousuke Furuta, et al. Favipiravir (T-705), a novel viral RNA polymerase inhibitor.- 2013,- Antiviral Research. Volume 100; Gowen B. B., et al. Efficacy of favipiravir (T-705) and T-1106 pyrazine derivatives in phlebovirus disease models.- 2010,- Antiviral Res., Volume 86, Issue 2, p. 121-12]. EC50 values in Plaque Forming Units (PFU) studies in cell culture started in the range of 0.9-30 cg/mL of the drug for Lassa, Punta Toro, Reef Valle, Acute Fever (SFTSV), Phlebotomy Fever, and Dobrava, Maporal, and Prospect Hill Hantaviruses [Tani H., et al. Efficacy of T-705 (Favipiravir) in the treatment of infections with lethal severe fever with thrombocytopenia syndrome virus. - 2016, - mSphere 1, e00061-15].

Use of favipiravir in in vitro and in vivo bunyavirus models

Thrombocytopenic fever virus (SFTSV) emerged several years ago as a seasonal disease in China, Korea and Japan [Yu X., Liang M., et al. Fever with thrombocytopenia associated with a novel bunyavirus in China.- 2011,- N. Engl. J. Med, 364, pp. 523-1532]. Favipiravir inhibited SFTSV replication in cell culture with EC values of 0.71-1.3 cg/mL.

The therapeutic effect of favipiravir has been demonstrated in interferon-a receptor knockout (IFNAR-/-) mouse models that do not develop an immediate immune response.

When favipiravir was administered orally at a dose of 300 mg/kg/day for 5 days, starting from day 3 post-infection, all experimental mice survived (P < 0.001), and survival rates improved significantly from days 4 and 5 post-infection. V group. Based on in vivo studies in Japan, the drug has entered clinical trials and has successfully completed them to date. Studies have shown the efficacy of favipiravir even after the onset of the disease and the onset of clinical symptoms (Yousuke Furuta, et al.. Favipiravir (T-705), a novel viral RNA polymerase inhibitor. - 2013, - Antiviral Research. Volume 100, Issue 2).

Flaviviridae

Favipiravir blocks the replication of viruses of the flaviviride family, including yellow fever virus (YFV) and West Nile virus (WNV) [Inlander J.G., et al. Activity of T-705 in a hamster model of yellow fever virus infection in comparison with a chemically related compound T-1106.- 2009,- Antimicrob. Agents Chemother, 53(1), p.-202-209; Morrey J.D., et al. Efficacy of orally administered T-705 pyrazine analog on lethal West Nile virus infection in rodents.- 2008,- Antiviral Res., 80(3), p. 377-379], however, at higher concentrations than needed to block influenza virus activity.

The EC90 of favipiravir against YFV is 51.8 cg/ml in in vitro studies to determine the release of active viral particles on Vero cell culture.

Use of favipiravir in in vivo models of flaviviruses

YFV-infected hamsters were treated orally with favipiravir at doses ranging from 200 to 400 mg/kg/day for 8 days starting treatment 4 hours prior to infection. This therapy significantly reduced the mortality rate of animals at the start of treatment [Inlander I.G., et al. Activity of T-705 in a hamster model of yellow fever virus infection in comparison with a chemically related compound T-1106.- 2009,- Antimicrob. Agents Chemother, 53(1), p. 202-209].

Complete recovery was achieved with the introduction of 400 mg/kg/day, starting from the 2nd day of post-infection.

In vitro and in vivo antiviral efficacy of favipiravir against West Nile virus was achieved at EC50 concentrations of 53 cg/ml in Vero cell culture.

Oral administration of favipiravir at doses of 400 mg/kg/day 2 times a day, 4 hours after infection, saved 90% of mice from death, and also significantly reduced the expression of viral proteins and viral RNA in brain tissues. The same efficacy was shown in lines infected with WNV, hamsters at the same doses. WNV envelope proteins were not detected in the brains of the treated animals.

Togaviridae Favipiravir exhibits antiviral activity against Western equine encephalitis virus (WEEV) in Vero cell culture, reaching an EC90 at 49 ng/mL [Julander JG, et al. Effect of T-705 treatment on western equine encephalitis in a mouse model. Antiviral Res, 82(3), p. 169-171].

In WEEV-infected mice, oral administration of favipiravir significantly increased survival and lifespan of infected animals when administered twice at a dose of 400 mg/kg/day for 7 days starting at 4 hours post-infection. Viral titers in the brain tissues were reduced on the 4th day of post-infection.

Favipiravir showed antiviral activity against Chikungunya virus (CHIKV) in Vero cell culture, reaching an EC50 at 0.3-9.4 cg/mL. In CHIKV-infected mice, oral administration of favipiravir improved survival rates at double doses of 300 mg/kg/day starting 24 hours before or 4 hours after infection [Delang L., et al. Mutations in the chikungunya virus non-structural proteins cause resistance to favipiravir (T-705), a broad-spectrum antiviral. - 2014, - J. Antimicrob. Chemother, 69(10), p. 2770-2784].

Picornaviridae

Use of favipiravir in in vitro models of picornaviruses

Replication of enterovirus vesicular stomatitis was inhibited by favipirovir in in vitro studies with an EC50 of 14 cg/ml [Sakamoto K., et al. The inhibition of FMD virus excretion from the infected pigs by an antiviral agent, T-1105. FAO report of the research group of the standing technical committee of european commission for the control of Foot-and-Mouth Disease.- 2006,- Paphos, Cyprus. FAO Appendix 64; Furuta Y., et al. T-705 (favipiravir) and related compounds: Novel broad-spectrum inhibitors of RNA viral infections. - 2009, Antiviral Res, ;82(3), p. 95-102].

Favipiravir also blocked poliovirus replication in Vero cell culture and rhinovirus in HeLa cell culture at 3K50s of 4.8 and 23 cg/ml, and with a selectivity index of 29 and >43, respectively [Furuta Y., et al. In vitro and in vivo activities of anti-influenza virus compound T-705. Antimicrob. 2002, Agents Chemother, 46(4), p. 977-981]. Favipiravir inhibited Enterovirus replication at EC50 at 23 cg/ml [Wang Y., et al. In vitro assessment of combinations of enterovirus inhibitors against enterovirus 71,- 2016,- Antimicrob. Agents Chemother, 60(9), p. 5357-5367].

Caliciviridae Favipiravir is active against murine noravirus with EC50 values of 39 cg/mL in viral plaque scoring studies in the RAW 264.7 mouse macrophage cell line. TTL? real-time revealed blocking of RNA synthesis using favipiravir with EC50 from 19 cg/ml [Rocha-Pereira J., et al. Favipiravir (T-705) inhibits in vitro norovirus replication. - 2012, - Biochem. Biophys. Res. Commun, 424(4), p. 777-780].

The use of favipiravir in in vivo models of the noravirus genus from the Calicivirus family

In a mouse model of persistent infection, oral administration of favpiravir at a dose of b00mg/kg/day twice for 8 weeks, 4 weeks post-infection, resulted in a significant decrease in viral titers in the feces of mice and the number of norovirus-positive mice. Scientific evidence also confirms that favipiravir-RTF inhibits the RNA polymerase activity of human Noraviruses [Jin Z., et al. Biochemical evaluation of the inhibition properties of Favipiravir and 2'-C-methyl-cytidine triphosphates against human and mouse norovirus RNA polymerases.- 2015 Antimicrob. Agents Chemother],

Filoviridae

Favipiravir showed antiviral activity against the Zaire Ebola virus (Mayinga 1976 strain) in Vero E6 cell culture with an EC50 of 10.5 cg/ml. In a strain of mice infected with the Mayinga 1976 strain lacking interferon-alpha receptor (IFNAR-/- C57BL/6), oral administration of favipiravir avoided death and reduced viral titers in the blood after two doses of 300mg/kg/day for 8 days from day 6 post-infection, while in the placebo group all mice died [Oestereich L., et al. Successful treatment of advanced Ebola virus infection with T-705 (favipiravir) in a small animal model.- 2014,- Antiviral Res, 105, p. 17-21]. Similarly, in the IFNAR-/- interferon receptor knockout A129 line infected with E718 Ebola shitamm, oral treatment with favipiravir completely saved all infected mice from death when the drug was administered twice at a dose of 300 mg/kg/day for 14 days, starting loro hours after infection [Smither S.J., et al.- Post-exposure efficacy of oral T-705 (Favipiravir) against inhalational Ebola virus infection in a mouse model.- 2014,- Antiviral Res, Volume 104, Pages 153-155] .

During the 2014 Ebola outbreak in West Africa, the French Institute for Health and Medical Research (INSERM) and the government of Guinea conducted a clinical trial of favipiravir in patients [Mentre F., Taburet AM Dose regimen of favipiravir for Ebola virus disease. 2015 - Lancet Infect. Dis, VOLUME 15, ISSUE 2, P. ISO-151]. Favipiravir was well tolerated by patients and reduced the number of deaths in patients with low viral titers. A group of Chinese researchers also noted an increase in survival of Ebola virus disease patients treated with favipiravir (T-705)-Sierra Leone in Sierra Leone [Bai CQ, Clinical and virological characteristics of Ebola virus disease patients treated with favipiravir (T-705)-Sierra Leone, 2016. Clin. Infect. Dis, 63(10), p.1288-1294].

Rhabdoviridae

The activity of favipiravir against rabies virus (RABV) was detected on the cell line of mouse neuroblastoma Neuro-2a with 3K50s at 5.1-7.0 cg/ml [Yamada K., et al. Efficacy of Favipiravir (T-705) in rabies postexposure prophylaxis. - 2016, - J. Infect. Dis, 213(8), p. 1253-1261]. Favipiravir significantly reduced morbidity and mortality in RABV-infected mice when given orally at doses of 300 mg/kg/day twice for 7 days, starting at the loro hour post-infection.

All the generalized data described above on the undeniable effectiveness of favipiravir against a very wide range of RNA viruses show that this drug perfectly “closes” the hitherto effectively uncovered niche of incurable, acute and fatal viral diseases, including a wide range of tropical fevers. Before studies on favipiravir, ribavirin and/or alpha-interferon were used against the above RNA infections, but the former has significantly less antiviral activity and efficacy against RNA viruses, and both drugs lead to debilitating side effects with long-term use.

Favipiravir, relying on a wide spectrum and proven mechanism of its action, can also alleviate the course of viral diseases, if taken on time, and also significantly reduce the viral load in the course of diseases with complications.

In view of the versatility and high efficacy demonstrated by favipiravir preparations, it seems necessary to use them during periods of epidemics.

However, this use is associated with a number of difficulties. Thus, in order to provide quick and high-quality assistance to the population, it is necessary to create a reserve of stable drugs, which in turn is associated with the possibility of their long-term storage. Currently, the only form of favipiravir available for medical use is oral tablets containing favipiravir 200 mg/tablet with a shelf life of 2 years.

At the same time, oral forms cause difficulties in taking medications in children, elderly patients and patients with dysphagia of various nature, as well as severe patients who are on intensive care, connected to a ventilator or in a state of coma, which can significantly complicate the necessary therapy. In addition, taking a large number of tablets, especially for a long time, can have a negative effect on the human digestive system.

In addition, entry of SARS-CoV into the host is mediated by the interaction between the virus-enveloped needle glycoprotein and the angiotensin-converting enzyme type 2 (ACE-2) receptor on human cells. At the highest concentration, the ACE-2 receptor, which serves as an entry gate for SARS-CoV-2, is expressed in the cells of the lungs, epithelium of the upper esophagus, as well as in enterocytes of the ileum and colon [She J, Liu L, Liu W. COVID-19 epidemic : disease characteristics in children. Journal of Medical Virology.- 2020; 92, p. 747-754]. SARS-CoV-2, acting on ACE-2 receptors in the gastrointestinal tract, is able to increase the permeability of the intestinal mucosa, which leads to disruption of the absorption of fluid and electrolytes by enterocytes. In addition to SARS-CoV-2 itself, the organs of the gastrointestinal tract are also seriously affected by the treatment of COVID-19 with antibiotics, antiviral and hormonal drugs, which put a great burden on the organs of the gastrointestinal tract. Thus, in people with COVID-19, there is a violation of the gastrointestinal tract, including nausea, vomiting, diarrhea, dysmotility, dysbacteriosis, etc., thereby changing the absorption rate of the drug and its bioavailability.

Based on the foregoing, it seems necessary to create new dosage forms of favipiravir with antiviral activity, with improved pharmacotherapeutic, technological, physicochemical characteristics, as well as with increased bioavailability, including dosage forms that allow the drug to be administered at therapeutically effective concentrations without a negative effect. on the digestive system inherent in oral forms.

DISCLOSURE OF THE INVENTION

AND The objective of the present invention was to develop a new commercially available formulation of favipiravir with improved processing characteristics, stability and bioavailability.

The technical results of the present invention are:

- improving the bioavailability of favipiravir;

- improving the uniformity of dosing of the active agent in medicines; improving the stability of the favipiravir composition (including photostability, stability in different climatic zones and long-term stability);

- synergistic antiviral activity;

- improvement of antiviral activity;

- improving the electrical properties of the drug favipiravir in powder form;

- reduction of caking of particles of the drug favipiravir in powder form;

- improving the safety of favipiravir formulations;

- reducing the time of obtaining the drug restored from the lyophilisate;

- reduction of local irritating action when injecting a composition of favipiravir with an amino acid;

- expanding the arsenal of antiviral drugs.

At the same time, the inventors unexpectedly found that favipiravir lyophilisates with hydrates of amino acids and/or their pharmaceutically acceptable salts are also characterized by a high dissolution rate in pharmaceutically acceptable carriers, thereby reducing the time for obtaining the drug recovered from the lyophilisate, leading to the formation of more stable and safe injectables. solutions.

Below are the terms that are used in the description of the present invention. Unless otherwise indicated, all technical and technical terms used in the description have the meaning generally accepted in the art.

The term "pharmaceutical composition" means a composition comprising favipiravir and at least one amino acid in an effective amount, and a pharmaceutical composition in the context of the present invention may additionally contain one of the components selected from the group consisting of pharmaceutically acceptable and pharmacologically compatible excipients, such as , not limited to specified, fillers, solubilizers, solvents, co-solvents, antioxidants, buffering agents, cryoprotectants, diluents, preservatives, stabilizers, humectants, emulsifiers, lubricants, lubricants, suspending agents, thickeners, sweeteners, fragrances, fragrances, antibacterial agents, fungicides, delayed delivery regulators, isotonic agents, pH adjusting agents, the choice and ratio of which depends on the nature, purpose and dosage.

Non-limiting (illustrative) examples of suspending agents are ethoxylated isostearyl alcohol, polyoxyethylene, sorbitol and sorbitol ether, as well as mixtures of these substances.

The protection of the pharmaceutical composition from the action of microorganisms can be achieved by using a variety of antibacterial and antifungal agents, for example, such as sorbic acid, parabens (methylparaben, propylparaben, ethylparaben, butylparaben, isobutylparaben, isopropylparaben, benzylparaben, heptylparaben and mixtures thereof), chlorobutanol and the like. connections.

As isotonic agents, the pharmaceutical composition may include, but is not limited to, sugars, sodium chloride, sodium bicarbonate, etc. Prolonged action of the pharmaceutical composition can be provided, but not limited to, using agents that slow down the absorption of the active agent (for example, hydrophilic and hydrophobic polymeric release inhibitors).

Non-limiting (illustrative) examples of suitable fillers are lactose, various types of starch, microcrystalline cellulose, calcium carbonate and phosphate, and others.

As solvents and diluents, water, suitable for parenteral forms, organic esters, ethanol, polyalcohols, and mixtures thereof can be used, but are not limited to. Examples of lubricants can be magnesium or calcium stearate, talc, sodium lauryl sulfate, sodium stearyl fumarate, etc. Silicon dioxide, talc, kaolin, bentonites, etc. can be used as lubricants. Various organic and inorganic acids or alkalis can be used to adjust the pH, such as, but not limited to, hydrochloric acid, malic, ascorbic, citric, acetic, succinic, tartaric, fumaric, lactic, aspartic, glutaric, glutamic, sorbic acids, sodium hydroxide, etc. Examples of dispersing agents and spreading agents are starch, alginic acid and its salts, silicates. The pharmaceutical composition can be administered to animals and humans orally, parenterally (intradermally, subcutaneously, intramuscularly, intravenously, intraarterially, in the cavity), sublingually, topically, including, but not limited to, ophthalmic, nasal administration, etc., rectally in a standard form of administration , as a mixture with traditional pharmaceutical carriers. Suitable unit forms of administration include (without limitation) oral forms: tablets, capsules, pellets, granules, powders, solutions, oral and nasal spray solutions, syrups, suspensions, etc., oral: solutions, suspensions, emulsions, preparation of injection and infusion dosage forms, aerosols and powders for inhalation administration, powders and lyophilizates for the preparation of injection and infusion dosage forms; rectal: suppositories, capsules, etc.; eye drops.

The term "excipient" in the context of the present invention characterizes substances of inorganic or organic origin used in the manufacturing process, the manufacture of drugs to give them the necessary physical and chemical properties.

"Pharmaceutical salt" means the relatively non-toxic organic and inorganic salts of the acids and bases of the present invention.

A "pharmaceutically acceptable solvate" in the context of the present invention characterizes the product of addition of a solvent to solutes.

A "pharmaceutically acceptable hydrate" in the context of the present invention characterizes the addition product of a solvent to solutes where water is the solvent.

The term "pharmaceutically acceptable" in the context of the present invention means that the substance or composition to which this term is applied must be compatible from the point of view of chemistry and / or toxicology with other ingredients that make up the drug, and are safe for the person who treated with the substance or composition.

The term "proteinogenic amino acids" in the context of the present invention characterizes amino acids that are incorporated into proteins during biosynthesis in ribosomes under the genetic control of messenger RNA. Proteinogenic non-standard amino acids arise from standard amino acids in the process of post-translational modifications. The term "non-proteinogenic amino acids" in the context of the present invention characterizes amino acids that do not take part in the formation of proteins. In some cases, there is a close structural relationship between non-proteinogenic and proteinogenic amino acids, since non-proteinogenic amino acids also include derivatives of proteinogenic amino acids.

The term "isoelectric point of amino acids" in the context of the present invention means the pH value at which the charge of an amino acid is zero.

The term "racemate" in the context of the present invention means a mixture of two enantiomers. An amino acid in the form of a racemate characterizes a mixture of L- and D- isomers of an amino acid in any proportions.

The term "drug" in the context of the present invention characterizes substances or combinations thereof that come into contact with the human or animal body, penetrate into the organs, tissues of the human or animal body, used for the prevention, treatment of diseases, obtained by synthetic methods. Medicinal products include pharmaceutical substances and drugs. The drug may be presented in various formulations intended for administration to an animal or human body in various ways, for example, but not limited to, orally, sublingually, topically, rectally, parenterally.

The term "lyophilizate" in the context of the present invention characterizes a solid drug in the form of a powder or a porous mass, obtained by lyophilization of liquid or soft drugs. Lyophilizates can be in the form of: powder; amorphous porous mass; porous mass compacted into a tablet, and other forms. Before use, lyophilizates are dissolved (dispersed) to obtain drugs in various dosage forms: solutions; suspensions; emulsions.

The term "concentrate" in the context of the present invention characterizes a liquid dosage form intended for use after dilution (dilution). The concentrate can be obtained, but not limited to, by dissolving the lyophilisate in a pharmaceutically acceptable solvent. If the conversion of the original dosage form into the application form is two-stage, the term "concentrate" is used to refer to the intermediate form. For example, if the lyophilisate is to be first dissolved in a small amount of solvent to form a concentrate, then the resulting solution must be further diluted in a larger amount of diluent before infusion. In this case, the solvent and the diluent may or may not be the same pharmaceutically acceptable excipient.

Also for the purposes of the present invention, the terms "comprising", "comprises", "including" mean that the specified combinations, compositions and concentrate include the listed components, but do not exclude the inclusion of other components.

The term "therapeutically effective amount" in the context of the present invention means the amount of a substance (as well as a combination of substances) which, when administered to a subject for the treatment or prevention of a disease, or at least one of the clinical symptoms of a disease or disorder, is sufficient to effect such treatment (prophylaxis) to a disease, disorder, or symptom. A “therapeutically effective amount” may vary depending on the form of the substance (e.g., polymorph, salt, solvate, hydrate, etc.), the disease, disorder, and/or symptoms of the disease or disorder, the severity of the disease, disorder, and/or symptoms of the disease or disorder. , as well as the age and/or weight of the subject who needs such treatment (prophylaxis).

The terms "about", "approximately", "about" characterize plus or minus ten percent of the specified value.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 - Dosage 100 mg favipiravir + 10 mg amino acid hydrate or salt.

Fig. 2 - Dosage 100 mg favipiravir + 120 mg amino acid hydrate or salt.

Fig. 3 - Dosage 1200 mg favipiravir + 120 mg amino acid hydrate or salt.

Fig. 4 - Dosage 1200 mg favipiravir + 750 mg amino acid hydrate or its salt.

IMPLEMENTATION OF THE INVENTION

The problem is solved, and the claimed technical result is achieved by obtaining a new pharmaceutical composition that exhibits prophylactic and/or therapeutic antiviral activity, containing favipiravir and at least one amino acid and/or its pharmaceutically acceptable salt in therapeutically effective amounts. One of the embodiments of the invention is a pharmaceutical composition, where the mass ratio of favipiravir to amino acid is 1.0:0, 1-

1.0: 1.2 respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.1, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.15, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.2, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.25, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.3, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.35, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.4, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.45, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.5, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.55, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.6, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.65, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.7, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.75, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.8, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.85, respectively. More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.9, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.95, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:1.0, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:1.05, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:1.1, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:1.15, respectively.

More preferably, the weight ratio of favipiravir to amino acid is 1.0:1.2, respectively.

The problem is solved, and the claimed technical result is achieved by obtaining a new pharmaceutical composition that exhibits prophylactic and/or therapeutic antiviral activity, containing in therapeutically effective amounts favipiravir or its pharmaceutically acceptable salt, solvate or hydrate, and at least one amino acid hydrate and/or its a pharmaceutically acceptable salt, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to at least one amino acid hydrate and/or its pharmaceutically acceptable salt is 1.0:0, 1-1.0:1.2, respectively.

The problem is solved, and the claimed technical result is achieved by obtaining a new pharmaceutical composition that exhibits prophylactic and/or therapeutic antiviral activity, containing in therapeutically effective amounts favipiravir or its pharmaceutically acceptable salt, solvate or hydrate, and at least one solvate or hydrate of an amino acid and/ or a solvate or hydrate of its pharmaceutically acceptable salt, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to at least one solvate, amino acid hydrate and/or solvate, hydrate of its pharmaceutically acceptable salt is 1.0:0, 1- 1.0: 1.2 respectively.

The problem is solved, and the claimed technical result is achieved by obtaining a new pharmaceutical composition that exhibits prophylactic and/or therapeutic antiviral activity, containing therapeutically effective amounts of favipiravir or a pharmaceutically acceptable salt, solvate or hydrate thereof, and at least one amino acid and/or a pharmaceutically acceptable salt thereof, wherein the weight ratio of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof to at least one amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1.0: 1.2, respectively. One of the embodiments of the invention is a pharmaceutical composition, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to amino acid hydrate and/or its pharmaceutically acceptable salt is 1.0:0, 1-1.0:1.2, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:1.1, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1.0:1.0, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.9, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.8, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.7, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.6, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.5, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.4, respectively. More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.3, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.2, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.1, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.15, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.2, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.25, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.3, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.35, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.4, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.45, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.5, respectively. More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.55, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.6, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.65, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.7, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.75, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.8, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.85, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.9, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.95, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:1.0, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:1.05, respectively. More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:1.1, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:1.15, respectively.

More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:1.2, respectively.

The problem is solved, and the claimed technical result is achieved by obtaining a new pharmaceutical composition that exhibits prophylactic and/or therapeutic antiviral activity, containing in therapeutically effective amounts favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and at least one amino acid and/or its pharmaceutically acceptable an acceptable salt, hydrate or solvate, and / or one hydrate or solvate of an amino acid and / or its pharmaceutically acceptable salt, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid and / or its pharmaceutically acceptable salt, hydrate or solvate, and/or the hydrate or solvate of its pharmaceutically acceptable salt is the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1.0:1.2, respectively.

The problem is solved, and the claimed technical result is achieved by obtaining a new pharmaceutical composition, in which the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or its pharmaceutically acceptable hydrate or solvate the acceptable salt of the amino acid hydrate and/or the pharmaceutically acceptable salt thereof is 1.0:0.1; 1.0:0.15; 1.0:0.2; 1.0:0.25; 1, 0:0.3; 1.0:0.35; 1.0:0.4; 1.0:0.45; 1.0:0.5; 1.0:0.55; 1.0:0.6; 1.0:0.65; 1.0:0.7; 1.0:0.75; 1.0:0.8; 1.0:0.85; 1.0:0.9; 1.0:0.95; 1.0: 1.0; 1.0: 1.05; 1.0: 1.1; 1.0: 1.15 or; 1.0:1.2.

One embodiment of the present invention is a pharmaceutical composition wherein favipiravir is in free base form.

One embodiment of the present invention is a pharmaceutical composition wherein the hydrate of an amino acid and/or a pharmaceutically acceptable salt thereof is a monohydrate, dihydrate or trihydrate. One embodiment of the present invention is a pharmaceutical composition wherein the amino acid hydrate and/or pharmaceutically acceptable salt hydrate thereof is monohydrate, dihydrate or trihydrate.

All amino acids have isomerism. The bulk of natural amino acids is represented by a-isomers, but there are also -, y-amino acids. All a-amino acids, except for glycine, have an asymmetric (chiral) a-carbon atom and exist as two enantiomers (L- and D-amino acids).

One embodiment of the invention is a pharmaceutical composition wherein at least one pharmaceutically acceptable amino acid and/or a pharmaceutically acceptable salt, solvate or hydrate thereof is an a-amino acid.

More preferably the a-amino acid is glycine, alanine, valine, leucine, glutamine, lysine, histidine, aspartic acid, glutamic acid, isoleucine, proline, arginine, phenylalanine, tryptophan, methionine, serine, threonine, asparagine, cysteine, tyrosine.

One embodiment of the invention is a pharmaceutical composition wherein at least one pharmaceutically acceptable amino acid and/or a pharmaceutically acceptable salt thereof has an isoelectric point between 2 and 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point between 2.5 and 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point between 3.0 and 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 3.5 to 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 4.0 to 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 4.5 to 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 5.0 to 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 5.5 to 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 6.0 to 11. More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point between 6.5 and 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point between 7.0 and 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point between 7.5 and 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 8.0 to 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 8.5 to 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 9.0 to 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 9.5 to 11.

More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 9.0 to 10.

One of the embodiments of the invention is a pharmaceutical composition in which the amino acid and/or its solvate, hydrate has an isoelectric point from 2 to 10.

One embodiment of the invention is a pharmaceutical composition wherein the amino acid has an isoelectric point between 2 and 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 2.5 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate or hydrate thereof has an isoelectric point of 3.0 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 3.5 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate or hydrate thereof has an isoelectric point of 4.0 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate or hydrate thereof has an isoelectric point of 4.5 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate or hydrate thereof has an isoelectric point of 5.0 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 5.5 to 10. More preferably, the pharmaceutically acceptable amino acid and/or solvate or hydrate thereof has an isoelectric point of 6.0 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 6.5 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 7.0 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 7.5 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 8.0 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 8.5 to 10.

More preferably, the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 9.0 to 10.

One embodiment of the invention is a pharmaceutical composition wherein at least one pharmaceutically acceptable solvate or hydrate of an amino acid has an isoelectric point between 2 and 10.

One embodiment of the invention is a pharmaceutical composition wherein at least one pharmaceutically acceptable amino acid is an amino acid in the L- or D-configuration, or as a racemate.

One embodiment of the invention is a pharmaceutical composition wherein at least one pharmaceutically acceptable amino acid and/or a pharmaceutically acceptable salt, solvate or hydrate thereof is an amino acid in the L or D configuration, or as a racemate.

One embodiment of the invention is a pharmaceutical composition wherein at least one amino acid and/or a pharmaceutically acceptable salt, hydrate or solvate thereof and/or a hydrate or solvate of its pharmaceutically acceptable salt is an amino acid and/or a pharmaceutically acceptable salt, hydrate thereof. or a solvate and/or a hydrate or solvate of a pharmaceutically acceptable salt thereof in the L- or D-configuration, or as a racemate.

One embodiment of the invention is a pharmaceutical composition wherein at least one amino acid and/or a pharmaceutically acceptable salt, hydrate or solvate thereof and/or a hydrate or solvate of its pharmaceutically acceptable salt is a hydrate or solvate of an a-amino acid and/or its pharmaceutically acceptable salt. One embodiment of the invention is a pharmaceutical composition wherein at least one amino acid is a proteinogenic amino acid.

One embodiment of the invention is a pharmaceutical composition wherein at least one amino acid is a proteinogenic amino acid, with the exception of arginine.

More preferably, the proteinogenic amino acid is a non-essential or non-essential amino acid.

More preferably, the proteinogenic amino acid is a standard or non-standard amino acid.

More preferably, the proteinogenic standard amino acid is L-lysine.

More preferably, the proteinogenic standard amino acid is L-glutamine.

More preferably, the proteinogenic standard amino acid is L-histidine.

More preferably, the proteinogenic standard amino acid is L-methionine.

More preferably, the proteinogenic standard amino acid is L-arginine.

More preferably, the proteinogenic standard amino acid is L-isoleucine.

More preferably, the proteinogenic standard amino acid is L-leucine.

More preferably, the proteinogenic standard amino acid is L-alanine.

More preferably, the proteinogenic standard amino acid is glycine.

More preferably, the proteinogenic standard amino acid is L-threonine.

More preferably, the proteinogenic standard amino acid is L-tryptophan.

More preferably, the proteinogenic standard amino acid is L-proline. More preferably, the proteinogenic standard amino acid is L-valine.

More preferably, the proteinogenic standard amino acid is L-cysteine.

More preferably, the proteinogenic standard amino acid is L-phenylalanine.

More preferably, the proteinogenic standard amino acid is L-asparagine.

More preferably, the proteinogenic standard amino acid is L-serine.

More preferably, the proteinogenic standard amino acid is L-tyrosine.

More preferably, the proteinogenic standard amino acid is L-glutamic acid.

More preferably, the proteinogenic standard amino acid is L-aspartic acid.

More preferably, the proteinogenic non-standard amino acid is L-selenocysteine.

More preferably, the proteinogenic non-standard amino acid is L-pyrrolysine.

In addition to proteinogenic amino acids, other non-proteinogenic pharmaceutically acceptable amino acids that do not participate in protein synthesis can be used in the present invention. Such amino acids are often formed as intermediate metabolic pathways for standard amino acids.

One embodiment of the invention is a pharmaceutical composition wherein at least one amino acid is a non-proteinogenic amino acid selected from, but not limited to, N-acetyl-D-alanine, ornithine, N-acetylglycine, hydroxylysine, hydroxyproline, noarginine, homoarginine, homolysin, 2,7-diaminoheptanoic acid, 2,4-diaminobutyric acid, 3-aminoalanine, dehydroalanine, hydroxyproline, cystine, sarcosine, acetylcysteine and/or their pharmaceutically acceptable salts, solvates or hydrates.

In preferred non-limiting embodiments of the present invention, the pharmaceutical composition contains an amino acid selected from an imino acid, aliphatic, aromatic, or heterocyclic amino acids. More preferably, the aliphatic amino acids are monoamino dicarboxylic amino acid amides, monoamino monocarboxylic, oxymono amino carboxylic, monoamino dicarboxylic, diaminomonocarboxylic or sulfur containing amino acids.

More preferably, the monoamino monocarboxylic amino acids are selected from, but not limited to, glycine, alanine, valine, isoleucine, or leucine.

More preferably, the oxymonoaminocarboxylic amino acids are selected from, but not limited to, serine or threonine.

More preferably, the monoaminodicarboxylic amino acids are selected from, but not limited to, aspartate or glutamate.

More preferably, the monoaminodicarboxylic amino acid amides are selected from, but not limited to, asparagine or glutamine.

More preferably, the diaminomonocarboxylic amino acids are selected from, but not limited to, lysine, arginine.

More preferably, the sulfur-containing amino acids are selected from, but not limited to, cysteine or methionine.

More preferably aromatic amino acids are selected from, but not limited to, phenylalanine, tyrosine, or tryptophan.

More preferably, heterocyclic amino acids are selected from, but not limited to, tryptophan, histidine, or proline.

In preferred non-limiting embodiments of the present invention, the pharmaceutical composition comprises an amino acid selected from polar uncharged, polar negatively charged, polar positively charged, or non-polar amino acids.

More preferably, polar uncharged amino acids are selected from, but not limited to, serine, threonine, cysteine, asparagine, glutamine, or tyrosine.

More preferably, polar negatively charged amino acids are selected from, but not limited to, aspartate or glutamate.

More preferably, polar positively charged amino acids are selected from, but not limited to, lysine, arginine, or histidine.

More preferably, non-polar amino acids are selected from, but not limited to, glycine, alanine, valine, isoleucine, leucine, proline, methionine, phenylalanine, or tryptophan. In preferred non-limiting embodiments of the present invention, the pharmaceutical composition comprises an amino acid selected from, but not limited to, glucogenic, ketogenic, or glucoketogenic amino acids.

More preferably, the glucogenic amino acids are selected from, but not limited to, glycine, alanine, valine, proline, serine, threonine, cysteine, methionine, aspartate, asparagine, glutamate, glutamine, arginine, or histidine.

More preferably, the ketogenic amino acids are selected from, but not limited to, leucine or lysine.

More preferably, the glucoketogenic amino acids are selected from, but not limited to, isoleucine, phenylalanine, tyrosine, or tryptophan.

One of the embodiments of the invention is a pharmaceutical composition, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 100 to 100,000 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 50,000 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 25,000 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 10,000 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 5000 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 4000 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 3700 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 110 to 3300 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 120 to 3000 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 130 to 2700 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 140 to 2400 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 150 to 2100 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 160 to 1800 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 170 to 1500 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 180 to 1200 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 190 to 900 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 200 to 600 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 200 to 400 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is 200 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is 300 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is 400 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is 600 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is 800 mg.

One of the embodiments of the invention is a pharmaceutical composition, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 1 to 90 wt.% of the total pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 5 to 90% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 10 to 90% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 15 to 90% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 20 to 90% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 25 to 90% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 30 to 90 wt.% of the total pharmaceutical composition. More preferably, the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 45 to 90 wt.% of the total pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 50 to 90% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 55 to 90% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 60 to 90 wt.% of the total pharmaceutical composition.

More preferably, the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 65 to 90 wt.% of the total pharmaceutical composition.

More preferably, the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 70 to 90 wt.% of the total pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 15 to 85% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 40 to 85 wt.% of the total pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 20 to 80% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 45 to 80 wt.% of the total pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 25 to 75% by weight of the entire pharmaceutical composition. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 50 to 75% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 30 to 70 wt.% of the total pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 35 to 70% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 40 to 70% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 45 to 70 wt.% of the total pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 50 to 70% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 55 to 70% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 55 to 65% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 85% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 80% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 75% by weight of the entire pharmaceutical composition. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 70% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 65% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 60% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 55% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 50% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 45% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 35% by weight of the entire pharmaceutical composition.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 25% by weight of the entire pharmaceutical composition.

One embodiment of the invention is a pharmaceutical composition in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 100,000 mg.

One embodiment of the invention is a pharmaceutical composition in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or hydrate or solvate of its pharmaceutically acceptable salt is from 10 to 100,000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 10,000 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 9000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 8000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 7000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 6500 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt a is from 10 to 6000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 5500 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 5000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 4500 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 4000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 3000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 2000 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 900 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 800 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 20 to 730 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 30 to 710 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 40 to 690 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 50 to 670 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 60 to 650 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 70 to 630 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 80 to 610 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 90 to 590 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 100 to 570 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 110 to 550 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 120 to 530 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 130 to 510 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 140 to 490 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 150 to 470 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 160 to 450 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 170 to 430 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 180 to 410 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 190 to 390 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 200 to 370 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 210 to 350 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 220 to 330 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 230 to 310 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 240 to 290 mg.

One of the embodiments of the invention is a pharmaceutical composition, in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 55.0 wt.% of the weight of the entire pharmaceutical composition.

One of the embodiments of the invention is a pharmaceutical composition in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or hydrate or solvate of its pharmaceutically acceptable salt is from 1 to 55.0 wt.% of the weight of the entire pharmaceutical composition .

One of the embodiments of the invention is a pharmaceutical composition, in which the amount of amino acid and/or its pharmaceutically acceptable salt is from 1 to 55.0 wt.% of the weight of the entire pharmaceutical composition.

One of the embodiments of the invention is a pharmaceutical composition, in which the amount of amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.5 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.5 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.0 wt.% of the weight of the entire pharmaceutical composition. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 53.5 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 53.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 52.5 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 52.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 51.5 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 51.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 50.5 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 50.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable acceptable salt is from 1.0 to 49.5 wt.% by weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 49.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 48.5 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 48.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 47.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 45.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 40.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 35.0 wt.% of the total pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 30.0 wt.% of the weight of the entire pharmaceutical composition. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 25.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 25.0 wt.% of the weight of the entire pharmaceutical composition. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 20.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 54.5 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 5.0 to 55 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 5.0 to 54.5 wt.% by weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10.0 to 54.5 wt.% by weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 15.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 20.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 25.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 30.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 35.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 45.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 50.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.

One embodiment of the invention is a pharmaceutical composition further comprising at least one pharmaceutically acceptable excipient.

More preferably, the pharmaceutically acceptable excipient is selected from the group including, but not limited to, a stabilizer, a buffering agent, or a pH adjusting agent. The pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 0 to 98% by weight of the entire pharmaceutical composition.

The pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 90% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 85% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 80% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 75% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 70% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 65% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 60% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 55% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 50% by weight of the entire pharmaceutical composition. More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 45% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 40% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 35% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 30% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 25% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 15% by weight of the total pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 10% by weight of the total pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 5% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of from 10% to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 15 to 98% by weight of the entire pharmaceutical composition. More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 20 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 25 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 30 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 35 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 40 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 45 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 50 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 55 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 60 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 65 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 70 to 98% by weight of the entire pharmaceutical composition. More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 75 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 80 to 98% by weight of the entire pharmaceutical composition.

More preferably, the pharmaceutically acceptable excipient in the pharmaceutical composition of the present invention is sodium hydroxide or hydrochloric acid.

More preferably, the sodium hydroxide of the present invention may be present in the pharmaceutical composition in an amount of 100 to 2000 mg.

One embodiment of the invention is a pharmaceutical composition exhibiting prophylactic and/or therapeutic antiviral activity, wherein the virus is an RNA-containing virus.

One of the embodiments of the invention is a pharmaceutical composition exhibiting prophylactic and/or therapeutic antiviral activity, where the virus is a virus whose genome is encoded by a single-stranded sense (+)-strand, as well as an antisense (-)-strand of RNA and which use viral RNA- dependent-RNA polymerase for its replication.

More preferably, the virus of the present invention is an influenza virus, coronavirus, picornavirus, arenavirus, flavivirus, bunyavirus, filovirus, phlebovirus, hantavirus, enterovirus, togavirus, calicivirus, respiratory syncytial virus, parainfluenza virus, rhinoviruses, metapneumoviruses, rotavirus, or noravirus.

More preferably, the virus of the present invention is a highly virulent or low virulent virus.

More preferably, the virus of the present invention is SARS-CoV, SARS-CoV-2, MERS-CoV or Influenza A, B, C.

More preferably, the influenza virus of the present invention is, but not limited to, influenza A virus, including strains A (H1N1), A (H1N1) pdm09, A (H1N2), A (H3N2), A (H2N2), A (H4N2) , A (H7N2), swine influenza type A, avian influenza type A, including highly pathogenic strains (including H5N1 and H7N9).

One embodiment of the invention is a pharmaceutical composition characterized in that it is a pharmaceutical composition in solid form. One embodiment of the invention is a pharmaceutical composition characterized in that it is a pharmaceutical composition in liquid form.

One embodiment of the invention is a pharmaceutical composition in which the amount of an amino acid and/or a pharmaceutically acceptable salt, solvate or hydrate thereof is from 0.1 to 20% w/v.

One embodiment of the invention is a pharmaceutical composition in which the amount of an amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or solvate or hydrate of its pharmaceutically acceptable salt is from 0.1 to 20 w/v%.

One embodiment of the invention is a pharmaceutical composition in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 0.1 to 20% w/v.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.2 to 17% w/v.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.3 to 15% w/v.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.4 to 13% w/v.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.5 to 10% w/v.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.6 to 7 w/v%.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.7 to 5 w/v%.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.8 to 5% w/v. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.9 to 4 w/v%.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 1.0 to 3% w/v.

One of the embodiments of the invention is a pharmaceutical composition, in which the amount of favipiravir and/or its pharmaceutically acceptable salt, MES or hydrate is from 0.1 to 20 w/v%.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.2 to 17% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.3 to 15% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.4 to 13% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.5 to 10% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.6 to 7% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.7 to 5% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.8 to 5% w/v. More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.9 to 4% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 1.0 to 3% w/v.

One of the embodiments of the invention is a pharmaceutical composition consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and an amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and / or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1.0: 1.2 respectively.

One of the embodiments of the invention is a pharmaceutical composition consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts and sodium hydroxide , where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1.0: 1 ,2 respectively.

One of the embodiments of the invention is a pharmaceutical composition consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, sodium hydroxide and injection water, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:1.2 respectively.

The problem is solved, and the claimed technical result is achieved by obtaining a medicinal product that exhibits prophylactic and/or therapeutic antiviral activity, containing pharmaceutical a composition of the present invention; and at least one pharmaceutically acceptable excipient.

The problem is solved, and the claimed technical result is achieved by obtaining a drug that exhibits prophylactic and/or therapeutic antiviral activity, containing a pharmaceutical composition of the present invention.

One of the embodiments of the invention is a medicinal product, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 100 to 4000 mg.

One of the embodiments of the invention is a medicinal product, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 100 to 2000 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 100 and 3900 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1900 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1800 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1700 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1600 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 110 to 1500 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 120 to 1400 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 130 and 1300 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 140 to 1200 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 150 and 1100 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 160 to 1000 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 170 to 900 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 180 to 800 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 190 to 700 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 200 and 600 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 3800 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 3700 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 110 to 3300 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 120 to 3000 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 130 and 2700 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 140 and 2400 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 150 and 2100 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 160 to 1800 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 170 to 1500 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 180 to 1200 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 190 to 900 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 200 to 400 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1900 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1800 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 120 to 1400 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 130 and 1300 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 180 to 800 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 190 to 700 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 200 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 300 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 400 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 600 mg.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 800 mg.

One of the embodiments of the invention is a drug, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 1 to 90 wt.% of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 5 to 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 10 to 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 15 to 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 20 to 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 25 to 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 30 to 90% by weight of the total drug. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 35 to 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 40 to 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 45 and 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 50 to 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 55 and 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 60 to 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 65 and 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 70 to 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 75 and 90% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 55 and 85% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 85% by weight of the total drug. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 80% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 75% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 70% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 65% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 60% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 55% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 50% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 45% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 35% by weight of the total drug.

More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 25% by weight of the total drug.

One embodiment of the invention is a medicinal product in which the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate is from 10 to 1000 mg.

One of the embodiments of the invention is a drug, in which the amount of amino acid and/or its pharmaceutically acceptable salt, solvate or a hydrate, solvate or hydrate of an amino acid and/or a pharmaceutically acceptable salt thereof is from 10 to 1000 mg.

One embodiment of the invention is a medicinal product in which the amount of an amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or solvate or hydrate of its pharmaceutically acceptable salt is from 10 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 950 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 900 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 850 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 800 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 750 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 710 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 700 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 650 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 600 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 550 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 500 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 450 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 400 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 350 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 300 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 250 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 200 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 150 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 20 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 50 to 1000 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 100 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 150 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 200 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 250 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 300 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 350 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 400 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 450 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 500 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 550 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 600 to 1000 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 650 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 700 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 750 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 800 to 1000 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 20 to 750 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 30 to 710 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 40 to 690 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 50 to 670 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 60 to 650 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 70 to 630 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 80 to 610 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 90 to 590 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 100 to 570 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 110 to 550 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 120 to 530 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 130 to 510 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 140 to 490 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 150 to 470 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 160 to 450 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 170 to 430 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 180 to 410 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 190 to 390 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 200 to 370 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 210 to 350 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 220 to 330 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 230 to 310 mg.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 240 to 290 mg.

One of the embodiments of the invention is a drug, in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 55.0 wt.% of the weight of the entire drug.

One of the embodiments of the invention is a drug, in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or hydrate or solvate of its pharmaceutically acceptable salt is from 1 to 55.0 wt.% of the mass of the entire drug .

One of the embodiments of the invention is a drug, in which the amount of amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 55.0 wt.% of the total drug.

One of the embodiments of the invention is a drug, in which the amount of amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.5 wt.% of the total drug. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.5 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 53.5% by weight of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 53.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 52.5 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 52.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 51.5 wt.% by weight of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 51.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 50.5 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 50.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 49.5 wt.% of the total drug. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 49.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 48.5 wt.% by weight of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 48.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 47.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 45.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 40.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 35.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 30.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 25.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 25.0% by weight of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 20.0 wt.% of the total drug. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 55.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 54.5 wt.% by weight of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 5.0 to 55.0 wt.% by weight of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 5.0 to 54.5 wt.% by weight of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10.0 to 54.5% by weight of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10.0 to 55.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 15.0 to 55.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 20.0 to 55.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 25.0 to 55.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 30.0 to 55.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 35.0 to 55.0 wt.% of the total drug. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 45.0 to 55.0 wt.% of the total drug.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 50.0 to 55.0 wt.% of the total drug.

One embodiment of the invention is a drug that is a solid drug.

More preferably, the solid drug of the present invention is, but not limited to, a tablet, capsule, pellet, sachet, dragee, powder, or lyophilisate.

Lyophilization (lyophilization) is a process of removing a solvent from a frozen material by sublimation (sublimation) of solvent crystals under vacuum, i.e. converting it to vapor without going through the liquid phase. The drug in the form of a lyophilizate fully retains its pharmacological activity.

The removal of the solvent during freeze-drying is carried out mainly by sublimation. Sublimation is the removal of a solvent from a frozen object without the formation of a liquid phase, it is carried out under vacuum or much less often in an inert gas. The freezing step is one of the determining steps for obtaining a quality drug in the form of a lyophilisate.

The dissolution of favipiravir or its pharmaceutically acceptable salts, hydrates or solvates in an aqueous solution of the solvates or hydrates of amino acids specified in the application and / or their pharmaceutically acceptable salts allows to obtain transparent, stable solutions with a concentration of favipiravir or its pharmaceutically acceptable salts, hydrates or solvates, without being limited to the specified , 10-150 mg/ml. The obtained solutions of favipiravir or its pharmaceutically acceptable salts, hydrates or solvates can be subjected to freeze drying to obtain the corresponding solid lyophilisates, which provide the best stability of the drug components during storage. Lyophilizates can be reconstituted into stable solutions with a favipiravir concentration of 10-150 mg/ml.

The auxiliary excipients used in freeze-dried medicinal preparations of the present invention include: solvents, solubilizers (EDTA, a-cyclodextrin, etc.), fillers (mannitol, glycine, glucose, sucrose, lactose, etc.), preservatives (benzyl alcohol, ethyl and methyl parahydroxybenzoate, etc.), pH regulators (buffer solutions, sodium chloride hydroxide, hydrochloric acid), stabilizers, cryoprotectants (dextran, gelatin, hydroxyethyl starch, etc.), tween, poloxamers.

In the form of lyophilisates according to the present invention, both individual medicinal substances and their mixtures with excipients can be presented.

The lyophilizate may be presented in the form of two or more components, in which favipiravir or its pharmaceutically acceptable salts, hydrates or solvates are packaged separately from other components. For example, the first component, eg in unit dosage form, eg sachet, vial or container, may contain favipiravir. The second component, for example, a unit dosage form, for example, a sachet (packaged form) or vial containing an amino acid.

At present, the problems of static electricity generation upon contact or impact of particles of dry components of lyophilized substances are known. A charge of static electricity occurs during any movement of the powder in the manufacture of compositions, during grinding, pouring, shaking. In addition, during the production and storage of solid dosage forms, adhesion of particles of drug components is often observed, which in turn negatively affects its therapeutic activity. When developing a drug in the form of a powder, it is also a problem to obtain a powder with relatively high flowability and low hygroscopicity.

The inventors have unexpectedly found that when using at least one amino acid and/or its pharmaceutically acceptable salt, or solvates, or hydrates of amino acids and/or their pharmaceutically acceptable salts in a solid dosage form containing favipiravir or its pharmaceutically acceptable salt, hydrate or solvate avoids all the disadvantages mentioned above.

One embodiment of the invention is a drug in liquid form.

One of the embodiments of the invention is a medicinal product, in which the amount of amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate is from 0.1 to 20 w/v%.

One embodiment of the invention is a medicinal product in which the amount of an amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or solvate or hydrate of its pharmaceutically acceptable salt is from 0.1 to 20 w/v%. One of the embodiments of the invention is a medicinal product, in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 0.1 to 20 w/v%.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.2 to 17 w/v%.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.3 to 15 w/v%.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.4 to 13 w/v%.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.5 to 10% w/v.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.6 to 7 w/v%.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.7 to 5 w/v%.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.8 to 5 w/v%.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.9 to 4 w/v%.

More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 1.0 to 3 w/v%.

One of the embodiments of the invention is a drug, in which the amount of favipiravir and/or its pharmaceutically acceptable salt, solvate or hydrate is from 0.1 to 20 w/v%. One of the embodiments of the invention is a drug, in which the amount of favipiravir and/or its pharmaceutically acceptable salt, solvate or hydrate is from 0.1 to 20 w/v%.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.2 to 17% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.3 to 15% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.4 to 13% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.5 to 10% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.6 to 7% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.7 to 5% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.8 to 5% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.9 to 4% w/v.

More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 1.0 to 3% w/v.

One of the embodiments of the invention is a medicinal product, which is a concentrate.

One of the embodiments of the invention is a medicinal product, which is a concentrate, in which the concentration of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 10 to 150 mg/ml. More preferably, the concentration of favipiravir in the concentrate of the present invention is from 10 to 140 mg/ml.

More preferably, the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 130 mg/ml.

More preferably, the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is between 10 and 120 mg/ml.

More preferably, the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 110 mg/ml.

More preferably, the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 100 mg/ml.

More preferably, the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 90 mg/ml.

More preferably, the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 80 mg/ml.

More preferably, the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 70 mg/ml.

More preferably, the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 60 mg/ml.

More preferably, the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is 10 to 50 mg/ml.

More preferably, the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 40 mg/ml.

More preferably, the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is 10 to 30 mg/ml. More preferably, the concentrate of the present invention has a pH of 6.5 to 8.5.

More preferably, the concentrate of the present invention has a pH of 7.0 to 7.5.

The concentrate of the present invention, also obtained by reconstitution of the lyophilisate, is in turn diluted to a solution suitable for injection or infusion into the patient. The volume of aqueous material used for reconstitution is dictated by the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the final pharmaceutical composition. Reconstitution using a smaller volume of reductant than the prelyophilization volume results in a composition that is more concentrated than before lyophilization.

One embodiment of the invention is a drug that is a parenteral drug.

Parenteral drug administration is a way of introducing drugs into the body, in which they bypass the gastrointestinal tract, in contrast to the oral route of drug administration. Parenteral medicinal products are sterile preparations intended for administration by injection, infusion, inhalation or implantation into the human or animal body. These include solutions, emulsions, suspensions, aerosols, powders and tablets for the preparation of solutions and implantation, powders for inhalation, lyophilized preparations for the preparation of dosage forms administered parenterally (subcutaneously, intramuscularly, intravenously, intraarterially, into various cavities).

Parenteral routes of administration include administration into tissues (intradermally, subcutaneously, intramuscularly, intraosseously), into vessels (intravenously, intraarterially, into lymphatic vessels), into cavities (into the pleural, abdominal, cardiac and articular cavities), into the subarachnoid space, as well as inhalation , intranasal and subconjunctival administration.

More preferably, the parenteral drug of the present invention is, but not limited to, an infusion solution, an injection solution, an inhalation drug, including an aerosol, spray, or powder.

More preferably, the parenteral drug of the present invention is an infusion solution. More preferably, the parenteral drug of the present invention is an injectable solution.

More preferably, the parenteral drug of the present invention is an inhalation drug.

One of the embodiments of the invention is a drug, which is a drug for topical administration.

Local administration of drugs refers to the application of a drug to mucous membranes (including ophthalmic, nasal, rectal, vaginal application, application to the gums, oral mucosa, etc.), as well as the introduction into the external auditory canal.

More preferably, the topical drug of the present invention is an ophthalmic, nasal, and rectal drug.

One embodiment of the invention is a drug that is a drug for rectal administration.

More preferably, the rectal drug of the present invention is, but not limited to, suppositories or capsules.

One embodiment of the invention is a medicament wherein the pharmaceutically acceptable excipients are selected from the group including, but not limited to, excipients, stabilizers, solubilizers, solvents, humectants, lubricants, lubricants, thickeners, sweeteners, fragrances, fragrances, fungicides, sustained release regulators, co-solvents, diluents, fillers, emulsifiers, preservatives, antioxidants, buffering agents, cryoprotectants, pH adjusting agents, isotonicity or corrective agents.

More preferably, the solvent of the present invention is, but is not limited to, saline, injection water, pyrogen-free water, distilled water, Ringer's solution, Hartman's solution, or glucose solution.

The pharmaceutically acceptable excipient of the present invention may be present in the drug in an amount of 0 to 98% by weight of the total drug.

The pharmaceutically acceptable excipient of the present invention may be present in the drug in an amount of 1 to 98% by weight of the total drug. More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 95 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 90 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 85 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 80 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 75 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 70 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 65 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 60 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 55 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 50 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 45 wt.% by weight of the total drug. More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 40 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 35 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 30 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 25 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the drug in an amount of 1 to 20% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 15 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the drug in an amount of 1 to 10% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 10 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 15 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 20 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 25 to 98 wt.% by weight of the total drug. More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 30 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 35 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 40 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 45 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 50 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 55 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 60 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 65 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 70 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 75 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 80 to 98 wt.% by weight of the total drug. More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 85 to 98 wt.% by weight of the total drug.

More preferably, the pharmaceutically acceptable excipient in the medicament of the present invention is, but is not limited to, sodium hydroxide or hydrochloric acid.

More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 5 to 200 mg.

More preferably, the sodium hydroxide of the present invention may be present in the drug in an amount of 10 to 200 mg.

More preferably, the sodium hydroxide of the present invention may be present in the drug in an amount of 10 to 190 mg.

More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 15 to 180 mg.

More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 20 to 170 mg.

More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 25 to 160 mg.

More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 30 to 150 mg.

More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 35 to 140 mg.

More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 40 to 130 mg.

More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 45 to 120 mg.

More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 50 to 110 mg.

More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 55 to 100 mg.

More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 60 to 90 mg.

More preferably, the sodium hydroxide of the present invention may be present in the drug in an amount of 65 to 80 mg. More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 50 to 150 mg.

One of the embodiments of the present invention is a medicinal product consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and at least one amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, and sodium hydroxide, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to an amino acid and / or its pharmaceutically acceptable salt, hydrate or solvate, and / or hydrate or solvate of its pharmaceutically acceptable salt is 1, 0:0, 1-1.0: 1.2 respectively.

One of the embodiments of the present invention is a medicinal product consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and at least one amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, sodium hydroxide and injection water, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid and / or its pharmaceutically acceptable salt, hydrate or solvate, and / or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1.0: 1.2 respectively.

One embodiment of the invention is a drug exhibiting prophylactic and/or therapeutic antiviral activity, wherein the virus is an RNA-containing virus.

One of the embodiments of the invention is a drug exhibiting prophylactic and/or therapeutic antiviral activity, where the virus is a virus whose genome is encoded by a single-stranded sense (+)-strand, as well as an antisense (-)-strand of RNA and which use viral RNA- dependent-RNA polymerase for its replication.

More preferably, the virus of the present invention is a highly virulent or low virulent virus. More preferably, the virus of the present invention is SARS-CoV, SARS-CoV-2, MERS-CoV or Influenza A, B, C.

Medicines of the present invention are used in human treatment, including the course.

The duration of the course, the daily dose, as well as the dosage form are determined by the task, the complexity of the disease and the individual characteristics of the patient and can be adjusted during therapy.

The duration of the prophylactic course can be from four days to four weeks and include, but is not limited to, one to five doses per day, which corresponds to 100-2000 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form).

One of the options for performing therapy is the following dosing regimen: 1600 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) 2 times on the 1st day of therapy, then 800 mg 2 times a day in within 10 days.

One of the options for performing therapy is the following dosing regimen: 1600 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) 2 times on the 1st day of therapy, then 600 mg 2 times a day in within 10 days.

One of the options for performing therapy is the following dosing regimen: 1800 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) 2 times on the 1st day of therapy, then 800 mg 2 times a day in within 10 days.

Dosages may be changed depending on the individual characteristics of the patient (including age and body weight).

In the case of parenteral administration, for the administration of a single dose of 1600 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form), according to the present invention, 4 x 10 ml vials or 2 x 20 ml vials of the concentrate are used according to the present invention. favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) (concentration 40 mg favipiravir / ml) according to of the present invention, for the introduction of 800 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form), use 2 vials of 10 ml or 1 vial of 20 ml of favipiravir concentrate or its pharmaceutically acceptable salt, hydrate or solvate ( in terms of favipiravir in free form) (concentration 40 mg favipiravir / ml).

One dose (volume equal to, but not limited to, 4 ml) of a parenteral solution with a concentration of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) 30-100 mg/ml, preferably 50 mg/ml. The introduction is carried out intravenously or intramuscularly.

In the case of parenteral administration, if the drug of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof is in the form of a powder (including a lyophilisate) for the preparation of a parenteral solution of the present invention, to administer a dosage of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof ( in terms of favipiravir in free form) 1600 mg should be used, but not limited to 4 vials of the drug of the present invention, 400 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) in each or 2 vial of 800 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) in each. To administer a dosage of favipiravir in the amount of 800 mg, it is necessary to use, but not limited to, 2 vials of the drug, 400 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) in each or 1 vial of 800 mg of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof (in terms of free form favipiravir) in each.

In the case of oral administration, for the administration of a single dose of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) in an amount of 1600 mg, 4 tablets of 400 mg of favipiravir or its pharmaceutically acceptable salt can be used, without limitation, hydrate or solvate (in terms of favipiravir in free form) (or 8 tablets of 200 mg of favipiravir) according to the present invention, for the administration of a single dosage of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) in an amount 800 mg, 2 favipiravir tablets (or 4 favipiravir 200 mg tablets) of the present invention can be used. The duration of the therapeutic course can be from one to four weeks and include taking from two to ten dosage forms per day, which corresponds to 400-4000 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form).

The problem is solved, and the claimed technical result is achieved through the use of the pharmaceutical composition of the present invention to obtain a drug that exhibits prophylactic and/or therapeutic antiviral activity.

The problem is solved, and the claimed technical result is achieved through the use of the pharmaceutical composition of the present invention to obtain a drug for the treatment and/or prevention of viral infections.

The problem is solved, and the claimed technical result is achieved through the use of a pharmaceutical composition or drug for the treatment and/or prevention of viral infections.

More preferably, the viral infection to be treated and/or prevented by the pharmaceutical composition or medicament of the present invention is an RNA-containing virus.

More preferably, the viral infection for the treatment and/or prevention of which the pharmaceutical composition or medicament of the present invention is used is a virus whose genome is encoded by a single-stranded sense (+)-strand as well as an antisense (-)-strand RNA and which use the viral RNA-dependent-RNA polymerase for its replication.

More preferably, the viral infection to be treated and/or prevented by the pharmaceutical composition or medicament of the present invention is influenza virus, coronavirus, picornavirus, arenavirus, flavivirus, bunyavirus, filovirus, phlebovirus, hantavirus, enterovirus, togavirus, calicivirus, respiratory -syncytial virus, parainfluenza virus, rhinoviruses, metapneumoviruses, rotavirus or noravirus.

More preferably, the influenza virus of the present invention is, but not limited to, influenza A virus, including strains A (H1N1), A (H1N1) pdm09, A (H1N2), A (H3N2), A (H2N2), A (H4N2), A (H7N2), swine influenza type A, avian influenza type A, including highly pathogenic strains (including H5N1 and H7N9).

The following are examples of the invention, which illustrate the invention, but do not cover all possible options for its implementation and do not limit the invention.

A person skilled in the art understands that other particular embodiments of the invention are also possible, including other dosage forms of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and an amino acid and/or its pharmaceutically acceptable salts, or a solvate, or a hydrate of an amino acid and/or its pharmaceutically acceptable salts in accordance with the present invention, not described in these examples.

EXAMPLES

Example 1. Preparation of a pharmaceutical composition of favipiravir with amino acids in the form of a solution.

1.1. Pharmaceutical compositions of favipiravir with hydrates of amino acids or their salts

The compositions listed in the table. 1 was obtained as follows. Previously, 50% of the calculated amount of favipiravir powder was mixed in a separate container with the calculated amount of amino acid hydrate powder (or its salt). Water for injection was placed in a container for preparing solutions and heated to 60-70°C, then it was alkalized, and pre-mixed powders of favipiravir with hydrates of amino acids or their salts were added to the resulting solution with stirring. Stirring was continued until complete dissolution of the components. The remaining amount of favipiravir was added to the resulting solution and stirring was continued at a temperature of 60-70°C until a transparent pharmaceutical composition was obtained in the form of a solution. Next, the pH of the solution was measured, and, if necessary, its value was corrected by adding a solution of sodium hydroxide or hydrochloric acid. When the required pH value was reached, the solution was adjusted with water for injection to a predetermined volume and filtered through a membrane filter, the filtrate was poured into a container and hermetically sealed.

Pharmaceutical compositions of favipiravir with other hydrates and/or solvates of amino acids and/or their pharmaceutically acceptable salts were prepared in a similar manner. Table 1. Compositions of pharmaceutical compositions of favipiravir with amino acid hydrates or their salts in the form of solutions.

1.2. Pharmaceutical compositions of favipiravir with amino acids in free form

Previously, 50% of the calculated amount of favipiravir powder was mixed in a separate container with the calculated amount of lysine powder. IN a container for preparing solutions was placed with water for injection and heated to 60-70 ° C, then it was alkalized and pre-mixed powders of favipiravir with lysine were added to the resulting solution with stirring. Stirring was continued until complete dissolution of the components. The remaining amount of favipiravir was added to the resulting solution and stirring was continued at a temperature of 60-70°C until a transparent pharmaceutical composition was obtained in the form of a solution. Next, the pH of the solution was measured, and, if necessary, its value was corrected by adding a solution of sodium hydroxide or hydrochloric acid. When the required pH value was reached, the solution was adjusted with water for injection to a predetermined volume and filtered through a membrane filter, the filtrate was poured into a container and hermetically sealed.

Pharmaceutical compositions of favipiravir with other amino acids and/or their pharmaceutically acceptable salts were prepared in a similar manner.

Also, the authors obtained and studied the compositions of favipiravir with various compounds of a basic nature, other than amino acids.

Compositions of favipiravir (total volume 50 ml) with sodium hydroxide solutions of various concentrations were prepared as follows. Water for injection was placed in a container for preparing solutions and heated to 60-70°C, then the calculated amount of sodium hydroxide solution was added with continuous stirring. The calculated amount of favipiravir was added to the resulting solution with stirring. Stirring was continued until complete dissolution of the components. Next, the solution was adjusted with water for injection to a predetermined volume and filtered through a membrane filter, the filtrate was poured into a container and hermetically sealed. Some of the results are presented in Table 2.

Table 2. Compositions of pharmaceutical compositions of favipiravir with sodium hydroxide solutions.

Composition 16 was a turbid solution with multiple inclusions of suspension. After 3 days of storage in the resulting solutions (compositions 14-16), the formation of a white cloudy precipitate was observed at the bottom of the vial. These solutions were filtered. After 4 days of storage, the solutions became cloudy, a pronounced suspension formed. In the compositions 18-19 on the next day of storage after shaking, single hairy inclusions could be seen. Two days later, a pronounced suspension formed in solutions 18–19.

Example 2. Preparation of favipiravir drugs with amino acids in the form of a lyophilisate and a concentrate.

Prepared in example 1 solutions of favipiravir with amino acids after filtration was poured into 10 ml vials and placed in a freeze dryer. First, the solutions were frozen to a temperature of minus 40°C for 2 hours. Then dried in vacuum for 1 hour at a temperature of 15-20°C. At the final stage, the temperature was raised to 30-40°C and the powder was dried for 4 hours. The vial was then hermetically sealed.

As a result, a vial of lyophilizate was obtained, adding 10 ml of water for injection into which a solution suitable for injection was formed with a favipiravir concentration of 25-100 mg/ml.

Solution recovery. The calculated amount of saline was slowly added to the vial of the obtained lyophilisate along the inner wall. The vial was vigorously shaken for about 30 seconds until the drug was completely dissolved. In the case of incomplete dissolution of the drug, stirring was repeated. Received a clear liquid drug favipiravir.

Lyophilizates and concentrates of favipiravir with other amino acids and/or their pharmaceutically acceptable salts, hydrates or solvates and/or hydrates or solvates of their pharmaceutically acceptable salts were prepared in a similar manner.

Studies of the resulting solutions unexpectedly showed that the recovery of solutions from lyophilisates containing hydrates of amino acids and/or their pharmaceutically acceptable salts occurred somewhat faster than with free amino acids.

Example 3 Study of the therapeutic effect of favipiravir salts with amino acids against the influenza virus.

The experiment was carried out on 85 adult mice. The animals were kept under standard vivarium conditions and received sterile rodent food and sterile water.

Modeling of viral infection in mice was carried out by intranasal administration of the calculated number of viral units of the highly pathogenic H3N2 avian influenza virus during anesthesia. During the experiment, the condition of the animals was recorded every day (changes in weight and clinical symptoms: fever, mucous secretions, activity level, breathing). Animals were randomly divided into seventeen groups of 5 individuals.

Injected drugs:

Dosage 100 mg favipiravir + 10 mg amino acid hydrate or salt

1st group: favipiravir drug: lysine hydrate;

2nd group: favipiravir preparation: asparagine sodium salt hydrate;

group 3: favipiravir: proline hydrate;

4th group: favipiravir preparation: histidine hydrate;

Dosage 100 mg favipiravir + 120 mg amino acid hydrate or salt

group 5: favipiravir: lysine hydrate;

6th group: favipiravir preparation: asparagine sodium salt hydrate;

group 7: favipiravir: proline hydrate;

8th group: favipiravir preparation: histidine hydrate;

Dosage 1200 mg favipiravir + 120 mg amino acid hydrate or salt

9th group: favipiravir preparation: lysine hydrate;

10th group: favipiravir preparation: asparagine sodium salt hydrate;

11th group: favipiravir preparation: proline hydrate;

group 12: favipiravir: histidine hydrate;

Dosage 1200 mg favipiravir + 750 mg amino acid hydrate or salt

13th group: favipiravir preparation: lysine hydrate;

14th group: favipiravir preparation: asparagine sodium salt hydrate;

group 15: favipiravir: proline hydrate;

16th group: favipiravir preparation: histidine hydrate; Control groups

17th group: physical. solution (placebo);

All dosages are per person.

Treatment was started 20 hours after infection. The drugs were administered intravenously into the tail vein as a solution twice a day. Similarly, the fourth group received physical. solution as an injection twice a day. The experiment was carried out for 5 days. Daily during the experiment, the virus titer was analyzed in the nasal lavage of individuals. Virus titers were determined using the standard plaque formation method [Stroganova, I.Ya. Use in cell culture virology: method, indications / I.Ya. Stroganova, A. A. Trukhonenko; Krasnoyar. state agrarian un-t. - Krasnoyarsk, 2013. - 48 p.].

Nasal lavage virus titers were assessed daily throughout the experiment. The average results are presented in the graphs (Fig. 1-4).

Studies have shown a decrease in viral load in nasal lavage in groups of mice treated with favipiravir compositions with amino acids, compared with the control group. These results confirm the high antiviral activity of favipiravir compositions with amino acids.

Example 4. Study of the antiviral activity of favipiravir compositions with amino acids against the SARS-CoV-2 virus.

The antiviral activity of the compositions of favipiravir with the amino acids of the compositions listed in table. 3 against the SARS-CoV-2 virus was carried out on a permanent culture of African green monkey kidney cells. Hank's saline medium containing fetal calf serum was used as a growth and maintenance medium.

The study used nine formulations of favipiravir with amino acids with different qualitative and quantitative characteristics (compositions 1a-3a, 5a-7a, 9a-11a) and three formulations containing an amount of favipiravir identical to its group (composition 4a: the amount of favipiravir identical to formulations 1a-3a; formulation 8a: identical amount of favipiravir to formulations 5a-7a, formulation 12a: identical amount of favipiravir to formulations 9a-11a) (Table 3). Saline solution (composition 13a) was used as a control.

To infect 13 samples of African green monkey kidney cells with the SARS-CoV-2 virus, the growth medium was removed from the cell monolayer and the SARS-CoV-2 virus was introduced, incubated for 60 min at a temperature of 37 ± 0.5°C, then the inoculum was removed, washed, fresh medium containing the studied samples of compositions 1-13, respectively, was introduced into the cell samples. The samples were incubated at a temperature of 37±0.5°C for 48 hours. The biological activity was assessed by titrating the resulting cell suspension according to the cytopathic effect of the virus 24 and 48 hours after infection. The research results are presented in table. 3.

The main criterion for evaluating the effectiveness of la-12a formulations in vitro was the coefficient of inhibition of the cytopathogenic effect of the virus (CI, %).

The inhibition coefficient (CI, %) was calculated by the formula:

KI \u003d ((Akontr - Aop) / Akontr) x 100%, where:

Аkontr — the biological activity of the virus, determined in cells without the introduction of the drug (using the control composition);

Aop is the biological activity of the virus, determined in cells with the introduction of the drug.

Table 3. Study of the antiviral activity of favipiravir compositions with amino acids against the SARS-CoV-2 virus.

Thus, the presented results of the experiment clearly demonstrate the antiviral activity of pharmaceutical compositions of favipiravir with various amino acids in mass ratios of 1.0:0, 1-1.0: 1.2. At the same time, these compositions exhibit a synergistic effect in relation to antiviral activity compared with favipiravir monotherapy in identical amounts.

Example 5 Study of the storage stability of favipiravir pharmaceutical compositions.

5.1. Study of the stability of pharmaceutical compositions of favipiravir with hydrates of amino acids or their salts during storage.

The authors investigated the stability during accelerated storage of the resulting solutions (example 1.1, compositions 1-13) in four indicators - transparency, the quantitative content of favipiravir. Transparency was determined visually, the quantitative content of favipiravir was determined by HPLC. Data on the stability of solutions of favipiravir are shown in table 4. Storage was carried out at a temperature of 40±2°C when exposed to light.

In accordance with GPM.1.1.0009.15, the “accelerated aging” method (storage at elevated temperature) is based on the dependence of the chemical reaction rate on temperature in accordance with the van’t Hoff rule: when the temperature rises by 10 ° C, the chemical reaction rate increases by 2-4 times. Testing the stability of the solutions was carried out by the method of accelerated aging at 40±2°C for 71 days, which corresponds to 3 years of storage under standard conditions (no more than 10°C).

The experiment was carried out on 3 series of each composition. The quantitative content of favipiravir was expressed in average values.

In table. 4 shows that after 71 days of storage under "accelerated aging" conditions, formulations 1-12 were stable and remained chemically pure. Composition 13 remained chemically pure for less than 28 days.

Table 4 Stability studies of favipiravir solutions with amino acids.

The conducted studies allow us to conclude that a change in the ratios relative to those stated in the present invention leads to a deterioration in the quality of the resulting solution. At the same time, additional studies were carried out on the stability of favipiravir formulations with amino acids in the free state. The results of the studies unexpectedly showed an improvement in the stability and safety of favipiravir formulations with hydrates of amino acids and/or their salts.

5.2. Study of the stability of a solid drug in the form of favipiravir lyophilisate with free amino acids during storage.

The stability of favipiravir drugs with amino acids in the form of lyophilisates obtained by the method described in example 1 was evaluated by the "accelerated aging" method according to the content of favipiravir and compared with the stability of lyophilisates containing only favipiravir.

Quantitative characteristics of drugs in the form of lyophilisates are presented in table 3.

In accordance with GPM.1.1.0009.15, the “accelerated aging” method (storage at elevated temperature) is based on the dependence of the chemical reaction rate on temperature in accordance with the Van’t Hoff rule: when the temperature rises by 10 ° C the rate of a chemical reaction increases by 2-4 times. Stability tests of lyophilizates were carried out by the method of accelerated aging at 40±2°C for 457 days, which corresponds to 5 years of storage under standard conditions (not more than 25°C). The experiment was carried out on 3 series of each drug. The quantitative content of favipiravir was expressed in average values.

The content of favipiravir was determined by HPLC using standards.

In table. 5 shows that after 457 days of storage under "accelerated aging" conditions, the favipiravir amino acid lyophilisate formulations of the present invention (formulations 1a-3a; 5a-7a; 9a-11a) had increased stability and remained chemically pure. Medicines of compositions 4a, 8a, 12a remained chemically pure for less than 150 days; by the end of the experiment, the content of the active substance decreased by more than 3.5-5%.

Table 5 Stability study of favipiravir lyophilisates with amino acids.

Thus, the favipiravir amino acid lyophilisate formulations of the present invention (formulations 1a-3a; 5a-7a; 9a-11a) have a statistically significant improved storage stability compared to formulations (4a; 8a; 12a).

Claims

CLAIM

1. Pharmaceutical composition exhibiting prophylactic and/or therapeutic antiviral activity, containing in therapeutically effective amounts favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and at least one amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/ or a hydrate or solvate of its pharmaceutically acceptable salt, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate and/or hydrate or solvate of its pharmaceutically acceptable salt is 1.0 :0, 1-1, 0:1, 2 respectively.

2. Pharmaceutical composition according to and. 1, in which the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1; 1.0:0.15; 1.0:0.2; 1.0:0.25; 1, 0:0.3; 1.0:0.35; 1.0:0.4; 1.0:0.45; 1.0:0.5; 1.0:0.55; 1.0:0.6; 1.0:0.65; 1.0:0.7; 1.0:0.75; 1.0:0.8; 1.0:0.85; 1.0:0.9; 1.0:0.95; 1.0:1.0; 1.0: 1.05; 1.0: 1.1; 1.0:1.15 or 1.0:1.2.

3. Pharmaceutical composition according to and. 1, in which favipiravir is in the free base form.

4. Pharmaceutical composition according to and. 1, in which the hydrate of the amino acid and/or its pharmaceutically acceptable salt is a monohydrate, dihydrate or trihydrate.

5. Pharmaceutical composition according to and. 1, in which at least one amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or a solvate of a pharmaceutically acceptable salt thereof in the L- or D-configuration, or as a racemate.

6. Pharmaceutical composition according to and. 1, wherein at least one amino acid and/or a pharmaceutically acceptable salt, hydrate or solvate thereof and/or a hydrate or solvate thereof of a pharmaceutically acceptable salt is a hydrate or solvate of an a-amino acid and/or a pharmaceutically acceptable salt thereof.

7. Pharmaceutical composition according to and. 1, in which the amino acid has an isoelectric point of 2 to 10.

95

8. Pharmaceutical composition according to and. 7, in which the amino acid has an isoelectric point of 3 to 10.

9. Pharmaceutical composition according to and. 8, in which the amino acid has an isoelectric point of 7 to 10.

10. Pharmaceutical composition according to and. 1, wherein the amino acid is a proteinogenic amino acid.

11. Pharmaceutical composition according to and. 10, wherein the proteinogenic amino acid is a non-essential or non-essential amino acid.

12. Pharmaceutical composition according to and. 10, wherein the proteinogenic amino acid is a standard or non-standard amino acid.

13. Pharmaceutical composition according to and. 12, wherein the proteinogenic standard amino acid is L-lysine, L-histidine, L-arginine, L-methionine, L-glutamine, L-isoleucine, L-leucine, L-alanine, glycine, L-threonine, L-tryptophan , L-proline, L-valine, L-cysteine, L-phenylalanine, L-asparagine, L-serine, L-tyrosine, L-glutamic acid or L-aspartic acid.

14. Pharmaceutical composition according to and. 12, wherein the proteinogenic non-standard amino acid is L-selenocysteine, L-pyrrolysine.

15. Pharmaceutical composition according to and. 1, in which the amino acid is N-acetyl-O-alanine, N-acetyl glycine, hydroxylysine, hydroxyproline, norarginine, homoarginine, homolysine, 2,7-diaminoheptanoic acid, 2,4-diaminobutyric acid, 3-aminoalanine, dehydroalanine, hydroxyproline, cystine, ornithine, sarcosine, or acetylcysteine.

16. Pharmaceutical composition according to and. 1, in which the amino acid is an imino acid, aliphatic, aromatic or heterocyclic amino acid.

17. Pharmaceutical composition according to and. 1, wherein the amino acid is a monoaminodicarboxylic amino acid amide, monoaminomonocarboxylic, oxymonoaminocarboxylic, monoaminodicarboxylic, diaminomonocarboxylic, or sulfur containing amino acid.

18. Pharmaceutical composition according to and. 1, wherein the amino acid is a polar uncharged, polar negatively charged, polar positively charged, or non-polar amino acid.

19. Pharmaceutical composition according to and. 1, wherein the amino acid is a glucogenic, ketogenic, or glucoketogenic amino acid.

96

20. Pharmaceutical composition according to and. 1, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 1 to 90 wt.%, from 5 to 90 wt.%, from 10 to 90 wt.%, from 15 to 90 wt.%, from 20 up to 90 wt.%, from 25 to 90 wt.%, from 30 to 90 wt.%, from 35 to 90 wt.%, from 40 to 90 wt.%, from 45 to 90 wt.%, from 50 to 90 wt.% or from 55 to 90 wt.% by weight of the entire pharmaceutical composition.

21. Pharmaceutical composition according to claim 1, in which the amount of amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is from 1 to 55 wt.%, from 5 to 55 wt. %, 10 to 55 wt.%, 15 to 55 wt.%, 20 to 55 wt.%, 25 to 55 wt.%, 30 to 55 wt.%, 35 to 55 wt.%, from 40 to 55 wt.%, from 45 to 55 wt.% or from 50 to 55 wt.% of the weight of the entire pharmaceutical composition.

22. Pharmaceutical composition according to and. 21, in which the amount of amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is from 1.0 to 54.5 wt.%, from 1.0 to 54.0 wt .%, from 1.0 to 53.5 wt.%, from 1.0 to 53.0 wt.%, from 1.0 to 52.5 wt.%, from 1.0 to 52.0 wt.% , from 1.0 to 51.5 wt.%, from 1.0 to 51.0 wt.%, from 1.0 to 50.5 wt.%, from 1.0 to 50.0 wt.%, from 1.0 to 49.5 wt.%, from 1.0 to 48.0 wt.%, from 1.0 to 47.0 wt.%, from 1.0 to 45.0 wt.%, from 1, 0 to 40.0 wt%, 1.0 to 35.0 wt%, 1.0 to 30.0 wt%, 1.0 to 25.0 wt%, or 1.0 to 20.0 wt.% by weight of the entire pharmaceutical composition.

23. Pharmaceutical composition according to claim 1, characterized in that it additionally contains at least one pharmaceutically acceptable excipient.

24. Pharmaceutical composition according to and. 23, characterized in that the pharmaceutically acceptable excipient is selected from the group consisting of a stabilizer, a buffering agent, or a pH adjusting agent.

25. Pharmaceutical composition according to and. 23, in which the amount of pharmaceutically acceptable excipients is from 1 to 98 wt.% of the weight of the entire pharmaceutical composition.

26. Pharmaceutical composition according to and. 25, in which the amount of pharmaceutically acceptable excipients is from 1 to 50 wt.% of the weight of the entire pharmaceutical composition.

27. Pharmaceutical composition according to and. 26, in which the amount of pharmaceutically acceptable excipients is from 1 to 25 wt.% by weight of the entire pharmaceutical composition.

97

28. Pharmaceutical composition according to and. 27, in which the amount of pharmaceutically acceptable excipients is from 1 to 15 wt.% of the total pharmaceutical composition.

29. Pharmaceutical composition according to and. 1, characterized in that it is a pharmaceutical composition in solid form.

30. Pharmaceutical composition according to and. 1, characterized in that it is a pharmaceutical composition in liquid form.

31. Pharmaceutical composition according to and. 1, consisting of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof and an amino acid or a pharmaceutically acceptable salt, hydrate or solvate thereof, and/or a hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, where the mass ratio of favipiravir or its pharmaceutically acceptable salt , hydrate or solvate to an amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1.0: 1.2, respectively.

32. Pharmaceutical composition according to and. 1, consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate and an amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and / or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts and sodium hydroxide, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to an amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:1, 2, respectively.

33. Pharmaceutical composition according to and. 1, consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and / or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, sodium hydroxide and injection water, where the mass ratio favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to an amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1.0:1.2, respectively.

34. A drug that exhibits prophylactic and/or therapeutic antiviral activity, containing a pharmaceutical composition according to pi. 1-33 and at least one pharmaceutically acceptable excipient.

98

35. The drug according to claim 34, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 100 to 2000 mg.

36. Medicinal product according to and. 35, wherein the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof is 100 to 1900 mg, 100 to 1800 mg, 100 to 1700 mg, 100 to 1600 mg, 110 to 1500 mg, 120 to 1400 mg , 130 to 1300 mg, 140 to 1200 mg, 150 to 1100 mg, 160 to 1000 mg, 170 to 900 mg, 180 to 800 mg, 190 to 700 mg, or 200 to 600 mg.

37. Medicine according to and. 35, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is 200 mg.

38. Medicine according to and. 35, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is 300 mg

39. Medicine according to and. 35, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is 400 mg.

40. Medicinal product according to and. 35, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is 600 mg.

41. Medicine according to and. 35, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is 800 mg.

42. Medicine according to and. 34, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 1 to 90 wt.%, from 5 to 90 wt.%, from 10 to 90 wt.%, from 15 to 90 wt.%, from 20 up to 90 wt.%, from 25 to 90 wt.%, from 30 to 90 wt.%, from 35 to 90 wt.%, from 40 to 90 wt.%, from 45 to 90 wt.%, from 50 to 90 wt.%, from 55 to 90 wt.%, from 60 to 90 wt.%, from 65 to 90 wt.%, from 70 to 90 wt.% or from 75 to 90 wt.% of the total medicinal product.

43. Medicine according to and. 34, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 1 to 85 wt.%, from 1 to 80 wt.%, from 1 to 75 wt.%, from 1 to 70 wt.%, from 1 up to 65 wt.%, from 1 to 60 wt.%, from 1 to 55 wt.%, from 1 to 50 wt.% of the total drug weight.

44. Medicine according to and. 34, in which the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate and/or hydrate or solvate of its pharmaceutically acceptable salt is from 10 to 1000 mg.

45. Medicinal product according to and. 44, in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is from 10 to 900 mg, from 10 to 800 mg, from 20 to 750 mg, from 30 to 710 mg, 40 to 690 mg, 50 to 670 mg, 60 to 650 mg, 70 to 630 mg, 80 to 610 mg, 90 to 590 mg, 100 to 570 mg, 110 to 550 mg, 120 to 530 mg, from 130

99 up to 510 mg, 140 to 490 mg, 150 to 470 mg, 160 to 450 mg, 170 to 430 mg, 180 to 410 mg, 190 to 390 mg, 200 to 370 mg, 210 to 350 mg, 220 to 330 mg, 230 to 310 mg, or 240 to 290 mg.

46. Medicinal product according to and. 34, in which the amount of amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is from 1 to 55 wt.%, from 5 to 55 wt.%, from 10 to 55 wt. %, 15 to 55 wt.%, 20 to 55 wt.%, 25 to 55 wt.%, 30 to 55 wt.%, 35 to 55 wt.%, 40 to 55 wt.% , from 45 to 55 wt.% or from 50 to 55 wt.% of the total drug.

47. Medicine according to and. 34, in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is from 1.0 to 54.5 wt.%, from 1.0 to 54.0 wt .%, from 1.0 to 53.5 wt.%, from 1.0 to 53.0 wt.%, from 1.0 to 52.5 wt.%, from 1.0 to 52.0 wt.% , from 1.0 to 51.5 wt.%, from 1.0 to 51.0 wt.%, from 1.0 to 50.5 wt.%, from 1.0 to 50.0 wt.%, from 1.0 to 49.5 wt.%, from 1.0 to 48.0 wt.%, from 1.0 to 47.0 wt.%, from 1.0 to 45.0 wt.%, from 1, 0 to 40.0 wt%, 1.0 to 35.0 wt%, 1.0 to 30.0 wt%, 1.0 to 25.0 wt%, or 1.0 to 20.0 wt.% of the total drug weight.

48. Medicine according to and. 34, characterized in that it is a solid drug.

49. Medicine according to and. 48, characterized in that it is a lyophilisate.

50. Medicinal product according to and. 34, characterized in that it is a liquid drug.

51. Medicine according to and. 34, characterized in that it is a concentrate.

52. Medicinal product according to and. 51, characterized in that the concentrate has a pH of 6.5 to 8.5.

53. Medicine according to and. 52, characterized in that the concentrate has a pH of 7.0 to 7.5.

54. Medicinal product according to and. 51, in which the concentration of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the concentrate is from 10 to 150 mg/ml.

55. Medicinal product according to and. 54, in which the concentration of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the concentrate is from 10 to 140 mg/ml, from 10 to 130 mg/ml, from 10 to 120 mg/ml, from 10 to 110 mg/ml, from 10 to

100 100 mg/ml, 10 to 90 mg/ml, 10 to 80 mg/ml, 10 to 70 mg/ml, 10 to 60 mg/ml, 10 to 50 mg/ml, 10 to 40 mg/ml ml or from 10 to 30 mg/ml.

56. Medicine according to and. 34, characterized in that it is a parenteral drug.

57. The drug according to claim 56, characterized in that it is an infusion solution.

58. The drug according to claim 56, characterized in that it is an injection solution.

59. The drug according to claim 34, characterized in that the pharmaceutically acceptable excipients are selected from the group including excipients, stabilizers, solubilizers, solvents, moisturizers, lubricants, lubricants, thickeners, sweeteners, flavors, flavors, fungicides, delayed delivery regulators , cosolvents, diluents, fillers, emulsifiers, preservatives, antioxidants, buffering agents, cryoprotectants, pH adjusting agents, isotonicity or corrective agents.

60. Medicinal product according to and. 59 wherein the pharmaceutically acceptable excipient is sodium hydroxide or hydrochloric acid.

61. Medicinal product according to and. 60, in which the amount of sodium hydroxide or hydrochloric acid is from 10 to 200 mg.

62. Medicinal product according to and. 61, wherein the amount of sodium hydroxide or hydrochloric acid is 10 to 190 mg, 15 to 180 mg, 20 to 170 mg, 25 to 160 mg, 30 to 150 mg, 35 to 140 mg, 40 to 130 mg, 45 to 120 mg, 50 to 110 mg, 55 to 100 mg, 60 to 90 mg, or 65 to 80 mg.

63. Medicinal product according to and. 59, characterized in that the solvent is saline, injection water, pyrogen-free water, distilled water, Ringer's solution, Hartman's solution, or glucose solution.

64. Medicinal product according to and. 60, consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and at least one amino acid and / or its pharmaceutically acceptable salt, hydrate or solvate, and / or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, and hydroxide sodium, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or

101 hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1.0:1.2, respectively.

65. Medicinal product according to pi. 60, 63 consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and at least one amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate and/or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, hydroxide sodium and injection water, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1 -1, 0:1, 2 respectively.

66. Use of a pharmaceutical composition according to pi. 1-33 to obtain a medicinal product for the treatment and/or prevention of viral infections.

67. Application according to and. 66, where the viral infection is caused by an RNA-containing virus.

68. Application according to and. 67, where the viral infection is a virus whose genome is encoded by a single-stranded sense (+)-strand as well as an antisense (-)-strand RNA and which use the viral RNA-dependent RNA polymerase for its replication.

69. Application according to and. 67, wherein the virus is influenza virus, coronavirus, picornavirus, arenavirus, flavivirus, bunyavirus, filovirus, phlebovirus, hantavirus, enterovirus, togavirus, calicivirus, respiratory syncytial virus, parainfluenza virus, rhinoviruses, metapneumoviruses, rotavirus, or noravirus.

70. Application according to and. 67, where the virus is a highly virulent or low virulent virus.

71. Application according to and. 69, where the virus is SARS-CoV, SARS-CoV-2, MERS-CoV or Influenza A, B C.

102