OPTIMIZATION OF VARIOUS PROCESS PARAMETERS FOR FORMULATION OF MODEL ANTI-HYPERLIPIDEMIC DRUG BY USING DRY GRANULATION METHODAbstract
The Tablet manufacturing process is a complex process, influenced by several process variables The aim of this study was to optimize blending; roller compaction and tablets compression processes using design space approach for a model Anti- Hyperlipidemic drug Fluvastatin. During each processes there are several factors which may affect product quality. So the main objective of present work was to identify various parameters and optimize the parameter for formulation of better product which includes Blending time, Roller force, Compression force and machine speed which were recognized as critical process parameters and were evaluated. A scale up batch is taken to evaluate and optimize the parameters. Critical quality attributes like Blend uniformity, granules parameters, flow behavior, tablet appearance, impact on tablet physical parameters and in-vitro drug dissolution release profile is evaluated to optimize the parameters. The data & test results of blend, granules and tablets at various in-process phases were complied with the specified limits and finished product sample analysis results found to be complying within specifications. This study and results obtained assures that the manufacturing process is reproducible, robust and will yield consistent product, which meets specification.
Himankar Baishya*, Athappan Chidambaram and Zhao Haitho
Senior Director, R & D, Beijing Sciecure Pharmaceuticals Co., Ltd., Beijing, China
19 May, 2016
13 June, 2016
09 August, 2016
01 October 2016