Manufacturing

Comparative studies of the US Pharmacopeia (645) "Conductivity" and the European Pharmacopeia "Heavy Metals" tests were conducted to demonstrate that the USP method can determine the presence or absence of heavy metals in process water samples.

The authors examine the effects of three superdisintegrants on the dissolution and absorption of tenoxicam from solid-dispersion formulations.

Pharmaceutical Science & Technology Innovations

This article examines the different types of dessicants avaliable to the pharmaceutical industry. It provides information on choosing the right type, and how and when it should be used.

The findings of PTE/PT's survey of employment-related issues in the European and US pharmaceutical industries.

DECSpotlight

This article provides guidance for developing dissolution testing for poorly soluble compounds. It is the second of a series of articles based on material from a 2003 PhRMA workshop about acceptable analytical practices.

Microspheres of Eudragit RL were developed for colonic delivery of albendazole. The effects of polymer concentration, stirring rate, and concentration of emulsifier on particle size and drug loading were studied. A comparative in vitro drug release study of the optimized formulation was carried out.

Pharmaceutical Science & Technology Innovations

Researchers are improving photodynamic therapies with new photosensitizers and light sources for deeper tissue penetration, more site-specific treatments, and reduced side effects.

Pharmaceutical Science & Technology News

December_Spotlight

KC News

Amid the finger-pointing, hand-wringing, and bloviating, the supply of hard, technical information remains frustratingly small.

This article provides guidance for minimally acceptable method validation practices and a foundation for assessing the risks and benefits associated with method validation programs.

A discussion of the validation and operation of two commercially available vapor-phase hydrogen peroxide decontamination systems is presented, based on a hands-on examination of both systems.

Pharmaceutical Science & Technology News

Pharmaceutical Science & Technology Innovations

With creative engineering and sophisticated chemistry, industry scientists offer big solutions for attaining small particle sizes and narrow distributions.

Granulation is one of the most important unit operations in the production of pharmaceutical oral dosage forms. However, there are many different technologies each having different strengths and weaknesses. Most companies choose which one to use simply based on their own experience. This article introduces different processes, compares them objectively and offers unbiased advice on the merits of each system. It then looks at the implications of selection on two different applications.

Packaging machines for new or existing lines are easier to operate and change over than they ever were before. Today's packaging machines also accommodate a greater variety of heights, diameters, finishes, or dosage regimen counts.

This article describes a novel approach to a scale-up management system, based on a holistic view of the scale-up lifecycle and an accompanying electronic development record of the information created.

The author argues that information technology solutions will play a major part in confirming-by experimental and statistical validation-that bioprocesses may be interchangeable and therefore generic. The bioprocessing ANDA will define both in-house and contract manufacturing.