Pharmaceutical Technology Europe-03-01-2003

Pharmaceutical Technology Europe

Standards for Supplements

March 01, 2003

Regulars

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As the US Food and Drug Administration (FDA) strives to streamline its regulatory process for bringing new drugs to market (see sidebar "Manufacturing data key to spurring drug development"), efforts to ensure the quality, safety and efficacy of dietary supplements and herbal medicines are gaining more attention.

A Corn Starch/a-Lactose Monohydrate Compound as a Directly Compressible Excipient

March 01, 2003

Features

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The tabletting properties of a new coprocessed excipient for direct compression were compared with a physical mixture of its components (separately and with drugs) and the individual constituents. The compaction properties were also investigated. Results indicated that the new excipient has excellent flow properties and demonstrates enhanced compressibility.

It's the money that counts

March 01, 2003

Regulars

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Brussels report

Experimental and computational methods for understanding pharmaceutical flows, Part I, Laboratory scale devices

March 01, 2003

Features

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Flow problems, such as process performance and reliability, can be improved using a combination of experimental and computational methods.

Design, Development and Optimization Using Computational Fluid Dynamics

March 01, 2003

Features

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Interest in more advanced drug delivery systems has increased, with an acceleration in the discovery and development of novel therapeutic macromolecules for targeted applications. Computational fluid dynamics is a design tool that allows producers of these and other products to evaluate different models rapidly and cost-effectively.

Installing Clean Process Lines

March 01, 2003

Features

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When planning the installation of a new stainless steel process pipeline, it is important to understand the significance of using the best possible materials and techniques to ensure it is clean when installed. This article examines the factors that must be considered when planning and constructing a new process line.

A Literature Review of Pharmaceutical Process Validation

March 01, 2003

Features

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The renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the development of pharmaceutical process validation, and demonstrate how industry opinion regarding the concept has shifted from that of a regulatory burden to something driving total quality management and cost benefits.