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A Review about Regulatory Status and Recent Patents of Pharmaceutical Co-Crystals

Authors :
Sandeep Kumar
Arun Nanda
Arun Kumar
Source :
Advanced Pharmaceutical Bulletin, Vol 8, Iss 3, Pp 355-363 (2018), Advanced Pharmaceutical Bulletin
Publication Year :
2018
Publisher :
Maad Rayan Publishing Company, 2018.

Abstract

Pharmaceutical Co-crystals are not new, they have gained much attention since the last decade among scientists and pharmaceutical industry. Pharmaceutical co-crystals are multicomponent systems composed of two or more molecules and held together by non-covalent interactions. The development of pharmaceutical co-crystals, a new solid crystalline form, offer superior physico-chemical properties (such as melting point, stability, solubility, permeability, bioavailability, taste masking, etc.) without altering the pharmacological properties. Recently, with the upsurge in the growth of Pharmaceutical co-crystals, the major concern is over the regulatory status of co-crystals. With the new guidelines from United States Food and Drug Administration (USFDA) and European Medicines Agency (EMA), the status has become even more complicated due to significantly different opinions. This review highlights whether co-crystals fulfil the requirements for the grant of a patent or not and how cocrystals are going to affect the present scenario of pharmaceuticals.

Details

ISSN :
22517308 and 22285881
Volume :
8
Database :
OpenAIRE
Journal :
Advanced Pharmaceutical Bulletin
Accession number :
edsair.doi.dedup.....66c4d4c5b075ae662e8381b907f58ce4
Full Text :
https://doi.org/10.15171/apb.2018.042