Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Reshaping Dosage Forms

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

Frontrunners in Bispecific Antibodies

Topic

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Articles

This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing. 

The Simplified Akers–Agalloco Method for Aseptic Processing Risk Analysis

Last week, the Generic Pharmaceutical Association (GPhA Arlington, VA) praised a proposal by the Senate Agricultural Appropriations Subcommittee that, if approved, would provide $10 million in additional funding for the US Food and Drug Administration?s (Rockville, MD) Office of Generic Drugs.

GPhA Praises Plan to Increase Funding for Office of Generic Drugs

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The US Food and Drug Administration (Rockville, MD) approved the first generic versions of "Zocor" (simvastatin), the anticholesterol drug by Merck & Co., Inc. (Whitehouse Station, NJ).

FDA Approves First Generic Version of Zocor

Pfizer, Inc. (New York, NY) reports the United Kingdom's Court of Appeal has upheld the exclusivity of the main patent covering atorvastatin, the active ingredient in "Lipitor."

Pfizer Gains Favorable Ruling Barring Generic Lipitor

Drug development opportunities, specification development, and new vaccine technologies were highlighted at the AAPS National Biotechnolgy Conference in Boston this week. More than 1100 attendees from 19 countries participated in the event.

Wrap Up: AAPS National Biotech Conference

GlaxoSmithKline PLC (GSK, London, UK) will invest more than GBP102 million ($188 million) over the next four years in a vaccine manufacturing plant in Singapore.

GlaxoSmithKline Plans Vaccine Plant in Singapore

This week?s PharmTech Annual Event (www.pharmtechevent.com) in Somerset, New Jersey, targeted approaches to improving drug development and quality through optimizing processes, managing risk, and controlling variations in manufacturing operations.

PharmTech Annual Event Highlights Process Optimization, Product Quality

Predictable outcomes lead to greater manufacturing efficiency and speed time to value.

Better Process Understanding Improves Quality, Lowers Risk

The biggest single recent trend in outsourcing solid-dosage processing has been the movement toward discovery and synthesis of more potent active pharmaceutical ingredients. 

Outsourcing Solid Dosage Manufacturing

The US Department of Health and Human Services (HHS, Washington, DC) will distribute more than $1 billion in contracts to accelerate the development of cell-based production technologies for influenza vaccines.