Stabilized teriparatide solutions

Details Stabilized teriparatide solutions Stabilized teriparatide solutions

2006-10-02

2009-06-23

Gupta, Anish (Department: 1654)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

C530S324000

Reexamination Certificate

active

07550434

ABSTRACT:
A stabilized pharmaceutical composition in the form of a solution for parenteral administration of a parathyroid hormone is described wherein the therapeutically active ingredient is stabilized with a buffer and a polyol. Preferred preparations contain in an aqueous solution human PTH(1-34), mannitol, an acetate or tartrate buffering agent and m-cresol or benzyl alcohol as a preservative.

REFERENCES:
patent: 4698328 (1987-10-01), Neer et al.
patent: 4833125 (1989-05-01), Neer et al.
patent: 5208041 (1993-05-01), Sindrey
patent: 5496801 (1996-03-01), Holthuis et al.
patent: 5563122 (1996-10-01), Endo et al.
patent: 5578567 (1996-11-01), Cardinaux et al.
patent: 5607915 (1997-03-01), Patton
patent: 5616560 (1997-04-01), Geddes et al.
patent: 5891086 (1999-04-01), Weston
patent: 6025467 (2000-02-01), Fukuda et al.
patent: 6454746 (2002-09-01), Bydlon et al.
patent: 6582728 (2003-06-01), Platz et al.
patent: 6770623 (2004-08-01), Chang et al.
patent: 6977077 (2005-12-01), Hock et al.
patent: 7144861 (2006-12-01), Chang et al.
patent: 7163684 (2007-01-01), Gaich et al.
patent: 2234724 (1998-04-01), None
patent: 302 772 (1989-02-01), None
patent: 0 490 806 (1992-06-01), None
patent: 0619119 (1994-10-01), None
patent: WO 91/06564 (1991-05-01), None
patent: WO 94/08613 (1994-04-01), None
patent: WO 95/17207 (1995-06-01), None
patent: WO 97/14429 (1997-04-01), None
patent: WO 99/55353 (1999-11-01), None
patent: WO 00/10596 (2000-03-01), None
Martin et al. “Effects of Benzyl Alcohol on PTH Recetpro-Adenylate Cyclase System of Canine Kidney”, American J. of Physiology vol. 248, pt. 1. E31-35. Jan. 1985.
U.S. Appl. No. 11/098,894, filed Sep. 8, 2005, Gaich, et al.
U.S. Appl. No. 11/098,909, filed May 4, 2006, Gaich, et al.
U.S. Appl. No. 11/541,863, filed Oct. 2, 2006, Chang, et al.
Chemical Abstracts, vol. 111, No. 26, Dec. 25, 1989, Columbus, Ohio, US, abstracts No. 239514, XP-002102408, see abstract & JP 01 016799 A (Toyo Jozo), Jan. 20, 1989.
Database WPI, week 8817, Derwent Publications Ltd, London, GB, AN88-115396 ‘17’ XP-002102409 & JP 63 060940 A (Toyo, Jozo), Mar. 17, 1988.
Hodsman et al., “Biochemical Responses to Sequential Human Parathyroid Hormone (1-38) and Calcitonin in Osteoporotic Patients”, Bone and Mineral, 9(2):137-152, 1990.
Hodsman et al., “Bone Densitometric and Histomorphometric Responses to Sequential Human Parathyroid Hormone (1-38) and Salmon Calcitonin in Osteoporotic Patients”, 14(1): 67-83, 1991.
Hulter et al., “Chronic Continuous PTH Infusion Results in Hypertension in Normal Subjects”, J. Clin Hypertens, 2(4): 360-370, 1986.
International Search Report For PCT/US98/26043 prepared by European Patent Office dated May 11, 1999.
Isaac et al., “Absence of Effect of 1-34 h PTH on Plasma TSH, GH, FSH, LH, ACTH and Cortisol in Normal Man”, Horm. Metab. Res., 12(9): 487-488, 1980.
Law, et al., “Rapid Development of Renal Resistance to Low Doses of Synthetic Bovine Parathyroid Hormone Fragment 1-34”, J. Clin Invest., 72(3): 1106-1113, 1983.
Martindale, The Extra Pharamacoepia, The Pharmacoepia Press, London, 29thEdition, 1989 p. 1338.
Jenkins, W.A., and K.R. Osborn, Packaging Drugs and Pharmaceuticals, Technomic Pub. 1993.
Reeve, et al., “Anabolic effect of human parathyroid hormone fragment on trabecular bone in involutional osteoporosis: a multicnetre trial”, Br. Med. J., 280(6228): 1340-1344, 1980.
Reeve, et al., “Anabolic Effect of Low Doses of a Fragment of Human Parathyroid Hormone on the Skeleton in Postmenopausal Osteoporosis”, The Lancet, 1:1035-1038, 1976.
Reeve, et al., “Preliminary Trial of Low Doses of a Fragment of Human Parathyroid Hormone 1-34 Peptide in Treatment of Osteoporosis”, Calcif. Tissue Res., 21:469-477, 1976.
Sato, M., et al., “Biosynthetic Human Parathyroid Hormone (1-34) Effects on Bone Quality in Aged Ovariectomized Rats” Endocrinology, 138(10):4330-4337 (1997).
Slovik, D., et al., “Short-term Effects of Synthetic Human Parathyroid Hormone(1-34) Administration on Bone Mineral Metabolism in Osteoporotic Patients”, J. Clin. Invest. 68:1261-1271 (1981).
Tsai et al., “Bone Responsiveness to Parathyroid Hormone in Normal and Osteoporotic Postmenopausal Women”, J. Clin. Endocrinol Metab., 69(5): 1024-1027, 1989.
European Opposition Written Decision dated Jul. 25, 2006; European Patent No. EP 0920873 B1.
Opponent's Written Statement Setting Our Grounds of Appeal dated Dec. 4, 2006; Appeal No. T1526/06-3304; European Patent No. EP 0920873 B1.
Lilly's Written Statement Setting Out Grounds of Appeal dated Dec. 4, 2006; European Patent No. 0920873 B1; Appeal No. T1526/06-3304.
Lilly's Reply to Opponent Grounds of Appeal dated Jun. 28, 2007; European Patent No. 0920873 B1; Appeal File No. T1526/06-3304.
EPO Appeal Board Decision dated Jul. 14, 2008 pertaining to patent No. EP0920873B1.
Martin, Kevin J., et al., “Effects of Benzyl Alcohol on PTH Receptor-Adenylate Cyclase System of Canine Kidney,” Amer. J. of Physiology, vol. 248, pt. 1, E31-35, Jan. 1985.

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