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31. October 2015
Amendments to Federal Law No. 61-FZ “On Circulation of Medicines” of April 12, 2010, come into force on January 1, 2016, and extend the requirements for information submitted by applicants in drug registration dossiers. The introduction of the new requirements necessitates the preparation of guidance materials concerning various sections of the registration dossier, including those for drug excipients. Regulations of the EU, USA, Japan, and Russia and the database of the Scientific Center...
30. October 2015
29. October 2015
29. October 2015
Highlights • A GF release system was consisted of fish Col/Ch/CS scaffold and PLGA MPs. • The release rate could be adjusted by the ratio of collagen to chitosan and the size of MPs. • The released bFGF retained its structure integrity and bioactivity. • The scaffolds/MPs could promote cell proliferation and tissue regeneration. • This scaffold/MP release system has the potential for skin tissue engineering. More
29. October 2015
29. October 2015
The aim of this study was to prepare and characterize chitosan-magnesium aluminum silicate (chitosan-MAS) microparticles, which can be used as matrix formers in sustained release tablets. The chitosan-MAS composites were prepared using spray drying. Physicochemical and micromeritic properties of the spray-dried chitosan-MAS microparticles were investigated. More
28. October 2015
Generics may differ from their reference product in terms of inactive ingredients, e.g. excipients, provided this does not affect the safety and efficacy of the product. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by such formulation differences between generic and originator drugs [1]. More
28. October 2015
Introduction: Choline bitartrate (CBT) is a vital nutrient for fetal brain development and memory function. It is hygroscopic in nature which is associated with stability related problem during storage such as development of fishy odor and discoloration. Aim: Microencapsulation method was adopted to resolve the stability problem and for this hydrogenated soya bean oil (HSO) was used as encapsulating agent. More