P: (609) 261-6920 | F: (609) 261-6921 112 Burrs Road Westampton, NJ 08060
At ProtoForm, we know it's vital that formulators obtain the most comprehensive physiochemical and physicomechanical data available prior to beginning the formulation process. To help with this, we have devised a comprehensive strategy that places formulation projects in the best position to ensure the development of quality and robust dosage forms—in a timeframe that is conducive to a successful product launch. This strategy is divided into three stages:
First Stage, our formulators acquire data such as pH solubility and partitioning for biopharmaceutical classification of a candidate drug.
Second Stage, we perform a thermal analysis of the drug candidate. We also perform forced degradations and intrinsic dissolution testing to characterize the drug candidate. This data allows us to evaluate its suitability for particular dosage forms that the final product may take.
Third Stage, our formulators gather data for the development of a quality dosage form with a robust manufacturing process. Within this stage, the most comprehensive of our preformulation strategy, we undertake analysis of excipient compatibility, micromeritics, rheology, compaction properties, and hygroscopicity.
This wide-range analysis during the preformulation stage puts drug candidates in an excellent position throughout the rest of the development process.
To learn more about how ProtoForm can help with the preformulation of your drug candidate