Pharma Excipients

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Low drug load, high retention mometasone furoate cream with polyglyceryl − 3 oleate as a chemical enhancer: Formulation development, in vivo and in vitro evaluation and molecular mechanisms

Abstract The study aimed to create a low loading, high retention, easier to apply O/W mometasone furoate (MF) cream using a chemical enhancer (CE) approach to provide more options for patients with atopic dermatitis (AD) and to investigate molecular mechanisms of its increased release and retention. A Box-Behnken design determined the optimal…
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A Case for Stage 3 Continued Process Verification

FDA Process Validation Guidance (Guidance for Industry: Process Validation- General Principles and Practices, Jan. 2011) outlines process validation activities in three stages - Stage 1: Process Design, Stage 2: Process Qualification and…

US FDA issues new bioavailability guidelines

25. March 2014 By Dan Stanton+, 25-Mar-2014 The US FDA has published guidance of how sponsors should best document the bioavailability of products for investigational new…

Unstandard Standards

12. March 2014 by Michael Anisfeld The need for a single worldwide accepted pharmacopoeia (compendium of drug quality standards) has been recognised for about 150 years when work first started in…
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