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Dissolution Testing of a Controlled- Release Capsule ...
6 Dissolution Technologies | MAY 2013 Dissolution Testing of a Controlled- Release Capsule Formulation: Challenges and Solutions Using a Semi-Automated Dissolution SystemLili Lo, Xujin Lu*, and David LloydAnalytical and Bioanalytical Development, Bristol-Myers Squibb, New Brunswick, NJ 08903 ABSTRACTA Controlled- Release formulation was developed using enteric-coated beads in a hard gelatin Capsule shell. This formulation requires two-stage Dissolution Testing at low and neutral pH. Because of high toxicity and limited stability of the active phar-maceutical ingredient in aqueous solution at room temperature, it is preferable to limit the analyst s contact with the sample solutions during Testing , and aliquots from the Dissolution vessel need to b
Dissolution Technologeis | MAY 2013 7 tance criteria for the acid stage when the amount released is limited to 10% or less of the labeled content, as well as for …
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