Transmucosal delivery of macromolecular drugs

Details Transmucosal delivery of macromolecular drugs Transmucosal delivery of macromolecular drugs

A - Human Necessities

61

M

A61M 31/00 (2006.01) A61K 9/00 (2006.01) A61K 9/70 (2006.01) A61K 47/28 (2006.01) A61M 37/00 (2006.01)

Patent

CA 2156708

A method and system for mucosally administering a macromolecular drug to the mucosa of the oral cavity is shown. The system comprises an inner drug/enhancer/polymer layer (11) having one surface adapted to contact and adhere to the mucosal tissue of the oral cavity and an opposing surface in contact with and adhering to an overlying inert layer (12). The inner layer (11) contains from about two to sixty percent by weight of a bile salt enhancer, five to sixty five percent by weight of a hydrophilic polymer which is water soluble or swellable and an effective amount of a macromolecular drug having a molecular weight of at least 500 daltons. Polysaccharides, polypeptides and proteins are preferred forms of macromolecular drugs. The bile salt enhancer facilitates the delivery of macromolecules such as low molecular weight heparin and calcitonin. The polymer serves as a plasticizer to prevent the crystallization and/or aggregation of such macromolecular drugs. Hydroxypropyl cellulose is a particularly suitable polymer.

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