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 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

The authors review current industry practices and regulatory expectations for the aseptic processing of sterile drugs. They compare and outline critical issues in current manufacturing technology and capabilities with regulatory requirements.

Aseptic Processing: A Review of Current Industry Practice

Using dimensionless analytical models, the authors establish the relationships among the essential parameters of a kneading complexation process.

Analysis of a Kneading Process to Evaluate Drug Substance-Cyclodextrin Complexation

Evaluations have shown, in most cases, visual observations are sensitive enough to verify equipment cleanliness. An experiment was conducted to explore the possibility of using a visible-residue limit as an acceptable cleaning limit in a pharmaceutical research facility, including an evaluation of the limits and subjectivity of ?visually clean? equipment.

Visible-Residue Limit for Cleaning Validation and its Potential Application in Pharmaceutical Research Facility

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

Big Pharma is ramping up capital spending in parenteral manufacturing at the same time that contract manufacturers are completing their own major investment programs.

Pharma Company Investment in Parenteral Manufacturing Capacity Picking Up

Transdermal drug technology specialists are meeting demands for methods that can painlessly deliver larger molecules in therapeutic quantities.

Breaking the Barrier: Advances in Transdermal Technology

Single-use products enhance sterile filtration by making it easier to maintain sterility and reduce cross-contamination risks.

Single-Use Technology for Sterilizing-Grade Filtration

Excel file and formula for Determining Probability of Passing the USP Content Uniformity Test

The authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.

Design of an Aseptic Process Simulation

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.

Use of the Bergum Method and MS Excel to Determine the Probability of Passing the USP Content Uniformity Test

Fernando J. Muzzio, PhD, is a professor and the director of the pharmaceutical engineering program at the Department of Chemical and Biochemical Engineering, Rutgers University, 98 Brett Road, Piscataway, NJ 08854-8058, tel. 732.445.3357.

In this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.