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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 quickly filtered and refrigerated immediately after sampling.
6 Dissolution Technologies | MAY 2013 Dissolution Testing of a Controlled-Release Capsule Formulation: Challenges and Solutions Using a Semi-Automated Dissolution System
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FDA Guidance for Industry Dissolution Testing of, Immediate release, Dissolution, Mg Prolonged-release Tablets PL, MG PROLONGED-RELEASE TABLETS, PL 27900, MG PROLONGED-RELEASE TABLETS PL 27900, Paper on the dissolution specification, Guideline for Bioequivalence, Release, ASEAN GUIDELINE ON STABILITY STUDY OF, Oral drug delivery