• USFDA provides recommendations regarding in vitro testing of oral drug products, administered via enteral feeding tube (hereinafter enteral tube).
• These products represent a wide range of oral dosage forms including, but not limited to, granules, pellets, powders, suspensions, capsules, and tablets.
• Administration of products through feeding tube studies is recommended in patients having underlying disease that makes it difficult to swallow or for intensive care patients.
• The recommendations for in vitro testing apply to products that are subject to the following and submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 21 CFR parts 312 and 314.

USFDA developed the product specific guidance for In-vitro enteral tube studies which include:

• Comparative recovery testing
• Particle size distribution study
• Comparative acid resistance stability testing
• Sedimentation volume and redispersibility testing

DALPL, having experienced team in Enteral Feeding Tube (NG/G) studies, method validation and method development, provides complete product development services utilizing in-vitro bioequivalence models and other scientific tools.

We have developed method for Rivaroxaban, Riluzole, Mycophenolate mofetil, Ticagrelor and Dexlansoprazole etc.