Formulation Development and Evaluation of Mycophenolate Sodium 360mg Delayedrelease Tablets

Ananth, R (2013) Formulation Development and Evaluation of Mycophenolate Sodium 360mg Delayedrelease Tablets. Masters thesis, Arulmigu Kalasalingam College of Pharmacy, Krishnankovil.

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Abstract

The present study formulation development was to formulate Mycophenolate sodium Tablets 360mg (Enteric coated), which are robust, stable and bio-equivalent to the Generic product of Myfortic 360mg Tablets marketed by Novartis pharma stein AG which is used as Reference Listed Product for comparison & Developmental studies. Product development was carried out on Mycophenolate sodium Tablets 360mg. All the critical process parameters identified at development stage were confirmed and proved that the process is capable of producing a drug product of the required quality with the proposed process & product parameters. TRIAL-D4 formulated tablets formula finalized, after passing of bio-equivalence and stability. The formulated tablets have to be studied for physico-chemical characteristics and stability for 6 months. Also the formulated tablets are to be submitted for bio-equivalence study with reference listed drug.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Mycophenolate Sodium 360mg Delayedrelease Tablets; Physico-chemical characteristics
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 09 Oct 2017 05:59
Last Modified: 09 Oct 2017 05:59
URI: http://repository-tnmgrmu.ac.in/id/eprint/3636

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