Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Preparing compound containing saccharide radical
Reexamination Certificate
2011-08-23
2011-08-23
Ward, Paul V. (Department: 1624)
Chemistry: molecular biology and microbiology
Micro-organism, tissue cell culture or enzyme using process...
Preparing compound containing saccharide radical
C514S052000, C536S026400
Reexamination Certificate
active
08003353
ABSTRACT:
A stable pharmaceutical mercury-free aqueous solution of cyanocobalamin comprised of cyanocobalamin and water wherein said solution of cyanocobalamin is suitable for intranasal administration, has a viscosity less than about 1000 cPs, and wherein said solution of cyanocobalamin has a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin with the proviso that the solution is essentially free of mercury and mercury-containing compounds. The present invention is also directed towards a method for elevating the vitamin B12 levels in the cerebral spinal fluid (CSF) comprising administering intranasally a sufficient amount of a mercury-free cyanocobalamin solution so as to increase the average ratio of vitamin B12 in the CSF to that in the blood serum (B12 CSF/B12 Serum×100) to at least about 1.1 comprising intranasally administering an aqueous solution of a cyanocobalamin, wherein said solution of cyanocobalamin has a bioavailability of at least 7% relative to an intramuscular injection of a cyanocobalamin.
REFERENCES:
patent: 2703302 (1955-03-01), Rickes et al.
patent: 2703303 (1955-03-01), Rickes et al.
patent: 2746796 (1956-05-01), Germain et al.
patent: 2914222 (1959-11-01), Meshberg
patent: 2951017 (1960-08-01), Speedie et al.
patent: 3000793 (1961-09-01), McDaniel
patent: 3018225 (1962-01-01), Long
patent: 3057851 (1962-10-01), Van Melle
patent: 3120508 (1964-02-01), Braun et al.
patent: 3120509 (1964-02-01), Bernhauer et al.
patent: 3282781 (1966-11-01), Macek et al.
patent: 3548057 (1970-12-01), Kelley et al.
patent: 3577537 (1971-05-01), Howe et al.
patent: 3584115 (1971-06-01), Gebhart et al.
patent: 3957968 (1976-05-01), Cordon
patent: 4174295 (1979-11-01), Bargigia et al.
patent: 4523341 (1985-06-01), Queen
patent: 4525341 (1985-06-01), Deihl
patent: 4724231 (1988-02-01), Wenig
patent: 4727231 (1988-02-01), Hayano et al.
patent: 4959176 (1990-09-01), Slocum et al.
patent: 5277311 (1994-01-01), Kuemmerle et al.
patent: 5797390 (1998-08-01), McSoley
patent: 5801161 (1998-09-01), Merkus
patent: 5825625 (1998-10-01), Esterberg et al.
patent: 5925625 (1999-07-01), Merkus
patent: 6406730 (2002-06-01), Banyard et al.
patent: 6665421 (2003-12-01), Farina
patent: 6685421 (2004-02-01), Reeves
patent: 6745760 (2004-06-01), Grychowski et al.
patent: 6911434 (2005-06-01), Baldridge et al.
patent: 2004/0043043 (2004-03-01), Schlyter et al.
patent: 2004/0109826 (2004-06-01), Malladi et al.
patent: 2006/0046969 (2006-03-01), Maggio
patent: 2006/0074034 (2006-04-01), Collins et al.
patent: 2006/0105432 (2006-05-01), Barg et al.
patent: 2006/0127320 (2006-06-01), Costantino et al.
patent: 1317881 (1993-05-01), None
patent: 0131315 (1984-02-01), None
patent: 0130550 (1984-06-01), None
patent: WO 86/05987 (1986-10-01), None
patent: WO 86/05988 (1986-10-01), None
Allen, 2002, “Prescription”, Intl. J. of Pharmaceutical Compounding, vol. 6(3): 208.
Anwar et al., 1984, “Studies on the intranasal absorption of Vitamin B12in the rat,” Final Report, Dec. 1984, University of Kentucky, College of Pharmacy, Lexington, KY.
Chandra et al., 1982, “Double-blind controlled crossover trial of 4% intranasal sodium crymoglycate solution in patients with seasonal allergic rhinitis,” Annals of Allergy, vol. 49, from the Dept. of Pediatrics, Memorial University of Newfoundland, Janeway Child Health Center and Health Sciences Center. St. John's, Newfoundland, Canada.
Chen et al., 1983, Characterization of dose delivery and spray pattern of a metered-dose flunisolide nasal spray, Drug development and industrial pharmacy, vol. 9(3):473-483, Institute of Pharmaceutical Sciences, Syntex Research, Palo Alto, CA Mercel Dekker, Inc.
Cutie et al., 1982, “Intranasal pharmaceutical aerosols, aerosal age, the international authority in spray packaging,” Aerosol Age Magazine, Oct. 1982, pp. 1-4.
Edited by James E.F. Reynolds, Cyanocobalamin, Martindale, The Extra Pharmacopoeia, 1982, Abstract 7853-d, and p. 1645. Cyanocobalamin Injection, 28thEdition. Published by direction of the Council of The Pharmaceutical Society of Great Britain and prepared in the Society's Dept. of Pharmaceutical Sciences, The Pharmaceutical Press, London, UK.
Forest Laboratories, Inc., 1972 “Long acting oral carrier,” Chemical Abstracts, vol. 77, p. 263, Abstract 105623(y).
Garcia-Arieta et al., 2001, “Spray-dried powders as nasal absorption enhancers of cyanocobalamin,” Biol. Pharm. Bull., vol. 24(2):1411-1416.
Harris et al., 1988, “Effect of viscosity on particle size, deposition, and clearance of nasal delivery systems containing desmopressin,” J. Pharm Sci., vol. 77(5):405-408.
Killander et al., 1961, “Studies on maintenance treatment of pernicious anaemia, Vitamin B12and instrinsic factor,” Europaisches Symposian Hamburg, pp. 663-687, Ed. H.c. Heinrich, Enke, Stuttgart, Dept. of Pediatris and Internal Medicine, Akademiska,Sjukhuset, Uppsala, Sweden.
Mathison et al., 1998, “Nasal route for direct delivery of solutes to the central nervous system: Fact or fiction?” J. of Drug Targeting, vol. 5(6):415-441.
Monto et al., 1953, “Crystalline B12inhallation therapy in pernicious anemia,” The American Journal of the Medical Sciences, vol. 2, pp. 113-119, Publisher, Division of Hematology and Department of Laboratories, The Henry Ford Hospital, Detroit, Michigan.
Monto et al., 1954, “Nasal instiliation and inhalation of crystalline Vitamin B12in pernicious anemia,” A.M.A. Archives 6 Internal Medicine, vol. 93:219-230, Division of Hematology (Dr. Monto) and the Dept of Laboratories (Dr. Rebuk), The Henry Ford Hospital.
Monto et al., 1955, “Observations on the mechanism of intranasal absorption of Vitamin B12in pernicious anemia,” Blood, vol. 10:1151-1155.
Nijst et al., 1990, “Vitamin B12and folate concentrations in serum and cerebrospinal fluid of neurological patients with special reference to multiple sclerosis and dementia,” J. of Neurology, Neurosurgey and Psychiatry, vol. 53:951-954.
Shinton et al., 1967, “Vitamin B12absorption by inhalation,” Brit J. Haematol., vol. 13:75-79.
Shinton et al., 1967, “Vitamin B12absorption by inhalation,” Chemical Abstracts, vol. 66, No. 15, Coden: Chaba8, The American Chemical Society , p. 6024, Abstract 64246(2).
Siarra, J.J. Aerosols, Chapter 92, year unknown, pp. 1614-1621, Arnold & Marie Schwartz, Collet of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY.
Slot et al., 1997, “Normalization of plasma vitamin B12concentration by intranasal hydroxocobalamin in Vitamin B12-defient patients,” Gastro, vol. 113:430-433.
U.S. Department of Health and Human Services, (Draft) 2003. “Guidance for Industry, Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action,” Apr. 2003, pp. 1-36 + attachments, U.S. FDA, Center for Drug Evaluation and Research, Biopharmaceutics.
U.S. Dept. of Health and Humans Services, 2002. “Guidance for Industry, Nasal spray and inhalation solution, suspension, and spray drug products-chemistry, manufacturing, and controls documentation,” Jul. 2002, pp. 1-44, FDA, Center for Drug Evaluatio and Research.
Valois, “Pumps for Pharmacy,” Year unknown (product brochure).
Aprile Peter C.
Go Zenaida O.
Quay Steven C.
Sileno Anthony P.
Arent & Fox LLP
Par Pharmaceutical, Inc.
Ward Paul V.
LandOfFree
Cyanocobalamin low viscosity aqueous formulations for... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Cyanocobalamin low viscosity aqueous formulations for..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Cyanocobalamin low viscosity aqueous formulations for... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2689614