Clear micellized formulations of beta-carotene and method of treating leukoplakia

A clear aqueous composition for topical application in the oral cavity of humans, the composition comprising:

• water;
• a water miscible pharmaceutically acceptable polyol;
• a pharmaceutically acceptable unsaturated fatty acid ester;
• a pharmaceutically acceptable surfactant, and
• β-carotene, said β-carotene being in a micellized form within said composition.

A clear aqueous gel composition for topical application in the oral cavity of humans, the composition having been prepared by a process comprising the steps of:

• admixing a suspension of β-carotene in edible oil with polyethoxylated castor oil and heating said admixture to approximately 160 to 180° C. and agitating said admixture in said temperature range of 160 to 180° C. until a clear homogeneous solution is obtained;
• thereafter cooling said admixture to approximately 130 to 135° C. and adding d-alpha-tocopherol, glycerol and ethyl linoleate to said admixture, the d-alpha-tocopherol, glycerol and ethyl linoleate being added to the admixture at such a rate of addition that the temperature of the resulting mixture is cooled to approximately 85 to 95° C.;
• maintaining the resulting mixture under agitation at 85 to 95° C. until a clear homogeneous mixture is obtained;
• thereafter adding under agitation water of approximately 55 to 60° C. temperature and cooling the mixture under agitation until a clear homogenous product is obtained.