Pharmaceutical Technology-03-02-2009

In Search of a Sterile Fill

Instead of protecting the public from unsafe drugs and contaminated foods, the Food and Drug Administration is a "hazard to public health," stated President Barack Obama in announcing his choices to head the agency and new efforts to improve food safety. Margaret Hamburg will be FDA's new commissioner, and Joshua Sharfstein principal deputy commissioner for drugs and medical products.

Scientists studying epilepsy have traditionally focused on the comings and goings of ions through molecular channels in nerve cells, and many current antiseizure therapies seek to modulate that dynamic.

Ultra high performance liquid chromatography is advantageous in a contract laboratory because it is faster, more sensitive, and relies on smaller volumes of organic solvents than HPLC.

USP's Stage 2 heparin monograph revisions address identification, potency, and impurities.

USP's revised chapter on injectables could harm anticounterfeiting efforts and drug administration.

The authors investigate the effects of a polyethylene glycol plasticizer and water on cellulose acetate film properties.

Broader disclosure of drug prices and conflicts of interest are central healthcare reform issues.

Industry has changed, but its basic tenets have not. INTERPHEX's RJ Palermo discusses a 7-step process to keep pharma moving forward.

The authors extend the range of a near-infrared calibration model for tablet assay using production 'seed' spectra and synthetic spectra generated from placebos and 'pure' active pharmaceutical ingredient spectra.

The source of a problem reveals itself after some investigation, or it may crash down on you.

When the business environment returns to "normal," our industry may appear quite different.

Small- and large-molecule drugmakers debate whether they can replicate other industries' success with just-in-time manufacturing.

Editors' Picks of Pharmaceutical Science & Technology Innovations

Brief pharmaceutical news items for March 2009.

Contract manufacturers of APIs and intermediates report gains, but express caution.

Contract manufacturers deploy a business model using operations in the US and Western Europe with facilities in Asia.

Integrated lines, flexible machines, and high-barrier materials enhance packaging options.

The author tests the ruggedness of VRL viewing conditions and defines optimal viewing conditions.

An updated book provides essential information for scientists who monitor microbial quality.

Pharmaceutical Technology's annual survey on equipment and machinery shows fewer companies increased spending in 2008 and still fewer will increase spending in 2009 as overall economic conditions affects purchasing decisions.

The authors present a simple and material-sparing approach for estimating the powder-flow performance of previously uncharacterized single-component bulk powders when only particle-size distribution data are available.

With the economy down and multinational firms capitalizing on patents in developing countries, India's R&D sector still has a long way to grow.