Cyanocobalamin low viscosity aqueous formulations for...

Special receptacle or package – Combined or convertible – Packaged assemblage or kit

Reexamination Certificate

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C424S434000, C424S001730, C435S086000, C536S026400

Reexamination Certificate

active

07404489

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), St. Germain
patent: 2914222 (1959-11-01), Meshberg
patent: 2951017 (1960-08-01), Speedle et al.
patent: 3000793 (1961-09-01), McDaniel
patent: 3018225 (1962-01-01), Long
patent: 3057851 (1962-10-01), Van Meele
patent: 3120509 (1964-02-01), Bernhauer
patent: 3282781 (1966-11-01), Evangelist
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: 3957966 (1976-05-01), Valan
patent: 4174295 (1979-11-01), Bargigia et al.
patent: 4525341 (1985-06-01), Deihl
patent: 4724231 (1988-02-01), Wenig
patent: 5797390 (1998-08-01), McSoley
patent: 5801161 (1998-09-01), Merkus
patent: 5925625 (1999-07-01), Merkus
patent: 6665421 (2003-12-01), Farina
patent: 6745760 (2004-06-01), Grychowski 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
Garcia-Arieta et al., Spray-Dried Powders as Nasal Absorption Enhancers of Cyanocobalamin. 2001., Biol. Phrm. Bull. 24(12) pp. 1411-1416.
Harris et al., Effect of Viscosity on Particle Size, Deposition, and Clearance of Nasal Delivery Systems Containing Desmopressin.1988., J. Pharm Sci. 77(5) pp. 405-408.
Slot et al., Normalization of Plasma Vitamin B12 Concentration by Intranasal Hydroxocobalamin in Vitamin B12-Deficient Patients. 1997., Gastro. 113., pp. 430-433.
U.S. Department of Health and Human Services, (Draft) Guidance for Industry, Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action, Apr. 2003, pp. 1-36 + attachments, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Biopharmaceutics.
Raymond W. Monto, John W. Rebuck, Michael Brennan, Crystalline B12Inhallation Theraphy in Perniciouos Anemia, The American Journal of the Medical Sciences, Feb. 1953, pp. 113-119, Publisher: Division of Hematology and Department of Laboratories, The Henry Ford Hospital, Detroit, Michicagn Published in: Detroit, MI, US.
Raymond W. Monto, John W. Rebuck, Nasal Instillation and Inhalation of Crystalline Vitamin B12in Pernicious Anemia, A.M.A. Archives 6 Internal Medicine, vol. 93, 1954, From the Division of Hematology (Dr. Monto) and the Department of Laboratories (Dr. Rebuck), The Henry Ford Hospital. pp. 219-230. Detroit, MI, US.
Raymond W. Monto, John W. Rebuck, Observations on the Mechanism of Intranasal Absorption of Vitamin B12in Pernicious Anemia. Blood, vol. 10, 1955, pp. 1151-1155, From the Division of Hematology (Dr. Monto) and the Department of Laboratories (Dr. Rebuck), The Henry Ford Hospital. Detroit, MI, US.
A. Killander and I. Werner, Studies on Maintenance Treatment of Pernicious Anaemia, Vitamin B12and Intrinsic Factor Europaisches Symposian Hamburg, 1961, pp. 663-667, Ed. H.c. Heinrich, Enke, Stuttgart, Department of Pediatris and Internal Medicine, Akademiska, Sjukhuset, Uppsala, Sweden.
N.K. Shinton and A.K. Singh, Vitamin B12absorption by inhalation, Chemical Abstracts, vol. 66, No. 15, Coden: Chaba8, The American Chemical Society, Apr. 10, 1967, p. 6024, Abstract 64246(e) Northhampton Sts, Easton, PA, US.
N.K. Shinton and A.K. Singh, Vitamin B12Absorption by Inhalation, Brit. J. Haemat, 1967, 13. pp. 75-79, Department of Haematology, Coventry and Warwickshire Hospital, Coventry.
Forest Laboratories, Inc., Long Acting oral carrier, Chemical Abstracts, vol. 77, Year 1972, p. 263, Abstract 105623(y).
Sally Mathison, Rakesh Nagilla, and Uday B. Kompella, Nasal Route for Direct delivery of Solutes to the Central Nervous System: Fact or Fiction? Journal of Drug Targeting, 1998, vol. 5, No. 6, pp. 415-441 Department of Pharmacal Sciense, Department of Chemistry, Auburn University, Auburn, AL US.
Anthony J. Cutie and John J. Sciarra, Intranasal Pharmaceutical Aerosols, Aerosal Age, The International authority in Spray Packaging, Aerosol Age Magazine, Oct. 1982, pp. 1-4.
R.K. Chandra, Gloria Heresi, and G. Woodford, Double-blind controlled crossover trial of 4% intranasal sodium cromoglycate solution in patients with seasonal allergic rhinitis, Annals of Allergy, Sep. 1982, vol. 49, From the Department of Pediatrics, Memorial University of Newfoundland, Janeway Child Health Center and Health Sciences Center, St. John's, Newfoundland, Canada.
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 Department of Pharmaceutical Sciences, The Pharmaceutical Press, London, UK.
Cheng Der Yu, Richard Jones, Jim Wright, and Maida Henesian, Characterization of dose delivery and spray pattern of a metered-dose flunisolide nasal spray, Drug development and Industrial Pharmacy, 1983, 9(3), pp. 473-483, Institute of Pharmaceutical Sciences, Syntex Research, Palo Alto, CA Marcel Dekker, Inc., US.
Anwar A. Hussain, Yukihiko Aramaki, Studies on the Intranasal Absorption of vitamin B12in the Rat, Final Report, Dec. 1984, University of Kentucky, College of Pharmacy, Lexington, KY, US.
Valois, Pumps for Pharmacy, Year Unknown (product brochure).
John J. Siarra, Aerosols, Chapter 92, Year Unknown, pp. 1614-1621, Arnold & Marie Schwartz Collet of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY, US.
T.Q.Nijst, R.A. Wevers, H.C. Schoonderwaldt, O.R. Hommes, A.F.J. De Haan, Vitamin B12 and folate concentrations in serum and cerebrospinal fluid of neurological patients with special reference to multiple sclerosis and dementia, Journal of Neurology, Neurosurgery, and Psychiatry, Year 1990; 53, p. 951-954.
Garcia-Arieta, A.; Torrado-Santiago, S.; Goya, L.; Torrado, J.J, Spray-dried powders as nasal absorption enhancers of cyanocobalamin, Biol.Pharm.Bull, date- 2001, vol. 24, issue- 12, pp. 1411-1416, Pharmaceutical Society of Japan.
U.S. Department of Health and Humans Services, Guidance for Industry, Nasal spray and inhalation solution, suspension,and spray drug products-chemistry, manufacturing, and controls documentation, Jul. 2002, pp. 1-44, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD, US.

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