Dissolution Tester Principle
Dissolution testing is the most important way to study, under in vitro conditions, the release of a drug from a solid dosage form, and thus represents an important tool to assess factors that affect the bioavailability of a drug from a solid preparation. During a dissolution test the cumulative amount of drug that passes into solution is studied as a function of time. The test thus describes the overall rate of all the processes involved in the release of the drug into a bioavailable form.
Dissolution studies are carried out for several reasons:
- To evaluate the potential effect of formulation and process variables on the bioavailability of a drug
- To ensure that preparations comply with product specifications.
- To indicate the performance of the preparation under in vivo conditions.
Dissolution is accomplished by locating the tablet in a chamber containing a flowing dissolution media. So that the method is reproducible, all factors that can affect the dissolution process must be standardized. Details on approved test methods and official monographs can be found in the European or US Pharmacopoeias.