IT202000022411A1 - FORMULATION OF DRUGS OF THE CLASS OF ANTIBIOTICS FOR THE PREVENTION AND TREATMENT OF INFECTIONS DUE TO PHAGIC FORMS OF CORONAVIRUS - Google Patents

FORMULATION OF DRUGS OF THE CLASS OF ANTIBIOTICS FOR THE PREVENTION AND TREATMENT OF INFECTIONS DUE TO PHAGIC FORMS OF CORONAVIRUS Download PDF

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IT202000022411A1
IT202000022411A1 IT102020000022411A IT202000022411A IT202000022411A1 IT 202000022411 A1 IT202000022411 A1 IT 202000022411A1 IT 102020000022411 A IT102020000022411 A IT 102020000022411A IT 202000022411 A IT202000022411 A IT 202000022411A IT 202000022411 A1 IT202000022411 A1 IT 202000022411A1
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formulation
coronavirus
prevention
treatment
pharmaceutical composition
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IT102020000022411A
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Carlo Brogna
Simone Cristoni
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Carlo Brogna
Simone Cristoni
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A61K31/424—Oxazoles condensed with heterocyclic ring systems, e.g. clavulanic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/14—Peptides containing saccharide radicals; Derivatives thereof, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pulmonology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Description

?Formulato di farmaci della classe degli antibiotici per la prevenzione e la cura di infezioni da forme fagiche dei coronavirus? ?Drug formulation of the antibiotic class for the prevention and treatment of infections by phage forms of the coronavirus?

La presente invenzione ? inerente ad un formulato di farmaci della classe degli antibiotici per la prevenzione e la cura di infezioni da forme fagiche dei coronavirus. In particolare, l?invenzione concerne un formulato di farmaci da somministrare per la prevenzione e la cura di malattie causate da forme fagiche di coronavirus, come ad esempio SARS-CoV-2 che causa COVID-19. Il formulato della presente invenzione permette di debellare la forma fagica dei coronavirus, come SARS-CoV-2, ed evitare l?accumulo nel tempo di tale forma virale a livello del tratto oro-fecale. The present invention ? relating to a formulation of drugs of the class of antibiotics for the prevention and treatment of infections by phage forms of the coronavirus. In particular, the invention concerns a drug formulation to be administered for the prevention and treatment of diseases caused by phage forms of coronavirus, such as for example SARS-CoV-2 which causes COVID-19. The formulation of the present invention allows to eradicate the phage form of coronaviruses, such as SARS-CoV-2, and to avoid the accumulation over time of this viral form at the level of the fecal-oral tract.

E? noto che il virus SARS-CoV-2 ha causato un pandemia globale di grave entit?. Il virus ha determinato una pandemia ed ha interessato tutto il pianeta. Numerosi laboratori a livello globale sono attualmente impegnati nella ricerca di un vaccino e di terapie profilattiche volte alla prevenzione mirata del contagio. AND? It is known that the SARS-CoV-2 virus has caused a serious global pandemic. The virus has caused a pandemic and has affected the whole planet. Numerous laboratories globally are currently engaged in the search for a vaccine and prophylactic therapies aimed at the targeted prevention of the infection.

Gli studi in essere puntano soprattutto sull?attivazione del sistema immunitario volta a contrastare direttamente il virus e la sua attivit?. Alla luce di quanto sopra esposto, appare evidente la necessit? di poter disporre di terapie efficaci contro le malattie causate da coronavirus, in particolare contro Covid-19.In questo contesto viene ad inserirsi la soluzione secondo la presente invenzione, che si propone di fornire una cura efficace contro le malattie causate da coronavirus e, in particolare, contro Covid-19. Current studies focus above all on the activation of the immune system aimed at directly countering the virus and its activity. In the light of the foregoing, the need is evident to be able to have effective therapies against the diseases caused by coronaviruses, in particular against Covid-19. The solution according to the present invention fits into this context, which aims to provide an effective cure against the diseases caused by coronaviruses and, in particular, against Covid-19.

I Richiedenti hanno sorprendentemente trovato che il virus SARS-CoV-2 ed i virus appartenenti alla famiglia dei coronavirus possano integrarsi, non solo con l?organismo umano, ma anche con organismi procariotici presenti nel corpo umano. I Richiedenti hanno quindi messo a punto una formulazione di quattro antibiotici efficace contro le infezioni da coronavirus. Come mostrato nell?esempio sperimentale, la formulazione di quattro antibiotici (metronidazolo, amoxicillina, vancomicina, azitromicina) secondo la presente invenzione ? in grado di eliminare le forme fagiche del virus che si replicano grazie alla combinazione del virus stesso con organismi procarioti (batteri, ecc) all?interno dell?organismo umano ed in diverse aree del medesimo (es: tratto-oro-fecale). Ci? consente di prevenire l?accumulo del virus all?interno dell?organismo ospite e di prevenire la diffusione del virus ed il contagio. Il formulato secondo l?invenzione ? in grado di eliminare le forme fagiche del virus SARS-CoV-2 con organismi eucarioti appartenenti ad esempio al mondo batterico. Il formulato potr? essere in forma solida per uso orale o in forma liquida per uso intramuscolare o endovenoso. The Applicants have surprisingly found that the SARS-CoV-2 virus and the viruses belonging to the coronavirus family can integrate, not only with the human organism, but also with prokaryotic organisms present in the human body. The Applicants have therefore developed a formulation of four antibiotics effective against coronavirus infections. As shown in the experimental example, the formulation of four antibiotics (metronidazole, amoxicillin, vancomycin, azithromycin) according to the present invention ? able to eliminate the phage forms of the virus which replicate thanks to the combination of the virus itself with prokaryotic organisms (bacteria, etc.) inside the human organism and in different areas of the same (eg: fecal-oral tract). There? it allows to prevent the accumulation of the virus inside the host organism and to prevent the spread of the virus and the infection. The formulation according to the invention ? able to eliminate the phage forms of the SARS-CoV-2 virus with eukaryotic organisms belonging for example to the bacterial world. The formulation can be in solid form for oral use or in liquid form for intramuscular or intravenous use.

Forma pertanto oggetto specifico della presente invenzione il formulato o composizione farmaceutica e i suoi usi come rivendicato. Therefore, the specific object of the present invention is the pharmaceutical formulation or composition and its uses as claimed.

Secondo una forma di realizzazione, il formulato secondo la presente invenzione pu? essere in forma solida. According to one embodiment, the formulation according to the present invention can be in solid form.

Secondo la presente invenzione, il formulato pu? essere composto dai seguenti farmaci e relative quantit?: According to the present invention, the formulation can be composed of the following drugs and their quantities?:

- Metronidazolo aggiunto ad una quantit? compresa tra 0 mg e 700 mg; - Metronidazole added to a quantity? between 0 mg and 700 mg;

- Amoxicillina aggiunto ad una concentrazione compresa tra 0 mg e 1575 mg; - Amoxicillin added at a concentration between 0 mg and 1575 mg;

- Vancomicina aggiunto to ad una concentrazione compresa tra 0 mg e 3150 mg; - Vancomycin added to a concentration between 0 mg and 3150 mg;

- Azitromicina aggiunto ad una quantit? compresa tra 0 mg e 500 mg. - Azithromycin added to a quantity? between 0 mg and 500 mg.

Le quantit? riportate sono somministrabili sia in forma solida, liquida, gassosa ed aerosol insieme agli eccipienti classici previsti per l?uso farmacologico. Pi? precisamente, la formulazione dell?invenzione pu? comprendere i seguenti farmaci: The quantities? reported can be administered both in solid, liquid, gaseous and aerosol form together with the classic excipients foreseen for pharmacological use. Pi? precisely, the formulation of the invention can? include the following drugs:

- Metronidazolo aggiunto ad una quantit? compresa tra 33 mg e 700 mg; - Metronidazole added to a quantity? between 33 mg and 700 mg;

- Amoxicillina aggiunto ad una concentrazione compresa tra 0 mg e 1575 mg; - Amoxicillin added at a concentration between 0 mg and 1575 mg;

- Vancomicina aggiunto to ad una concentrazione compresa tra 0 mg e 2800 mg; - Vancomycin added to a concentration between 0 mg and 2800 mg;

- Azitromicina aggiunto ad una quantit? compresa tra 0 mg e 420 mg. - Azithromycin added to a quantity? between 0 mg and 420 mg.

Le quantit? riportate sono somministrabili sia in forma solida, liquida, gassosa ed aerosol insieme agli eccipienti classici previsti per l?uso farmacologico. Ancora pi? precisamente, la formulazione secondo la presente invenzione pu? comprendere i seguenti elementi farmaci: The quantities? reported can be administered both in solid, liquid, gaseous and aerosol form together with the classic excipients foreseen for pharmacological use. even more precisely, the formulation according to the present invention can? include the following drug elements:

- Metronidazolo aggiunto ad una quantit? compresa tra 50 mg e 665 mg - Metronidazole added to a quantity? between 50 mg and 665 mg

- Amoxicillina aggiunto ad una concentrazione compresa tra 0 mg e 1000 mg - Amoxicillin added at a concentration between 0 mg and 1000 mg

- Vancomicina aggiunto to ad una concentrazione compresa tra 0 mg e 2100 mg - Vancomycin added to at a concentration between 0 mg and 2100 mg

- Azitromicina aggiunto ad una quantit? compresa tra 0 mg e 350 mg. - Azithromycin added to a quantity? between 0 mg and 350 mg.

Le quantit? riportate sono somministrabili sia in forma solida, liquida, gassosa ed aerosol insieme agli eccipienti classici previsti per l?uso farmacologico. L?invenzione verr? descritta nel seguito a titolo illustrativo, ma non limitativo, con particolare riferimento ad alcuni esempi illustrativi. The quantities? reported can be administered both in solid, liquid, gaseous and aerosol form together with the classic excipients foreseen for pharmacological use. The invention will come described below for illustrative, but non-limiting purposes, with particular reference to some illustrative examples.

ESEMPIO 1: Studio di efficacia degli antibiotici contro SARS-CoV-2 EXAMPLE 1: Antibiotic efficacy study against SARS-CoV-2

Attraverso un approccio di nuovo concetto ? stato documentato un aumento della replicazione virale (Sars-Cov2) nelle cellule procariotiche, attraverso terreni di coltura multipotenti. Through a new concept approach ? An increase in viral replication (Sars-Cov2) has been documented in prokaryotic cells, through multipotent culture media.

Le colture sono state divise in pozzetti e la carica di concentrazione virale ? stata determinata al tempo zero e al tempo massimo 30 gg. La carica virale ? stata monitorata con test specifici Luminex tecnology.( Dunbar SA. Clin. Chim. Acta Int. J. Clin. Chem., vol. Were the cultures divided into wells and the viral concentration load ? was determined at time zero and at the maximum time of 30 days. The viral load? been monitored with specific Luminex technology tests. (Dunbar SA. Clin. Chim. Acta Int. J. Clin. Chem., vol.

363, n. 1, pagg. 71?82, gen. 2006, doi: 10.1016/j.cccn.2005.06.023.). Ci? ? stato posto in evidenza con antibiogramma a 3 e 6 giorni per eliminare la piattaforma batterica che aiuta la replicazione virale (Tabella 1) in cui il valore 0 indica l?assenza della forma virale, mentre i numeri di valore maggiore sono direttamente proporzionali all?abbondanza del Virus. La tabella 1 mostra i dati Luminex relativi all?efficacia delle formulazioni testate su batteri in coltura. 363, no. 1, p. 71?82, Jan. 2006, doi: 10.1016/j.cccn.2005.06.023.). There? ? been highlighted with an antibiogram at 3 and 6 days to eliminate the bacterial platform that helps viral replication (Table 1) in which the value 0 indicates the absence of the viral form, while the numbers with higher values are directly proportional to the abundance of the Virus. Table 1 shows Luminex data on the efficacy of formulations tested on cultured bacteria.

Tabella 1 Table 1

Claims (7)

RIVENDICAZIONI 1. Composizione farmaceutica comprendente metronidazolo, amoxicillina, vancomicina e/o azitromicina, in combinazione con eccipienti, per l?uso nella prevenzione e nel trattamento di un?infezione da forme fagiche di un coronavirus, come SARS-CoV-2, all?interno dell?organismo umano e degli animali.1. Pharmaceutical composition comprising metronidazole, amoxicillin, vancomycin and/or azithromycin, in combination with excipients, for use in the prevention and treatment of an infection with phage forms of a coronavirus, such as SARS-CoV-2, within of the human body and animals. 2. Composizione farmaceutica secondo la rivendicazione 1, per l?uso secondo la rivendicazione 1, in cui la concentrazione di Metronidazolo ? compresa tra 0 mg e 700 mg, preferibilmente tra 33 mg e 700 mg, pi? preferibilmente tra 50 mg e 665 mg.2. Pharmaceutical composition according to claim 1, for use according to claim 1, wherein the Metronidazole concentration is ? between 0 mg and 700 mg, preferably between 33 mg and 700 mg, plus? preferably between 50 mg and 665 mg. 3. Composizione farmaceutica secondo una qualsiasi delle rivendicazioni 1-2, per l?uso secondo la rivendicazione 1, in cui la concentrazione di Amoxicillina ? compresa tra 0 mg e 1575 mg, preferibilmente tra 0 mg e 1000 mg.3. Pharmaceutical composition according to any one of claims 1-2, for the use according to claim 1, wherein the concentration of Amoxicillin is ? between 0 mg and 1575 mg, preferably between 0 mg and 1000 mg. 4. Composizione farmaceutica secondo una qualsiasi delle rivendicazioni 1-3, per l?uso secondo la rivendicazione 1, in cui la concentrazione di Vancomicina ? compresa tra 0 mg e 3150 mg, preferibilmente tra 0 mg e 2800 mg, pi? preferibilmente tra 0 mg e 2100 mg.4. Pharmaceutical composition according to any one of claims 1-3, for use according to claim 1, wherein the concentration of vancomycin is ? between 0 mg and 3150 mg, preferably between 0 mg and 2800 mg, more? preferably between 0 mg and 2100 mg. 5. Composizione farmaceutica secondo una qualsiasi delle rivendicazioni 1-4, per l?uso secondo la rivendicazione 1, in cui la concentrazione di azitromicina ? compresa tra 0 mg e 500 mg, preferibilmente tra 33 mg e 700 mg, pi? preferibilmente 0 mg e 350 mg.5. Pharmaceutical composition according to any one of claims 1-4, for use according to claim 1, wherein the concentration of azithromycin is ? between 0 mg and 500 mg, preferably between 33 mg and 700 mg, plus? preferably 0 mg and 350 mg. 6. Composizione farmaceutica secondo una qualsiasi delle rivendicazioni 1-5, per l?uso secondo la rivendicazione 1, in cui detta composizione ? in forma solida, liquida, gassosa o di aerosol.6. Pharmaceutical composition according to any one of claims 1-5, for the use according to claim 1, wherein said composition is in solid, liquid, gaseous or aerosol form. 7. Composizione farmaceutica secondo una qualsiasi delle rivendicazioni 1-6, per l?uso secondo la rivendicazione 1, in cui detta malattia ? Covid-19. 7. Pharmaceutical composition according to any one of claims 1-6, for use according to claim 1, wherein said disease is COVID-19.
IT102020000022411A 2020-09-23 2020-09-23 FORMULATION OF DRUGS OF THE CLASS OF ANTIBIOTICS FOR THE PREVENTION AND TREATMENT OF INFECTIONS DUE TO PHAGIC FORMS OF CORONAVIRUS IT202000022411A1 (en)

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Citations (3)

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RU2396074C1 (en) * 2009-02-11 2010-08-10 Государственное научное учреждение "Прикаспийский зональный научно-исследовательский ветеринарный институт" Российской академии сельскохозяйственных наук (ГНУ "Прикаспийский ЗНИВИ" Россельхозакадемии) Complex preparation for treating acute gastrointestinal disturbances in calves
CN111671762A (en) * 2020-01-30 2020-09-18 沈阳福洋医药科技有限公司 Application of acylated spiramycin in preparing medicine for treating coronavirus infection disease
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RU2396074C1 (en) * 2009-02-11 2010-08-10 Государственное научное учреждение "Прикаспийский зональный научно-исследовательский ветеринарный институт" Российской академии сельскохозяйственных наук (ГНУ "Прикаспийский ЗНИВИ" Россельхозакадемии) Complex preparation for treating acute gastrointestinal disturbances in calves
WO2020214716A1 (en) * 2019-04-17 2020-10-22 Gilead Sciences, Inc. 2-imino-5-oxo-imidazolidine inhibitors of hiv protease
CN111671762A (en) * 2020-01-30 2020-09-18 沈阳福洋医药科技有限公司 Application of acylated spiramycin in preparing medicine for treating coronavirus infection disease

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GHAREBAGHI REZA ET AL: "Metronidazole a Potential Novel Addition to the COVID-19 Treatment Regimen", ARCHIVES OF ACADEMIC EMERGENCY MEDICINE, vol. 8, 30 March 2020 (2020-03-30), pages 40, XP055806277, Retrieved from the Internet <URL:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7114714/pdf/aaem-8-e40.pdf> DOI: 10.2139/ssrn.3559020 *
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