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• W1566503513 abstract "To the Editor: Dr. Spector and his colleagues question the relevancy of our report on food-induced dose dumping of Theo-24 because of the “unusual” dose of theophylline that was not “in keeping with the current package insert,” the “very heavy fat content” of the breakfast, and our failure to discuss “data that foods will affect many theophylline products;” they particularly note that we failed to discuss their unpublished report that “absorption of Theo-Dur tablets given once per day was significantly delayed with food.” In point of fact, the limitation of a 900 mg once daily dosage in the current package insert of Theo-24 resulted from a meeting between FDA and Searle on February 16, 1984 that was initiated after FDA’s evaluation of the data included in our published report in Chest (1985; 87:758-65). Searle’s argument that this was a generic problem was rejected, and they were directed by FDA to restrict dosing recommendations and draft a “Dear Doctor” letter warning that “food may significantly increase the absorption of Theo-24”.1Prettyman CW Memorandum of conference regarding G. D. Searle’s Theo-24 on February 16, 1984. FDA Freedom of Information Office, Rockville, MDFebruary 16, 1984Google Scholar An FDA evaluation of the formulation also demonstrated that dissolution of Theo-24 greatly increased at alkaline pH levels, an in vitro correlate to our clinical findings of dose dumping.2Malinowski H. Evaluation of Theo-24 Formulation, (memorandum to Jerome P. Skelly, Acting Director; Division of Biopharmaceutics) February 10, 1984.Google Scholar As a consultant to Searle at the June 20, 1983 meeting of the FDA’s Pulmonary/Allergy Drugs Advisory Committee on once-a-day theophylline products,3Transcript of Pulmonary/Allergy Drugs Advisory Committee Meeting of June 20, 1983. Rockville, MD: FDA Freedom of Information Office, pp 50-54Google Scholar Dr. Spector should also be aware that data submitted to the FDA reported by Searle showed mean steady state peak and trough concentrations of 10.1 and 5.5 μg/ml, respectively, after the fifth day of 900 mg/day, compared to 17.7 and 11.1 μg/ml after 1500 mg/day (Fig 1).4Weinberger M Theophylline QID TID, BID, and now QD? A report on 24 hour dosing with slow-release theophylline formulations with emphasis on analysis of data used to obtain Food and Drug Administration approval for Theo-24.Pharmacotherapy. 1984; 4: 181-198Crossref PubMed Scopus (31) Google Scholar Furthermore, early advertisements for Theo-24 contained a graph of mean steady state serum concentrations between 10 and 20 μg/ml at a dose of 1200 to 1500 mg/day.5SearleAdvertisement for Theo-24.J Allergy Clin Immunol. 1983; 72: 35AAbstract Full Text PDF Google Scholar The low serum concentration after multiple doses of 900 mg/day are consistent with the incomplete delivery of Theo-24 when taken fasting, since at this dose completely absorbed products, on average, achieve therapeutic serum concentrations in non-smoking adults. A subsequent FDA investigation has apparently found additional evidence consistent with food-induced dose-dumping and has reportedly recommended prosecution of Searle and five of its employees for withholding this information from FDA.6Washington Drug Letter 17 (24), June 17, 1985Google Scholar, 7Millenson ML. FDA probes Searle on problems with asthma drug. Chicago Tribune, June 21, 1985, Section 3, p 3Google Scholar While the breakfast used in our study was somewhat large in calories and fat content by standards of the calorie-conscious “Pepsi generation”, it was quite consistent with traditional American weekend breakfasts, and the fat content was consistent with the usual 40 percent dietary fat content of our society. Since maintenance therapy with theophylline frequently continues for months or years, it seems likely that many patients will encounter situations similar to the fasting and post-breakfast conditions of this study and thereby experience the consequences of large variations in rate and extent of the delivered dose of theophylline from Theo-24 on at least some occasions. In contradistinction to the implication of Dr. Spector and his colleagues, we did indeed discuss extensively the effects of food on other theophylline formulations. Moreover, ten references (18, 19, 22, and 26-32) of original studies included four examining Theo-Dur tablets. One of these (reference 22), used the same breakfast as our study and confirmed both our findings for Theo-24 and three previous reports of a slight delay in rate without significant effect on extent of absorption when Theo-Dur tablets were taken after breakfast. In contrast, the marked increase in both rate and extent of absorption of theophylline from Theo-24 following food was qualitatively different from that reported for any other formulation. Whatever the potential advantages may be of once daily dosing with regard to compliance, the demands on the delivery system are increased when the total day’s dose is given once every 24 hours as compared with multiple daily doses. Attempts to slow absorption further than the slowest of the completely absorbed products already marketed have thus fsr resulted in incomplete delivery.8Karim A Burns T Wearley L Streicher J Palmer M Food-induced changes in theophylline absorption from controlledrelease formulations. Part I. Substantial increased and decreased absorption with Uniphyl tablets and Theo-Dur Sprinkle.Clin Pharmacol Ther. 1985; 38: 77-83Crossref PubMed Scopus (95) Google Scholar, 9Hendeles L Weinberger M Theophylline product and dosing interval selection for chronic asthma.J Allergy Clin Immunol. 1985; 76: 285-291Abstract Full Text PDF PubMed Scopus (7) Google Scholar While some variation in onset and rate of absorption as a result of gastrointestinal, positional, or poorly defined circadian variables may be unavoidable with any currently available formulation, incomplete delivery of the administered dose and major effects on rate and completeness of absorption from meals are definable and avoidable by informed product selection.10Hendeles L Iafrate RP Weinberger M A clinical and pharmacokinetic basis for the selection and use of slow-release theophylline products.Clin Pharmacokinetics. 1984; 9: 95-135Crossref PubMed Scopus (141) Google Scholar" @default.
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• W1566503513 title "Theophylline Dose-dumping" @default.
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