Chewable gelled emulsions

Abstract

An oral pharmaceutical composition in unit dose form, each unit dose comprising a lipophilic drug substance within a unitary carrier body, said body comprising a soft, chewable, gelled oil-in-water emulsion.

1 . An oral pharmaceutical composition in unit dose form, each unit dose comprising a lipophilic drug substance within a unitary carrier body, said body comprising a soft, chewable, gelled oil-in-water emulsion. 
     
     
         2 . A composition as claimed in  claim 1  wherein said drug substance is ibuprofen. 
     
     
         3 . An oral pharmaceutical composition in unit dose form, each unit dose comprising a hydrophilic drug substance within a unitary carrier body, said body comprising a soft, chewable, gelled water-in-oil-in-water double emulsion. 
     
     
         4 . A composition as claimed in one of  claims 1  to  3  wherein said emulsion contains gelatin as a gelling agent. 
     
     
         5 . A composition as claimed in any one of  claims 1  to  4  consisting of a said gelled emulsion containing said drug substance. 
     
     
         6 . A pharmaceutical package comprising a foil-encased composition as claimed in any one of  claims 1  to  5 . 
     
     
         7 . A package as claimed in  claim 6  in the form of a blister pack. 
     
     
         8 . A process for preparing an oral pharmaceutical composition in unit dose form, which process comprises: forming an oil phase comprising a lipophilic drug substance dissolved or dispersed in a physiologically tolerable oil; forming an aqueous phase comprising an aqueous solution of a physiologically tolerable gelling agent; forming an oil-in-water emulsion with said oil phase and said aqueous phase, allowing said emulsion to gel to form a soft chewable mass; and, before, during or after gelling of said emulsion, dividing said emulsion into dose units. 
     
     
         9 . A process for preparing an oral pharmaceutical composition in unit dose form, which process comprises: forming an oil phase comprising a physiologically tolerable oil; forming an aqueous phase comprising an aqueous solution of a hydrophilic drug substance dissolved or dispersed therein; forming a water-in-oil emulsion with said oil phase and said aqueous phase, forming an oil-in-water emulsion with said water-in-oil phase and a further aqueous phase, comprising an aqueous solution of a physiologically tolerable gelling agent, allowing said emulsion to gel to form a soft chewable mass; and, before, during or after gelling of said emulsion, dividing said emulsion into dose units. 
     
     
         10 . An oral pharmaceutical composition in dose unit form comprising a physiologically tolerable calcium compound within a unitary carrier body, said body comprising a soft, chewable, gelled oil-in-water emulsion, and wherein the calcium content per dose unit is at least 125 mg Ca, for example 125 to 2000 mg Ca, especially 400 to 1200 mg Ca. 
     
     
         11 . A composition as claimed in  claim 10  containing particulate calcium carbonate. 
     
     
         12 . A composition as claimed in either of  claims 10  and  11  containing xylitol. 
     
     
         13 . A composition as claimed in any one of  claims 10  to  12  wherein said emulsion contains gelatin as a gelling agent. 
     
     
         14 . A composition as claimed in any one of  claims 10  to  13  consisting of a said gelled emulsion containing said drug substance. 
     
     
         15 . A pharmaceutical package comprising a foil-encased composition as claimed in any one of  claims 10  to  14 . 
     
     
         16 . A package as claimed in  claim 15  in the form of a blister pack. 
     
     
         17 . A method of treatment of a human subject with an effective amount of a drug substance, said method comprising administering said substance to said subject orally in a composition as claimed in any one of  claims 1  to  5  and  10  to  14 . 
     
     
         18 . A method as claimed in  claim 17  wherein said drug substance is a lipophilic chemotherapeutic agent and said subject is a human undergoing anticancer chemotherapy. 
     
     
         19 . A method as claimed in  claim 17  comprising administering an effective amount of a hydrophilic drug substance affecting cardiovascular functions to a patient in need thereof. 
     
     
         20 . A method as claimed in  claim 17  comprising administering an effective amount of a hydrophilic antimicrobial drug substance to a patient in need thereof. 
     
     
         21 . A method as claimed in  claim 17  comprising administering an effective amount of a hydrophilic vitamin to a patient in need thereof. 
     
     
         22 . A method as claimed in  claim 17  comprising administering an effective amount of a hydrophilic anti-inflammatory agent to a patient in need thereof. 
     
     
         23 . A method as claimed in  claim 17  comprising administering an effective amount of a hydrophilic analgesic agent to a patient in need thereof. 
     
     
         24 . A method as claimed in  claim 17  wherein said drug substance is within a unitary carrier body, said body comprising a soft, chewable, gelled water-in-oil-in-water double emulsion.