The purpose of a dissolution test is to determine or establish drug dissolution or release characteristics of a product, in particular tablet or capsule. To determine dissolution characteristics, or any other characteristic in general, one would require a method and/or tester or apparatus. Prior to its use, it must be established that the method/tester is capable of providing an expected outcome, i.e. in this case the method/tester is capable of providing dissolution characteristics of a (tablet/capsule) product. In other words, the dissolution method/tester should be qualified and validated.
Unfortunately, at present, suggested and commonly used dissolution testers have never been shown as qualified and validated dissolution testers. Therefore, reported results, and by extension conclusions drawn from these results, are of limited or no relevance or use. It is all an illusionary science and interpretation of data/results.
The crescent shape spindle has been proposed to address this present-day difficulty. The use of the spindle provides an ability to test products using a common, simple testing and product-independent approach.
