Development of Non-Commercial Strength Formulation for a Clinical Trial

Background

A regional hospital wanted to explore the use of a non-commercial strength formulation of a progestin in a clinical trial study. However, it could not manufacture such a formulation in-house. Therefore, this hospital leveraged PGC's innovation solution services to manufacture the desired formulation.

Challenge

The hospital's clinical trial protocol required the manufacturing of a new formulation on a small scale. The new formulation also required analytical development and validation. However, the hospital did not have the facility or capability to construct this formulation.

Results

PGC teamed up with this hospital to understand the study's objectives and requirements. Understanding that the hospital desired to explore a non-commercial strength, PGC identified options for formulations, and, ultimately, selected one to develop. Drug-excipient compatibility studies were undertaken on various formulations to assess the best combination. Furthermore, PGC adapted the USP analytical methods (Identification, Assay, Organic Impurities, Dissolution, Uniformity of Dosage Units and Loss on Drying) from the approved product's monograph of the commercially available lower dose to use for this new higher-dose formulation. PGC validated these analytical methods for the higher dose, developed the manufacturing process, and performed accelerated, intermediate, and long-term stability studies on the finished drug product. This project took three months from concept to delivery (with formulation development and production taking four weeks), and PGC delivered the new formulation in ample quantities required to complete the study in a cost-effective and timely manner. The client actually requested additional drug product a year later, and PGC was able to fulfill this request. Cleaning validation and verification were also developed and performed.