A biorelevant in vitro release/permeation system for oral transmucosal dosage forms

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• 作者：Poonam R. Delvadia^a ; ¹ ; ^{delvadiapr@vcu.edu} ; William H. Barr^b ; ² ; ^{whbarr@aol.com} ; H. Thomas Karnes^a ; ^{htkarnes@vcu.edu}
• 关键词：Oral transmucosal dosage forms ; Biorelevant in vitro release testing ; Modified USP IV flow-through apparatus ; Vertical diffusion cell ; Bidirectional transmucosal apparatus
• 刊名：International Journal of Pharmaceutics
• 出版年：2012
• 期刊代码：24_03785173
• 类别：pha
• 出版时间：1 July, 2012
• 卷：430
• 期：1-2
• 页码：104-113
• 文件大小：672 K

摘要

This research describes the development and validation of a biorelevant in vitro release/permeation system to predict the in vivo performance of oral transmucosal dosage forms. The system is a biorelevant bidirectional transmucosal apparatus which allows better simulation of oral cavity physiological variables in comparison to compendial dissolution apparatuses and therefore may be a better predictor of in vivo behavior. The feasibility of the bidirectional apparatus was studied using smokeless tobacco (snus) as a model oral transmucosal product. In this research, nicotine release and permeation was investigated from commercially available snus using a modified USP IV flow-through apparatus, a commercially available vertical diffusion cell and a fabricated novel bidirectional transmucosal apparatus. The percent nicotine released/permeated was utilized as an input function for the prediction of in vivo plasma nicotine profiles by back calculation based on the Wagner-Nelson method. The prediction errors in C_max and AUC_{0-鈭?/sub> with the USP IV flow-through device, vertical diffusion cell and novel apparatus were 4.03, 22.85 and 1.59 and 鈭?.85, 5.85 and 鈭?.27%respectively. This work demonstrated the suitability of the novel bidirectional transmucosal apparatus for predicting the in vivo behavior of oral transmucosal products.}