A Strategy for Quality Control Dissolution Method Development for Immediate-Release Solid Oral Dosage Forms

Development of an appropriate dissolution method for quality control purposes requires consideration of many factors and a balance of different needs. The method is typically distinctive to each drug product because of the unique characteristics of the active ingredient, the formulation, and the manufacturing process. The method development and selection process remains subjective due to the potential range of profiles that could be considered acceptable. This article presents a strategy and detailed recommendations for developing a quality control dissolution method for immediate-release solid oral dosage forms for the purpose of quality control and formulation or process development. The strategy is developed based on an understanding of dissolution technology, regulatory expectations, literature, and experiences in developing various dissolution methods. A case study demonstrating this strategy with the discriminatory potential of an appropriately developed dissolution method is also described.