2024-12-26

Q: What differentiates Gattefossé’s pharmaceutical excipients from those of its competitors in the global market?

At Gattefossé, we provide lipid-based excipients that have the particularity of being versatile, meaning that they can be used for a variety of administration routes (oral, topical, rectal, vaginal), a variety of dosage forms and for different markets (human health, animal health and nutraceuticals). Moreover, our excipients are highly functional: they bring valuable assets to formulations, for example via boosting an API bioavailability or modifying its release. Our application laboratories regularly conduct studies to showcase their abilities and are consistently working on new applications for our excipients. Finally, it is important to mention our commitment to responsible sourcing of our excipients. As the main raw material for our excipients’ production is palm oil, we are aware of its link with deforestation. Therefore, we have been, for several years now, an active member of the RSPO (Roundtable on Sustainable Palm Oil) to ensure a responsible supply of palm oil, in line with our CSR strategy.

Q: How is Gattefossé addressing the trend of personalized medicine in its pharmaceutical offerings?

Personalized medicine is a major aspect of the future of innovation in healthcare. When tailoring a treatment to an individual, it is also necessary to find a formulation and a formulation technology that can easily be tailored to different APIs in different doses. Recently, we have been working on how to use our excipients in 3D printing, because 3D printing technology allows for precise control on drug dosage and is ideal for on-demand production. We demonstrated that our surfactants, Gelucire® 44/14 and Gelucire® 48/16 could successfully be used to design 3D-printed tablet exhibiting enhanced drug delivery performance. We believe in this technology and continue to work on it, as lipid-based excipients have clear advantages: their low melting temperatures (30–75 °C) and rapid recrystallization make them easy to process during printing.

Q: What challenges are associated with formulating sustained-release drug products using Gattefossé’s excipients?

Several approaches exist to achieve a sustained release (SR) in oral dosage forms, SR matrices in tablets being one of them.  Formulators can either use a polymer matrix that will swell in the presence of water, forming a “gel” around the tablet, or use our lipid-based excipient Compritol® 888 ATO.

Compritol® 888 ATO is an inert high-melting point glyceride that can be used in both cold and hot processes; hence it is an easy-to-process excipient, suitable for a wide range of APIs, with no nitrosamines constraints. The way it works is by forming a hydrophobic matrix around the tablet, in which the water diffuses slowly to dissolve the API. Compritol® 888 ATO already has wide precedence of use and can even be used in combination with the polymer approach to create a dual matrix. We built several case studies with metformine, bupropion, and other APIs to inspire formulators and demonstrate Compritol® 888 ATO’s ability to achieve targeted release profile within the USP specifications.

Q: How does Gattefossé support the formulation of BCS (Biopharmaceutics Classification System) class II and IV drugs?

Nowadays BCS class II and IV represent most of the new drugs coming on the market. Bioavailability enhancement is a major focus of formulation research, and several technologies have already proven their worth. Lipid-based formulations (LBF) is one of those enabling technologies and at Gattefossé, we are proud to offer lipid-based excipients for all kinds of LBFs thanks to our wide portfolio, containing oils, surfactants and solvents.

Besides increasing the solubility, lipids can enhance intestinal permeation, making them the unique dual functionality excipients addressing the challenges of BSC Class IV drugs. Gattefossé offers 3 products recognized as dual functional excipients. Thanks to their composition rich in C8 and C10 fatty acids, Labrafac™ MC 60, Capryol® 90 and Labrasol® ALF are acknowledged as intestinal permeation promoters.

In addition to lipid-based formulations, lipid-based excipients can also be used in synergy with polymers, notably in amorphous solid dispersions. It is a new territory to explore for our excipients, but our first studies on combining Gelucire® with polymers in hot-melt extrusion proved that lipids could act as plasticizers and improve the API release performance through boosting the supersaturation and delaying reprecipitation. Hence, we are confident that our products have not yet fully revealed their potential in bioavailability enhancement.

Q: What is the current R&D focus areas for Gattefossé in the pharmaceutical sector, especially for Asia Pacific?

As many other players, we are embracing the potential of artificial intelligence in our day-to-day lab work. More specifically, we are looking into using models to predict the in vivo fate of a drug formulation, hence providing our customers with a robust and quickest formulation toolbox for their developments. It is a project that is particularly interesting for the Asia Pacific region, which is known to be the cradle of generics and super generics, a market that can be on the lookout for innovative excipients to differentiate from the competition.

We are also focusing on improving our offer for oral solid dosage forms. Nowadays, tablets remain the most favorite dosage form for the pharmaceutical industries, and even if a large majority of our excipients are already being used in tablets, we know that we can expand in this dosage form.

Q: How does Gattefossé ensure that its excipients meet FDA and other international regulatory requirements?

We have a dedicated regulatory affairs team in charge of monitoring the regulations for our main markets, and this team can also assist our customers in meeting their regulatory requirements. For example, we offer comprehensive and regularly updated documentation for each of our excipients. This includes all necessary data and specifications for evaluation, such as:

• Drug Master Files (DMFs) in the USA or Canada, Bundling Reviews in China and their respective Letters of Authorization.
• A wide array of certificates to help our customers confirm the compliance of their formulations and build their own risk and safety assessment.

Q: How does Gattefossé’s new facility contribute to the growing Indian pharmaceutical market?

Beyond its massive domestic potential, India has become a true global player in the pharmaceutical industry. For instance, India today supplies over 40% of the generic drugs required by the U.S. and it has the largest number of U.S. FDA-approved plants after the U.S. itself.

India has been a part of the Gattefossé story since 2005, when we first established a liaison office here. In 2007, our presence was elevated to a full affiliate, marking the beginning of a significant journey in one of the world’s most dynamic markets. Our investment reflects the immense potential of the local market alongside India’s vital role in supporting the global health sector. Indeed, our new Indian Technical Center of Excellence, FDA-approved is designed to foster collaboration and innovation. It houses advanced laboratories dedicated to the design of formulation prototypes and to the customers' support through hands-on training and technical advice. 

Moreover, this year, we opened a new manufacturing plant in Lufkin, Texas, which will produce its first pharmaceutical batches in 2025. This facility strengthens our supply chain with back-up solutions on three continents. With this new plant, we are increasing our production capacity, improving business continuity and meeting the growing needs of our customers around the world.