Laboratory Testing Case Studies

Challenge: The technological objective of this Diteba project was to develop an in vitro release test method for Lidocaine Ointment USP 5%, a local anesthetic agent that is administered topically.  There were no suitable in vitro release test methods available and the method was necessary as part of the FDA's drug approval process.  The in vitro release test method was to be developed in accordance with the FDA issued guidance covering practice of Scale-up and post approval changes with semi-solids (SUPAC-SS).  A key element in the in vitro release test is to determine if the diffusion release of a drug found in a formulation is the same following the changes made to the formulation.

Challenge: Diteba was commissioned by a sponsor to conduct research for the development of an analytical method for in vitro determination of the release rate of sulfanilamide in topical vaginal cream. The method was developed and based on a modified Franz Diffusion Cells fitted with synthetic membranes.