Claims for Patent: 5,849,322

Summary for Patent: 5,849,322

Title:	Compositions and methods for buccal delivery of pharmaceutical agents
Abstract:	A composition for transmucosally administering a drug to the oral cavity comprises an adhesive layer comprising a hydrophilic polymer having one surface adapted to contact a first tissue of the oral cavity and adhere thereto when wet and an opposing surface in contact with and adhering to an adjacent drug-containing layer comprising an effective amount of a drug and optionally an effective amount of a permeation enhancer, wherein the drug-containing layer is adapted to contact and be in drug transfer relationship with a mucosal tissue of the oral cavity when the adhesive layer contacts and adheres to the first tissue. Preferred drugs include peptides, such as glucagon-like insulinotropic peptides. A method of transmucosally administering a drug to the oral cavity is also disclosed.
Inventor(s):	Ebert; Charles D. (Salt Lake City, UT), Heiber; Sonia J. (Salt Lake City, UT), Gutniak; Mark K. (Hasselby, SE)
Assignee:	Theratech, Inc. (Salt Lake City, UT)
Application Number:	08/546,994
Patent Claims:	1. A system for transmucosally administering a drug to the oral cavity comprising an adhesive layer comprising a hydrophilic polymer having one surface adapted to contact a first tissue of the oral cavity and adhere thereto when wet and an opposing surface in contact with and adhering to an adjacent drug-containing layer comprising an effective amount of a drug and optionally an effective amount of a permeation enhancer, said drug-containing layer adapted to contact and be in drug transfer relationship with a mucosal tissue of the oral cavity when said adhesive layer contacts and adheres to said first tissue. 2. The system of claim 1 wherein said permeation enhancer is a member selected from the group consisting of cell envelope disordering compounds, solvents, steroidal detergents, chelators, surfactants, non-surfactants, fatty acids, and mixtures thereof. 3. The system of claim 2 wherein said permeation enhancer is a steroidal detergent. 4. The system of claim 3 wherein said permeation enhancer is a bile salt. 5. The system of claim 4 wherein said drug is a peptide. 6. The system of claim 5 wherein said hydrophilic polymer comprises at least one member selected from the group consisting of hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethylcellulose, ethylcellulose, carboxymethyl cellulose, dextran, gaur-gum, polyvinyl pyrrolidone, pectins, starches, gelatin, casein, acrylic acid polymers, polymers of acrylic acid esters, acrylic acid copolymers, vinyl polymers, vinyl copolymers, polymers of vinyl alcohols, alkoxy polymers, polyethylene oxide polymers, polyethers, and mixtures thereof. 7. The system of claim 6 in the form of a bilayer tablet wherein said adhesive layer additionally contains one or more members selected from the group consisting of fillers, tableting excipients, lubricants, flavors; and dyes and wherein said drug-containing layer additionally contains one or more members selected from the group consisting of tableting excipients, fillers, flavors, taste-masking agents, dyes, stabilizers, enyzme inhibitors, and lubricants. 8. The system of claim 7 wherein said bile salt enhancer is a salt of a conjugate of a bile acid with taurine. 9. The system of claim 8 wherein said hydrophilic polymer comprises a mixture of polyethylene oxide and polyacrylic acid. 10. The system of claim 9 wherein said peptide is a member selected from the group consisting of insulinotropic peptides and precursors, analogues, and fragments thereof. 11. The system of claim 10 wherein said peptide is a member selected from the group consisting of GLP-1(7-36)amide, and precursors, analogues, and fragments thereof. 12. The system of claim 11 wherein said peptide is GLP-1(7-36)amide. 13. The system of claim 10 wherein said peptide is a member selected from the group consisting of insulin and precursors, analogues, and fragments thereof. 14. The system of claim 13 wherein said peptide is insulin. 15. The system of claim 10 wherein said peptide is member selected from the group consisting of amylin and precursors, analogues, and fragments thereof. 16. The system of claim 9 wherein said peptide is a member selected from the group consisting of calcitonin and precursors, analogues, and fragments thereof. 17. The system of claim 16 wherein said peptide is calcitonin. 18. The system of claim 9 wherein said peptide is a member selected from the group consisting of desmopressin and precursors, analogues, and fragments thereof. 19. The system of claim 18 wherein said peptide is desmopressin. 20. The system of claim 9 wherein said peptide is a member of the group consisting of parathyroid hormone and precursors, analogues, and fragments thereof. 21. The system of claim 20 wherein said peptide is parathyroid hormone. 22. The system of claim 1 wherein said first tissue is gingival tissue and said mucosal tissue is buccal mucosa. 23. A method for transmucosally administering a drug to an oral cavity comprising applying to a first tissue of the oral cavity a system comprising an adhesive layer comprising a hydrophilic polymer having one surface adapted to contact said first tissue of the oral cavity and adhere thereto when wet and an opposing surface in contact with and adhering to an adjacent drug-containing layer comprising an effective amount of a drug and optionally an effective amount of a permeation enhancer, said drug-containing layer adapted to contact and be in drug transfer relationship with a mucosal tissue of the oral cavity when said adhesive layer contacts and adheres to said first tissue. 24. The method of claim 23 wherein said permeation enhancer is a member selected from the group consisting of cell envelope disordering compounds, solvents, steroidal detergents, chelators, surfactants, non-surfactants, fatty acids, and mixtures thereof. 25. The method of claim 24 wherein said permeation enhancer is a steroidal detergent. 26. The method of claim 25 wherein said permeation enhancer is a bile salt. 27. The method of claim 26 wherein said drug is a peptide. 28. The method of claim 27 wherein said hydrophilic polymer comprises at least one member selected from the group consisting of hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethylcellulose, ethylcellulose, carboxymethyl cellulose, dextran, gaur-gum, polyvinyl pyrrolidone, pectins, starches, gelatin, casein, acrylic acid polymers, polymers of acrylic acid esters, acrylic acid copolymers, vinyl polymers, vinyl copolymers, polymers of vinyl alcohols, alkoxy polymers, polyethylene oxide polymers, polyethers, and mixtures thereof. 29. The method of claim 28 in the form of a bilayer tablet wherein said adhesive layer additionally contains one or more members selected from the group consisting of fillers, tableting excipients, lubricants, flavors, and dyes and wherein said drug-containing layer additionally contains one or more members selected from the group consisting of tableting excipients, fillers, flavors, taste-masking agents, dyes, stabilizers, enyzme inhibitors, and lubricants. 30. The method of claim 29 wherein said bile salt enhancer is a salt of a conjugate of a bile acid with taurine. 31. The method of claim 30 wherein said hydrophilic polymer comprises a mixture of polyethylene oxide and polyacrylic acid. 32. The method of claim 31 wherein said peptide is a member selected from the group consisting of insulinotropic peptides and precursors, analogues, and fragments thereof. 33. The method of claim 32 wherein said peptide is a member selected from the group consisting of GLP-1(7-36)amide, and precursors, analogues, and fragments thereof. 34. The method of claim 33 wherein said peptide is GLP-1(7-36)amide. 35. The method of claim 32 wherein said peptide is a member selected from the group consisting of insulin and precursors, analogues, and fragments thereof. 36. The method of claim 35 wherein said peptide is insulin. 37. The method of claim 32 wherein said peptide is member selected from the group consisting of amylin and precursors, analogues, and fragments thereof. 38. The method of claim 31 wherein said peptide is a member selected from the group consisting of calcitonin and precursors, analogues, and fragments thereof. 39. The method of claim 38 wherein said peptide is calcitonin. 40. The method of claim 31 wherein said peptide is a member selected from the group consisting of desmopressin and precursors, analogues, and fragments thereof. 41. The method of claim 40 wherein said peptide is desmopressin. 42. The method of claim 31 wherein said peptide is a member of the group consisting of parathyroid hormone and precursors, analogues, and fragments thereof. 43. The method of claim 42 wherein said peptide is parathyroid hormone. 44. The method of claim 23 wherein said first tissue is gingival tissue and said mucosal tissue is buccal mucosa.

Details for Patent 5,849,322

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2039-02-26