Liquid oral pharmaceutical dosage form

Abstract

A liquid oral pharmaceutical dosage form, comprising pharmacologically effective amounts of at least one histamine H2-receptor antagonist in a hydrophobic/lipophilic liquid substantially free from water comprising at least one viscosity enhancing agent, and pharmacologically effective amounts of one or more antacid(s) in a liquid comprising at least one viscosity enhancing agent and at least one flavor, wherein the two liquids are physically separated from each other and wherein the two liquids have matching rheological profiles and a package comprising multiple liquid oral dosage forms as well as a method of treating a gastric disease or disorder by use of the liquid oral pharmaceutical dosage form.

1 - 18 . (canceled) 
     
     
         19 . A liquid oral pharmaceutical dosage form, comprising:
 a) a first liquid dosage form comprising pharmacologically effective amounts of famotidine in a hydrophobic/lipophilic liquid that comprises one or more medium chain triglycerides and that is substantially free of water, wherein the first liquid dosage form further comprises a first viscosity enhancing agent that that is selected from the group consisting of ethyl cellulose polymers, lauroylpolyoxyl glycerides, glycerol dibehenate, cellulose ethyl ether, glyceryl distearate, fumed silica, or mixtures thereof; and   b) a second liquid dosage form comprising pharmacologically effective amounts of one or more antacid in an aqueous liquid, wherein the second liquid dosage form further comprises a second viscosity enhancing agent selected from the group consisting of vegetable gum, poly vinyl pyrrolidone, hydroxy ethyl cellulose, hydroxy propyl cellulose, microcrystalline cellulose, cellulose powders and mixtures thereof,
 wherein the first and second liquid dosage forms are physically separated from each other, and 
 wherein the first and second liquid dosage forms are adapted for simultaneous administration to a subject in need thereof. 
   
     
     
         20 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein the one or more medium chain triglycerides are of standard purity. 
     
     
         21 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein the one or more medium chain triglycerides are super refined. 
     
     
         22 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein the one or more medium chain triglycerides is selected from the group consisting of hexanoic acid, octanoic acid, decanoic acid and dodecanoic acid. 
     
     
         23 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein the first viscosity enhancing agent consists of glycerol dibehenate and cellulose ethyl ether. 
     
     
         24 . The liquid oral pharmaceutical dosage form according to  claim 23 , wherein the glycerol dibehenate is present in an amount of about 1 to about 10% w/w based on the total percentage by weight of the first liquid dosage form, and the cellulose ethyl ether is present in an amount of about 0.5 to about 6% w/w based on the total percentage by weight of the first liquid dosage form. 
     
     
         25 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein the one or more antacid is selected from the group consisting of calcium carbonate, sodium bicarbonate, magnesium hydroxide, aluminum hydroxide, magnesium oxide, magnesium carbonate, aluminum phosphate, magaldrate and magnesium trisilicate. 
     
     
         26 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein the one or more antacid is selected from the group consisting of calcium carbonate, magnesium hydroxide and aluminum hydroxide. 
     
     
         27 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein the one or more antacid is a combination of calcium carbonate and magnesium hydroxide or a combination of aluminum hydroxide and magnesium hydroxide. 
     
     
         28 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein the second liquid dosage form further comprises at least one flavor. 
     
     
         29 . The liquid oral pharmaceutical dosage form according to  claim 28 , wherein the at least one flavor is selected from the group consisting of peppermint, spearmint, eucalyptus, licorice, vanilla, herbs, caramel, berries or mixed berries, mixed fruits, black currant, blue berries, cherry, lemon and mixtures thereof. 
     
     
         30 . The liquid oral pharmaceutical dosage form according to  claim 19 , further comprising simethicone, dimethicone or mixture thereof or alginate in the first or second liquid dosage form. 
     
     
         31 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein the famotidine is present in an amount of from about 2 to about 30 mg. 
     
     
         32 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein the one or more antacid is present in an amount of from about 200 to about 3000 mg. 
     
     
         33 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein each of first and second liquid dosage forms is present in an amount of from about 2 to about 20 ml. 
     
     
         34 . The liquid oral pharmaceutical dosage form according to  claim 19 , being in the form of a two-compartment stick pack or two-compartment sachet. 
     
     
         35 . A method of treating a gastric disease or disorder comprising simultaneously administering the first and second liquid dosage forms of the liquid oral pharmaceutical dosage form according to  claim 19  to a subject in need thereof. 
     
     
         36 . The liquid oral pharmaceutical dosage form according to  claim 19 , wherein the vegetable gum is selected from the group consisting of alginate, guar gum, locust bean gum, xanthan gum, carrageenan, gellan gum and mixtures thereof.