Have you considered the importance of choosing the right solid-state form for your Active Pharmaceutical Ingredient (API) in drug development? The API's physico-chemical properties depend on its solid state, which can be a free base, salt, hydrate, solvate, polymorph, or cocrystal.
Selecting the solid-state form early in drug development is crucial to avoid costly issues like repeating toxicology testing and impurity qualification. Many drugs are developed as API salts. Choosing the right API salt is essential for factors like crystallinity, dissolution rate, bioavailability, formulation, stability, manufacturability, and intellectual property.
It is also important to develop an API salt that is patentable and FDA acceptable. Drug Discovery Alliances can provide guidance on API salt screening, polymorph screening, API salt selection, and drug product development. Reach out to us today to learn more!