Manufacturing

The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.

Pharmaceutical Science & Technology Innovations

Analytical instrument suppliers are developing manufacturing-tailored tools that are small, precise, and easy to use.

European Directive 2004/27/EC will have massive repercussions on the manufacture and marketing of APIs and some excipients across Europe...

A look at how process analytical technology promises to be the most radical change in pharmaceutical manufacturing in 30 years...

FDA cites Essential Pharmacy Compounding (Omaha) for bulk-compounding of verterinary drugs.

Laser-Marking Technique Improves Tablet Branding

ISA-88 Automation Standard Gains IEC PAS Status

Albumin-Bound Nanoparticle Drug Nabs FDA Approval

MHRA to Reinspect Chiron Flu Vaccine Plant

FDA Warning Letters December 2004

Cellular Chemical Factory Lowers Cost of Malaria Treatment

Engineered Oilbodies Produce Vaccines and Adjuvants

Engineered Oilbodies Produce Vaccines and Adjuvants

The author reviews the effects of moisture on flow properties, tensile strength, Heckel plot, energies involved in compaction, and elastic recovery.

A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented.

From solving complex formulation challenges to delivering full product-development programs, outsourcing services organizations provide valuable expertise, experience, and technical know-how.

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