Pierre Fabre Medicament - Supercritical Fluids Division won the CPhI Silver Innovation Award for its FORMULPLEX ® technology

The Supercritical Fluids Division of Pierre Fabre Medicament has been named winner of the 2008 silver « innovation award » at the CPhI worldwide conference in Frankfurt, Germany. This price rewards the extensive expertise in supercritical fluid technologies.

Indeed, from 2004, the « Supercritical Fluids Division » of the second independent French pharmaceutical company is focused on the development of new formulation tools using pressurized carbon dioxide as a solvent. It's an innovative way to carry out crystallisation, impregnation, complexation or many pharmaceutical operations at low temperature, without any organics solvents or mechanical stress. Carbon dioxide is safe, and after depressurization, final product is totally dry, free from residual solvent.

The technology awarded during CPhI is FORMULPLEX ® : a complexation process with cyclodextrin in supercritical CO2 medium. It's a new way to obtain inclusion complexes in mild conditions and to improve bioavailability of poorly soluble drugs.

Cyclodextrins, a family of oligosaccharides, are commonly used to form inclusion complexes with hydrophobic organic molecules in order to enhance the Active Pharmaceutical Ingredient apparent solubility. Therefore complexes obtained in supercritical CO2 present structure characteristics different from those obtained with other techniques. An interesting property is that in many cases, the interactions between the active ingredient and the cyclodextrins are more efficient, resulting in a higher apparent solubility of the complex obtained.

FORMULPLEX ® presents great advantages such as mild and free-solvent operating conditions, or energy-lower cost. Indeed, it's a batch process, without stirring, at mild temperature using only pressurised carbon dioxide and a small amount of water.

Besides FORMULPLEX ®, Pierre Fabre Medicament has developed also others patented technologies based on the use of pressurised carbon dioxide. FORMULDISP ® lead to a stable solid dispersion with enhanced excipient functionality. With FORMULCOAT ®, supercritical CO2 is used to coat particles for taste masking, stabilization. Finally, RESS or SAS process can be used to increase the surface specific area of an API with a narrow size distribution and a mastered crystalline form

Dr. Hubert LOCHARD, in charge of R&D projects, said « Firstly, we developed this technology with public research centre (ENSTIMAC, CEA), but in 2004, we decided to cross the gap and to build a multi-purpose platform in compliance with cGMP ». This unique facility able to produce 30kg batches for clinical trials has been already used for different outsourcing activities in the medical or paramedical field. The firm proposes indeed to its partners to help their for pharmaceutical development of poorly bioavailable drugs or for Life Cycle management.