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Evaluation of an enteric-coated naproxen pellet formulation
J G Hardy1, G L Lamont, D F Evans
1Queen's Medical Centre, Nottingham, UK.
Alimentary Pharmacology & Therapeutics
|February 1, 1991
Summary
This study compared enteric-coated naproxen pellets with uncoated ones. While food delayed absorption onset for coated pellets, total naproxen absorption remained consistent across all tested formulations.
Area of Science:
- Pharmacokinetics and Drug Delivery
- Gastrointestinal Physiology
Background:
- Enteric-coated formulations are designed to protect drugs from stomach acid and release them in the small intestine.
- Naproxen is a common nonsteroidal anti-inflammatory drug (NSAID) used for pain and inflammation relief.
Purpose of the Study:
- To evaluate the gastrointestinal transit and absorption of an enteric-coated naproxen pellet formulation.
- To compare the behavior of enteric-coated pellets with uncoated naproxen pellets.
- To assess the effect of food intake on the drug's absorption profile.
Main Methods:
- Eight healthy subjects received 153Sm-labelled enteric-coated naproxen pellets (fasted and post-meal) and uncoated naproxen pellets.
- Gastrointestinal transit was monitored using gamma scintigraphy.
- Drug absorption and gastrointestinal pH were measured using radiotelemetry capsules.
Main Results:
- Dosing after breakfast delayed gastric emptying but did not alter small intestinal transit of enteric-coated pellets.
- The onset of naproxen absorption was fastest with uncoated pellets and slowest with enteric-coated pellets taken after a meal.
- Total naproxen absorption was equivalent across all tested conditions (enteric-coated fasted, enteric-coated fed, uncoated).
Conclusions:
- Food intake significantly impacts the absorption rate, but not the extent, of enteric-coated naproxen pellets.
- The enteric coating effectively protects naproxen from the acidic stomach environment.
- Naproxen absorption profiles can be modulated by formulation and meal status.