IT202000016816A1 - COMPOSITIONS INCLUDING ANTIOXIDANT COMPOUNDS AS AID IN THE TREATMENT OF VIRAL INFECTIONS - Google Patents
COMPOSITIONS INCLUDING ANTIOXIDANT COMPOUNDS AS AID IN THE TREATMENT OF VIRAL INFECTIONS Download PDFInfo
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- IT202000016816A1 IT202000016816A1 IT102020000016816A IT202000016816A IT202000016816A1 IT 202000016816 A1 IT202000016816 A1 IT 202000016816A1 IT 102020000016816 A IT102020000016816 A IT 102020000016816A IT 202000016816 A IT202000016816 A IT 202000016816A IT 202000016816 A1 IT202000016816 A1 IT 202000016816A1
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- erdosteine
- treatment
- use according
- aid
- viral infections
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- 208000036142 Viral infection Diseases 0.000 title description 2
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- 239000000203 mixture Substances 0.000 title description 2
- 229960003262 erdosteine Drugs 0.000 claims description 23
- QGFORSXNKQLDNO-UHFFFAOYSA-N erdosteine Chemical compound OC(=O)CSCC(=O)NC1CCSC1=O QGFORSXNKQLDNO-UHFFFAOYSA-N 0.000 claims description 23
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- 229960004099 azithromycin Drugs 0.000 description 1
- MQTOSJVFKKJCRP-BICOPXKESA-N azithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)N(C)C[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 MQTOSJVFKKJCRP-BICOPXKESA-N 0.000 description 1
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- 239000003246 corticosteroid Substances 0.000 description 1
- 229960001334 corticosteroids Drugs 0.000 description 1
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- 229960003957 dexamethasone Drugs 0.000 description 1
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 description 1
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- XXSMGPRMXLTPCZ-UHFFFAOYSA-N hydroxychloroquine Chemical compound ClC1=CC=C2C(NC(C)CCCN(CCO)CC)=CC=NC2=C1 XXSMGPRMXLTPCZ-UHFFFAOYSA-N 0.000 description 1
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- RWWYLEGWBNMMLJ-MEUHYHILSA-N remdesivir Drugs C([C@@H]1[C@H]([C@@H](O)[C@@](C#N)(O1)C=1N2N=CN=C(N)C2=CC=1)O)OP(=O)(N[C@@H](C)C(=O)OCC(CC)CC)OC1=CC=CC=C1 RWWYLEGWBNMMLJ-MEUHYHILSA-N 0.000 description 1
- RWWYLEGWBNMMLJ-YSOARWBDSA-N remdesivir Chemical compound NC1=NC=NN2C1=CC=C2[C@]1([C@@H]([C@@H]([C@H](O1)CO[P@](=O)(OC1=CC=CC=C1)N[C@H](C(=O)OCC(CC)CC)C)O)O)C#N RWWYLEGWBNMMLJ-YSOARWBDSA-N 0.000 description 1
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- 229960000329 ribavirin Drugs 0.000 description 1
- HZCAHMRRMINHDJ-DBRKOABJSA-N ribavirin Natural products O[C@@H]1[C@H](O)[C@@H](CO)O[C@H]1N1N=CN=C1 HZCAHMRRMINHDJ-DBRKOABJSA-N 0.000 description 1
- NCDNCNXCDXHOMX-XGKFQTDJSA-N ritonavir Chemical compound N([C@@H](C(C)C)C(=O)N[C@H](C[C@H](O)[C@H](CC=1C=CC=CC=1)NC(=O)OCC=1SC=NC=1)CC=1C=CC=CC=1)C(=O)N(C)CC1=CSC(C(C)C)=N1 NCDNCNXCDXHOMX-XGKFQTDJSA-N 0.000 description 1
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Classifications
-
- 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
- A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
- A61K31/381—Heterocyclic compounds having sulfur as a ring hetero atom having five-membered rings
-
- 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
Description
Descrizione del brevetto per invenzione industriale avente per titolo: Description of the patent for an industrial invention entitled:
?COMPOSIZIONI COMPRENDENTI COMPOSTI ANTIOSSIDANTI COME COADIUVANTI NEL TRATTAMENTO DI INFEZIONI VIRALI? ?COMPOSITIONS INCLUDING ANTIOXIDANT COMPOUNDS AS ADJUVANTS IN THE TREATMENT OF VIRAL INFECTIONS?
La presente invenzione ha per oggetto composizioni farmaceutiche comprendenti come principio attivo erdosteina per uso nel trattamento di pazienti affetti da infezioni respiratorie virali, in particolare infezioni da Coronavirus. The present invention relates to pharmaceutical compositions comprising erdosteine as the active ingredient for use in the treatment of patients affected by viral respiratory infections, in particular Coronavirus infections.
Stato della tecnica State of the art
Erdosteina (nome chimico: acido 2-[N-3-(2-oxotetraidro tieni)]acetamido-tioglicolico), descritto in FR 2,502,153 e US 4,411,909, ? un farmaco con comprovata attivit? mucolitica, potenziatrice della terapia antibiotica, antinfiammatoria e antiossidante. Erdosteine (chemical name: 2-[N-3-(2-oxotetrahydro thien)]acetamido-thioglycolic acid), described in FR 2,502,153 and US 4,411,909, ? a drug with proven activity? mucolytic, enhancer of antibiotic, anti-inflammatory and antioxidant therapy.
Grazie alle sue propriet? farmacologiche, erdosteina trova indicazioni soprattutto nel trattamento delle affezioni sia croniche, sia acute che interessano le vie aeree superiori ed inferiori. In particolare, l'efficacia ? significativa nel diminuire i sintomi associati alla broncopneumopatia cronica ostruttiva, riducendo sia la frequenza, sia la durata delle esacerbazioni sintomatiche tipiche di questa malattia. L?impiego di erdosteina in associazione a beta?agonisti per il trattamento di broncopneumopatia cronica ostruttiva ? stato descritto in EP 1 857 106. Thanks to its properties pharmacological, erdosteine finds indications above all in the treatment of both chronic and acute diseases affecting the upper and lower airways. In particular, the effectiveness ? significant in decreasing the symptoms associated with chronic obstructive pulmonary disease, reducing both the frequency and the duration of symptomatic exacerbations typical of this disease. The use of erdosteine in combination with beta?agonists for the treatment of chronic obstructive pulmonary disease? been described in EP 1 857 106.
Erdosteina si presenta in forma di racemo ed ? somministrata per via orale. Forme polimorfe di erdosteina sono state descritte in EP 2 207 771, CN 106146456, CN 104983693. E? stato, inoltre, descritto l?uso di erdosteina per via iniettabile per il trattamento di intossicazioni da paracetamolo (EP 2 320 890). Erdosteine comes in the form of raceme and ? administered orally. Polymorphic forms of erdosteine have been described in EP 2 207 771, CN 106146456, CN 104983693. E? The use of injectable erdosteine for the treatment of paracetamol intoxications has also been described (EP 2 320 890).
Nel mese di Dicembre 2019, una serie di casi di polmonite di eziologia sconosciuta si ? manifestata in Cina, nella cittadina di Wuhan. In December 2019, a series of cases of pneumonia of unknown aetiology occurred. demonstrated in China, in the town of Wuhan.
L?analisi mediante sequenziamento di campioni del tratto respiratorio ha portato all?individuazione di un nuovo Coronavirus (SARS-CoV-2), la cui infezione ? stata denominata COVID-19. Analysis by sequencing of respiratory tract samples has led to the identification of a new Coronavirus (SARS-CoV-2), whose infection is ? been referred to as COVID-19.
COVID-19 ? caratterizzata da una sintomatologia di gravit? molto variabile, soprattutto a carico del sistema respiratorio: da sintomi di tipo influenzale (febbre, tosse, dolori osteoarticolari) fino a gravissime polmoniti interstiziali che possono portare il paziente ad una talvolta letale insufficienza respiratoria acuta da richiedere il trattamento in unit? di terapia intensiva. COVID-19 ? characterized by symptoms of gravity very variable, especially in relation to the respiratory system: from flu-like symptoms (fever, cough, osteoarticular pain) to very serious interstitial pneumonia which can lead the patient to sometimes lethal acute respiratory failure requiring treatment in the respiratory unit. of intensive care.
E? stata, inoltre, osservata una serie di complicanze dell?infezione da SARS-CoV-2 a carico del sistema cardio-circolatorio (infarti, ictus, miocarditi, vasculiti, trombosi), dei reni e del sistema nervoso centrale. In attesa di un vaccino efficace, sono stati utilizzati diversi approcci terapeutici, rivolti da un lato a cercare di contrastare direttamente l?infezione e la replicazione virale con farmaci quali remdesivir, ritonavir/lopinavir, faviparivir, ribavirina, idrossiclorochina, azitromicina e dall?altro a contenere i danni conseguenti alla violenta risposta immunitaria provocata dal virus. Per questo ultimo scopo sono stati utilizzati anticorpi anti-citochine, corticosteroidi (in particolare desametasone) ed eparine. L?impiego di mucolitici non ? stato finora proposto nel trattamento di patologie dovute a virus respiratori. AND? Furthermore, a series of complications of SARS-CoV-2 infection affecting the cardio-circulatory system (heart attacks, strokes, myocarditis, vasculitis, thrombosis), the kidneys and the central nervous system have been observed. While waiting for an effective vaccine, various therapeutic approaches have been used, aimed on the one hand at trying to directly combat the infection and viral replication with drugs such as remdesivir, ritonavir/lopinavir, faviparivir, ribavirin, hydroxychloroquine, azithromycin and on the other to contain the damage resulting from the violent immune response caused by the virus. For this latter purpose, anti-cytokine antibodies, corticosteroids (in particular dexamethasone) and heparins have been used. The use of mucolytics is not been proposed so far in the treatment of pathologies due to respiratory viruses.
Descrizione dell?invenzione Description of the invention
Si ? ora trovato che la somministrazione di erdosteina in pazienti affetti da COVID-19 consente un miglioramento della sintomatologia e la riduzione o la prevenzione delle complicazioni dell?infezione. Yes ? now found that the administration of erdosteine in patients with COVID-19 allows for an improvement in symptoms and the reduction or prevention of complications of the infection.
L?invenzione ha pertanto per oggetto erdosteina per uso nel trattamento di infezioni da virus respiratori, in particolari da SARS-CoV-2. The invention therefore relates to erdosteine for use in the treatment of infections by respiratory viruses, in particular by SARS-CoV-2.
I dosaggi giornalieri sono i medesimi di quelli gi? impiegati per le indicazioni note di erdosteina (solitamente 300 mg per via orale, due volte al giorno). The daily dosages are the same as those already? used for known indications of erdosteine (usually 300 mg orally, twice daily).
Erdosteina pu? essere usata in qualsiasi forma nota (sali, forme polimorfe, enantiomeri) eventualmente anche in associazione con altri farmaci gi? considerati per il trattamento di COVID-19. Erdosteine can be used in any known form (salts, polymorphic forms, enantiomers) possibly also in combination with other drugs already? considered for the treatment of COVID-19.
Le forme di dosaggio preferite sono capsule o granulati solubili in acqua. Il trattamento con erdosteina pu? avvenire in qualunque fase dell?infezione ed ? risultata particolarmente efficace come terapia di mantenimento nelle fasi di regressione e convalescenza della malattia. The preferred dosage forms are water soluble capsules or granules. Treatment with erdosteine can occur at any stage of? infection and ? proved to be particularly effective as maintenance therapy in the regression and convalescence phases of the disease.
L?effetto positivo di erdosteina ? stato evidenziato in una sperimentazione clinica effettuata su 20 pazienti con diagnosi di COVID-19 confermata da tampone e ricoverati in ospedale con un quadro clinico caratterizzato dai seguenti valori medi: The positive effect of erdosteine ? been highlighted in a clinical trial carried out on 20 patients with a diagnosis of COVID-19 confirmed by a swab and hospitalized with a clinical picture characterized by the following average values:
L?et? media dei pazienti, 17 uomini e 3 donne, era di 55 anni. L?et? mean of the patients, 17 men and 3 women, was 55 years.
Il trattamento ospedaliero ha previsto la somministrazione di farmaci antinfiammatori, antivirali, antibiotici, eparine, ventilazione con ossigeno (70% dei casi) e CPAP (continuous positive airway pressure) nel 50% dei casi. Hospital treatment involved the administration of anti-inflammatory drugs, antiviral drugs, antibiotics, heparins, oxygen ventilation (70% of cases) and CPAP (continuous positive airway pressure) in 50% of cases.
Dopo dimissione, ai pazienti era somministrata 1 capsula di erdosteina 300 mg per os due volte al giorno per 15 giorni come terapia di mantenimento. After discharge, patients were administered 1 capsule of erdosteine 300 mg orally twice daily for 15 days as maintenance therapy.
I risultati hanno dimostrato che i pazienti trattati con erdosteina presentano un sensibile miglioramento in termini di sintomatologia e qualit? di vita, con riduzione degli indici di infiammazione e scomparsa di astenia. The results have shown that patients treated with erdosteine show a significant improvement in terms of symptoms and quality of treatment. of life, with reduction of inflammation indices and disappearance of asthenia.
Bench? preliminari, i risultati ottenuti rendono plausibile un effetto terapeutico di erdosteina che risulta in grado di migliorare il quadro clinico complessivo dei pazienti affetti da infezioni da Coronavirus e di prevenire complicanze a carico non solo del sistema respiratorio. Bench? preliminary, the results obtained make plausible a therapeutic effect of erdosteine which is able to improve the overall clinical picture of patients affected by Coronavirus infections and to prevent complications affecting not only the respiratory system.
Claims (7)
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102020000016816A IT202000016816A1 (en) | 2020-07-10 | 2020-07-10 | COMPOSITIONS INCLUDING ANTIOXIDANT COMPOUNDS AS AID IN THE TREATMENT OF VIRAL INFECTIONS |
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| Application Number | Priority Date | Filing Date | Title |
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| IT102020000016816A IT202000016816A1 (en) | 2020-07-10 | 2020-07-10 | COMPOSITIONS INCLUDING ANTIOXIDANT COMPOUNDS AS AID IN THE TREATMENT OF VIRAL INFECTIONS |
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| IT202000016816A1 true IT202000016816A1 (en) | 2022-01-10 |
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|---|---|---|---|---|
| FR2502153A1 (en) | 1981-03-19 | 1982-09-24 | Rech Pharmaceutiq Medicale | (2-OXO-3-TETRAHYDROTHIENYLCARBAMOYL) -ALKYLTHIO) ACETIC ACIDS, THEIR SALTS AND ESTERS, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME |
| EP0974353A2 (en) * | 1998-06-05 | 2000-01-26 | Edmond Pharma S.R.L. | The use of homocysteine derivatives for the preparation of medicaments inhibiting bacterial adhesiveness |
| EP1857106A1 (en) | 2006-05-16 | 2007-11-21 | Edmond Pharma S.R.L. | Combinations of erdosteine and beta-2 agonists for treating COPD |
| EP2207771A2 (en) | 2007-11-16 | 2010-07-21 | Edmond Pharma S.R.L. | Polymorphs of enantiopure erdosteine |
| EP2320890A2 (en) | 2008-09-08 | 2011-05-18 | Rafifarm S.R.L. | Indication of use of erdosteine as antidote in a large number of intoxications, especially in heavy metals like lead or mercury, and paracetamol |
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| CN106146456A (en) | 2015-04-30 | 2016-11-23 | 苗怡文 | A kind of method of the erdosteine compound preparing treatment respiratory inflammation |
| EP3505164A1 (en) * | 2017-12-31 | 2019-07-03 | Abdi Ibrahim Ilac Sanayi ve Ticaret A.S. | An effervescent composition comprising erdosteine |
| WO2020139240A1 (en) * | 2018-12-28 | 2020-07-02 | Atatürk Üni̇versi̇tesi̇ Bi̇li̇msel Araştirma Projeleri̇ Bi̇ri̇mi̇ | Pharmaceutics composition providing extended release comprising ibuprofen, pseudoephedrine and erdosteine |
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2020
- 2020-07-10 IT IT102020000016816A patent/IT202000016816A1/en unknown
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2502153A1 (en) | 1981-03-19 | 1982-09-24 | Rech Pharmaceutiq Medicale | (2-OXO-3-TETRAHYDROTHIENYLCARBAMOYL) -ALKYLTHIO) ACETIC ACIDS, THEIR SALTS AND ESTERS, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME |
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| EP0974353A2 (en) * | 1998-06-05 | 2000-01-26 | Edmond Pharma S.R.L. | The use of homocysteine derivatives for the preparation of medicaments inhibiting bacterial adhesiveness |
| EP1857106A1 (en) | 2006-05-16 | 2007-11-21 | Edmond Pharma S.R.L. | Combinations of erdosteine and beta-2 agonists for treating COPD |
| EP2207771A2 (en) | 2007-11-16 | 2010-07-21 | Edmond Pharma S.R.L. | Polymorphs of enantiopure erdosteine |
| EP2320890A2 (en) | 2008-09-08 | 2011-05-18 | Rafifarm S.R.L. | Indication of use of erdosteine as antidote in a large number of intoxications, especially in heavy metals like lead or mercury, and paracetamol |
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