What is a high-fat meal and what its purpose?

A high-fat FDA meal is a standardized meal that is orally administered along with a drug product to create fed state/condition in human clinical trials.

 

 

 

 

 

 

Composition of high-fat meal

Purpose of high-fat meal

This meal elicits a strong physiological digestive response within the gastrointestinal tract. Intake of this meal enables the impact of high calorific food on the pharmacokinetics of a drug product to be examined in a well-controlled manner. The high-fat content of the meal can significantly change the way a food-drug interaction occurs in the stomach and intestine.

There are different reasons for exploring the administration of a high-fat meal:

  • Food can help improve the tolerability of drugs by reducing localized gastric irritation of some drugs e.g. naproxen
  • Improve the absorption of an insoluble drug typically by increasing drug solubility and dissolution e.g. rivaroxaban tablets 20mg
  • Food may increase adversely e.g. nilotinib, decrease e.g. indinavir sulphate, or have no effect e.g. canagliflozin on the systemic drug level in a patient

Clinical usages of high-fat meal

Usages of this meal in clinical studies are described in various FDA draft Guidance for Industry:

  • Bioavailability Studies Submitted in NDAs or INDs (April 2022)
  • Assessing the Effects of Food on Drugs in INDs and NDAs (June 2022)
  • Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (DRAFT August 2021)

In vitro high-fat meal

FEDGAS (Early/Mid/Late) media are in vitro media that simulate the different stages of in vivo fed state gastric fluids by replicating the fat and carbohydrate composition of a high-fat meal. The media help developers to examine and understand food-effect interactions (based on dissolution and solubility) using standard USP dissolution apparatus and HPLC analysis.