Process Validation Articles

To establish criteria for the design of controlled release products, a number of variables must be considered mainly

1. Drug properties: The physicochemical properties of a drug, including stability, solubility, partitioning characteristic, charge and protein binding propensity play a dominant role in the design and performance of controlled release system.

2.Route of drug delivery: The area of the body in which drugs will be applied or administered can be restrictive on the basis of technological achievements of a suitable controlled release mechanism or device. Performance of controlled release systems may also be influenced by physiological constraints imposed by the particular route, such as first pass metabolism, gastrointestinal motility, blood supply and sequestration of small foreign particles by the liver and spleen.