Assay and pharmacokinetics of dyphylline following oral administration in humans Public Deposited

http://ir.library.oregonstate.edu/concern/graduate_thesis_or_dissertations/p5547v69d

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  • Improved assay methods for determination of dyphylline levels in plasma, saliva, and urine utilizing high pressure liquid chromatography have been developed. Detection of levels as low as 25 ng/ml from 0.5 ml plasma and 50 ng/ml from 0.5 ml saliva were possible. Both procedures utilized the same extraction process. A separate extraction process was used for dyphylline analysis in urine due to the presence of interfering substances occurring with previous methods. The method was applied to samples of one subject's plasma, saliva and urine after administration of dyphylline. Plasma, saliva, and urine dyphylline concentrations were measured after administration of a single oral dose of 15 mg/kg to six healthy male subjects. Improved analytical methods have allowed sampling over longer time periods than have previously been reported. The resultant plasma, saliva and urine data show that dyphylline pharmacokinetics cannot be described by traditional one or two compartment open models. Model independent pharmacokinetic parameters, including renal clearance, drug excreted, time to plasma peak, and peak plasma values have been determined. In contrast with a previous report, the analysis of dyphylline in urine has established that dyphylline is primarily eliminated unchanged in the urine. The observed rapid and reproducible rise in plasma dyphylline levels is consistent with prediction of rapid onset of action following oral dosing with the tablet investigated. A high degree of correlation was found between saliva and plasma dyphylline concentrations of individuals using parabolic equations, the r² values ranging from 0.935 to 0.996. This relationship suggests nonlinear protein binding of dyphylline occurs within the range of plasma levels attained by the dose given in the study. These observations should prove to be useful for designing future pharmacokinetic studies and clinically when monitoring of plasma dyphylline levels via saliva sampling is anticipated.
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