Theophylline-Controlled Release Preparations and Fatty Food: An in Vitro Study Using the Rotating Dialysis Cell Method

Abstract:

The in vitro dissolution behavior of four controlled-release theophylline products was investigated utililzing the rotating dialysis cell method. The effects of pH, oil, and enzymes on the dissolution profiles were studied. The wide range of pH values and the content of oil and enzymes in the dissolution media in the dialysis cell, which functioned as an in vitro model, were simulated to mimic physiological changes due to food along the entire gastrointestinal tract. Treatment with oil affected the dissolution behavior of Uniphyl and especially Theo-Dur Sprinkle but had little or no effect on the dissolution profiles of Theo-Dur tablets and Theo-24 capsules. The in vitro observations of the oil effect were related to the food effect obtained from published in vivo studies. The rotating dialysis cell can be a useful tool in studying factors which may be responsible for dissolution-related food effects on the absorption of controlled-release products.

Keywords: theophylline; controlled release; food effect; in vitro dissolution; rotating dialysis cell

Language: English

Document Type: Regular paper

Affiliations: 1: Biopharmaceutics Research Branch, Food and Drug Administration, Washington, D.C. 20204. Present address: National Research Centre, Dokki-Cairo, Egypt. 2: Biopharmaceutics Research Branch, Food and Drug Administration, Washington, D.C. 20204. To whom correspondence should be addressed at Biopharmaceutics Research Branch, Food and Drug Administration, Washington, D.C. 20204. 3: Office of Research Resources, Food and Drug Administration, 5600 Fisher Lane, Rockville, Maryland 20857.