Risk-based approach for systematic development of gastroretentive drug delivery system
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- 作者：A. G. Mirani ; S. P. Patankar ; V. J. Kadam
- 刊名：Drug Delivery and Translational Research
- 出版年：2016
- 出版时间：October 2016
- 年：2016
- 卷：6
- 期：5
- 页码：579-596
- 全文大小：1,808 KB
- 刊物主题：Pharmaceutical Sciences/Technology;
- 出版者：Springer US
- ISSN：2190-3948
- 卷排序：6
文摘
The research envisioned was the development of diltiazem hydrochloride effervescent floating matrix tablet using a risk-based approach. Preliminarily, the in vitro drug release profile was derived which theoretically simulated the in vivo condition after oral administration. Considering this as a rationale, the formulation development was initiated with defining the quality target product profile (QTPP) and critical quality attributes (CQAs). The preliminary studies were conducted to screen material attributes and process parameters followed by their risk assessment studies to select the plausible factors affecting the drug product CQAs, i.e., floating lag time and drug release profile. A 32 full factorial design was used to estimate the effect of the amount of swelling polymer (X1) and gas-generating agent (X2) on percent drug release (Qt1h and Qt8h) and floating lag time. Response and interaction plots were generated to examine the variables. Selection of an optimized formulation was done using desirability function and further validated. The model diagnostic plots represent the absence of outliers. The optimized formula obtained by the software was further validated, and the result of drug release and floating lag time was close to the predicted values. In a clear and concise way, the current investigations report the successful development of an effervescent floating matrix tablet for twice daily administration of diltiazem hydrochloride.KeywordsRisk-based approachQuality by designTheoretical releaseGastroretentive systemDiltiazem hydrochloride