Gattefossé has designed and manufactured functional lipid excipients since 1950, developing strong capabilities in raw material qualification, synthesis reactions, process analytical technology, and quality control analysis.

Raw material qualification

Gattefosse oilOur lipid excipients are manufactured using vegetable oils—including corn oil, apricot kernel oil, a wide array of plant-derived fatty acids—and alcohols—such as fatty alcohols, polyethylene glycol (PEG), propylene glycol (PG), and polyglycerol.

Raw materials are subject to strict quality control before use to ensure they meet pharmacopeia standards and often stricter company specifications.

Synthesis reactions

Three reactions are commonly utilized in the manufacture of our excipients:

  • esterification, a reaction between acid and alcohol leading to ester and water

  • interesterification, a reaction between esters to produce new esters

  • transesterification, a reaction between ester and alcohol to produce a different ester and alcohol

Depending on the raw materials used, these reactions enable the manufacture of solid, semisolid, or liquid excipients. The fatty-acid chain length and composition in terms of fatty alcohols and mono-, tri-, and diglycerides impact end-product physicochemical—hence functional—properties. Our oleochemists are thus able to develop pharmaceutical, nutraceutical, and cosmetic ingredients having targeted properties through the selection of raw materials and the design of synthesis reactions.

Robust processes

Since lipid excipients are made with natural plant-derived raw materials with intrinsic variability, process robustness is critical. Our oleochemists work with production teams to optimize synthesis processes and establish appropriate in-process controls that consistently deliver high product quality and batch-to-batch reproducibility.

Their input helps fine-tune processes to control impurity levels that can impact excipient performance and stability.

They are also working on processes that enable the reduction of waste materials, water consumption, and the use of catalysts.

Oleochemistry R&D laboratory

Many of our lipid excipients are complex multicomponent products. Our oleochemists develop and validate specialized analytical methods which serve four main purposes:

  • To elucidate the relationship between excipient composition and function and Critical Material Attributes
  • To provide analytical support for the Quality by Design principles applied to excipients in pharmaceutical drug development
  • To develop and analytically characterize new and custom excipients
  • To contribute to Gattefossé customer technical support

Gattefossé has and continues to be a source of new validated analytical methods for lipid excipients, many of which have been incorporated into the European Pharmacopoeia.