CHEWABLE GELLED EMULSIONS
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.