Dissolution is defined as the process by which a known amount of drug substance goes into solution per unit of time under standardized conditions.
The primary goal of dissolution testing is to be used as a qualitative tool to provide measurements of the bioavailability of a drug as well as to demonstrate bioequivalence from batch-to-batch. The bioavailability and bioequivalence data obtained as a result of dissolution testing can be used to guide the development of a new formulation and product development processes toward product optimization, as well as to ensure continuig product quality and performance of the manufacturing process. In addition, dissolution is a requirement for regulatory approval for product marketing and is a vital component of the overall quality control program.
Dissolution testing is conducted using a dissolution apparatus , such as the Vankel 7010, Vankel 7000, Hanson SR8 Plus, Distek 6100 Bathless Systems all sold by AST Scientific and tested, refurbished prior to shipping. The instruments must conform to the specifications outlined in the United States Pharmacopeia. There are seven types of dissolution apparatus; the apparatus chosen to perform dissolution testing depends primarily on the drug dosage form.
In order to have a high degree of assurance that the dissolution apparatus is consistent and accurate in its performance, validation is required. Validation is defined as documented evidence that provides a high degree of assurance that a specific instrument performs according to the manufacturer's specifications and user requirements.
Written by : Sharon M. Averell Frost
Wyeth Vaccines, 4300 Oak Park, Sanford, NC 27330