Pharmaceutical Technology Europe-06-01-2011

Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.

The greatest challenge faced by the EMA is the continuing expansion of the EU.

BASF's Jan Bebber explains why immediate-release formulations boost drug efficacy and aid patient compliance.

The rising popularity of fast dissolving, immediate-release dosage forms can be attributed to their convenience and ease of administration.

It was a mixed crowd hosted by Dusseldorf in the middle of May.

Microdosing for better medicines

When it comes to immediate-release tablet formulations, the choice of disintegrant can have a significant effect on the rate and extent of drug dissolution.

Regions around the world are starting to follow the US trend in disposables and are working to solve common challenges.

In January 2011, a new version of Annex 11 was released by the European Commission along with a revision of Chapter 4 of its GMP on documentation to reflect the actualities of electronic record keeping, all of which come into full effect in June 2011.

The authors compare three systems of single-screw extrusion using binary formulations for their suitability for producing pellets of various formulations and under various spheronization conditions.

In January 2011, the European Medicines Agency (EMA) announced the new revision of EudraLex Volume 4 (GMP) - Annex 11 'Computerised Systems', and the consequential amendment of EudraLex Volume 4 - Chapter 4 ?Documentation?.