02. September 2018
The current study was aimed to develop extended release (ER) pellets formulations containing zaltoprofen as a model drug and cross-linked starch-κ-carrageenan (Sκ-C) hydrogel composite as a binder and extended release polymer. The Sκ-C cross-linked hydrogel composites were prepared using a 32full factorial design approach and characterized by FTIR, DSC, XRD and SEM analysis. The matrix pellets were prepared by extrusion-spheronization technique and characterized production yield, FTIR, DSC,...
25. February 2017
Abstract The SeDeM Expert Diagram System is a galenic pre-formulation system, which evaluates the suitability of excipients and active pharmaceutical ingredients (API's) for direct compression into tablets as well as predicting possible formulations (i.e. ratios of API:excipient) to obtain acceptable direct compressible tablets. In this study, the prediction ability of the SeDeM Expert Diagram System with a special focus on testing the limits of the system was investigated. Three different...
24. October 2016
Abstract The rapidly growing medical expense going with aging population in Japan requires the use of generic products derived from off-patent active pharmaceutical ingredients (APIs) formulations to reduce the financial burden for the national health insurance system, while at the same time avoiding undermining the quality of medical care. This article provides an overview of the regulatory approaches available to confirm the quality of generic products and gain their greater acceptance by...
23. May 2015
Kurt Nielson (Catalent), Vivek Sharma (Piramal) and Alan Sheppard (IMS Health) join panel CPhI Worldwide, organised by UBM EMEA, announces its expert panel for CPhI Worldwide 2015 ahead of the third edition of the annual report to be released in September and October 2015, in three parts. The report presents a holistic overview of pharmaceuticals with key industry leaders providing expertise across the entire pharma supply chain....
28. April 2015
Rockville, Md., April 27, 2015 — A newly elected Council of Experts of the United States Pharmacopeial Convention (USP) will be responsible for establishing quality standards for medicines, dietary supplements and food ingredients for the next five years. The 2015–2020 Council of Experts was elected at the April 22–25, 2015, USP Convention Meeting in Washington, D.C. http://www.usp.org/news/usps-newly-elected-2015-2020-council-experts-announced