Gattefossé Expands its Offer With the Launch of Three New Pharmaceutical Excipients

Gattefossé, supplier of specialty ingredients for the health and beauty industries, announces the launch of three new pharmaceutical ingredients: Labrafac™ MC60 and Gelucire® 59/14, for the for oral administration route and Emulfree® Duo for the topical administration route. The group celebrated its 140th anniversary last year and has stayed the course despite the past two years which were marked by the global pandemic and resulting health crisis.
With the launch of these three excipients, Gattefossé demonstrates its commitment to exploring the very best of nature and science since 1880.

Rare & Unprecedented News
Launching three ingredients in the same year is unusual in the pharmaceutical ingredient industry, given the long and complex research & development and regulatory demands that are placed on the developer. But once completed, new ingredients can successfully and safely address many formulation challenges that are present in the industry.
To ensure their international launches and successes, Labrafac™ MC60, Gelucire® 59/14 and Emulfree® Duo conform to all regulatory requirements.

“This last quarter of 2021 is both exciting and challenging. We are proud to launch three new lipidic excipients, expand our range and offer new solutions to address our customers’ needs. With everything we do, we always look to innovate, while remaining dedicated to providing solid customer support and technical
assistance. As specialists in lipid chemistry, we provide formulation expertise supported by our reliable, effective and safe ingredients,” said Eduardo de Purgly, Chief Executive Officer of Gattefossé group.

What is Labrafac™ MC60 used for?
Labrafac™ MC60 is used for oral bioavailability enhancement of poorly water-soluble, poorly permeable drugs. It acts as a solubilizer for a wide range of molecules and as an intestinal permeation enhancer.

What is the chemistry behind Labrafac™ MC60?
With its unique and respected expertise in lipid chemistry, Gattefossé has developed a robust and validated esterification process, between glycerol and capric and caprylic fatty acids, to produce a high quality, highly reproducible excipient composed of mono- and di-glycerides. Labrafac™ MC60 has mild surfactant properties and an HLB=5.

What is the regulatory status and precedence of use of this excipient?
Labrafac™ MC60 complies to USP-NF and Ph. Eur. Pharmacopoeias. Glycerol monocaprylocaprate has been used for decades in the pharmaceutical industry in numerous drug products around the world.

What is Gelucire® 59/14 used for?
Gelucire® 59/14 is a self-emulsifying excipient used for oral bioavailability enhancement of poorly water-soluble drugs, owing to its high solubilization capacity.

What is the chemistry behind Gelucire® 59/14?
It is a mixture of lauroyl PEG-32 glycerides EP/NF and PEG 6000 EP/NF with surfactant properties (HLB=14±1).

What is the regulatory status and precedence of use of this excipient?
Both components are compliant to European and US pharmacopeias and are listed in the FDA inactive ingredient database.

How does it compare to other Gelucire® grades?
The melting point is the key difference. Gattefossé’s range of Gelucire® consists of three grades of self-emulsifying excipients: Gelucire® 44/14, Gelucire® 50/13 and Gelucire® 59/14, having melting points of about 44, 50 and 59°C, respectively. Gelucire® 59/14 is supplied in pellets, making it easy to handle and an interesting addition to the
Gelucire® range.

What is Emulfree® Duo used for?
Emulfree® Duo is a ready-to-use system designed to stabilize the oil phase in bigels by ensuring fine and homogeneous dispersions within the aqueous phase.

What is a bi-gel?
A bi-gel consists of an intimate mixture between aqueous and oily gels. Although bi-gels are known in the cosmetic and food industries, it is emerging as an innovative pharmaceutical dosage form. Due to its dual nature, bi-gels provide advantages such as cooling and moisturizing effects, improved spreadability, and enhanced drug absorption through the skin. It is suitable for both lipophilic and hydrophilic drugs.

How different from an emulsion is it?
Bi-gels obtained with Emulfree® Duo look like emulsions but they are not as they do not contain emulsifier. Macroscopically, bi-gels can range from light sprayable lotions to rich creams, and microscopically their dispersions are fine and homogenous. And this happens with a PEG-free stabilizing agent.

Snapshots of our New Products

Labrafac™ MC60
Labrafac™ MC60 is used to enhance oral bioavailability of poorly water-soluble and poorly permeable drugs. It acts as a solubilizer and intestinal permeation enhancer for a wide variety of molecules.

Labrafac™ MC60 can successfully be used in lipid-based Type I (oily solutions) and Types II and III (SEDDS) formulations.

Gelucire® 59/14
Gelucire® 59/14 is a self-emulsifying excipient used for oral bioavailability enhancement of poorly water-soluble drugs, thanks to its high solubilization capacity. Upon contact with aqueous or digestive media, it spontaneously forms a fine dispersion.

Gelucire® 59/14 is supplied in pellets, making it easy to handle and an interesting addition to Gattefossé’s Gelucire® range of products. A key difference to other Gelucire® grades is its higher melting point.

Emulfree® Duo
Emulfree® Duo is the new functional excipient developed by Gattefossé. It is dedicated to topical drugs and medications which are applied on the body or to mucosal areas.

As a mixture of excipients, Emulfree® Duo is a ready-to-use PEG-free system. It has been designed to stabilize the oil phase within a bi-gel by ensuring fine and homogeneous dispersions in the aqueous phase. This new excipient offers unique and innovative textures in formulations while improving treatments and patient adherence.

Gattefossé is a French company that develops, manufactures and sells specialty ingredients to the personal care and pharmaceutical industries. Specializing in lipid chemistry and plant extraction, the group offers recognized formulation expertise through its four application laboratories located on three continents. Gattefossé markets its products in more than 60 countries through its 12 affiliated companies combined with a network of local agents and distributors who provide solid technical support to customers. The company remains a family-run, independent business since its creation in 1880.