EP1424077A1 — Isulin-containing oral spray and the preparation method thereof

USPTO Abstract

The present invention provides an insulin-containing buccal spray and the preparation method thereof. The insulin buccal spray of the invention is a microemulsion having the average diameter of less than 200nm, comprising 10000u-70000u of insulin, 5-50g of soybean lecithin as absorption promoter, 20-80g of propylene glycol as cosolvent, and balanced with phosphate buffer of pH 6.8-7.8 to 1000ml, based on 1000ml microemulsion. The preparation method comprises: a) adding soybean lecithin to propylene glycol, mixing sufficiently, then adding phosphate buffer to result solution, and sonicating, thus obtaining the oil phase of the microemulsion; b) dissolving insulin in phosphate buffer; c) adding the insulin solution to the oil phase, sonicating again, thus obtaining the emulsion of the invention. The efficiency and stability of the emulsion of the invention are improved significantly, and administration of the invention is convenient.