Drug molecules may show different solid forms, including polymorph, hydrate, solvate, salt, cocrystal, and amorphous. Various solid forms of a drug substance may have different chemical and physical properties, including crystallinity, hygroscopicity, chemical reactivity, apparent solubility, dissolution rate, and stability. These properties can have a direct effect on the ability to manufacture the drug substance and the drug product, as well as on drug product stability, dissolution, and bioavailability. Thus, different solid forms can affect the quality, safety, and efficacy of the drug product. The appearance of a new solid form during late stages of development may delay filing and a new form appearing in drug product may cause product withdrawal. Therefore, it is critical to identify and select the optimal form during early drug development. A thorough solid form screening also provides rationale for form selection as required by regulatory filing.
At Porton J-STAR, we employ an integrated approach to screen and select the most suitable solid form. We conduct effective screening and rigorous assessments for polymorphs, salts, cocrystals, as well as amorphous solid dispersions, applying comprehensive expertise and experience including:
