Pharmaceutical Technology Europe-09-01-2007

Pharmaceutical Technology Europe
APIs

September 01, 2007

Fiera Milano Rho Exhibition Centre, Milan, Italy 2–4 October 2007

Validation
Pharmaceutical Technology Europe

September 01, 2007

The recently published Orange Guide 2007 contains significant changes to the GMP requirement placed on pharmaceutical manufacturers, but there have been additional changes to good distribution practice that should not be overlooked.

Pharmaceutical Technology Europe

A new economical method for producing fast-melting lamina-like dosage forms.

Pharmaceutical Technology Europe
Validation

September 01, 2007

The authors discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.

Pharmaceutical Technology Europe
Drug Delivery

September 01, 2007

This article investigates how the industry can test inhalers in a way that is most representative of typical use.

Pharmaceutical Technology Europe

This article describes how rapidly disintegrating tablets containing a large quantity of an intensely bitter drug were successfully developed with a suitable level of masking, tablet hardness, disintegration property, dissolution profile and mouth feel.

Drug Delivery
Pharmaceutical Technology Europe

September 01, 2007

Is consolidated distribution the key to combating counterfeit drugs and parallel imports?

Biopharmaceuticals
Pharmaceutical Technology Europe

September 01, 2007

Getting from a cell culture to a purified biotech product is a demanding exercise involving many operations. Increasing productivity in the upstream part of biotech production is placing new demands on the purification process, which may lead to adopting new technologies.

Pharmaceutical Technology Europe

A new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate.

Pharmaceutical Technology Europe
Manufacturing & Processing

September 01, 2007

The authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulation equipment at the laboratory, pilot and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.