Modified release amoxicillin products

摘要

An amoxicillin product comprising: at least one modified release component(s), wherein the at least one modified release component(s) comprises at least amoxicillin and a pharmaceutically acceptable carrier; and wherein when administered to a patient or subject in the fed state said amoxicillin product exhibits a pharmacokinetic profile for amoxicillin in the plasma characterized as follows: (1) the ratio of the portion of the AUC as measured from 2 hours post-administration to 5 hours post-administration to the portion of the AUC as measured from administration to 2 hours post-administration is at least 2.0:1; and (2) the ratio of the portion of the AUC as measured from 5 hours post-administration to 12 hours post-administration to the portion of the AUC as measured from administration to 2 hours post-administration is at least 1.1:1.

主权项

1. A once-a-day amoxicillin product comprising: an immediate release component that includes amoxicillin and at least one modified release component, wherein the at least one modified release component comprises a first delayed release component that comprises amoxicillin coated with methacrylic acid copolymer dispersion and that initiates release of amoxicillin after the immediate release component, and a second delayed release component that comprises amoxicillin coated with a methacrylic acid copolymer dispersion and hypromellose acetate succinate and that initiates release of amoxicillin after the first delayed release component; said product when administered as a single dose in the fed state having: (a) a ratio of AUC(2-5) to AUC(0-2) of at least 2.0:1 and (b) a ratio of AUC(5-12) to AUC(0-2) of at least 1.1:1, and wherein AUC(2-5) to AUC(0-2) ratio is no greater than 10:1 and the AUC(5-12) to AUC(0-2) ratio is no greater than 10:1 and wherein the product is a once-a-day product.