Human health
We are committed to accompanying our customers to develop safe and efficient human medicines for oral, topical, rectal and vaginal routes of administration, from the early stages of development to the marketing authorization and commercialization.
Dosage forms tailored to patient needs
To deliver an active pharmaceutical ingredient, several administration routes co-exist, each presenting benefits for a targeted population. Going further in an administration route, Gattefossé can assist in perfecting a suitable dosage form to optimize drug delivery and enhance patient adherence.
Developing formulations for all ages
Pediatric dosage forms are fascinating and diverse due to the unique challenges and considerations involved in treating children. Their physiology varies significantly because of their size, weight, and developmental stage, hence necessitating tailored medication forms that ensure safety, efficacy, and ease of administration. This diversity includes liquid formulations, chewable or mini tablets, dissolvable strips, and more, each designed to address specific needs such as taste masking, accurate dosing, and ease of swallowing.
Geriatric patients often require multiple medications, which can lead to complex dosing schedules and increased risk of non-adherence. Sustained release formulations offer a significant advantage by releasing the active ingredient gradually over an extended period. This reduces the frequency of doses required per day, simplifying medication regimens and enhancing patient compliance. By maintaining more consistent drug levels in the bloodstream, sustained release formulations not only improve therapeutic outcomes but also minimize side effects, ultimately contributing to a better quality of life for elderly patients.
Our regulatory expertise in human health
To assist our customers in meeting their regulatory requirements, we offer comprehensive and regularly updated documentation for each excipient. This includes all necessary data and specifications for evaluation, such as:
- Drug Master Files (DMFs) in the USA or Canada, Bundling Reviews in China for our pharmaceutical ingredients, 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.
Our top priority is developing safe ingredients for workers, formulators, and end users. We design toxicological evaluations according to the market applications.
Our membership of several professional associations allows us to closely monitor the shifting international regulatory landscape for the pharmaceutical industry. We are members of:
- The International Pharmaceutical Excipients Council (IPEC),
- The European Oleochemicals and Allied Products Group (APAG),
- The French Society of pharmaceutical sciences and technologies (SFSTP).
- The European Pharmacopoeia Group of Experts