Insights of Dosage form Design: Polymorphs and Cocrystals

Formulators are charged with the responsibility to formulate a bioequivalent product (in case of ANDA) product which is physically and chemically stable, manufacturable at commercial scale. Different crystal structures in polymorphs arise when the drug substance crystallizes in different crystal packing arrangements and/or different conformations. Besides, Polymorphs cocrystallization is now important method to achieve crystalline forms of molecules where alternative polymorphs or salts or solvates are desired. Regulatory road map for polymorphs approval is quite clear and for cocrystals draft guidance is on scientific advisory form public. From Intellectual property perspectives polymorphs and cocrystal patents are approved in different countries within the meaning specified in the act. Overall the patentability of polymorphs and cocrystals directly affects the business driven strategy for research based Pharmaceuticals as well as collaborative research universities for science updation for better health care.

Over the past number of years, the fraction of new chemical entities (NCE) approaching the marketplace are very infrequent and steadily decreasing. For the successful development and commercialization of NCEs (also called as API) it required that API should possess adequate processability, stability, and bioavailability. Once the complete understanding of the physicochemical and biopharmaceutical properties of the drug substance are known then the formulator can design dosage of clinical relevance. Based on powder morphology; drugs are classified as amorphous and crystalline form; wherein each has its own set of merits and demerits for design of dosage form. Crystal engineering is an emerging area which relates to molecular solids possess crystalline state. The field of Crystal modification is gaining an increased interest within the pharmaceutical industry because it enables preparation of materials with modified and desirable physical properties. There are few challenges associated with the nature of API in the development and manufacturing of solid dosage forms such as tablet is poor tabletting performance. In particular, usually the industry demands for crystals with stable and better processing characteristics such as flow properties and compressibility.1 Nowadays pharmaceutical co-crystals have become an important part of a landscape that was previously occupied only by polymorphs, salts, and solvates/hydrates as it offers opportunity to diversify the number of crystal forms known for an API and to improve their physical properties of clinical relevance with patent protection as a business driven strategy.

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With Regards,

Annie Grace Sarah

Editorial Assistant

Journal of Fisheries Research