X hits on this document

Powerpoint document

Quality by Design: Next Steps to Realize Opportunities? - page 6 / 37

135 views

0 shares

0 downloads

0 comments

6 / 37

Design Features: TABLET FORMULATION Larry L. Augsburger and Mark J. Zellhofer

Optimal drug dissolution and, hence, availability from the dosage form for absorption consistent with intended use (i.e., immediate or extended release).

Accuracy and uniformity of drug content.

Stability, including the stability of the drug substance, the overall tablet formulation, disintegration, and the rate and extent of drug dissolution from the tablet for an extended period.

Patient acceptability. As much as possible, the finished product should have an attractive appearance, including color, size, taste, etc., as applicable, in order to maximize patent acceptability and encourage compliance with the prescribed dosing regimen.

Manufacturability. The formulation design should allow for the efficient, cost-effective, practical production of the required batches.

Document info
Document views135
Page views135
Page last viewedTue Jan 24 09:35:10 UTC 2017
Pages37
Paragraphs609
Words2099

Comments