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

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 pharm...

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Detalles Bibliográficos
Autores principales: Kumar, Arun, Kumar, Sandeep, Nanda, Arun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Tabriz University of Medical Sciences 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6156475/
https://www.ncbi.nlm.nih.gov/pubmed/30276131
http://dx.doi.org/10.15171/apb.2018.042
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author Kumar, Arun
Kumar, Sandeep
Nanda, Arun
author_facet Kumar, Arun
Kumar, Sandeep
Nanda, Arun
author_sort Kumar, Arun
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description 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.
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spelling pubmed-61564752018-10-01 A Review about Regulatory Status and Recent Patents of Pharmaceutical Co-Crystals Kumar, Arun Kumar, Sandeep Nanda, Arun Adv Pharm Bull Review Article 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. Tabriz University of Medical Sciences 2018-08 2018-08-29 /pmc/articles/PMC6156475/ /pubmed/30276131 http://dx.doi.org/10.15171/apb.2018.042 Text en ©2018 The Authors. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution (CC BY), which permits unrestricted use, distribution, and reproduction in any medium, as long as the original authors and source are cited. No permission is required from the authors or the publishers.
spellingShingle Review Article
Kumar, Arun
Kumar, Sandeep
Nanda, Arun
A Review about Regulatory Status and Recent Patents of Pharmaceutical Co-Crystals
title A Review about Regulatory Status and Recent Patents of Pharmaceutical Co-Crystals
title_full A Review about Regulatory Status and Recent Patents of Pharmaceutical Co-Crystals
title_fullStr A Review about Regulatory Status and Recent Patents of Pharmaceutical Co-Crystals
title_full_unstemmed A Review about Regulatory Status and Recent Patents of Pharmaceutical Co-Crystals
title_short A Review about Regulatory Status and Recent Patents of Pharmaceutical Co-Crystals
title_sort review about regulatory status and recent patents of pharmaceutical co-crystals
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6156475/
https://www.ncbi.nlm.nih.gov/pubmed/30276131
http://dx.doi.org/10.15171/apb.2018.042
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