EFFECT OF COMPACTION PROCESS IN GRANULOMETRYAbstract
Quetiapine is indicated for the treatment of schizophrenia as well as for the treatment of acute manic episodes associated with bipolar I disorder. The aim of the present study is to evaluate the effect of manufacturing process on critical quality attribute on In-process parameters (Granules). Quetiapine fumarate was selected as a model drug for sustained release drug delivery system manufactured by wet granulation process 1. To identify the effect of compacted Magnesium Oxide Light in the release behavior of model drug. During the study different percentage of Magnesium Oxide light compacted and granulated by using dichloromethane as granulating solvent. Other excipients with different functionality were added in the formulation such as Microcrystalline Cellulose, Lactose monohydrate, Controlled release polymer Carrageenan, Povidone and Magnesium stearate. Initially Magnesium Oxide light was compacted by using vertical type Roller compactor. From the compacted material 40%- 50% screened & 50%-60% retained over #60 mesh is optimized ratio, and this ratio must be maintained to get the targeted release of the said drug from the final uncoated Tablet. To find the release profile of the model drug, Citrate Phosphate buffer at pH 6.4-6.6 with volume 1000ml was selected as dissolution media, apparatus used is USP 2 with stationary basket.
Himankar Baishya*, Shirley Thomas, Vivekanand Verma and Libin
Formulation Development Department, Beijing Sciecure Pharmaceuticals Co., Ltd., Beijing, China
25 August, 2015
09 December, 2015
16 January, 2016
01 February, 2016