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

Filling active ingredients directly into capsules is probably the quickest option for entering clinical trials. This case study compares manual and automated methods of capsule filling.

Manual and Automated Filling of Powder in Capsules for Clinical Trials

FDA is asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications.

Regulatory Roundup: FDA asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications

The authors develop a pratical approach to avoid unwanted interactions between pepsin and SLS in dissolution Tier II tests.

Gelatin Capsule Shell Cross-Linking

Emerging methods could provide alternative ways of producing inhalable drug particles.

Beyond Micronization

Innovator and generic-drug companies need to adapt to compete in the biosimilars market.

Manufacturing Strategies for Biosimilars

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.

The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised.

Regulation of Aseptic Processing in the 21st Century

A technical forum moderated by Patricia Van Arnum

Strategies in Parenteral Drug Manufacturing

Amy Ritter was Scientific Editor, BioPharm International.

The IMS institute has released its report on the use of medicines in the United States during 2010.

IMS: Growth in Drugs Stalls, Generic Use Up

We want to fill one of our oxygen-sensitive products inside an isolator system. Can we run an isolator with pure nitrogen and defined humidity?

A Nitrogen-Filled Isolator?

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Increased competition, the rising role of emerging markets, and targeted opportunities in niche segments are factors influencing the generic-drug market and related supply base.