STABLE ORAL FORMULATION CONTAINING 1-(3-CYANO-1-ISOPROPYL-INDOL-5-YL)PYRAZOLE-4-CARBOXYLIC ACID

The present invention relates to a stable oral formulation containing 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid or a pharmaceutically acceptable salt thereof as an API. Being characterized by the maintenance of stability even though containing no stabilizers as excipients, the sta...

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Bibliographic Details
Main Authors YUN, Duck Il, LEE, Sun, PARK, Junghong, YOO, Seok Cheol, SUN, Hyun Ji
Format Patent
LanguageEnglish
French
Korean
Published 09.06.2022
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Summary:The present invention relates to a stable oral formulation containing 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylic acid or a pharmaceutically acceptable salt thereof as an API. Being characterized by the maintenance of stability even though containing no stabilizers as excipients, the stable oral formulation according to the present invention contains an increased content of API in place of the inclusion of a stabilizer and as such, can be improved in terms of dose convenience. La présente invention concerne une formulation orale stable contenant de l'acide 1-(3-cyano-1-isopropyl-indol-5-yl)pyrazole-4-carboxylique ou un sel pharmaceutiquement acceptable de celui-ci en tant que principe actif pharmaceutique (API, pour "active pharmaceutical ingredient"). Étant caractérisée par le maintien de la stabilité même si elle ne contient pas de stabilisants comme excipients, la formulation orale stable selon la présente invention contient une teneur accrue en API à la place de l'inclusion d'un stabilisant et, en tant que tel, peut être améliorée en termes de commodité de dose. 본 발명은 1-(3-시아노-1-아이소프로필-인돌-5-일)피라졸-4-카르복실산 또는 이의 약학적으로 허용가능한 염을 API로 포함하는 안정한 경구용 제제에 관한 것이다. 본 발명에 따른 안정한 경구용 제제는 부형제로 안정화제를 포함하지 않더라도, 안정성이 유지된다는 특징을 가지고, 안정화제를 포함하지 않는 대신 증대된 API의 함유량을 가지므로, 복용편의성이 증대될 수 있다.
Bibliography:Application Number: WO2021KR17842