IPEC e-newsletter - Excipients Insight March 2018 - 28-03-18


Inside this issue


Recommended reading

'Problem' excipients: be cautious when making clinical decisions on formulation

The Pharmaceutical Journal

We are writing in response to the article ‘How to identify and manage ‘problem’ excipients in medicines for children’, written by Sara Arthur and Anna Burgess and published in The Pharmaceutical Journal (2017;299(7903):42­–45). The article helpfully raises awareness of the potential toxicity issues associated with ‘problem’ excipient use in children’s medicines and directs readers to age-based safety limits recommended by the European Medicines Agency (EMA).

Renewed interest in 'understudied' co-crystals to drive better meds, says scientist


Pharmaceutical co-crystals can improve the properties of active substances and ultimately make better medicines, says researcher.

Facility and excipient information shortfalls identified by FDA as among key contributors to ANDA review delays


FDA’s Office of Generic Drugs (OGD) is cautioning ANDA sponsors to pay more attention to making sure that current information is provided on all of the facilities involved in the development, manufacturing, control testing and warehousing of APIs and finished dosage forms in both the Form 356h and application module 3.2.S.2.





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