Knowledge Center

Article / 2013

Bridging API manufacturing and formulation through particle design

Scientific article by Márcio Temtem, Filipe Neves, Conrad Winters

Authors:
  • Marcio Temtem
  • Conrad Winters
  • Filipe Neves
Source:
European Industrial Pharmacy, June 2013
The interface between the Active Pharmaceutical Ingredients (API) manufacturing and formulation development is of paramount importance in the pharmaceutical world. Chemists, engineers and formulators are not exposed, by training, to the same challenges. As presented in Figure 1, on the one hand there are API suppliers, characterized by a service orientation mindset, used to addressing synthesis route issues (e.g. impurities, yields), solid state characterization (e.g. polymorphs, polymorph control), raw material sourcing, etc); on the other hand, formulators are used to a different type of language and daily concerns (e.g. bioavailability, patience compliance, administration route, efficacy and processibility).