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

A ready-to-fill closed vial can improve aseptic filling quality and reduce process complexity.

A New Concept in Aseptic Filling: Closed-Vial Technology

Pure water is a raw material of particular importance to the pharmaceutical industry. Drinking water is the basis for the treatment of water for pharmaceutical applications; it is the starting point for the production of the various pharmaceutical water qualities, such as purified water, highly purified water and water for injection.

Removal of Particles by Ultrafiltration Systems

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 complete elimination of human-derived contamination is possible only with the elimination of human intervention.

Aseptic Processing: A Vision of the Future

The appropriate barrier system should be selected using a logical, risk-based approach, with awareness of all the possible sources of contamination.

Isolator Technology With the Patient in Mind

Crucell and NIH Sign Ebola Vaccine Manufacturing Contract

HHS Awards $97-Million Vaccine Development Contract

The principles of direct compression haven’t changed in more than a century. So why can the topic still pack a ballroom?

Evolutions in Direct Compression

Bruno C. Hancock is a scientist in the solids development group at Pfizer.

X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage.This article describes the basic principles of the technique and provides examples of its potential applications.

X-ray Microtomography of Solid Dosage Forms

An increasing number of new compounds are being introduced into pharmaceutical pilot plants.The knowledge base for these compounds regarding their toxicities,physical handling, and cleaning is limited.The authors examine various approaches for addressing the cleaning validation of new compounds and discuss the role of determining appropriate visible residue limits.

Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility

To meet the requirements of the USP ^755& Minimum Fill and ^698& Deliverable Volume tests, target fill levels greater than 100% must be established.This article proposes a criterion for establishing an appropriate target fill level such that a sample will have a 95% probability of passing these USP tests at 95% confidence.