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ABSTRACT
| Title |
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FORMULATION, DESIGN AND DEVELOPMENT OF MIFEPRISTONE IMMEDIATE RELEASE TABLET |
| Authors |
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Kaveri Verma, Pramod Kumar Sharma, Rupesh Dudhe, Sraman Kumar Patro |
| Keywords |
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Mifepristone, Optimization, Wet granulation technique, Immediate release tablet, Disintegration time, Slugging. |
| Issue Date |
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November 2014 |
| Abstract |
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Mifepristone tablet is being developed for the termination of 49 days pregnancy following regulatory submissions. The proposed commercial formulation for Mifepristone tablet is an immediate release tablet, with strength (350/200 mg) is proposed for commercialization. This study presents a summary of the process optimization of Mifepristone tablet. The purpose of this research is to prepare Mifepristone immediate release tablet by wet granulation technique. In order to obtain the best, optimized product six different formulations were developed. Different filler, disintigrants and lubricants were taken as variables in different ratios. Weight variation, thickness, hardness, friability, disintegration time; In-vitro release and pharmaceutical assay were studied as response variables. Poor flow property was observed with the formulation containing less concentration of Colloidal silicon anhydrous during slugging. However, in the remaining four formulations containing constant concentration of Colloidal silicon anhydrous, improved flow property was observed due to absence of static charges during slugging. The formulation F-6 was selected as an optimized product. The different physical properties and in-vitro release profile showed F-6, best comparable with reference product. Optimization has been proven an effective tool in product development. |
| Page(s) |
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760-769 |
| ISSN |
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0975-9492 |
| Source |
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Vol. 5, No.11 |
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