Oral Drug Products Administered Via Enteral Feeding Tube. In Vitro Testing

TOMER RAM, R&D, Dexcel Pharma Technologies Ltd. , Jerusalem , ISRAEL (Tomer.Ram@dexcel.com)

For generic drug products, that can be administrated through feeding tubes, a bioequivalence in vitro testing is required.

These products include wide range of oral dosage forms such as granules, pellets, powders, suspensions, capsules, and tablets.

The administration of drug products via enteral feeding tubes has received growing regulatory attention due to increasing clinical use and associated risks.

The presentation will include an overview of drug feeding tube administration testing, and will focus on key factors such as: tube type, medium and drug dose which significantly influence successful drug delivery performance.

The presentation will discuss the main challenges in feeding tube administration, such as successful drug recovery and tube blockage during administration. Differences in regulatory requirements and documentation between the U.S. and EU markets will be highlighted.

A case study will be presented of an oral suspension successfully administrated through feeding tubes and submitting it to the authorities.

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Short Biography of Presenting Author

Mr. Ram received his B.Sc in Pharmaceutical engineering (2011) from the Azrieli College of Engineering in Jerusalem.

Mr. Ram has 14 years of professional experience in analytical R&D. He joined Dexcel Pharma Ltd in 2016.

In his current role, Team leader which specialize in analytical studies of Oral Drug Products Administered Via Enteral Feeding Tubes.

In addition, he has experience in submitting generic drug products to the US and EU markets.