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

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Articles

The Question-Based Review (QbR) initiative of the Office of Generic Drugs has reached its second full year in 2009. Special from the Journal of Validation Technology.

FDA Office of Generic Drugs Question-Based Review Initiative: An Update

The United States Department of Health and Human Services (HHS) this week placed an initial order with Sanofi Pasteur (Lyon, France) for a vaccine to fight influenza A (H1N1) infection.

HHS Orders H1N1 Vaccines and Vaccine Antigen

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Sanofi-aventis announced this week that it plans to construct a new vaccine-manufacturing center in Neuville-sur-Saône, France.

Sanofi-aventis To Build New Vaccine-Manufacturing Plant

Angie Drakulich was editorial director of Pharmaceutical Technology.

Covance talks about the risks, challenges, and tests required to develop a pandemic vaccine.

How to Make a Swine Flu Vaccine

Jason Hansell is Junior Applications Technologist at Colorcon Inc. (PA, USA).

Ngoc Do is Senior Technical Manager Film Coatings & Excipients at Colorcon Inc. (PA, USA).

Thomas P. Farrell is Global Director, Immediate Release Technologies, at Colorcon Inc. (PA, USA).

Based on formulation simplicity and blinding capability, hard gelatin capsules are preferrable compared with other oral solid dosage forms, including tablets, in the early clinical phases of drug development.

Narrowing the gap between clinical capsule formulations and commercial film-coated tablets

Pradeep Karatgil is from Custom Pharmaceutical Services, Dr Reddy's Laboratories Ltd (India).

Raviraj Pillai is Vice President, Integrated Product Development, at Dr Reddy's Laboratories Ltd (India). ravip@drreddys.com

Orally disintegrating tablets offer numerous advantages compared with traditional tablets and capsules, and can be an effective solution for developing line extensions of currently marketed therapies.

Orally disintegrating tablets: the path to improved patient compliance and enhanced life cycle management

Bulk Inspection of Tablets-Symetix Application Note

The identification of an increasing number of drug targets coupled with advances in manufacturing technology could lead to many more blockbuster therapeutic antibodies.

Therapeutic antibodies: the next generation

Theodore H. Meltzer is principle of Capitola Consultancy.

Jean-Marc Cappia is vice-president of marketing for fluid management technology at Sartorius Stedim Biotech FMT, Aubagne, France.

The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.

Disposable Components in Aseptic Processing

Yoshi Izumi is executive vice-president at Shibuya Hoppmann Co., a subsidiary of Shibuya Kogyo, Co. Ltd.

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

The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.