PIERRE FABRE CDMO Supercritical Fluids

A supercritical CO2 GMP Unit for Pharmaceutical Applications.

16 Rue Jean Rostand, Gaillac 81603, France



Pierre Fabre's Supercritical CO2 GMP unit.

Pierre Fabre CDMO Supercritical Fluids is a Supercritical CO2 good manufacturing practice (GMP) unit for Pharmaceutical applications, which proposes development and manufacturing services.

The company is well known as a contract manufacturer and it performs pre-formulation of active pharmaceutical ingredients (API) through patented processes Formulcoat®, Fomulplex®, and Formuldisp®.

This French manufacturing plant also performs technical transfer and cleaning of medical components by supercritical carbon dioxide technology.

Drug Delivery enhancement of API using supercritical CO2

The Supercritical Fluids department of Pierre Fabre Group began its activity in drug delivery enhancement performing pre-formulations of API using three developed patented processes.

For product requests involving changes to solubility, bioavailability, or taste-masking, Pierre Fabre contract and development manufacturing organisation (CDMO) conducts a feasibility study to ensure the customer’s needs are met. These are performed once a quotation has been approved. After evaluation and modifications have been made, a development and supply agreement can be implemented.

The company’s development workshop can treat a wide range of API, including high-potency drugs.

Active pharmaceutical ingredient taste-masking

The FORMULCOAT® process is used for the taste-masking of bitter APIs. It is an innovative patented coating process, which uses a uniform and homogeneous layer of lipidic agent without any agglomeration.

Formulcoat® is able to coat particles even less than 50µm without any use of organic solvents. The process can be applied to large batches and it occurs at room temperature.

Improving bioavailability of poorly-soluble API and making new formulations of pre-marketed API

The FORMULPLEX® process improves the bioavailability of poorly-soluble APIs. This novel patented process involves complexation with cyclodextrin in supercritical CO2.

It is considered as a first step of the formulation process by Health Authorities and helps make new formulations of already marketed API’s, generating property (life cycle management).

Formulplex® is a single step process, which is solvent-free and uses a simple and reproducible reaction.

FORMULDISP® process increases excipient functionality. This innovative, single step, patented process uses high-pressure CO2 as a medium to load an API in an excipient matrix.

The result is a totally stable solid dispersion, with enhanced properties. This process is suitable for oral administration using G.R.A.S polymer.

Scale-up of supercritical CO2 processes via a GMP unit

In addition to these Drug Delivery enhancement services, Pierre Fabre CDMO Supercritical Fluids offers to scale-up other supercritical CO2 processes in its specialised good manufacturing practice (GMP) unit.

Located in Southwest of France, the state-of-the-art unit can ensure the optimisation process and the manufacturing of clinical and commercial batches for pharmaceutical applications.

Its workshop is a multipurpose platform, which is recognised as a pharmaceutical establishment by French authorities. The facility is located in a Food and Drug Administration (FDA) inspected site and also accords to ICHQ7A guidelines.

Cleaning of medical devices

Pierre Fabre CDMO Supercritical Fluids now applies its supercritical technology to clean medical components such as gaskets used in metered-dose inhalers or medical textiles.

The process achieves efficient results, degreasing without toxic or dangerous solvents and without a drying step. Contaminants such as oils and lubes are removed, even from small cracks and crevices. Furthermore, performance and quality of the treated materials are unaffected.

The cleaning of medical components by supercritical fluids is a totally green and efficient process. Products are treated in reactors of 2-and50 litre capacity in an ISO 7 clean room.

Custom Purification of Injectable Polymers

Pierre Fabre Médicament's supercritical division has industrialised a process to extract monomers or low molecular weight fraction from an injectable polymer.

Cleaning of Medical Devices

Pierre Fabre's supercritical (SC) fluids unit proposes its services to clean medical components by SC CO2.

Pierre Fabre CDM: Supercritical Fluids Expertise

Pierre Fabre Médicament - Supercritical Fluids Division is a specific department of the French independent pharmaceutical Pierre Fabre laboratories, using supercritical fluids for pharmaceutical applications.

Meet Pierre Fabre Médicament – Supercritical Fluids Division in 2011

Pierre Fabre Médicament - Supercritical Fluids Division, a unit of Pierre Fabre Médicament, the second independent pharmaceutical French laboratory, is pleased to announce that it will attend the following events in 2011: 26-28 January 2011: Drug Delivery Partnership (DDP) Mia

Innovative Formulations at the AAPS Annual Meeting in New Orleans

From 15 to 17 November 2010, Pierre Fabre Medicament will be exhibiting at the AAPS annual meeting in the Morial Convention Centre in New Orleans, Louisiana, US. Do you have critical problems in terms of solubility, bioavailability, stabilisation, taste-masking and more? We have SuperC

PFM – Supercritical Fluids Division to Exhibit at CPhI Japan 2010

From 21 to 23 April 2010, Pierre Fabre Medicament will be exhibiting at CPhI Japan 2010 in Tokyo, at the Tokyo Big Sight Exhibition Centre. Interested in our extensive expertise in supercritcal fluids focused on the development of innovative API formulations? Please contact us to make a

Pierre Fabre Medicament : Exhibitor at CPhI Worldwide Madrid 2009

From 13-15 October 2009, Pierre Fabre Medicament will be exhibiting at CPhI Worldwide 2009 in Madrid. Interested in our extensive expertise in supercritcal fluids focused on the development of innovative API formulations? Please contact us to make an appointment for CPhI Worldwide 2009. You can a

Pierre Fabre Medicament to Exhibit at Controlled Release Society 2009

Pierre Fabre Medicament will exhibit at Controlled Release Society 2009, which will be held from 20 July to 22 July in Copenhagen's Bella Center, Denmark. The supercriticalfluids division will present its updated technologies using supercritical fluid at stand 408.

Supercritical Fluids Division: Exhibitor at CPhI Japan 2009.

Pierre Fabre Medicament will exhibit at CPhI Japan 2009, which will be held on 21-23 April 2009 at Tokyo Big Sight Exhibition Center. Our supercritical fluids division will present its updated technologies using supercritical fluid at Pierre Fabre Medicament's stand, number D-18.

Supercritical Fluids Division: Exhibitor at AAPS Atlanta 2008

Pierre Fabre Medicament will exhibit at AAPS Atlanta 2008, which will be held between the 16th and the 20th of November 2008. Our supercritical fluids division will present its updated technologies using supercritical fluid at stand Pierre Fabre Medicament, number 2637. We will also have a poste

Conference on Bioavailability Enhancement by a Supercritical Process

Dr Hubert Lochard, R&D Project Manager, will give a conference at Dissolution Testing, Bioavailability & Bioequivalence organised by Informa on November, 21st in Berlin. The topic of his presentation is Bioavailability Enhancement by a Supercritical Process. He will give

Patented Drug Delivery Technologies: FORMULPLEX and FORMULCOAT

Based on our know-how in supercritical fluids, we have developed a multi-purpose technology platform. Today, three main technologies are available from development to commercial production: nanoparticles, FORMULPLEX® and FORMULCOAT®. NANOPARTICLES Enhancing t

Stabilization, Protection and Taste Masking of APIs

Pierre Fabre Medicament (active ingredients division) will be participating in the following events : Strategies to Enhance Solubility, Permeability and Absorption of Drugs, Amsterdam. December 12th and 13th Drug Delivery Partnerships, Las Vegas, NV. January, 22nd to 24

Innovative Coating Technology - SuperCritical Fluids

Pierre Fabre Medicament - active ingredient division - has recently enlarged its Drug Delivery Technology portfolio based on its knowledge in SuperCritical Fluids. This innovative coating technology enables the coating of small-sized particles and an alternative process enables

Natural Product Extraction and Purification - Botanical Drug Substance

Pierre Fabre Medicament - active ingredients division - will be attending Natural Products in Drug Discovery & Development on the 21-22 June 2006 in London. Based on 40 years' experience, Pierre Fabre Medicament is highly active in the development of plant-derived APIs. From

Solubility Enhancement of a Poorly Soluble API

Pierre Fabre Medicament - active ingredients division - will be exhibiting at INFORMEX (Stand #1342) and will give two presentations on the 14th of February : 11:20 am - 11:40 am : Technology Showcase AN INNOVATIVE SOLUTION TO DEVELOP POORLY SOLUBLE APIS - BIOAVAILABIL

Development Of Poorly-Soluble APIs

On the occasion of CPhI, Pierre Fabre Medicament, Active Ingredients Division, will present its innovative technology enabling the development of poorly-soluble APIs. PFM has developed an extensive expertise in solubility enhancement of molecules exhibiting a low bioavailability. RESS,

Dramatic bioavailability increase of API in SuperCritical medium.

Dramatic bioavailability increase of API in SuperCritical medium. Plantes & Industrie, development and manufacturing site of Pierre Fabre Group, has published an article in the April issue of Speciality Chemicals Magazine (http://www.specchemonline.com/). This press release provid

Bioavailability Enhancement of APIs Using SuperCritical CO2

Plantes & Industrie, the development and manufacturing site of Pierre Fabre Group, has successfully launched its two new state-of-the-art development and production units. These facilities are dedicated to the industrial production of nanopowders and complexation with cyclodextrins. The main

PIERRE FABRE CDMO Supercritical Fluids