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DEVELOPING AS DISCRIMINATIVE DISSOLUTION METHODS IN CORRELATION WITH IN VITRO IN VIVO FOR QUETIAPINE FUMARATE FILM COATED TABLETS 300MG

. A Bharath kumar and Dr. Pabba Parameshwar


Abstract

Discriminative drug dissolution profiles are testing can play an important role in predicating and estimation of in-vivo performance with bioequivalence studies for drug products development in pharmaceutical industry. The main objective of this study was to determine the Discriminative dissolution media enabling predicting in-vivo performance of Quetiapine Fumarate Tablets Discriminatory dissolution should provide the drug and dosage-form performance and should be used to formulation development, to identify and predicting on the bioavailability of orally drug product development, and to identify solubility limitations and stability issues. The importance of the development of predicting dissolution testing is increased by the fact that the majority of drugs currently in development. Biorelevant dissolution testing were performed and evaluation of Quetiapine Fumarate Tablets. Although in-vitro dissolution test findings showed the similarity of release profile of test product and reference drug products, the in-vivo results demonstrated that they may not be similar. The profiles based only on pharmaceutical attributes have also been described as discriminatory. This appears to have created confusion in properly defining and developing discriminating profiles. So, those proper discriminating profiles may be developed for improved evaluation of pharmaceutical products. Due to this reason, discriminating profiles was investigating the potential to be further used to establish in-vitro in-vivo correlation (IVIVC) during the development of Quetiapine Fumarate Tablets in solid dosage form.

Key words : Invitro-invivo, Quetiapine Fumarate, Film coated tablets.

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