Specialty Dosage Formulation Development - Project B


Based on marketing research, an animal health-related company identified that an active pharmaceutical ingredient in its product had an objectionable taste. This company needed a method to mask the taste of the low-dose active ingredient to improve patient compliance. PGC provided formulation development services to identify an ideal solution for this company's needs.


The company's product was formulated as a combination product, so a technique was needed to be identified that would improve the overall product taste but would not affect the content uniformity and efficacy of the product based on the manufacturing process. Uniformity and machinability of soft chew product were of great concern for the company. Additionally, the optimal curing time has to be determined in order to produce soft chews that did not clump or fuse together in the final package.


PGC collaborated with this company to comprehend the issues driving low patient satisfaction. Upon understanding the problems, PGC isolated the taste-affecting active pharmaceutical ingredient and explored options for improving the product's overall taste. PGC derived a technique to mask the taste of the material by incorporating the active ingredient in granules using fluid bed processing and then spray coating the particles with a polymer to mask the unpleasant taste of the active ingredient. PGC first worked with the process on laboratory equipment to demonstrate the feasibility of the process and then moved to a larger-scale process that accommodated the initial commercial quantities. In doing so, PGC's approach provided added value to the product by increasing patient compliance.