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Erratic absorption of a slow-release theophylline sprinkle product
Insights
Food significantly impacts slow-release theophylline absorption in children. Bioavailability dropped from 91% fasting to 44% with meals, complicating safe asthma therapy.
Area of Science:
- Pharmacokinetics
- Pediatric Pharmacology
- Drug Bioavailability
Background:
- Theophylline is a bronchodilator used for asthma management.
- Slow-release formulations aim for consistent drug levels.
- Food interactions can alter drug absorption and efficacy.
Purpose of the Study:
- To evaluate theophylline bioavailability and absorption from a slow-release sprinkle in asthmatic children.
- To compare drug absorption under fasting versus fed conditions.
Main Methods:
- 12 asthmatic children participated in the study.
- Theophylline absorption was measured after oral administration of a slow-release sprinkle.
- Intravenous theophylline served as the reference for bioavailability calculations.
- Comparisons were made under fasting and post-meal conditions.
Main Results:
- Theophylline was well absorbed under fasting conditions (91% bioavailability).
- Concomitant food intake significantly reduced bioavailability to 44% (P < .001).
- Food intake also delayed the absorption pattern of theophylline.
Conclusions:
- Food intake critically affects the absorption and bioavailability of slow-release theophylline sprinkles in children.
- Therapeutic drug monitoring is essential due to erratic absorption with food.
- Pre-clinical studies must assess drug absorption with and without food for accurate dosing.
Abstract:
The bioavailability and absorption pattern of theophylline from a slow-release theophylline sprinkle preparation were investigated in 12 asthmatic children both in fasting conditions and after a standardized meal. Theophylline given intravenously was used as a reference. Theophylline from the slow-release theophylline product was well absorbed under fasting conditions, but both absorption pattern and bioavailability were severely affected by concomitant food intake: a delay in absorption was found and the bioavailability was reduced from 91% (fasting) to 44% (P less than .001). The erratic absorption of theophylline after food intake complicates safe therapy with the preparation and calls attention to the fact that it is not sufficient to investigate the absorption characteristics of slow-release theophylline preparations under fasting conditions only.