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A Review about Regulatory Status and Recent Patents of Pharmaceutical Co-Crystals
- 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.
- Subjects :
- business.industry
lcsh:RM1-950
Pharmaceutical Science
Review Article
02 engineering and technology
010402 general chemistry
021001 nanoscience & nanotechnology
01 natural sciences
0104 chemical sciences
Food and drug administration
Crystal Engineering
lcsh:Therapeutics. Pharmacology
Pharmaceutical Co-crystals
Multicomponent systems
Taste masking
Business
General Pharmacology, Toxicology and Pharmaceutics
Regulatory guidelines
0210 nano-technology
Patents
Industrial organization
Pharmaceutical industry
Subjects
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