Development

Articles

The author reviews dimensional analysis as a straight-forward approach to scale up.

How to Scale Up Scientifically

The author points out some major obstacles to effective scale-up and describes methods available to pharmaceutical scientists for addressing scalability issues.

Scale Up of Liquid and Semisolid Manufacturing Processes

In the manufacture of many pharmaceutical products, dry-particle blending is a critical step that directly affects content uniformity.

Scale Up of Powder-Blending Operations

This article describes a novel approach to a scale-up management system, based on a holistic view of the scale-up lifecycle and an accompanying electronic development record of the information created.

Integrated Information Management Approach to Drug Substance and Drug Product Scale-Up

Charles R. Cunningham is a global technical manager at Colorcon, 415 Moyer Boulevard, West Point, PA 19486, tel. 215.699.7733, fax 215.661.2626.

Poly(vinyl acetate) phthalate-based and acrylic-based enteric coating systems are evaluated for their performance on acetylsalicylic acid tablets in areas such as acid resistance and coated-tablet stability.

One-Step Aqueous Enteric Coating Systems: Scale-Up Evaluation

David G. Sixsmith is a senior quality consulant for Bovis Tanvec, Tanshire House, Shackleford Rd., Elstead GU8 6LB, UK, tel. 44 1252 703 663, fax 44 1252 703 684.

Careful planning and decision-making can circumvent possible delays in technology transfers.