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Here, Dave Elder explores proposals for new FDA rules on tobacco product manufacturing. How could strategies for controlling tobacco-specific nitrosamines compare with those for nitrosamine drug substance-related impurities?
The course of drug development rarely does run smooth. Here, Dave Elder considers how sourcing key excipients impacts the process, highlighting potential consequences of a dual sourcing strategy and suggesting how to approach problems of inter-supplier variability.
Particle size reduction is a fast and cost-effective answer to increasing the exposure of poorly soluble oral drugs by increasing surface area and thereby improving dissolution rate. This approach will only work for DCS IIa1 drugs where dissolution rate is the rate-limiting factor for absorption. This may be applicable to…
When the United States Food and Drug Administration (FDA) called for a shakeup of pharmaceutical production in 2002 it recommended the early adoption of technological advances and the application of modern quality management techniques. It believed that this would make manufacturing processes more robust and improve product quality.1
The EMA recently introduced labelling requirements for some common excipients based on an in-depth assessment of their safety profiles, particularly in the paediatric population.1 This article considers their use in multidose products...
Film coating is a common step in tablet manufacture that can be used to improve product appearance, organoleptic properties, or to facilitate swallowing. Functional film coats can also be used as a part of the product’s stabilisation strategy and to modify or delay drug release.
During 2002, the United States Food and Drug Administration (FDA) requested rationalisation and modernisation of the manufacturing base for pharmaceutical production. This was in the hope that modernising the supply chain would enhance the robustness of manufacturing processes, thereby reducing product failures and, importantly, significantly enhancing product quality.1 The FDA’s…
