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Sutar M.R.,Institute of Pharmaceutical Education and Research Borgaon Meghe | Tenpe C.R.,Institute of Pharmaceutical Education and Research Borgaon Meghe
International Journal of Pharmaceutical Sciences Review and Research | Year: 2013

Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (R&D) efforts of the company to the market. Various government agencies are involved in regulating drugs within their market, namely, USFDA-US, EDQM-Europe, TGA-Australia, MHRA-UK and TPD-Canada. A regulatory affair is becoming increasingly influential in the overall drug development process and is increasingly populated by highly trained scientists and medical professionals. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of drugs. This article will focus the similarities and differences in drug approval process of Europe, USA & Indian regulatory bodies. Years ago, a regulatory affair was often just a place where paperwork was done. There is still a lot of paperwork, although much of it is now in electronic format, but science and strategy now take precedence. So this paper point up the comparative regulatory approval process & requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India. Source

Singhavi D.J.,Institute of Pharmaceutical Education and Research Borgaon Meghe | Khan S.,Institute of Pharmaceutical Education and Research Borgaon Meghe | Yeole P.G.,Institute of Pharmaceutical Education and Research Borgaon Meghe
Journal of Materials Science: Materials in Medicine | Year: 2013

The objective of this study was to develop submicron carriers of two drugs that are practically insoluble in water, i.e. meloxicam and aceclofenac, to improve their dissolution behavior. The phase solubility of the drugs was studied using different concentrations of sparingly methylated β-cyclodextrin, Kleptose® Crysmeβ (Crysmeb), in the presence and absence of 0.2 % w/v water-soluble chitosan. Drug-loaded submicron particles (SMPs) were prepared using chitosan chlorhydrate and Crysmeb by the ionotropic gelation method. The SMPs were characterized in terms of powder X-ray diffraction, Fourier transforms infrared spectroscopy, size determination, process yield, drug loading, encapsulation efficiency, surface morphology and in vitro release. The drug loading in the SMPs was enhanced in the presence of Crysmeb. The in vitro drug release was found to be enhanced with SMPs prepared using higher concentrations of Crysmeb. These results indicate that SMPs formed from chitosan chlorhydrate and Crysmeb are promising submicron carriers for enhancing the dissolution of meloxicam and aceclofenac. © 2013 Springer Science+Business Media New York. Source

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