Patent ID: 7018980

Claim:
A method for preparation of orally administrated insulin formulation, comprising: 1) dissolving an amount of insulin in an aqueous buffer, resulting in solution A, of which the pH value is between 3 and 5, and in which the concentration of insulin is 0.1–0.5 mg/mL; 2) adding acidic solution A to a liquid nonionic surfactant or an amphiphilic ester or a mixture thereof with 10<HLB<20, wherein the volume ratio of solution A to that of the surfactant or the amphiphilic ester or their mixture is from 1:5 to 1:50, and then mixing at 5–30° C. with agitation to form homogeneous solution B; 3) adding solution B to an hydrophobic emulsifier with 0<HLB<10, wherein the volume ratio of solution B to that of the hydrophobic emulsifier is from 1:1 to 1:10, and then mixing at 5–30° C. with agitation to form formulation C, which is stored at 4–10° C.; 4) adding an amount of antioxidant, wherein when the antioxidant is hydrophobic, the antioxidant is added to solution B during step 3), and when the antioxidant is hydrophilic, the antioxidant is added to solution A during step 2); wherein the formulation does not include an oil.