Specialty Dosage Formulation Development - Project A


An animal health company wanted to launch a new line of soft chews. To launch such a product, it needed to develop a process to produce the formulation in small volumes for veterinary clinical trials, and this process would have to be able to scale up for commercialization if studies were successful. PGC provided the innovative solutions required by this company to manufacture the formulation required for these trials.


Formulating soft chews required specialty product process development that entailed materials processed in nonstandard equipment. Uniformity and machinability of dosage form were of great concern for the company. Additionally, the optimal curing time had to be determined.


PGC collaborated with this animal health company to understand the desired specifications for a soft chew formulation. To manufacture this product, PGC developed a cleaning verification/validation process and qualified nonstandard equipment. Due to diligent planning and extensive experience, PGC was able to demonstrate both product uniformity and machinability of the dosage form, as specified by the client. Moreover, PGC was able to optimize product curing time through product stress testing. Several different formulations were tested and calculated to achieve the appropriate wet massing without the soft chews crumbling. Each batch of soft chews developed in the lab and cured was evaluated and tested for content uniformity. Final curing time was performed with each formulated soft chews batch for optimization by using a texture analyzer. PGC created intellectual property for the client, including the optimized process to scale up, if the client chose to use it for commercialization purposes. This process was successfully transferred to another site for scale-up and commercialization.