Food-induced changes in theophylline absorption from controlled-release formulations. Part II. Importance of meal composition and dosing time relative to meal intake in assessing changes in absorption

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Abstract
Theo‐24 (G. D. Searle & Co.) is an ultra‐slow‐absorbing formulation of theophylline suitable for once‐a‐day dosing in slow and normal metabolizers of theophylline. Relative to fasting conditions, increased rate and extent of theophylline absorption occur when this product is administered immediately after a breakfast with a high fat content. Our study demonstrated that factors such as meal composition (fat content) or dosing time relative to meal intake can modify the high fat–induced changes in absorption. For consistent, slow absorption, patients taking high doses (≥ 900 mg) of Theo‐24 once a day should take this product in the morning under fasting conditions or with a breakfast containing ≤ 10 gm fat. If a high‐fat breakfast (> 55 gm fat) is taken, then Theo‐24 should be administered at least 1 hour before the meal. Clinical Pharmacology and Therapeutics (1985) 38, 642–647; doi:10.1038/clpt.1985.238