ORALLY DISSOLVING THIN FILMS CONTAINING ALLERGENS AND METHODS OF MAKING AND USE

摘要

The present invention provides a thin mucoadhesive sublingual film composition which provides improved allergen delivery and efficacy at a smaller dose while prolonging the contact time between the allergen and oral antigen presenting cells (APCs), and therefore minimizing the risk of systemic side effects. The thin film compositions of the present invention are also easier to standardize, and removes any need for measuring allergen doses at the physician's office, and which allows for a simplified dosing schedule. Methods of making the thin film compositions and methods for their use are also disclosed.

主权项

1. A pharmaceutical composition suitable for use in the treatment of an allergic response in a subject comprising:
a) about 10 to about 100% w/w of a primary film forming agent, wherein the agent comprises at least one or more water soluble polymers selected from the group consisting of pullulan, hydroxypropyl methyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl polymer, high amylase starch, hydroxypropylated high amylase starch, dextrin, pectin, chitin, chitosan, levan, elsinan, collagen, gelatin, zein, gluten, soy protein isolate, whey protein isolate, and casein; b) about 0.1 to about 20% w/w of a biodegradeable plasticizer selected from the group consisting of glycerols, sorbitol, poly(ethylene glycol), acetylated monoglycerides and alkyl citrates; c) about 0.1 to about 30% w/w of pharmaceutically acceptable excipients and carriers; d) about 0.1 to about 20% w/w of at least one or more mucoadhesive polymers; and e) about 0.00001% to about 70% w/w of at least one allergen extract.