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Evaluation of a new sustained-release theophylline tablet for children
Insights
A new sustained-release theophylline tablet improves asthma treatment for children by providing more stable blood levels and reducing side effects. This new formulation ensures a correct dose regimen, enhancing therapeutic outcomes.
Area of Science:
- Pharmacology
- Pediatric Pulmonology
Background:
- Theophylline is a common treatment for asthma.
- Achieving optimal theophylline dosing can be challenging, especially in children.
- Fluctuations in serum theophylline concentration can lead to side effects and reduced efficacy.
Purpose of the Study:
- To evaluate a new low-dose, sustained-release theophylline tablet for pediatric asthma patients.
- To assess the pharmacokinetic profile and clinical effectiveness of the new formulation.
- To compare the new sustained-release tablet with conventional theophylline tablets.
Main Methods:
- A new 128 mg sustained-release theophylline tablet (Euphyllin retard mite w/groove) was developed.
- Bioavailability and peak serum concentration times were determined in adults.
- 25 pediatric patients switched from plain theophylline tablets to the sustained-release formulation.
- Serum theophylline concentrations were monitored before morning doses and throughout dosing intervals.
Main Results:
- The sustained-release tablet demonstrated good bioavailability (0.91) and a prolonged peak serum concentration time (8.7 h) in adults.
- Pediatric patients on the sustained-release formulation had higher pre-dose serum theophylline concentrations (29 mumol/l higher).
- Serum concentration fluctuations were significantly reduced (13 mumol/l reduction) with the sustained-release tablet.
- Mild gastrointestinal side effects associated with plain theophylline tablets resolved after switching to the sustained-release formulation.
Conclusions:
- The new sustained-release theophylline tablet facilitates a correct dose regimen in pediatric asthma patients.
- This formulation leads to more stable serum theophylline concentrations, potentially improving treatment efficacy.
- The sustained-release tablet effectively reduces gastrointestinal side effects, enhancing patient tolerability.
Abstract:
A new, low dose sustained-release tablet of theophylline has been developed in order to facilitate a correct dose regimen in asthmatic children treated with theophylline. The formulation (Euphyllin retard mite w/groove) contains 128 mg of theophylline, and can easily be divided. The extent of bioavailability in adults is 0.91, and the peak serum concentration is reached after 8.7 h. 25 children treated with plain theophylline tablets were followed when changing to the sustained-release tablets. Compared to the plain tablets, the serum theophylline concentration before the morning dose was 29 mumol/l higher (range 12-51) when the same daily dose was given as a sustained-release preparation. The serum concentration fluctuations during one dosing interval were reduced with 13 mumol/l (0-26). Mild gastrointestinal side effects reported by the children when using the plain theophylline tablets all disappeared on changing to the sustained-release tablets.