Dissolution Method for Quality Control of Modified Release Dosage Forms

3.6.2.1 Dissolution Media

The media used for modified-release dosage forms are generally the same as those used for immediate-release dosage forms. However, as opposed to the dissolution test used for immediate-release products that always uses one pH, more than one dissolution media with different pH values may be employed for testing of extended-release dosage forms to simulate the change in pH along the GI tract.

3.6.2.2 Apparatus and Test Conditions

The most common types of apparatus used for routine quality testing of extended-release products are the basket and paddle methods. The reciprocating cylinder may be used particularly for enteric-coated or extended-release dosage forms, when the pH of the medium needs to be changed in order to mimic the pH changes in the GI tract. The operating conditions for the basket and paddle methods are very similar to those used for immediate-release dosage forms, with an exception of the test duration, which can be as long as 12 h for extended-release products.

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