Quantification of the effect of excipients on bioavailability by means of response surfaces I: Amoxicillin in fat matrix.
A study was carried out to determine the effect of a fat excipient on the bioavailability of amoxicillin tablets. Three formulations with a fat excipient content of 10, 20, and 30%, respectively, were administered to 15 healthy volunteers according to a Latin-square design. The excretion curves were characterized with the help of two parameters, namely, the quantity of drug excreted between 0-2 and 0-12 hr postadministration, respectively. The effect of the fat excipient content was quantified with the use of polynomials whose corresponding orders were given by the ANOVA. In the case of both parameters, a quadratic response to the fat excipient content was found. At the same time, a dissolution study was carried out using a previously established method. Here, the parameters used to characterize the dissolution curves were the quantities of dissolved drug in 30 and 180 min, respectively. Again, a quadratic response to the fat excipient content was observed in the case of both parameters.
D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000378:metabolism*; D001682:Biological Availability; D005079:Excipients; D005223:Fats; D005260:Female; D006801:Humans; D007700:Kinetics; D008297:Male; D012995:Solubility; D013499:Surface Properties; D013810:Therapeutic Equivalency; D013997:Time Factors
D005079:Excipients; D005223:Fats; D000658:Amoxicillin