ABSTRACT

This paper compares and analyses the similarity factor of drug release profiles for modified-release (MR) dosage forms using the Cubic Spline Interpolation method. The Cubic Spline Interpolation (CSI) method is employed to approximate the percentage drug release at intermediate time points of in-vitro drug release profiles; the changes in the similarity factor f2 is noted. To test the method, percentage drug release of Quetiapine Fumarate MR tablets is considered. The CSI method explains the interpretation and comparison of supplemental mediating timepoint observations in the ex-vivo environment. This method may aid industries in monitoring the characteristics of in-vitro release studies with a few changes in timepoint selection or to achieve comparative drug release profile for early-stage drug dosage form preparation. Keywords: Drug release profiles, Similarity factor f2, Cubic spline interpolation MSC: 03C40, 41A15
Publication date: 01/11/2024

https://ijbpas.com/pdf/2024/November/MS_IJBPAS_2024_8473.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.11.8473