Abstract
In vitro dissolution profiles are increasingly used to evaluate drug release characteristics of pharmaceutical products. The dissolution methods is expected to be an appropriate tool for checking consistency of the pharmaceutical attributes by discriminating similarities and dissimilarities between different drug formulations. Expansion in development of novel “special” dosage forms, due to the manner in which these dosage forms release the active pharmaceutical ingredient, usually requires applying non-compendial dissolution strategy that differs from the traditional compendial recommendations. For demonstrating sameness in the dissolution profile, in vitro drug release comparison between test and reference product of highly viscous oral suspension by applying non-compendial peak vessel against conventional hemispheric vessel was demonstrated in this study. All reference batches exhibited high variability in dissolution data when using hemispheric vessel due to forming mound compact mass at the bottom of the vessel. Different strategies for samples manipulation, before and during dissolution period, were performed in order to eliminate additional variabilities. Modifications of conventional USP 2 apparatus such as using peak vessel provided with more reproducible and reliable result for distinguishing in vitro similarities between different formulations of oral suspensions. Misinterpretation of dissolution data can lead to negative impact on product development. Taking time to observe and evaluate what is happening to the product in the vessel during dissolution is of curtail consideration for proper selection of the dissolution strategy. Keywords: oral suspensions; in-vitro release; hydrodynamic variability; USP apparatus 2/ Paddle apparatus; peak vessel
Highlights
Pharmaceutical oral suspensions are liquid preparations consisting of solid particles, usually medicinal agent, dispersed through liquid phase in which
After oral administration of the product, the extent of desired pharmacological effect depends of the amount of absorption of the active pharmaceutical ingredient (API) in gastrointestinal tract (GIT)
This is not the case in pH 4.5 and pH 1.2 were solubility is respectively decreasing, which is to be expected since the API is week acid with pKa value around 4, those showing no satisfactory sink conditions
Summary
Pharmaceutical oral suspensions are liquid preparations consisting of solid particles, usually medicinal agent, dispersed through liquid phase in whichDepending of the route of administration, oral administration remains the preferred route with theE. Pharmaceutical oral suspensions are liquid preparations consisting of solid particles, usually medicinal agent, dispersed through liquid phase in which. Depending of the route of administration, oral administration remains the preferred route with the. Trajkovic-Jolevska highest degree of patient compliance and is the most userfriendly form of drug delivery with majority of 84% of the most-sold pharmaceutical products in the European market and US (Fotaki and Vertzoni, 2010). After oral administration of the product, the extent of desired pharmacological effect depends of the amount of absorption of the active pharmaceutical ingredient (API) in gastrointestinal tract (GIT). Determination of the dissolution rate of drug product which is prerequisite for bioequivalence since the drug must dissolve before it can be absorbed is of special analytical challenge
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