Claims for Patent: 8,435,554

Summary for Patent: 8,435,554

Title:	Compositons for nasal administration of pharmaceuticals
Abstract:	Compositions for nasal administration, which comprise a pharmaceutical, a physiologically active peptide, or a peptide-related compound, and as the carrier thereof, crystalline cellulose with a specific particle diameter and/or partially pregelatinized starch are provided. Such compositions improve the in vivo absorption efficiency of pharmaceuticals.
Inventor(s):	Oki; Toshikazu (Yokohama, JP), Hanafusa; Takashi (Kobe, JP), Haruta; Shunji (Kagoshima, JP)
Assignee:	Shin Nippon Biomedical Laboratories, Ltd. (Kagoshima, JP)
Application Number:	12/346,537
Patent Claims:	1. A powdered pharmaceutical composition comprising: a) a physiologically active peptide or a peptide-related compound, wherein the peptide or peptide-related compound has a molecular weight of 30,000 or less; and b) a carrier consisting of crystalline cellulose, having a mean sieving particle diameter of less than 50 .mu.m, wherein when administered intranasally to a primate, at least one pharmacokinetic parameter is improved compared to the pharmacokinetic profile of an intranasally administered powdered pharmaceutical composition comprising a carrier having a mean sieving particle diameter of at least 50 .mu.m. 2. The pharmaceutical composition of claim 1, wherein the at least one improved pharmacokinetic parameter is a higher area under the curve (AUC) for blood concentration-time profile. 3. The pharmaceutical composition of claim 2, wherein the higher AUC is from about 1.78 to about 2.78-fold higher. 4. The pharmaceutical composition of claim 1, wherein the at least one improved pharmacokinetic parameter is a higher maximum blood concentration (C.sub.max). 5. The pharmaceutical composition of claim 4, wherein the higher C.sub.max is from about 1.05 to about 2.72-fold higher. 6. The pharmaceutical composition of claim 1, wherein the at least one improved pharmacokinetic parameter is an increased amount of time for the drug concentration in blood to decline by half (t.sub.1/2). 7. The pharmaceutical composition of claim 1, wherein two or more pharmacokinetic parameters are improved. 8. The pharmaceutical composition of claim 7, where the two or more improved pharmacokinetic parameters are selected from the group consisting of higher AUC, higher C.sub.max and increased t.sub.1/2. 9. The pharmaceutical composition of claim 1, wherein the physiologically active peptide is insulin and wherein the at least one improved pharmacokinetic parameter is a higher AUC. 10. The pharmaceutical composition of claim 1, wherein the physiologically active peptide is insulin and wherein the at least one improved pharmacokinetic parameter is a higher C.sub.max. 11. The pharmaceutical composition of claim 1, wherein the physiologically active peptide is growth hormone and wherein the at least one improved pharmacokinetic parameter is a higher AUC. 12. The pharmaceutical composition of claim 1, comprising the physiologically active peptide, wherein the physiologically active peptide is growth hormone and wherein the at least one improved pharmacokinetic parameter is a higher C.sub.max. 13. The pharmaceutical composition of claim 1, comprising the physiologically active peptide, wherein the physiologically active peptide is glucagon and wherein the at least one improved pharmacokinetic parameter is a higher AUC. 14. The pharmaceutical composition of claim 1, comprising the physiologically active peptide, wherein the physiologically active peptide is glucagon and wherein the at least one improved pharmacokinetic parameter is a higher C.sub.max. 15. The pharmaceutical composition of claim 1, comprising the physiologically active peptide, wherein the physiologically active peptide is glucagon and wherein the at least one improved pharmacokinetic parameter is an increased t.sub.1/2. 16. The pharmaceutical composition of claim 1, comprising the physiologically active peptide, wherein the physiologically active peptide is calcitonin and wherein the at least one improved pharmacokinetic parameter is a higher AUC. 17. The pharmaceutical composition of claim 1, comprising the physiologically active peptide, wherein the physiologically active peptide is calcitonin and wherein the at least one improved pharmacokinetic parameter is a higher C.sub.max. 18. The pharmaceutical composition of claim 1, comprising the physiologically active peptide, wherein the physiologically active peptide is parathyroid hormone (1-34) and wherein the at least one improved pharmacokinetic parameter is a higher AUC. 19. The pharmaceutical composition of claim 1, comprising the physiologically active peptide, wherein the physiologically active peptide is parathyroid hormone (1-34) and wherein the at least one improved pharmacokinetic parameter is a higher C.sub.max. 20. The pharmaceutical composition of claim 1, wherein the physiologically active peptide or peptide related compound is selected from the group consisting of growth hormone, calcitonin, glucagon, parathyroid hormone, parathyroid hormone (1-34), glucagon-like peptide-1, interferon, interleukin, erythropoietin, luteinizing hormone-releasing hormone, somatostatin, vasopressin, oxytocin, enkephalin, adrenocorticotropic hormone, growth hormone-releasing hormone, granulocyte colony formation-stimulating factor, thyroid-stimulating hormone-releasing hormone, angiotensin, prolactin, luteinizing hormone, gastric inhibitory polypeptide (GIP), C-peptide, cyclosporine, and FK-506. 21. The pharmaceutical composition of claim 1, comprising the physiologically active peptide, wherein the physiologically active peptide is insulin, growth hormone, calcitonin, glucagon, parathyroid hormone, glucagon-like peptide-1, or parathyroid hormone (1-34). 22. The pharmaceutical composition of claim 1, comprising the physiologically active peptide, wherein the physiologically active peptide is glucagon-like peptide-1. 23. The pharmaceutical composition of claim 1, comprising the peptide-related compound, wherein the peptide-related compound is selected from the group consisting of a parathyroid hormone (1-34) related compound comprising at least one peptide bond in the molecular structure, a glucagon-like peptide-1 related compound comprising at least one peptide bond in the molecular structure, and a vasopressin related compound comprising at least one peptide bond in the molecular structure. 24. A powdered pharmaceutical composition comprising: a) glucagon-like peptide-1; and b) a carrier consisting of crystalline cellulose having a mean sieving particle diameter of less than 50 .mu.m, wherein when administered intranasally to a primate, at least one pharmacokinetic parameter is improved compared to the pharmacokinetic profile of an intranasally administered powdered pharmaceutical composition comprising glucagon-like peptide-1 and a carrier having a mean sieving particle diameter of at least 50 .mu.m. 25. The pharmaceutical composition of claim 20, wherein the physiologically active peptide or peptide related compound is FK-506.

Details for Patent 8,435,554

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2023-02-21