ABSTRACT:
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.
Cite this article:
Akshay R. Yadav, Shrinivas K. Mohite. Different Techniques and Characterization of Polymorphism with their Evaluation: A Review. Asian J. Pharm. Tech. 2020; 10(3):213-216. doi: 10.5958/2231-5713.2020.00035.5
Cite(Electronic):
Akshay R. Yadav, Shrinivas K. Mohite. Different Techniques and Characterization of Polymorphism with their Evaluation: A Review. Asian J. Pharm. Tech. 2020; 10(3):213-216. doi: 10.5958/2231-5713.2020.00035.5 Available on: https://ajptonline.com/AbstractView.aspx?PID=2020-10-3-14
REFERENCES:
1. Panchagnula R, Sundramurthy P, Pillai O, Shrutidevi A, Yasvanth A. Solid State Characterization of Mefenamic Acid. Journal of Pharmaceutical Science. 2004;93(4):1019-1029.
2. Cesur S, Gokbel S. Crystallization OfMefenamic Acid and Polymorphs. Crystal Research Technology 2008;43(7):720-728.
3. Hosokawa K, Goto J, Hirayama N. PredicitionOf Solvents Suitable for Crystallization Of Small Organic Molecules. Chemical and Pharmaceutical Bulletin. 2005;53(10):1296-9.
4. Manavalan R, Ramasamy C. Physical Pharmaceutics. VigneshPublisher, India 2004: 20 -43.
5. Bahl B, Tuli G, Bahl A, Essential of Physical Chemistry. Twenty-Fourth, India.1997: 565.
6. Vrecer F, Srcic S, Korbar S. Investigation OfPiroxicam Polymorphism. International Journal of Pharmaceutics. 1991;68: 3541.
7. Gary N, Christopher S. Physico-Chemical Characterization of The Orthorhombic Polymorph of Paracetamol Crystallized from Solution. Journal of Pharmaceutical Science. 1998;87: 684-693.
8. Bauer, J, Spanton, S, Henry R, Quick J, Dziki W, Porter W, Morris J. Ritonavir: An Extraordinary Example of Conformational Polymorphism. Pharm. Res. 2001; 18: 859–866.
9. Threlfall T. Analysis of Organic Polymorphs. A Review. Analyst 1995; 120: 2435–2460.
10. Haleblian J, Mccrone W. Pharmaceutical Applications of Polymorphism. Journal of Pharmaceutical sciences. 1995; 58: 911–929.
11. Stahly, G. Diversity in Single- And Multiple-Component Crystals. The Search for and Prevalence of Polymorphs and Cocrystals. Cryst. Growth Des. 2007; 7:1007–1026.
12. Taylor L, Langkilde F. Evaluation of Solid-State Forms Present in Tablets By Raman Spectroscopy. Journal of Pharmaceutical sciences. 2000; 89:1342–1353.
13. Santos O. Polymorphism: An Evaluation of The Potential Risk to The Quality of Drug Products from The Famacia Popular RedePropria. British journal of pharmacology. 1994; 25 :1984-1989.
14. Farias M and Carneiro R, Simultaneous Quantification of Three Polymorphic Forms of Carbamazepine In The Presence Of Excipients Using Raman Spectroscopy. Molecules 2014; 19: 14128-14138.