IPEC e-newsletter - Excipients Insight February 2018 - 28-02-18


Inside this issue


Recommended reading

Eye on Excipients: Effect of HPC molecular weight on granules and tablets prepared by two wet granulation methods

The authors studied six different grades of HPC to determine how they performed in high-shear and fluid-bed granulation.

Tablets & Capsules (Free registration required)

EC publishes new safety features Q&A document

The European Commission has published the latest iteration of its questions & answers document on safety features for medicines.


US FDA’s co-crystal final guidance to reduce cGMP burden

In response to stakeholder feedback, the US FDA has issued a final guidance detailing changes to the regulatory classification of co-crystals, from intermediate to API.


EU penalties for falsified medicines 'varied'

26 EU member states have introduced changes to their legislation in relation to penalties for the falsification of medicines, active substances and excipients.


Formulation and functional considerations for delivering biologics in prefilled syringes

Prefilled syringes represent a win–win scenario for both end-users and manufacturers. This drug-delivery system is widely used across a range of therapeutic areas because of its broad acceptance among healthcare workers, patients, and caregivers. As a result, there is a lot interest in the development of biologic drug products in prefilled syringes within the bio/pharmaceutical industry. Graham Reynolds, vice-president and general manager, Global Biologics at West Pharmaceutical Services, Inc., shares with Pharmaceutical Technology the various aspects that have to be taken into account when developing a biologic drug product in a prefilled syringe.





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