Pharmaceutical Technology-03-02-2005

pharmaceutical science and technology news

Pharmaceutical packaging can no longer be an afterthought in pharmaceutical product development.

Some published articles purport to demonstrate the difficulties and problems of the laser diffraction technique without mentioning that these apparent problems are inherent in all particle-sizing techniques. This article discusses some of the advantages of using laser diffraction for particle sizing-including repeatability, ease of verification, and speed of measurement-and why it has become the preferred technique in a range of industries.

After a five-year downturn, cautious optimism is taking hold among API manufacturers.

pharmaceutical science and technology innovations

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

In this time of liability reform, pharma deserves the chance to align its economic interests with its ethical obligations to the patient.

This article outlines a comprehensive approach for organizing a firm's aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations, and determining which vials to incubate.

As newer and more elaborate hardware and software systems are installed in automated manufacturing environments, companies are further incorporating good practices into their validation process.

The authors evaluate the implications of product photosensitivity and how it influences various aspects of product development. They discuss a product photosensitivity classification system and present a photosensitive pharmaceutical product case study.

New fixed-dose combination drugs aim to enhance safety and efficacy, while regulators clear a path for more drug–device combination products.