In-Vitro Evaluation of Feeding Tube (NG/G) Studies
Many oral drug products — granules, pellets, powders, suspensions, capsules and tablets — are administered via nasogastric (NG) or gastrostomy (G) feeding tubes for patients with swallowing difficulty or in intensive care. US FDA recommends in-vitro testing to confirm that a product's performance is not compromised by feeding-tube preparation and administration, and that generic products behave comparably to the reference product when given this way.
DALPL's Pharma Testing Division designs, develops and validates enteral feeding tube in-vitro test methods aligned to current FDA recommendations.
Applicable Drug Products
The feeding-tube evaluation scope is focused on oral drug products administered through NG or G feeding tubes.
Why Feeding Tube Evaluation Matters
Preparation and administration through a feeding tube can affect product performance.
Drug Recovery
Determine whether the expected drug amount is recovered after tube passage.
Physical Behaviour
Identify aggregation, clogging, sedimentation or inadequate redispersion where relevant.
Product Performance
Evaluate applicable characteristics before and after tube delivery.
Our Feeding Tube (NG/G) Study Services
DALPL evaluates key product-performance attributes before and after feeding-tube administration, with the study design selected according to the dosage form and relevant product characteristics.
Recovery Testing
Percentage of drug recovered after passing through the tube as labelled, checking for aggregation or clogging.
Sedimentation Volume & Redispersibility Testing
Evaluation of whether settled insoluble components redisperse adequately for administration.
Particle Size Distribution Study
Particle size distribution before and after tube delivery, using validated methods such as laser diffraction and reporting D10, D50 and D90.
Acid Resistance Testing
For enteric-coated products, evaluation of whether coating integrity is maintained through tube administration.
From Tube Preparation to Product Performance
The evaluation follows the administration pathway to identify whether preparation and passage through the feeding tube affect critical product-performance attributes.
Select the Applicable Product
Identify the dosage form and feeding-tube administration scenario relevant to the study.
Prepare for Tube Administration
Evaluate the product using the specified preparation and administration approach.
Assess Tube Delivery
Evaluate recovery and relevant physical or performance characteristics after passage through the tube.
Compare Product Performance
Assess applicable attributes before and after tube delivery, such as particle size distribution, redispersibility or coating integrity.
Support Assessment
Generate study data to support evaluation of product performance during NG/G administration.
Drugs We've Developed Methods For
DALPL has developed feeding-tube evaluation methods for multiple pharmaceutical products, including:
Why DALPL
Delivering high-accuracy impurity profiling with uncompromised regulatory integrity.
Frequently Asked Questions
Get a Feeding Tube (NG/G) Study Quote
Speak with our Pharma Testing team about your oral drug product, feeding-tube administration requirements and in-vitro evaluation needs.