METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN
A method for administration of ibuprofen to a subject in need of ibuprofen treatment is provided, in which an oral dosage form comprising a therapeutically effective amount of ibuprofen and a therapeutically effective amount of famotidine is administered three times per day.
1 . A method for treating a patient with an ibuprofen-responsive condition comprising:
administering a first dose of an oral dosage form comprising from 775 mg to 825 mg ibuprofen and from 25 mg to 28 mg famotidine, the ibuprofen and famotidine being present in a weight ratio in the range 29:1 to 31:1, wherein the ibuprofen and the famotidine are formulated for immediate release;
administering a second dose of the oral dosage form;
administering a third dose of the oral dosage form,
wherein the first dose, the second dose, and the third dose are administered within a 24 hour dosing cycle.
2 . The method of claim 1 , wherein the ibuprofen and the famotidine are admixed in the oral dosage form.
3 . The method of claim 1 , wherein the ibuprofen and the famotidine are in separate compartments in the oral dosage form.
4 . The method of claim 1 , wherein the ibuprofen and the famotidine are formulated to release at least 60% of the ibuprofen and the famotidine within about 20 minutes under neutral pH conditions.
5 . The method of claim 1 wherein the subject is an adult with a normal body weight (Body-Mass Index in the range 20-25).
6 . An oral dosage form comprising from 775 mg to 825 mg ibuprofen and from 25 mg to 28 mg famotidine, the ibuprofen and famotidine being present in a weight ratio in the range 29:1 to 31:1, wherein the ibuprofen and the famotidine are formulated for immediate release.
7 . The oral dosage form of claim 6 comprising a first portion containing ibuprofen and a second portion containing famotidine, wherein the famotidine is in the form of barrier-coated particles distributed in the ibuprofen portion.
8 . A method of reducing the likelihood that a patient receiving combined ibuprofen-famotidine therapy will experience a 24-hour median pH less than 2.5, comprising administering a oral unit dosage form of claim 6 to said patient on a TID (three-times-per-day) schedule.
9 . A method for reducing patient-to-patient variability with respect to gastric pH in a population of patients in need of an ibuprofen-famotidine combination therapy, comprising administering to patients in said population an oral unit dosage form containing ibuprofen and famotidine, wherein the ibuprofen and famotidine are in a weight ratio in the range of 29:1 to 31:1, the oral unit dose form is administered three-times-per-day (TID), and the total daily dose is about 2400 mg ibuprofen and about 80 mg famotidine.
10 . The method of claim 9 wherein the oral unit dosage form comprises about 800 mg ibuprofen and about 26.67 mg famotidine or about 400 mg ibuprofen and about 13.33 mg famotidine and the total daily dose is about 2400 mg ibuprofen and about 80 mg famotidine.
11 . An improved method for treating a population of patients in need of an ibuprofen-famotidine combination therapy, the method comprising administering to patients in said population an oral unit dosage form containing ibuprofen and famotidine, wherein the ibuprofen and famotidine are in a weight ratio in the range of 29:1 to 31:1, the oral unit dose form is administered three-times-per-day (TID), and the total daily dose is about 2400 mg ibuprofen and about 80 mg famotidine, whereby inter-patient variability with respect to gastric pH in the population is reduced.