Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

New York, NY (Jan. 31)-Pfizer, Inc. scored a victory over Synthon IP in a patent infringement lawsuit over the manufacturing process for ?Norvasc? (amlodipine).

Pfizer Wins Court Battle Over Manufacturing Process for Norvasc

St. Louis, MO, (Feb. 8)-SAFC, the custom manufacturing and fine chemicals unit of Sigma-Aldrich Corporation, is seeking to build a footprint in Asia, eying possible acquisitions in India and China.

SAFC Seeks to Build Footprint in India and China

As custom manufacturers gather for InformexUSA this month, strategies in asymmetric synthesis and catalysis prevail.

Innovations in API Synthesis

Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report.

Sixty deals were completed in 2006, with a total value of $2 billion.

Merger and Acquisition Drivers Remain in Place for 2007

The same phenomena that create lightning and thunderstorms are around us every day, producing incredibly high voltages, which cause sparks and shocks. Static electricity is a mighty force. Each year excessive electrical charge build cause explosions in the grain industry.1 Look around any flammable storage area and you will see both grounding bars on the wall and cables, from the grounding bars connected to the drums of solvents. Take any material safety data sheet (MSDS) for a powder and look in section V; it highlights that any dry powder has the potential to attract and store a charge.

Static electricity in solid dosage manufacturing

Raman spectroscopy has become a commonly used technique for physicochemical analysis that possesses many advantages over other analytical techniques. It is a very attractive characterization tool, not least because it enables measurements in water. However, very few examples of its application in an aqueous environment exist in literature. This paper provides some recent applications of Raman spectroscopy in pharmaceutical material and process characterization when water is present.

Applications of Raman spectroscopy in aqueous environments

Terpenes are widely used in topical preparations. This paper focuses on the skin penetration of terpenes depending on their physicochemical properties and influence of the type of dermatological vehicle that was used. The structure of human skin and the skin penetration process is also briefly described.

Skin penetration of terpenes

Pfizer's restructuring plan provides yet another example of new supply-chain strategies by the pharmaceutical majors, which involve rationalization of manufacturing facilities and cost improvement. A review of these moves, an outlook for the pharmaceutical market in 2007, and analysis of US pharmaceutical production and trade.

Changing Fortunes in Pharmaceutical Manufacturing

Rockville, MD (Jan. 12)-To prevent the spread of bovine spongiform encephalopathy (BSE) and related diseases, the US Food and Drug Administration has proposed banning certain cattle tissues and tissue-products from the manufacture of drugs for human and ruminant use. Though cattle products are used in 75% of pharmaceutical processes and 90% of biotechnology processes, the Agency says that no approved or investigational drug appears to contain bovine material that would be prohibited under the rule.

FDA Proposes Ban on Cattle Tissue in Drugs

In 2007, the global pharmaceutical market is expected to grow moderately while biologics, generic drugs, and specialty-initiated drugs are projected to increase at double-digit rates. These trends for finished pharmaceuticals are reflected in the global market for active pharmaceutical ingredients (APIs), where the merchant generic API market is expected to see strong demand. On a production basis, India and China are forecast to raise their shares of the global generic API market against industry strongholds Italy and Spain. Meanwhile, the United States is expected to hold its its position as the leading producer of biotechnology-based APIs in an area traditionally dominated by captive production. And biogenerics or biosimilars gradually reshape the market.

Ingredients