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, characterised by a service orientation mindset, used to addressing synthesis route issues (e.g. impurities, yields), solid state characterisation (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).
Article / Jun 01, 2013
Bridging API manufacturing and formulation through particle design
European Industrial Pharmacy, June 2013