Patent ID: 7229639

Claim:
A pharmaceutically acceptable composition in the form of a solution for a liquid filling for a hard shell capsule comprising, based upon the total weight of the composition, a) from 35 to 75% by weight of a racemic mixture of ibuprofen, b) from 0.2 to 0.35 mole equivalents of an alkali hydroxide selected from the group consisting of sodium hydroxide and potassium hydroxide per mole of ibuprofen, c) from 40 to 55% by weight of an emulsifier which is a polyoxyethylene castor oil derivative and d) from 12 to 18% weight of a medium chain triglyceride, having a density in the range of 0.85–1.1 at 60 degrees C. and selected from the group consisting of (i) a polyoxoethylene alkyl ether selected from the group consisting of polyoxyl 2 cetyl ether, polyoxyl 10 cetyl ether, polyoxyl 20 cetyl ether, polyoxyl 4 lauryl ether, polyoxyl 23 lauryl ether, polyoxyl 2 oleyl ether, polyoxyl 10 oleyl ether, polyoxyl 20 oleyl ether, polyoxyl 2 stearyl ether, polyoxyl 10 stearyl ether, polyoxyl 2 stearyl ether, polyoxyul 10 stearyl ether, polyoxyl 20 stearyl ether, polyoxyl 100 stearyl ether polyoxyl 20 cetostearyl ether and mixtures thereof; (ii) a propylene glycol ester selected from the group consisting of propylene glycol dicocoate, propylene glycol distearate, propylene glycol dioctanoate, propylene glycol dipelargonate, propylene glycol diundecanoate, propylene glycol monostearate, propylene glycol monohydroxystearate, propylene glycol monolaurate, propylene glycol monomyristate, propylene glycol monooleate and mixtures thereof; (iii) a glyceryl ester selected from the group consisting of glyceryl monooleate, glyceryl monostearate, glyceryl palmitosterate and mixtures thereof; (iv) a sorbitan ester selected from the group consisting of sorbitan di-isostearate, sorbitan dioleate, sorbitan monolaurate, sorbitan monoisosterate, sorbitan monooleate, sorbitan monopalmitate, sorbitan monostearate, sorbitan sesqui isostearate, sorbitan tri-isostearate, sorbitan trioleate, sorbitan tristearate and mixtures thereof; (v) a polyoxyethylene castor oil derivative selected from the group consisting of polyoxy 5 castor oil, polyoxy 9 castor oil, polyoxy 15 castor oil, polyoxyl 35 castor oil, polyoxyl 40 castor oil, polyoxyl 40 hydrogenated castor oil, polyoxyl 60 hydrogenated castor oil and mixtures thereof; (vi) a polyoxyethylene sorbitan fatty ester selected from the group consisting of polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85, polysorbate 120 and mixtures thereof; (vii) a polyoxyethylene stearate selected from the group consisting of polyoxyl 6 stearate, polyoxyl 8 stearate, polyoxyl 12 stearate, polyoxyl 20 stearate and mixtures thereof; and mixtures of (i)–(vii),] and wherein the viscosity of the composition is in the range of 1000–4000 cps at 25 degrees C.