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Dissolution of Pharmaceuticals - Current Issues and Challenges.
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| Author:
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UPLOADED BY-ADMIN, PRATIK SHAH, NIRAV PATEL, PRAGNA SHELAT, K SHUKLA
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| Abstract:
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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.
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| Keyword:
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Dissolution, Continuous Dissolution–Absorption System, Fiber Optics Dissolution Testing, Perturbation Study, Biorelevant Media.
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| EOI:
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| DOI:
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| Download:
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