Quantification of the effect of excipients on bioavailability by means of response surfaces II: Amoxicillin in fat-silica matrix.
This report studies the bioavailability of amoxicillin in different fat-silica matrixes. A urinary excretion study was carried out on four formulations containing fat and silica excipients. The formulations were administered to 24 healthy volunteers according to a Latin-square design. The following percent proportions of fat-silica were used: 15:3.75, 15:7.50, 30:3.75, and 30:7.50. The urinary excretion curves were characterized using the quantity of unchanged drug excreted between 0-2 and 0-12 hr postadministration, respectively as parameters. The ANOVA results showed that both excipients had an additive effect on the quantity of drug excreted between 0 and 2 hr, whereas the effect on the quantity of drug excreted between 0 and 12 hr was also one of interaction between both excipients. Quantification of the ANOVA results in terms of excipient content was conducted by means of the adequate linear functions. At the same time, a dissolution study was carried out using the quantity of drug dissolved in 30 and 180 min as parameters. The behavior was similar to that encountered for the in vivo parameters.
D000293:Adolescent; D000328:Adult; D000658:Amoxicillin / Q000378:metabolism*; D001682:Biological Availability; D005079:Excipients; D005223:Fats; D005260:Female; D006801:Humans; D007700:Kinetics; D008297:Male; D012822:Silicon Dioxide; D012995:Solubility; D013499:Surface Properties; D013997:Time Factors
D005079:Excipients; D005223:Fats; D012822:Silicon Dioxide; D000658:Amoxicillin