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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 Regulatory road map for polymorphs approval is quite clear and for cocrystals draft guidance is on scientific advisory form public.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.
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Author(s): Sonawane Aravind R Rawat Swati S Janolkar Nandkishor N
cocrystal, polymorph, dosage form, regulatory performs, intellectual property.