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.

Oral delivery

By far the most appreciated administration route by patients, oral dosage forms are simple for the patient yet sometimes complex for formulators. Luckily, Gattefossé develops a full range of excipients (solubilizers, surfactants) to help in enhancing the bioavailability, modifying the API release, or taste-masking the API, as well as in optimizing lubrication in manufacturing processes.

Topical delivery

Skin is the largest organ of the human body and is therefore an interesting administration route for formulators. In addition to local drug delivery for skin diseases, it is possible to achieve systemic delivery thanks to our skin penetration enhancers. To maximize patient adherence to treatment, formulation texture is key – Gattefossé large range of excipients (emulsifiers, solubilizers, thickeners…) is ideal to create a wide variety of dosage forms.

Rectal delivery

Mostly known for pediatric patients, rectal delivery is nevertheless a powerful administration route for all, avoiding first-pass metabolism and achieving a fast bioavailability. It is also useful for local delivery in intestinal diseases. Gattefossé offers the wide Suppocire® range for suppository bases, guaranteeing there will always be one Suppocire® tailored to your API. Other dosage forms can be developed with our excipients, such as foams, gels, ointments…

Vaginal delivery

Women’s health is an important science and Gattefossé is committed to providing the best excipients for pessaries, creams, tablets, caspules… to achieve a local or systemic effect. We have a wide precedence of use of our excipients in combination with antifungals, hormones and probiotics.

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.

A kid is given a cup of syrup
An old person takes a tablet from its container

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