Comparative Fitting of Mathematical Models to Carvedilol Release Profiles Obtained from Hypromellose Matrix Tablets

Author:

Ojsteršek Tadej12,Vrečer Franc12,Hudovornik Grega1

Affiliation:

1. KRKA, d. d., 8501 Novo Mesto, Slovenia

2. Faculty of Pharmacy, University of Ljubljana, 1000 Ljubljana, Slovenia

Abstract

The mathematical models available in DDSolver were applied to experimental dissolution data obtained by analysing carvedilol release from hypromellose (HPMC)-based matrix tablets. Different carvedilol release profiles were generated by varying a comprehensive selection of fillers and carvedilol release modifiers in the formulation. Model fitting was conducted for the entire relevant dissolution data, as determined by using a paired t-test, and independently for dissolution data up to approximately 60% of carvedilol released. The best models were selected based on the residual sum of squares (RSS) results used as a general measure of goodness of fit, along with the utilization of various criteria for visual assessment of model fit and determination of the acceptability of estimated model parameters indicating burst release or lag time concerning experimental dissolution results and previous research. In addition, a model-dependent analysis of carvedilol release mechanisms was carried out.

Publisher

MDPI AG

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