Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2011-08-30
2011-08-30
Landau, Sharmila G. (Department: 1611)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C514S352000
Reexamination Certificate
active
08007826
ABSTRACT:
A pharmaceutical composition which comprises a therapeutically effective amount of a aminopyridine dispersed in a release matrix, including, for example, a composition that can be formulated into a stable, sustained-release oral dosage formulation, such as a tablet which provides, upon administration to a patient, a therapeutically effective plasma level of the aminopyridine for a period of at least 12 hours, preferably 24 hours or more and the use of the composition to treat various neurological diseases.
REFERENCES:
patent: 4386095 (1983-05-01), Gibson et al.
patent: 4508715 (1985-04-01), Booth et al.
patent: 4721619 (1988-01-01), Panoz et al.
patent: 4894240 (1990-01-01), Geoghegan et al.
patent: 4946853 (1990-08-01), Bannon et al.
patent: 5370879 (1994-12-01), Masterson et al.
patent: 5540938 (1996-07-01), Masterson et al.
patent: 5545648 (1996-08-01), Hansebout et al.
patent: 5580580 (1996-12-01), Masterson et al.
patent: 5597827 (1997-01-01), Miller et al.
patent: 5597828 (1997-01-01), Miller et al.
patent: 5869480 (1999-02-01), Shutske et al.
patent: 5952357 (1999-09-01), Blass et al.
patent: 6284473 (2001-09-01), Whitaker
patent: 6288026 (2001-09-01), Exner et al.
patent: 2005/0025744 (2005-02-01), Lane
patent: 2005/0228030 (2005-10-01), Blight et al.
patent: 2005/0276851 (2005-12-01), Cunningham et al.
patent: 2006/0276537 (2006-12-01), Goren et al.
patent: 2007/0037848 (2007-02-01), Masters et al.
patent: 2009/0150180 (2009-06-01), Cohen et al.
patent: 2010/0272795 (2010-10-01), Cunningham
patent: 2010/0272796 (2010-10-01), Cunningham
patent: 2010/0272807 (2010-10-01), Cunningham
patent: 2085785 AA (1994-06-01), None
patent: 113562 (1984-07-01), None
patent: 117027 (1984-08-01), None
patent: 325843 (1989-08-01), None
patent: 484186 (1992-05-01), None
patent: 82916 (2003-06-01), None
patent: WO 2004/082684 (2004-09-01), None
patent: WO2005/099701 (2005-10-01), None
patent: WO2007/035958 (2007-03-01), None
patent: WO2010/030755 (2010-03-01), None
patent: WO2010/093838 (2010-08-01), None
patent: WO2010/093839 (2010-08-01), None
patent: WO2010/090730 (2010-09-01), None
Roche, E.B. (ed.),Bioreversible Carriers in Drug Design, American Pharmaceutical Association and Pergamon Press, 1987 (TOC).
Barge, S.M. et al.,Pharmaceuticals Salts, J. Pharm. Sci., 66:1-19, 1977.
Hayes et al., Pharmacokinetic Studies of Single and Multiple Oral Doses of Fampridine-SR (Sustained-Release 4-Aminopyridine) in Patients with Chronic Spinal Cord Injury , 2003, Clinical Neuropharmacology 26(4):185-192.
Cohen et al., Responder analysis of walking speed applied to a trial of Fampridine in subjects with MS, 2005, Neurology 64(Suppl. 1):A388, P06.169.
Gonzalez et al., Influence of enteric citric acid on the release profile of 4-aminopyridine from HPMC matrix tablets; Int. J. of Pharmaceutics 251, Issue 1-2; Jan. 30, 2003; pp. 183-193.
Martinez-Gonzalez et al., Effect of varying the restriction degree of 4-aminopyridine release from HPMC matrices on the mechanism controlling the process, 2003, Int. J. Pharmaceutics 257:253-264.
Juarez et al., Influence of admixed carboxynethylcellulose and release of 4-aminopyridine from hydroxypropyl methylcellulose matrix tablets, Int. J. Pharmaceutics 216:115-125.
Hayes et al., Pharmacokinetics of an immediate release oral formulation of Fampridine (4 aminopyridine) in normal subjects and patients with spinal cord injury, Apr. 2003, J. Clin. Pharm. 43(4):379-385.
Segal et al., Absorption Characteristics of Sustained-Release 4-Aminopyridine (Fampridine SR) in Patients with Chronic Spinal Cord Injury, 2000, Journal of Clinical Pharmacology 40(4):402-409.
Barker et al., Alzheimer's Disease, Jan. 26, 1991, Pharmaceutical Journal, pp. 116-118.
Davidson et al., 4-Aminopyridine in the treatment of Alzheimer's Disease, 1988, J. of Biological Psychiatry 23:485-490.
Bever Jr., et al., Preliminary Trial of 3, 4-Diaminopyridine in Patients with Multiple Sclerosis, Apr. 1990, Annals of Neurology 27(4):421-427.
Wesseling et al., Effects of 4-aminopyridine in elderly patients with Alzheimer's Disease, Apr. 1984, New England Journal of Medicine 310(15):988-989.
Burchiel et al., Effects of potassium channel-blocking agents on spontaneous discharges from neuromas in rats, 1985, J. of Neurosurgery 63:246-249.
Blight et al., Effect of 4-aminopyridine on action potential conduction in myelinated axons of chronically injured spinal cord; Department of Neurosurgery and Physiology; NYU Medical Center, Spinal Cord and Brainstem 62:21.15.
Gruner et al., Recovery of motor function in chronic experimental spinal cord injury enhanced by 4-aminopyridine; Department of Neurosurgery and Physiology; NYU Medical Center.
Mitsov, Analgesic activity of pimadine (4-Aminopyridine), Jul.-Aug. 1988, Russian Journal of Pharmacology and Toxology 51(4):122-125.
Biessels et al., Comparison of the pharmacological actions of some new 4-aminopyridine derivatives, 1984, European Journal of Pharmacology 106:319-325.
Nockles et al., Pharmacologic Strategies in the Treatment of Experimental Spinal Cord Injury, 1992, J. Neurotrauma 9, Supplement 1:S211-S217.
Myers, Therapy of multiple sclerosis, 1990, Neurology and Neurosurgery 3:208-212.
Pratt et al., Plasma and Cerebrospinal Fluid Concentrations of 4-Aminopyridine Following Intravenous Injection and Metered Intrathecal Delivery in Canines, 1995, Journal of Neurotrauma 12(1):23-39.
Hansebout et al., 4-Aminopyridine in Chronic Spinal Cord Injury: A Controlled, Double Blind, Crossover Study in Eight Patients, 1993, The Journal of Neurotrauma 10(1):1-18.
Arhem et al., A Model for the fast 4-aminopyridine effects on amphibian myelinated nerve fibers. A study based on voltage-clamp experiments, 1989, Acta Physiol. Scand. 137:53-61.
Beric et al., Central dysesthesia syndrome in spinal cord injury patients., 1988, Pain 34:109-116.
Beric, Altered Sensation and Pain in Spinal Cord Injury, in: Recent Achievements in Restorative Neurology, 3 Altered Sensation and Pain. Dimitrijevic et al. eds., Karger:Basel, pp. 27-36, 1990.
Blight, Cellular Morphology of Chronic Spinal Cord Injury in the Cat: Analysis of Myelinated Axons by Line-Sampling, 1983a, Neuroscience 10(2):521-543.
Blight et al., Morphometric Analysis of Experimental Spinal Cord Injury in the Cat: The Relation of Injury Intensity to Survival of Myelinated Axons, 1986, Neuroscience. 19(1):321-341.
Bever, The Current Status of Studies of Aminopyridines in Patients with Multiple Sclerosis, 1994, Ann. Neurol., 36:S118-S121.
Bever et al., The Effects of 4-Aminopyridine in Multiple Sclerosis Patients: Results of a Randomized, Placebo-Controlled, Double-Blind, Concentration-Controlled, Crossover Trial, 1994, Neurology, 44(6):1054-1059.
U.S. Appl. No. 12/557,015, filed Sep. 10, 2009, Blight et al.
Van Diemen et al., The Effect of 4-Aminopyridine on Clinical Signs in Multiple Sclerosis: A Randomized, Placebo-Controlled, Double-Blind, Cross-Over Study, 1992, Ann. Neurol., 32(2):123-130.
Van Diemen et al., 4-Aminopyridine in Patients with Multiple Sclerosis: Dosage and Serum Level Related to Efficacy and Safety, 1993, Clin. Neuropharm., 16(3):195-204.
Meglio et al., Spinal Cord Stimulation and Peripheral Blood Flow: Part 1, In: Indications for Spinal Cord Stimulation, 1981, Y. Hosebuchi and T. Corbin (eds), Excerpta Medica: Amsterdam, pp. 60-66.
Hayes, The Use of 4-Aminopyridine (Fampridine) in Demyelinating Disorders, 2004 Winter, CNS Drug Reviews, 10(4):295-316.
Martinez-Gonzalez et al., Influence of Enteric-Coated Lactose on the Release Profile of 4-Aminopyridine from HPMC Matrix Tablets, 2004, Pharm. Dev. Technol., 9(2):145-153.
Hayes et al., Pharmacokinetics and Safety of Multiple Oral Doses of Sustained-Release 4-Aminopyridine (Fampridine-SR) in Subjects with Chronic, Incomplete Spinal Cord Injury, Jan. 2004, Arch. Phys. Med. Rehabil., 85(1):29-34.
Potter et al., Randomized Double-Blind Crossover Trial of Fampridine-SR (Sustained Release 4-Aminopyridine) in Patients With Incomplete Spinal Cord Injury, Oct, 1998, J. Neurotrauma, 15(10):837-849.
U.S. Appl. No. 12/824,133, filed Jun. 25, 2010, Blight et al.
U.S. Appl. No. 1
Blight Andrew R.
Cohen Ron
Acorda Therapeutics, Inc.
Jones Day
Landau Sharmila G.
Welter Rachael
LandOfFree
Sustained release aminopyridine composition does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Sustained release aminopyridine composition, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Sustained release aminopyridine composition will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2709252