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Crystal Form Selection
The properties of a solid influence its efficacy as a drug or excipient are highly dependent on form: Is it crystalline, amorphous, a hydrate? Selecting the optimum solid form for manufacture is critical to secure FDA approval of an
Our expertise ranges from synthesis to salt formation, and to specialised techniques for manufacture of cocrystals and metastable polymorphic forms. We can generate and characterise crystalline polymorphs, hydrates, solvates, de-solvated solvates, salts, and amorphous forms.
Our customers need to determine the optimal form of a drug as early as practicable in the drug development cycle (see table below). We work with you to plan a research protocol aimed at the selection of the best form of your compound for development and manufacture using a progressive approach. Almac Sciences follows a tiered approach to select the optimal physical form for your application: salt selection; polymorph and cocrystal screening; and comparative property determinations.
Properties of the API will vary depending on the solid form selected:
Form selection choices include: