Pharmaceutical Technology Europe-06-01-2011

Pharmaceutical Technology Europe

Optimising High-Potency Manufacture

June 03, 2011

Ingredients

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6

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

News

June 01, 2011

News

23

6

Microdosing for better medicines

The Influence Of Superdisintegrants On Immediate Release

June 01, 2011

Special Feature

23

6

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.

Annex 11: Progress in EU Computer Systems Guidelines

June 01, 2011

Regulation

23

6

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.

A Comparison of Three Extrusion Systems (Part II)

June 01, 2011

Peer-Reviewed Research

23

6

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.

New Annex 11: Enabling Innovation

June 01, 2011

Regulation

23

6

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?.