Pharmaceutical Technology-04-02-2002

Powdered self-emulsified dosage forms provide an attractive alternative to filled-capsule preparations, but the selection of a proper excipient is crucial.

In this study, the authors examine the suitability of 0.45 &#181m&#150rated filters to be used as sterilizing and bioburden-reduction filters against significant populations of organisms such as B. diminuta in a wide range of differential pressures.

The author discusses the current soft demand and excess capacity in the contract-manufacturing market of small molecule actives and intermediates.

By moving uniformity monitoring back to the blender phase, blend variations that result from factors such as particle distribution and environmental temperature and humidity can be identified early.

This article discusses the use of ion mobility spectrometry as an alternative to high-performance liquid chromatography to reduce the amount of time spent on the cleaning verification process.

Proposed funding increases for FDA reflect plans to significantly increase user fees collected from manufacturers under the Presciption Drug User Fee Act.

Eventual change in the dissolution characteristics of some dosage forms, which is ascribed to cross-linking of gelatin, continues to present challenges to drug manufacturers. The authors discuss the causes, mechanisms, and solutions to the problem.

Reverse auctions can benefit both buyers and suppliers of goods and services, but extensive preparation and careful management are required to obtain those benefits.

In Part I of this two-part series, the authors discuss the need to follow GMPs for lipid-vesicle fabrication that result in size uniformity, delivery of sufficient drug concentration, and stability.