PROCESS OPTIMIZATION: A CRITICAL FACTOR FOR EFFECTIVE DRUG DOSAGE DELIVERYAbstract
The critical nature of pharmaceutical dosage forms requires that both formulation and process variables are optimized in order to achieve desired quality outcome. In this study, process optimization is examined with a view to position the final product in such a way as to deliver the expected performance. Six formulations were designed with similar excipients and nifedipine as model drug. Each formulation went through wet granulation process, during which the granulation time, amount of granulation liquid and wet milling using different sieve sizes were modified to reflect the parameters being investigated. Results vindicated the importance of modification of process variables to the extent that significant difference was observed in the physicochemical parameters, especially in vitro dissolution and drug release rates. Data from in vitro dissolution testing was fitted into different kinetic models so as to predict the order and mechanism of drug release. It could be concluded from this research work that through logical process optimization, it is possible to identify critical process parameters that can be modified to enable designing and building of desired qualities into the final product.
Musibau A. Mustapha
Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, University of Lagos, Idi-Araba Campus, P. M. B. 12003, Lagos, Nigeria
08 April, 2013
08 June, 2013
27 July, 2013
01 August, 2013