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 be quic

6 Dissolution Technologies | MAY 2013 Dissolution Testing of a Controlled-Release Capsule Formulation: Challenges and Solutions Using a …

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  Challenges, Solutions, Release, Capsule, Controlled, Formulation, Challenges and solutions, Controlled release capsule formulation

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