Pierre Fabre Medicament - Supercritical Fluids Division - Bioavailability Enhancement – Improvement of Solubility – Taste-Masking – Particle Design

Supercritical fluids division: the SuperCritical solutions to your critical problems. Our SuperCritical Fluids Research & Development Center (CDFSC) is a recent unit of Pierre Fabre Médicament, second independent pharmaceutical French laboratory.

This department has developed an extensive expertise in SuperCritical Fluids, focused on the development of innovative API formulations. At Pierre Fabre our main patented technologies are performed in a multi-purpose platform in compliance with cGMP, (recognized as a pharmaceutical establishment by French health authorities). Formulplex, Formuldisp, Formulcoat and Micro-Nano particle processes are used to improve bioavailability, solubility, or for taste-masking and particle design.

We propose our services to external partners (from start-up to multinational) in the medical or paramedical field and from the early stage of development to commercial scale.

Formulplex®: improvement of bioavailability

Formulplex® is a novel patented formulation process in a supercritical medium complexation with cyclodextrin in a solid form. It permits enhancement of the apparent solubility of a poorly soluble drug.

Formulplex®'s key advantages

Formulplex® is considered as a first step of formulation process by health authorities and consequently permits new formulations of API's already marketed, generating intellectual property (Life Cycle Management). Formulplex® is also a single step process, solvent free scaling-up mastered, with a production yield of 100% using a reaction simple and reproducible.

Please refer to our latest whitepaper to see our results.

Formuldisp®: stable solid dispersion

Formuldisp® is an innovative single step patented process using CO2 as medium to load an API in an excipient matrix.

Formuldisp®'s key advantages include:

Formuldisp® is a suitable formulation process for oral administration using GRAS (generally recognized as safe) polymer. Formuldisp® is a solvent free and low temperature process which permits a total and stable amorphisation with a 100% yield.

Please refer to our latest whitepaper to see our results.

Formulcoat®: taste-masking with lipidic agent

Formulcoat® is an innovative patented coating process using lipidic agent and leading to a uniform and homogeneous layer without agglomeration.

Formulcoat® permits to coat very small particles (<50µm) without any use of organic solvent during the coating process and at room temperature, with a high productivity (60kg/h).

Please refer to our latest whitepaper to see our results.

Nano-particle & particle design - enhancing the dissolution rate

Enhancing the dissolution rate by increasing the surface specific area of an API.

Two processes are performed:

• RESS (rapid expansion of supercritical solution) for CO2 soluble API
• SAS (supercritical anti solvent) for CO2 insoluble API. RESS, SAS processes are available to produce nano or microsized particles with a narrow size distribution and a mastered crystalline form

Please refer to our latest whitepaper to see our results.

Recognized quality engagement

• A multi-purpose platform in compliance with cGMP
• Recognized as pharmaceutical establishment by French health authorities
• FDA approved site
• ISO 14001 certified site since 1998 and awarded by the French Ministry of environment for our efforts within environment protection.
• CPhI Silver Innovation Award for our Formulplex® technology

Applications area:

• Extraction
• Fractionation / enrichment of natural substances
• Purification
• Cleaning / treatment of medical device etc...