Claims for Patent: 5,948,749

Summary for Patent: 5,948,749

Title:	Pharmaceutical preparations for intranasal administration
Abstract:	A pharmaceutical preparation for intranasal administration having a better absorption rate and less irritant effects is provided. The pharmaceutical preparation comprises a mixture of a powder of an adsorbent resin and a biologically active peptide having a drug effect under the condition that they are dry prior to or after the mixing.
Inventor(s):	Igarashi; Rie (Kawasaki, JP), Takenaga; Mitsuko (Kawasaki, JP), Muramatsu; Hiroshi (Hino, JP), Ebata; Tetsuo (Kunitachi, JP), Kosaka; Yasuo (Matsudo, JP)
Assignee:	Fuji Yakuhin Company, Limited (JP)
Application Number:	08/922,775
Patent Claims:	1. A dry pharmaceutical preparation for intranasal administration comprising a powder of a nonpolar adsorbent resin in admixture with a pharmacologically active compound, wherein the nonpolar adsorbent resin is styrene-divinylbenzene copolymer. 2. A pharmaceutical preparation for intranasal administration according to claim 1, wherein the particle size of the pharmacologically active compound is 10 .mu.m-0.001 .mu.m. 3. A pharmaceutical preparation for intranasal administration according to claim 1, wherein prior to the mixing, a biologically active peptide powder which has been dried under drying conditions is mixed with a dried powder of said nonpolar adsorbent resin. 4. A pharmaceutical preparation for intranasal administration according to claim 3, wherein after the mixing an aqueous solution or suspension of the biologically active peptide powder is mixed with a powder of styrene-divinylbenzene copolymer resin, then made into a powder by evaporation to dryness. 5. A pharmaceutical preparation for intranasal administration according to claim 3, wherein the pharmacologically active compound is a non-peptide pharmaceutical and wherein the pharmacologically active compound has an electrostatic charge. 6. A pharmaceutical preparation for intranasal administration according to claim 1, wherein an extender is added. 7. A pharmaceutical preparation for intranasal administration according to claim 1, wherein a lubricant is added. 8. A pharmaceutical preparation for intranasal administration according to claim 3, wherein the average particle size of the nonpolar adsorbent resin powder is 100 .mu.m-10 .mu.m. 9. The pharmaceutical preparation according to claim 3, wherein the pharmacologically active peptide is selected from the group consisting of insulin, glucagon, calcitonin, gastrin, parathyroid hormone, angiotensin, growth hormone, secretin, lactotropic hormone, thyrotropic hormone, melanocyte stimulating hormone, thyroid stimulating hormone, luteinizing hormone stimulating hormone, human menopausal gondotropin, vasopressin, oxytocin, protirelin, corticotropin, and somatotropin. 10. A dry pharmaceutical preparation for intranasal administration comprising a powder of a nonpolar adsorbent resin in admixture with a pharmacologically active peptide or protein. 11. A pharmaceutical preparation according to claim 10 which is obtained by mixing a dry powder of a nonpolar adsorbent resin with a pharmacologically active peptide or protein that has been dried prior to mixing. 12. A pharmaceutical preparation for intranasal administration according to claim 10, wherein the particle size of the biologically active peptide or protein is from 0.001 .mu.m to 10 .mu.m. 13. A pharmaceutical preparation according to claim 10 which is obtained by mixing the nonpolar adsorbent resin with a pharmacologically active peptide or protein and subsequently drying the resulting resin. 14. A pharmaceutical preparation for intranasal administration according to claim 10, wherein the average particle size of the adsorbent resin powder is 100 .mu.m-10 .mu.m. 15. The pharmaceutical preparation according to claim 10, wherein the pharmacologically active peptide is selected from the group consisting of insulin, glucagon, calcitonin, gastrin, parathyroid hormone, angiotensin, growth hormone, secretin, lactotropic hormone, thyrotropic hormone, melanocyte stimulating hormone, thyroid stimulating hormone, luteinizing hormone stimulating hormone, human menopausal gonadotropin, vasopressin, oxytocin, protirelin, corticotropin, and somatotropin. 16. The pharmaceutical preparation according to claim 10, wherein the pharmacologically active protein is selected from the group consisting of growth hormone stimulating factor, G-CSF, erythropoietin, EGF, interferon and interleukin. 17. The pharmaceutical preparation according to claim 10, wherein the protein is an enzyme selected from the group consisting of SOD, urokinase and lysozyme. 18. The pharmaceutical preparation according to claim 10, wherein the powder of the nonpolar adsorbent resin and the pharmacologically active peptide have both been dried prior to mixing. 19. A dry pharmaceutical preparation according to claim 10, wherein said nonpolar adsorbent resin is styrene-divinylbenzene copolymer resin. 20. A dry pharmaceutical preparation according to claim 10, which is obtained by a process comprising mixing a dry powder of a pharmaceutically active peptide with a dry powder of the nonpolar adsorbent resin in the presence of an organic solvent. 21. A pharmaceutical preparation for intranasal administration according to claim 20, wherein the organic solvent is ethanol. 22. A pharmaceutical preparation for intranasal administration according to claim 20, wherein an extender is added. 23. A pharmaceutical preparation for intranasal administration according to claim 22, wherein a lubricant is added.

Details for Patent 5,948,749

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Microbix Biosystems Inc.	KINLYTIC	urokinase	For Injection	021846	01/16/1978		2016-10-07
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2016-10-07