Claims for Patent: 5,578,324

Summary for Patent: 5,578,324

Title:	Peptide proteinaceous drug nasal powder composition
Abstract:	A peptide proteinaceous drug nasal powder composition containing (i) an absorption accelerant comprised of a compound, or its salt, having in its molecule a group expressed by the formula (I): ##STR1## wherein, ##STR2## indicates a cyclohexane ring or a benzene ring which may be substituted at least one of its 3-position, 4-position, and 5-position and n is an integer of 1 to 3 and (ii) a therapeutically effective amount of a peptide proteinaceous drug.
Inventor(s):	Dohi; Masahiko (Hino, JP), Nishibe; Yoshihisa (Fuchu, JP), Makino; Yuji (Hino, JP), Suzuki; Yoshiki (Hino, JP)
Assignee:	Teijin Limited (Osaka, JP)
Application Number:	08/407,000
Patent Claims:	1. A peptide proteinaceous drug nasal powder composition comprising (i) an absorption accelerant comprising a compound, or its salt, having in the compound molecule a group expressed by the formula (II): ##STR10## wherein, represents a cyclohexane ring or a benzene ring; n is an integer of 1 or 2; R.sup.1, R.sup.2 and R.sup.3 are, independently, a member selected from the group consisting of a hydrogen atom -COOR, -COR, -OR', and -SO.sub.2 NH.sub.2, which may be substituted; provided that at least one of R.sup.1, R.sup.2 or R.sup.3 is a hydrogen atom; R represents a hydrogen atom, a C.sub.1 -C.sub.6 lower alkyl group which may be substituted, or CH.sub.2 CH.sub.2 COOR'; R' represents a hydrogen atom, a C.sub.1 -C.sub.6 lower alkyl group which may be substituted, a phenyl group which may be substituted, or a C.sub.7 -C.sub.8 aralkyl group which may be substituted, and (ii) a therapeutically effective amount of a peptide proteinaceous drug. 2. A nasal powder composition as set forth in claim 1, wherein ##STR11## in formula (II) is a cyclohexane ring and n=1. 3. A nasal powder composition as set forth in claim 2, wherein the cyclohexane ring is substituted by a member selected from the group consisting of a hydrogen atom, -CO-C.sub.6 H.sub.5 -(CH.sub.2).sub.2 COOH, a carboxyl group, and -COO-C.sub.6 H.sub.5 -(CH.sub.2).sub.2 COOH. 4. A nasal powder composition as set forth in claim 2, wherein R.sup.1 and R.sup.3 in formula (II) are each a hydrogen atom and R.sup.2 is -COO -CH.sub.6 H.sub.5 -(CH.sub.2).sub.2 COOH. 5. A nasal powder composition as set forth in claim 2, wherein R.sup.1 and R.sup.3 in formula (II) are each a hydrogen atom and R.sup.2 is -CO-C.sub.6 H.sub.5 -(CH.sub.2).sub.2 -COOH. 6. A nasal powder composition as set forth in claim 2, wherein R.sup.1 and R.sup.3 in formula (II) are each a hydrogen atom and R.sup.2 is a carboxyl group. 7. A nasal powder composition as set forth in claim 1 wherein ##STR12## in formula (II) is a benzene ring. 8. A nasal powder composition as set forth in claim 7, wherein the benzene ring is substituted by a member selected from the group consisting of a hydrogen atom, a carboxyl group, a hydroxyl group and a sulfamine group. 9. A nasal powder composition as set forth in claim 7, wherein R.sup.1 and R.sup.3 in formula (II) are each a hydrogen atom, R.sup.2 is a carboxyl group and n is 1. 10. A nasal powder composition as set forth in claim 7, wherein R.sup.1 and R.sup.3 in formula (II) are each a hydrogen atom, R.sup.2 is a sulfamine group, and n is 1. 11. A nasal powder composition as set forth in claim 7, wherein, in formula (II), R.sup.1 is a hydrogen atom, R.sup.2 and R.sup.3 are each a hydroxyl group, and n is 2. 12. A nasal powder composition as set forth in claim 1, wherein the peptide proteinaceous drug is at least one peptide proteinaceous drug selected from the group consisting of calcitonins, insulins, somatostatin (GIF)and derivatives thereof, parathyroid hormones (PTH), substance P, platelet derived growth factors (PDGF), galanin, gastrin, neurokinins, interleukins, neurotensin, endo serine, growth hormones (GH), growth hormone-releasing hormone (GHRH) and derivatives thereof, growth hormone releasing factor (GRF), luteinizing hormone-releasing hormone (LHRH) and derivative thereof, enkephalin and derivatives thereof, secretin, bradykinin and derivatives thereof, adrenocorticotrophic hormone (ACTH) and derivatives thereof, glucagon, insulin growth factor (IGF), calcitonin gene related peptide (CCRP) interferons, vasopressin and derivatives thereof, atrial natrium peptide (ANP), erythropoietin, and granulocyte colony stimuli factor (G-CSF). 13. A nasal powder composition as set forth in claim 1, wherein the peptide proteinaceous drug is at least one peptide proteinaceous drug selected from the group consisting of calcitonins, insulins, somatostatin (GIF) and derivatives thereof, parathyroid hormones (PTH), substance P, platelet derived growth factors (PDGF), growth hormone-releasing hormone (GHRH) and derivatives thereof, luteinizing hormone-releasing hormone (LHRH) and derivatives thereof, adrenocorticotrophic hormone (ACTH) and derivatives thereof, glucagon, and calcitonin gene related peptide (CGRP). 14. A nasal powder composition as set forth in claim 1, wherein the peptide proteinaceous drug is at least one peptide proteinaceous drug selected from the group comprising salmon, eel, human, pig, and chicken natural calcitonin and derivatives thereof. 15. A nasal powder composition as set forth in claim 1, wherein the peptide proteinaceous drug is at least one peptide proteinaceous drug selected from the group consisting of human, rat, and pig natural somatostatin and derivatives thereof. 16. A nasal powder composition as set forth in claim 1, wherein the peptide proteinaceous drug is at least one peptide proteinaceous drug selected from the group consisting of bovine, human, and rat natural parathyroid hormone (PTH) and derivatives thereof. 17. A nasal powder composition as set forth in claim 1, wherein the peptide proteinaceous drug is at least one peptide proteinaceous drug selected from the group consisting of bovine, human, rat, and pig natural luteinizing hormone-releasing hormone (LHRH) and derivatives thereof. 18. A nasal powder composition as set forth in claim 1, wherein the peptide proteinaceous drug is at least one peptide proteinaceous drug selected from the group consisting of human, rat, and pig natural growth hormone-releasing hormone (GHRH) and derivatives thereof.

Details for Patent 5,578,324

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2013-11-26