Can you perform preformulation studies for a generic product?
Yes, preformulation development can be performed for generic pharmaceutical products to understand the properties and behavior of the drug substance before developing the final dosage form. Pharmaceutical preformulation studies help evaluate important drug characteristics such as solubility, pKa, particle size and distribution, polymorphism, hygroscopicity, thermal properties, stability, flow properties, and compatibility with commonly used excipients.
At Molkem, pharmaceutical preformulation and formulation can be considered as connected stages of the development process. The information obtained during preformulation provides a scientific basis for formulation development, helping in the preparation and optimization of prototypes and supporting the development of a stable, consistent, and manufacturable generic pharmaceutical product.
