Related Experiment Video
Updated: Dec 13, 2025

Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles
Published on: August 28, 2015
In Vitro Evaluation of Enteric-Coated HPMC Capsules-Effect of Formulation Factors on Product Performance
Maoqi Fu1, Johannes Andreas Blechar1, Andreas Sauer2
1Department of Biopharmaceutics and Pharmaceutical Technology, Johannes Gutenberg University Mainz, D-55099 Mainz, Germany.
Abstract:
A comparative study on different enteric-coated hard capsules was performed. The influence of different formulation factors like choice of enteric polymer, triethyl citrate (TEC) concentration (plasticizer), talc concentrations (anti-tacking agent), and different coating process parameters on the sealing performance of the capsule and the disintegration time were investigated. Furthermore, the influence of different disintegration test methods (with disc vs. without disc and 50 mM U.S. Pharmacopoeia (USP) buffer pH 6.8 vs. biopredictive 15 mM phosphate buffer pH 6.5) was evaluated. All formulations showed sufficient but not equivalent acid resistance when tested. Polymer type was the main factor influencing the capsule sealing and disintegration time. In addition, TEC and talc could affect the performance of the formulation. Regarding the choice of the disintegration test method, the presence of a disc had for the most part only limited influence on the results. The choice of disintegration buffer was found to be important in identifying differences between the formulations.
Related Concept Videos
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
Factors Influencing Drug Absorption: Pharmaceutical Parameters
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
Drug Product Performance: In Vitro–In Vivo Correlation
Biopharmaceutical Factors Influencing Drug Product Design: Overview
Bioavailability Enhancement: Drug Stability Enhancement and GI Retention

