01. October 2017
In general, it is an important criterion that excipients remain inert throughout the shelf life of the formulated pharmaceutical product. However, depending on the functionality in chemical structure of active drug and excipients, they may undergo interaction. The well-known Maillard reaction occurs between a primary amine with lactose at high temperature to produce brown pigments. The reactivity of Maillard reaction may vary depending on the concentration as well as other conditions....
26. September 2017
In general, it is an important criterion that excipients remain inert throughout the shelf life of the formulated pharmaceutical product. However, depending on the functionality in chemical structure of active drug and excipients, they may undergo interaction.
15. January 2017
Introduction The International Conference on Harmonization (ICH) finalized the ICH Q3D Guideline for elemental impurities in December 2014.1 Regulators are now implementing the requirements worldwide, with some start dates already in place as of June 2016. ICH Q3D is the most comprehensive guideline for limits and risk assessment approaches for elemental impurities in final drug products to date; however, it does not specify limit for the major components of drug products. This brings...
25. April 2016
In the present study, the effect of Hydroxy Propyl Methyl Cellulose (HPMC) on the crystallization of ortho-aminobenzoic acid (OABA) was investigated by seeded and unseeded cooling crystallization experiments. The influence of HPMC on the induction time, crystal shape of Forms I and II of OABA and the polymorphic transformation time was studied. Furthermore, the capability of HPMC to inhibit growth of Form I was evaluated quantitatively and modelled using population balance equations (PBE)...
10. March 2016
With the first deadline for the ICH Q3D guideline on elemental impurities just a few weeks away, pharma companies are still facing some uncertainty about how to comply with the requirements. After June of this year, any pharma company in ICH regions wishing to file a marketing application for a drug will have to comply with the guidance, while established products will have to be ICH Q3D-ready by December 2017. In essence, ICH Q3D introduces a risk-based approach to the control of elemental...
29. January 2016
The objective of the current research article is to provide a comprehensive review of excipients impact on the stability of the drug product and their implications during the product development. Recent developments in the understanding of the degradation pathways further impact methodologies used in the pharmaceutical industry for potential stability assessment. The formation of drug excipient adducts was very common based on the sensitive chemical moieties in the drugs and the excipients. The...
20. January 2016
In the pharmaceutical world, the application of a definition developed for one purpose to other areas frequently has unintended consequences, resulting in confusion and unnecessary compliance burdens. The term "impurity" is one such example and was a subject of lengthy debate at IPEC-Americas Dec. 8 Excipient Composition Committee. READ MORE
19. October 2015
BY AJIT S. NARANG, MIKE TOBYN, AND ROBERT A. REED Excipient variability has been studied in areas such as particle characteristics, cross-linking, or reactive impurities with the goals of (a) identifying and quantitating potential variability in commonly used excipients, and (b) either designing formulations and processes that can accommodate expected variability or developing an understanding of the excipient variability design space and a control strategy for drug product and excipients....
13. August 2015
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