Does the performance of wet granulation and tablet hardness affect the drug dissolution profile of carvedilol in matrix tablets?

Drug Development and Industrial Pharmacy
Darjan KoširF Vrečer

Abstract

Wet granulation is mostly used process for manufacturing matrix tablets. Compared to the direct compression method, it allows for a better flow and compressibility properties of compression mixtures. Granulation, including process parameters and tableting, can influence critical quality attributes (CQAs) of hydrophilic matrix tablets. One of the most important CQAs is the drug release profile. We studied the influence of granulation process parameters (type of nozzle and water quantity used as granulation liquid) and tablet hardness on the drug release profile. Matrix tablets contained HPMC K4M hydrophilic matrix former and carvedilol as a model drug. The influence of selected HPMC characteristics on the drug release profile was also evaluated using two additional HPMC batches. For statistical evaluation, partial least square (PLS) models were generated for each time point of the drug release profile using the same number of latent factors. In this way, it was possible to evaluate how the importance of factors influencing drug dissolution changes in dependence on time throughout the drug release profile. The results of statistical evaluation show that the granulation process parameters (granulation liquid quantity and type of n...Continue Reading

References

Aug 1, 1998·Journal of Controlled Release : Official Journal of the Controlled Release Society·R V NelloreL L Augsburger
May 20, 1999·Journal of Controlled Release : Official Journal of the Controlled Release Society·G S RekhiL L Augsburger
May 20, 2005·The Journal of Pharmacy and Pharmacology·Chi L LiMatthew Roberts
Apr 19, 2011·Journal of Controlled Release : Official Journal of the Controlled Release Society·Cristina MaderueloJosé M Lanao
Sep 16, 2011·Pharmaceutical Development and Technology·S Devjak NovakS Baumgartner
Oct 16, 2016·Drug Development and Industrial Pharmacy·Darjan Košir, Franc Vrečer
Nov 24, 2016·Pharmaceutical Development and Technology·Darjan KoširFranc Vrečer

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