Claims for Patent: 9,138,410

Summary for Patent: 9,138,410

Title:	Compositions 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 (Kanagawa, JP), Hanafusa; Takashi (Hyogo, JP), Haruta; Shunji (Kagoshima, JP)
Assignee:	Shin Nippon Biomedical Laboratories, Ltd. (Kagoshima, JP)
Application Number:	13/827,859
Patent Claims:	1. A method of intranasally administering a physiologically active peptide or peptide-related compound, the method comprising: intranasally administering a powdery pharmaceutical composition comprising: the physiologically active peptide or peptide-related compound; and a carrier, wherein: the physiologically active peptide or peptide-related compound has a molecular weight of 30,000 or less, and the carrier comprises crystalline cellulose particles, wherein 85 wt % or more of the crystalline cellulose particles are in a sieving particle diameter range of 20-60 .mu.m, and wherein the crystalline cellulose particles have an average polymerization degree of about 20 to 250. 2. The method of claim 1, wherein the physiologically active peptide or peptide-related compound is selected from the group consisting of insulin, human 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, parathyroid hormone, thyroid-stimulating hormone-releasing hormone, angiotensin, prolactin, luteinizing hormone, gastric inhibitory polypeptide (GIP), C-peptide, cyclosporine, and FK-506. 3. The method of claim 1, wherein the powdery pharmaceutical composition comprises insulin. 4. The method of claim 1, wherein the powdery pharmaceutical composition comprises human growth hormone. 5. The method of claim 1, wherein the powdery pharmaceutical composition comprises glucagon. 6. The method of claim 1, wherein the powdery pharmaceutical composition comprises glucagon-like peptide-1. 7. The method of claim 1, wherein the powdery pharmaceutical composition comprises calcitonin. 8. The method of claim 1, wherein the powdery pharmaceutical composition comprises parathyroid hormone. 9. The method of claim 1, wherein the powdery pharmaceutical composition comprises parathyroid hormone (1-34). 10. The method of claim 1, wherein the powdery pharmaceutical composition comprises luteinizing hormone-releasing hormone. 11. The method of claim 1, wherein the physiologically active peptide or peptide-related compound is in the form of a powder finer than the crystalline cellulose particles. 12. The method of claim 1, wherein the crystalline cellulose particles have a sieving particle diameter distribution of: about 10 wt % or fewer particles with a diameter smaller than 25 .mu.m; about 20 to 60 wt % particles with a diameter of about 25 to 38 .mu.m; about 20 to 60 wt % particles with a diameter greater than 38 .mu.m and smaller than 53 .mu.m or equal to about 53 .mu.m; and the remaining particles having a diameter greater than 53 .mu.m but up to 60 .mu.m or less. 13. The method of claim 1, wherein the crystalline cellulose particles have an average polymerization degree of about 30 to 50. 14. The method of claim 1, wherein the crystalline cellulose particles have a bulk density of about 0.22 to 0.65 g/cm.sup.3. 15. The method of claim 1, wherein the crystalline cellulose particles have a bulk density of about 0.22 to 0.40 g/cm.sup.3. 16. The method of claim 1, wherein the crystalline cellulose particles have a bulk density of about 0.22 g/cm.sup.3. 17. The method of claim 1, wherein the physiologically active peptide is intranasally administered. 18. The method of claim 1, wherein the physiologically active peptide-related compound is intranasally administered.

Details for Patent 9,138,410

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10/28/1982		2039-02-26
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	12/29/2015		2039-02-26
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	08/06/1998		2039-02-26