Pharmaceutical Technology Europe-12-01-2004

Size reduction of materials through comminution is employed in many industries, including agrochemicals, minerals, ceramics and pharmaceuticals. The reasons for particle size reduction depend on the industry in question. Within the pharmaceutical industry, a large percentage of products are formed from powders and undergo processing to improve dosage form properties. Particle size reduction prior to compacting to tablets can aid with dissolution and homogeneity. Such processing of powders is, in part, dependent on their mechanical properties and balancing these properties is crucial in achieving desired manufacturing performance. Generally, pilot-scale milling trials are run to determine the most effective and efficient mill and operating conditions for each material. These trials, however, require relatively large quantities of material as well as time, and are normally run in early development when sufficient material becomes available. Hence, it would be highly beneficial to identify a physical property..

The collection, investigation and monitoring of suspected adverse drug reactions (SADRs), and associated product use and complaint information, is a regulatory requirement for all manufacturers of pharmaceuticals for human use.1 This process, called pharmacovigilance or drug safety, appears to be fairly standardized between different pharmaceutical companies and usually contains the elements outlined in Figure 1.

Defenders of the research-based industry are hoping for an early Christmas present from the European Court of Justice (ECJ). All the signs are that a small but significant victory is on the way against parallel importing. Right at the end of October, a senior judge responsible for a leading case at the court made clear his view that international drug firms do not necessarily have to make life easy for parallel importers. The formal ruling on the case at issue is expected within weeks.

A harmonized global specification is possible providing that the procedures and acceptance criteria defined are acceptable to regulatory authorities in all regions.