Methods and medicaments for administration of ibuprofen

Abstract

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 to said patient 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 to said patient a second dose of the oral dosage form;   administering to said patient 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,   wherein the ibuprofen and the famotidine are in separate compartments in the oral dosage form, and   wherein the patient does not suffer at the times of administering from a condition characterized by hypersecretion of gastric acid and/or from active severe oesophagitis and/or Barrett's ulceration, and/or from gastroesophageal reflux disease.   
     
     
         2 .- 5 . (canceled) 
     
     
         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 and wherein the ibuprofen and the famotidine are in separate compartments in the oral dosage form. 
     
     
         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 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . The method of  claim 1  wherein the oral unit dosage form comprises about 800 mg ibuprofen and about 26.67 mg famotidine and the total daily dose is about 2400 mg ibuprofen and about 80 mg famotidine. 
     
     
         11 . (canceled) 
     
     
         12 . The oral dosage form of  claim 6  wherein the oral unit dosage form comprises about 800 mg ibuprofen and about 26.6 mg famotidine and the total daily dose is about 2400 mg ibuprofen and about 80 mg famotidine. 
     
     
         13 . A method for manufacturing an oral dosage form of  claim 6  wherein the method comprises the steps of:
 providing granules comprising ibuprofen, at least one binder, at least one disintegrant, and at least one glidant; 
 blending the granules with at least one binder, at least one disintegrant, at least one glidant, and at least one lubricant; 
 compressing the blend to form a core; 
 optionally coating the core with a barrier coat; 
 applying a layer comprising famotidine to said core; and 
 optionally applying an overcoating layer to yield the oral dosage form. 
 
     
     
         14 . The method of  claim 13  wherein the oral dosage form has a content uniformity of at least about 95%. 
     
     
         15 . The method of  claim 13  wherein the oral dosage form has a content uniformity of at least about 97%. 
     
     
         16 . A container comprising a plurality of oral dosage forms of  claim 6  and instructions to take the oral dosage form three times daily to treat an ibuprofen-responsive condition, wherein the instructions are affixed to the container or packaged with the container. 
     
     
         17 . A method comprising:
 manufacturing a plurality of oral dosage forms of  claim 6 , and   selling the oral dosage form to pharmacies or hospitals with instructions to take the oral dosage form three times daily to treat an ibuprofen-responsive condition.