Department of Pharmaceutical Chemistry, Rajarambapu College of Pharmacy, Kasegaon, Dist - Sangli, Maharashtra, India-415404
*Corresponding Author E-mail: akshayyadav24197@gmail.com
Online published on 16 September, 2020.
Polymorphism has emerged as a major focus for industry and regulatory agencies respectively. Polymorphism can affect physical and chemical stability, apparent solubility, dissolution, bioavailability and bioequivalence and drug product manufacturability, which require special attention during product development as it affects drug product quality, protection and effectiveness.It describes to exsist in two or more crystalline phases which have different arrangement of molecules in solid state with different arrangements or conformations of constituents in crystal lattices. The knowledge of the thermodynamic stability and thermokinetics is desired for better understanding of transformations and the time required for these transformations. Some of techniquesexamines difference in temperature form between reference and sample like function of temperature. It is useful in vapourization, boiling, fusion; solid-solid transition crystallization structure inversion and also used to characterize polymorphism to provide a powerful to isolate and identify of crystalline modification and its size and shape plays important role if they used as sustained release dosage. It usually have important role in properties like hardness of tablet and suspension stability and used to know difference between anhydrous and solvate form then for identification of polymorphs. Furthermore, the effect of polymorphism, polymorphism monitoring and regulation, and polymorphic knowledge reporting scheme in Abbreviated New Drug Application.
Dissolution, Bioavailability, Bioequivalence and New Drug Application