16–18 Dec 2022
Birla Institute of Technology, Mesra
Asia/Kolkata timezone

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Understanding critical quality attributes focus on tablet dissolution

16 Dec 2022, 09:30
2h
Main Building/Ground Floor-CAT Hall - Seminar Hall (Birla Institute of Technology, Mesra)

Main Building/Ground Floor-CAT Hall - Seminar Hall

Birla Institute of Technology, Mesra

300
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Keynote Networking

Speaker

Krishnan Tirunellai (Ottawa, Canada)

Description

The Indian pharmaceutical industry is rapidly growing (expected @ 10-11%). Mny of these companies are seeking market authoirzation in North America, Europe, etc. or are contract manufacturing organizations and exporting to these counrtries. To gain from this momentum the talent pool should have relevant scientific knowledge tht will be useful for the Pharma Industry. This is where Pharmacy graduates can take advantage of their multi-disciplinary knowledge, and build on to attract industry's attention to be hired, mostly for the Generic drugs. The scientific guidance and requirements for pre-market authorization are similar in most countries mentioned above. Indian companies involved in exporting drugs have to follow them. Although Critical Quality Attributes (CQAs) of tablets are well known, they are seldom well understood. Among these (tablets) dissolution is the most important attribute as it could be linked to bioavailability. Hence, the dissolution test could make or break a drug product and needs to be understood well from development to commercialization. A reliable dissolution test is necessary for approval of expiry period. Dissolution failure is also linked to product failutre and costly recalls that could be avoided.

Primary author

Krishnan Tirunellai (Ottawa, Canada)

Presentation materials

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