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Pierre Fabre Médicament: Supercritical Fluids Division

Supercritical Fluids Division (PFM SuperCritical Fluids) is a specialized division of Pierre Fabre Médicament the second largest independent pharmaceutical laboratory in France, focusing on ethical drugs, health products and dermocosmetic products.

The division has developed specialized expertise in supercritical fluids technology for pharmaceutical applications, in particular in Drug Delivery Systems (DDS).

In particular, PFM SuperCritical Fluids is responsible for the development and application of Pierre Fabre Medicament’s Formulplex® process that uses Supercritical CO2 as a reactive medium to increase the solubility of pharmaceutical active ingredients, along with proprietary technologies.

Supercritical Fluid Technologies

Supercritical fluids expertise has enabled the development of green processes for preformulation of API’s in development or already marketed, even in the OTC area.

Formulplex®

Formulplex is a complexation process that uses cyclodextrins in a supercritical CO2 fluid medium. This provides a new means to obtain inclusion complexes in mild conditions, and to improve bioavailability of Active Pharmaceutical Ingredients (APIs) with poor solubility.

Cyclodextrins, a family of oligosaccharides, are commonly used to form inclusion complexes with hydrophobic organic molecules. Complexes obtained in supercritical CO2 present different structure characteristics from those obtained with other techniques. In many cases, one property is stronger interaction between the API and the cyclodextrins, resulting in a higher apparent solubility of the resulting complex.

Formulcoat®

Formulcoat is a patented and an innovative coating process that uses expansion of pressurized CO2 combined with lipidic agent to create a uniform and homogeneous layer without agglomeration. The combination causes the coating agent to solidify around particles and then form a surrounding shell on the active compound.

The Formulcoat process eliminates mechanical stress or need for organic solvent during the coating process and allows coating of very small particles (<50 µm).

Main applications are for taste masking APIs, controlled or targeted release, protecting sensitive APIs or to isolating ingredients from other reactive molecules in pharmaceutical formulations.

Formuldisp®

Formuldisp is an innovative batch process that uses supercritical fluids to produce stable solid dispersion. Supercritical carbon dioxide is used as the medium to load an API in an excipient matrix.

Key advantages include a solvent free process, low process temperature, absence of mechanical stress and achievement of more complete and stable amorphisation.

Formuldisp can provide an ideal formulation process for oral administration using GRAS (generally recognized as safe) polymers such as PVP or cellulosic excipient.

Cristallisation

Cristallisation uses supercritical CO2 to enhance dissolution rate by increasing the surface specific area of an API. This can be done by using the supercritical fluid as a solvent in a RESS Process or as an antisolvent in SAS Process.

These processes produce fine powders with narrow size distribution. Cristallisation can also be used in co-process with excipients to obtain composite particles.

Cristallisation is applicable when research goals include obtention of a specific polymorph, micronization of particles (<1µm), enhancement of an API's specific surface area, obtention of a dry particle (RESS Process) or particle design for special administration form.

Services

PFM SuperCritical Fluids offers services in the fields of pharmaceutical development, life cycle management and outsourcing in a cGMP environment that can be used by a range of life sciences companies, from start-ups to multinationals.

These services can be applied to all aspects of projects from early stage development to commercial scale production.

Supercritical Fluids services include:

  • Process development, optimization
  • Scale up
  • Production of clinical and commercial batches
  • Regulatory dossiers filing
  • Technology Transfer
  • Analytical Development

The company has used its specialist know-how to develop multi-purpose cGMP platforms that can:

  • Enable the pharmaceutical development of poorly bioavailable and insoluble APIs (BCS class II)
  • Permit new formulations of API’s already marketed, generating Intellectual Property (Life Cycle management)
  • Use supercritical CO2 for different outsourcing activities in the medical or paramedical field to provide the whole range of mass spectral databases in various data formats

Facilities and Standards

Supercritical Fluids Division is located at an FDA-approved production plant in Gaillac, near Toulouse, in the Tarn Department of France.

The division operates two production workshops, each of 150m2; one dedicated to development and the other to production. These facilities can work with toxic molecules and at various scales, from grams to several tens of kilograms.

State-of-the-art equipment allows a high degree of flexibility and adaptability and includes:

  • High-pressure vessels from 250 ml to 50 liters
  • High pressure CO2 pump (up to 500 Kg/h)
  • A 500 ml fractionation column
  • A semi-preparative SFC
  • Semi-continuous extraction units
  • Cyclonic Separators 10 and 20 liters
  • Mixer-dryer
  • Dedicated handling zone for high potency drugs

The Supercritical Fluids Division is ICHQ7A, GMP and BPF (Bonnes Pratiques de Fabrication) compliant. Since 2005, French health authorities have accepted it as a Recognized Pharmaceutical Establishment.

To learn more about Supercritical Fluids products and services and how they can assist your business, please contact the supplier directly.



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  • Drug Delivery
  • Formulation & Ingredients
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