Accelerated Formulation Development of an orally administered dosage form to Meet NDA Submission Goal

Situation: The client wished to accelerate the timeline of developing an extended release dual active solid oral formulation, which required a major change in their development approach. A wide array of excipients were under investigation in order to achieve proper product stability and desired active release profile. These activities generated an immense number of samples requiring testing. Rapid turn-around time was critical for formulation decisions and meeting the targeted clinical and submission dates.

Task: Develop a revised analytical process and method to accommodate the high volume of samples to provide accurate results to meet decision time lines and submission goals.

Action: AAIPharma optimized the extraction process of the sample preparation and redeveloped the chromatographic conditions of the potency and related substances method. These efforts reduced sample preparation time by half and HPLC run time by a third. With the process in place, the client shipped samples overnight to a waiting analytical group at AAIPharma ready to test having solutions, reagents, chromatographic and dissolution systems prepared ahead of the sample arrival.

Result: Final results (including 22 hour dissolution data) and chromatograms were delivered to the client in two days from the date of sample receipt. The effective analytical support (fast turn-around time, outstanding technical evaluation of the method for the different formulation matrices) that AAIPharma provided greatly assisted the client on meeting the targeted submission date and selecting the optimum formulation for their clinical program.