Browse > Article

Development of Dissolution Test for Itopride Hydrochloride Tablets and Tiropramide Hydrochloride Tablets  

Kim, Jung Hyun (National Institute of Food and Drug Safety Evaluation (NIFDS-MFDS))
Lee, Jong Hwa (National Institute of Food and Drug Safety Evaluation (NIFDS-MFDS))
Choi, Lan (National Institute of Food and Drug Safety Evaluation (NIFDS-MFDS))
Choi, Yeon Hee (National Institute of Food and Drug Safety Evaluation (NIFDS-MFDS))
Lee, Jong Chul (National Institute of Food and Drug Safety Evaluation (NIFDS-MFDS))
An, Ji Hye (National Institute of Food and Drug Safety Evaluation (NIFDS-MFDS))
Lee, Gwang Moon (National Institute of Food and Drug Safety Evaluation (NIFDS-MFDS))
Shim, Young Hoon (National Institute of Food and Drug Safety Evaluation (NIFDS-MFDS))
Kang, Shin-Jung (National Institute of Food and Drug Safety Evaluation (NIFDS-MFDS))
Sah, Hong-Kee (College of Pharmacy, Ewha Womans University)
Choi, Hoo-Kyun (College of Pharmacy, Chosun University)
Kim, In-Kyu (National Institute of Food and Drug Safety Evaluation (NIFDS-MFDS))
Publication Information
YAKHAK HOEJI / v.57, no.3, 2013 , pp. 205-212 More about this Journal
Abstract
Dissolution test has been performed to control drug quality and to predict in vivo drug release profile of solid dosage forms, so there's a drift towards setting dissolution test instead of disintegration test. However, some solid dosage forms in Korea Pharmaceutical Codex (KPC) are not established the dissolution test yet, so these monographs are necessary to set the specification of dissolution test. In this study, we developed the specification and test method of dissolution test for 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 Specification of Dissolution test for Oral dosage form" of Korean Pharmacopoeia (KP), we validated and established each development method. Based on the preliminary dissolution profile, we set the dissolution condition(paddle apparatus, pH 1.2 media, 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 will be included the next supplement of KPC and also contributed to the quality control of medicines.
Keywords
dissolution test; itopride hydrochloride; tiropramide hydrochloride;
Citations & Related Records
연도 인용수 순위
  • Reference
1 대한민국약전 9개정 : 의약품등 분석법의 밸리데이션에 대한 지침 (2007).
2 대한민국약전 9개정 : 경구용의약품의 용출 규격 설정 지침 (2007).
3 Iwanaga, Y., Miyashita, N., Morikkawa, K., Mizumoto, A., Kondo, Y. and Itoh, Z. : A novel water-soluble dopamine-2 antagonist with anticholinesterase activity in gastrointestinal motor activity: comparison with domperidone and neostigmine. Gastroenterology 99, 401 (1990).   DOI
4 Sakaguchi, J., Nishino, H., Ogawa, N., Iwanaga, Y., Yasuda, S., Kato, H. and Ito, Y. : Synthesis, gastrointestinal prokinetic activity and structure-activity relationships of novel N-[[2- (dialkylamino)-ethoxy]benzamide derivatives. Chem. Pharm. Bull. (Tokyo) 40, 202 (1992).   DOI   ScienceOn
5 Iwanaga, Y., Kimura, T., Miyashita, N., Morikawa, K., Nagata, O., Itoh, Z. and Kondo, Y. : Characterization of acetylcholinesterase inhibition by itopride. Jpn. J. Pharmacol. 66, 317 (1994).   DOI   ScienceOn
6 Vidal, Y., Plana, R. R., Cifarelli, A. and Setnikar, I. : Mechanism of smooth muscle relaxation by tiropramide. J. Pharm. Pharmacol. 33, 19 (1981).   DOI
7 Setnikar, I., Cereda, R., Pacini, M. A., Ravel, L. and Mackovec, F. : Pharmacological characterization of the smooth muscle antispasmodic agent tiropramide. Arzeim-Forsch/Drug. Res. 39, 1114 (1989).
8 Pillai, S. and Singhvi, I. : Quantitative estimation of itopride hydrochloride and rebeprazole sodium from capsule formulation. Indian J. Pharm. Sci. 70, 658 (2008).   DOI   ScienceOn
9 Imran, K., Punnamchand, L. and Natvarlal, S. M. : A simple sample preparation with HPLC-UV method for estimation of tiropramide from plasma : Application to bioequivalence study. J. Pharm. and Bio. Anal. 43, 1135 (2007).   DOI   ScienceOn