List view / Grid view

Articles

Guide to Outsourcing

18 October 2017 | By

Welcome to European Pharmaceutical Review’s Guide to Outsourcing, the fourth in our series of ‘Guide to…’ supplements. In this edition, five leading companies that provide outsourcing services explain how their portfolio meets current industry needs.

Compressed gases: an important component of an environmental monitoring programme

25 August 2017 | By , ,

The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…

Extractables – leachables correlations for packaging

22 August 2017 | By

Plastic materials, widely used in pharmaceutical packaging systems, can interact with the packaged product by transferring leachables. Leaching is important, as foreign leachable impurities can adversely affect the quality, efficacy and safe use of the packaged product, due to their chemical or physical nature, reactivity, and/or toxicity.

Quality control of freeze-dried oral formulations; challenges when developing novel approaches for the delivery of poorly-soluble drugs

22 August 2017 | By ,

A common obstacle encountered in the early stages of drug development is the formulation of poorly water-soluble drugs (PWSDs). One effective approach to improve the dissolution of PWSDs is to render such drugs into their amorphous or disordered form. However, amorphous materials are both physically and chemically unstable, and tend…