이토프리드염산염 정과 티로프라미드염산염 정의 용출시험법 개발 (Development of Dissolution Test for Itopride Hydrochloride Tablets and Tiropramide Hydrochloride Tablets)

서지정보

· 발행기관 : 대한약학회
· 수록지 정보 : 약 학 회 지 / 57권 / 3호 / 206 ~ 212페이지
· 저자명 : 김정현, 이종화, 최란, 최연희, 이종철, 안지혜, 이광문, 심영훈, 강신정, 사홍기, 최후균, 김인규

초록

Dissolution test has been performed to control drug quality and to predict in vivo drug release profile of soliddosage forms, so there's a drift towards setting dissolution test instead of disintegration test. However, some solid dosageforms in Korea Pharmaceutical Codex (KPC) are not established the dissolution test yet, so these monographs are necessaryto set the specification of dissolution test. In this study, we developed the specification and test method of dissolution testfor itopride hydrochloride tablets and tiropramide hydrochloride tablets which are not established the dissolution test yet.
According to the 「Manual for Guideline Application for Validation of Analytical Procedures」 and 「Guidelines on Specificationof Dissolution test for Oral dosage form」 of Korean Pharmacopoeia (KP), we validated and established each developmentmethod. Based on the preliminary dissolution profile, we set the dissolution condition(paddle apparatus, pH 1.2media, 50 rpm). For this condition, we performed the main dissolution test to determine the specification (45 min, 85%).
Finally, we validated each analytical method by specificity, linearity, accuracy and precision. These developed methods willbe included the next supplement of KPC and also contributed to the quality control of medicines.

영어초록

Dissolution test has been performed to control drug quality and to predict in vivo drug release profile of soliddosage forms, so there's a drift towards setting dissolution test instead of disintegration test. However, some solid dosageforms in Korea Pharmaceutical Codex (KPC) are not established the dissolution test yet, so these monographs are necessaryto set the specification of dissolution test. In this study, we developed the specification and test method of dissolution testfor itopride hydrochloride tablets and tiropramide hydrochloride tablets which are not established the dissolution test yet.
According to the 「Manual for Guideline Application for Validation of Analytical Procedures」 and 「Guidelines on Specificationof Dissolution test for Oral dosage form」 of Korean Pharmacopoeia (KP), we validated and established each developmentmethod. Based on the preliminary dissolution profile, we set the dissolution condition(paddle apparatus, pH 1.2media, 50 rpm). For this condition, we performed the main dissolution test to determine the specification (45 min, 85%).
Finally, we validated each analytical method by specificity, linearity, accuracy and precision. These developed methods willbe included the next supplement of KPC and also contributed to the quality control of medicines.

참고자료

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