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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
ISSN
0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Dissolution of Pharmaceuticals - Current Issues and Challenges.

Author: UPLOADED BY-ADMIN, PRATIK SHAH, NIRAV PATEL, PRAGNA SHELAT, K SHUKLA
Abstract: Adequate oral bioavailability is a key pre-requisite for any orally administered drug to be systemically effective. Dissolution (release of the drug from the dosage form) is of primary importance for all conventionally constructed, solid oral dosage forms in general, and for modifiedrelease dosage forms in particular, and can be the rate limiting step for the absorption of drugs administered orally but the dissolution test has been under scrutiny in several areas like clinically relevant specifications, hydrodynamic fluid flow patterns that emerge from the vessel and paddle interaction, the use of the calibrator tablets. The US Food and Drug Administration’s Quality by Design and Process Analytical Technology (PAT) initiatives focus on drugs and drug products much more thoroughly than in the present practice with dissolution technologies. This review focus on the current issues and challenges associated with the present dissolution practices and possible solution of them. Further more it includes future aspects of the technologies which can improve efficiency and performance of the present practices.
Keyword: Dissolution, Continuous Dissolution–Absorption System, Fiber Optics Dissolution Testing, Perturbation Study, Biorelevant Media.
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