PHARMACEUTICAL COMPOSITION CONTAINING CLOMIPRAMINE AND PREPARATION METHOD THEREFOR

• Main Authors: PARK, HYUN-JUNG, KWAK, SEONG-SHIN, LEE, BONG-SANG, KIM, JUNG-HWA, LEE, DONG-JIN, JEON, HONG RYEOL
• Format: Patent
• Language: English; French; Korean
• Published: 09.07.2015
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

The present invention provides a pharmaceutical preparation comprising clomipramine having improved stability and a preparation method therefor, wherein the pharmaceutical preparation comprises clomipramine or pharmaceutically acceptable salts thereof (preferably, clomipramine hydrochloride) as a first active ingredient and sildenafil or pharmaceutically acceptable salts thereof (preferably, sildenafil citrate) as a second active ingredient. Specifically, the present invention provides a pharmaceutical preparation comprising both active ingredients, and prepared by using a wet granulation method, the pharmaceutical preparation comprising clomipramine having improved stability, and a preparation method therefor. La présente invention concerne une préparation pharmaceutique comprenant de la clomipramine qui possède une stabilité améliorée, et son procédé de préparation. Ladite préparation pharmaceutique comprend de la clomipramine ou ses sels pharmaceutiquement acceptables (de préférence du chlorhydrate de clomipramine) en tant que premier principe actif, et du sildénafil ou ses sels pharmaceutiquement acceptables (de préférence du citrate de sildénafil) en tant que second principe actif. Plus spécifiquement, la présente invention concerne : une préparation pharmaceutique comprenant les deux principes actifs et préparée au moyen d'un procédé de granulation humide, ladite préparation pharmaceutique comprenant de la clomipramine qui présente une stabilité améliorée ; et son procédé de préparation. 제1유효성분으로 클로미프라민 또는 이의 약학적으로 허용 가능한 염(바람직하게는 클로미프라민염산염)을 포함하고, 제2유효성분으로 실데나필 또는 이의 약학적으로 허용 가능한 염(바람직하게는 실데나필구연산염)을 포함하는 약학 제제에 있어서, 본 발명은 클로미프라민의 안정성이 개선된 약학 제제 및 이러한 약학 제제를 제조하는 방법을 제공한다. 특히, 본 발명은 상기 두 가지 유효성분을 포함하고, 습식과립법을 이용하여 제조되는 약학 제제에 있어서, 클로미프라민의 안정성이 개선된 약학 제제 및 이러한 약학 제제를 제조하는 방법을 제공한다.