Approaches for Dissolution Testing of Novel Drug Delivery Systems

摘要

Dissolution technique is an excellent tool for monitoring batch-to-batch quality control and to understand drug release in in-vivo conditions. Dissolution methods are mostly recommended for solid oral dosage forms. However, they have also been extended to other dosage forms such as suspensions, transdermal patches, chewing gums, etc. Choosing the right in-vitro method and apparatus provides an excellent view of the formulated dosage form. Over the past two decades, efforts towards harmonization between pharmacopoeias have led to more uniform methods for in-vitro dissolution of conventional dosage forms across the board. Dissolution studies for novel drug delivery systems have been limited primarily to literature citations and are yet to find a place in the pharmacopoeia.