IPEC e-newsletter - Excipients Insight January 2018 - 20-01-18


Inside this issue


Recommended reading

FDA and MHRA most recent inspection observations

Part of a comprehensive GMP Intelligence program is the monitoring of enforcement actions, including FDA 483s, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent GMP inspection data from CDER and MHRA.  The CDER data are from inspections conducted in FY2016 and the MHRA data come from inspections conducted in 2015.


Aqueous solubility-enhancing excipient technologies: a review of recent developments

At least some degree of solubility in water is necessary for active ingredients in pharmaceutical products to be effective in vivo. However, as efforts to discover and synthesise new active ingredients are pursued by industrial and academic medicinal chemists, achieving sufficient aqueous solubility can often be a significant limitation to clinical and commercial success…

European Pharmaceutical Review

Medications should be labeled 'gluten free,' says FDA

For people living with celiac disease, everything that goes into the body has to be assessed for gluten. Even tiny amounts (trace amounts) of gluten can cause illness in some people with celiac disease. In order to do that, people need to know what they are putting into their bodies.


APDN teams up with Colorcon for pharma authentication

Applied DNA Sciences has formed an alliance with excipient and coating specialist Colorcon for the commercialization of DNA-based taggants used to authenticate products. The project will combine APDN’s molecular taggant and authentication markers with Colorcon’s portfolio of film coating systems, inks and colour dispersions for use in solid oral dosage forms.


Continuing the trend

Continuous processing is being adopted in pharma and biopharma. Could continuous cell therapies be next?

The Medicine Maker




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