Department of lek dd, verovskova ulica 57, 1526 Ljubljana, Slovenia
Research Article
Understanding the in Vivo Performance of Immediate Release Tablet Formulations with Atypical Disintegration by Using Non Conventional Disintegration and Dissolution Methods
Author(s): Katja Berginc*, Aleksovski Aleksandar, Vrbanac Helena, Gantar Kaja, Sersa Igor and Mikac Urska
Disintegration and dissolution testing is often seen as in-process/release control step, not relevant from the perspective of product bio-performance. The aim of this paper was to develop discriminative and bio-relevant (Fasting conditions) disintegration and dissolution methods for an immediate release generic tablet with poorly soluble BCS 4 drug substance with known wetting issues and tendency to aggregate. Tablet with atypically long disintegration, similar to reference product, had to be developed. Several non-standard disintegration methods were designed and those simulating no mechanical stress and fasting gastric environment were found to correlate best with in vivo result. To assure fast high-throughput screening of samples for developmental purposes, conditions identified in disintegration tests were incorporated into custom made dissolution test that covers both disintegrat.. View More»
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