Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2005-12-27
2005-12-27
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S474000, C424S484000
Reexamination Certificate
active
06979463
ABSTRACT:
A film-coated extended release solid oral dosage composition containing a nasal decongestant, pseudoephedrine or salt thereof, e.g., pseudoephedrine sulfate in a core effective to provide a geometric maximum plasma concentration of pseudoephedrine of about 345 ng/mL to about 365 ng/mL at a time of about 7.60 hrs to about 8.40 hrs and having two or three film-coatings on the core, the second one containing an amount of the non-sedating antihistamine, desloratadine, effective to provide a geometric maximum plasma concentration of desloratadine of about 2.15 ng/mL to about 2.45 ng/mL at a time of about 4.0 hours to about 4.5 hours, and use of the composition for treating patients showing the signs and symptoms associated with allergic and/or inflammatory conditions of the skin and airway passages are disclosed.
REFERENCES:
patent: 3536809 (1970-10-01), Applezweig
patent: 3598123 (1971-08-01), Zaffaroni
patent: 3845770 (1974-11-01), Theeuwes et al.
patent: 3916899 (1975-11-01), Theeuwes et al.
patent: 3940485 (1976-02-01), Levinson et al.
patent: 4008796 (1977-02-01), Aylon
patent: 4282233 (1981-08-01), Vilani
patent: 4371516 (1983-02-01), Gregory et al.
patent: 4552899 (1985-11-01), Sunshine et al.
patent: 4659716 (1987-04-01), Villani et al.
patent: 4731447 (1988-03-01), Schumacher et al.
patent: 4777170 (1988-10-01), Heinrich
patent: 4783465 (1988-11-01), Sunshine et al.
patent: 4804666 (1989-02-01), Piwinski et al.
patent: 4863931 (1989-09-01), Schumacher et al.
patent: 4906647 (1990-03-01), Kouchiwa et al.
patent: 4990535 (1991-02-01), Cho et al.
patent: 5019591 (1991-05-01), Gardner et al.
patent: 5089496 (1992-02-01), Piwinski et al.
patent: 5100675 (1992-03-01), Cho et al.
patent: 5314697 (1994-05-01), Kwan et al.
patent: 5407941 (1995-04-01), Carceller et al.
patent: 5476856 (1995-12-01), Carceller et al.
patent: 5595997 (1997-01-01), Aberg et al.
patent: 5731319 (1998-03-01), Aberg et al.
patent: 5807579 (1998-09-01), Vilkov et al.
patent: 5900421 (1999-05-01), Handley et al.
patent: 5939426 (1999-08-01), McCullough
patent: 6051585 (2000-04-01), Weinstein et al.
patent: 6100274 (2000-08-01), Kou
patent: 6132758 (2000-10-01), Munayyer et al.
patent: 6270796 (2001-08-01), Weinstein
patent: 6506767 (2003-01-01), Schumacher et al.
patent: 6514520 (2003-02-01), Munayyer et al.
patent: 6521254 (2003-02-01), Weinstein et al.
patent: 0 264 259 (1988-04-01), None
patent: 0 288 640 (1988-11-01), None
patent: 0 396 404 (1990-11-01), None
patent: 0 577 957 (1994-01-01), None
patent: 0 396 404 (1994-02-01), None
patent: WO 85/03707 (1985-08-01), None
patent: WO 92/00293 (1992-01-01), None
patent: WO 92/11034 (1992-07-01), None
patent: WO 92/20377 (1992-11-01), None
patent: WO 96/16641 (1996-06-01), None
patent: WO 96/20708 (1996-07-01), None
patent: WO 98/34614 (1998-08-01), None
patent: WO 00/2560 (2000-01-01), None
Andersen, et al., “Adverse drug interactions clinically important for the dermatologist”, Arch Dermatol, Apr., 1995, vol. 131, pp. 468-473.
Babe, et al., “Histamine, Bradykinn, and their Antagonists” in The Pharmacological Basis of Therapeutics (9thedition), The McGraw-Hill Co. Inc., pp. 581-599 (1996).
Barnett, et al., “Pharmacology of Non-Sedating H1 Antihistamines”,New Perspectives in Histamine Research,Birkhauser Verlag Basel, pp. 181-196 (1991).
Berge, et al., “Pharmaceutical Salts”, J. of Pharm. Sciences, Jan., 1977, vol. 66, No. 1, pp. 1-19.
Berthon, et al., “In Vitro inhibition, by loratadine and descarboxyethoxyloratadine, of histamine release from human basophils, and of histamine release and intracellular calcium fluxes in rat basophilic leukemia cells (RBL-2H3)”, Biochem. Pharm., 1994, vol. 47, No. 5, pp. 789-794.
Blaug, et al., “Interaction of dextroamphetamine sulfate with spray-dried lactose”, J. of Pharm. Sciences, Nov., 1972, vol. 61, No. 11, pp. 1770-1775.
Brandes, et al., “Enhanced cancer growth in mice administered daily human-equivalent doses of some H1-antihistamines: predictive in vitro correlates” , J. of the National Cancer Inst., May 18, 1994, vol. 86, No. 10, pp. 770-775.
Brandes, et al., “Stimulation of malignant growth in rodents by antidepressant drugs at clinically relevant doses”, Cancer Research, Jul. 1, 1992, vol. 52, pp. 3796-3800.
Brion, et al., “Evaluation of the antimuscarinic activity of atropine, terfenadine and mequitazine in healthy volunteers”, Br. J. Clin. Pharmac. 1988, vol. 25, pp. 27-32.
Carmeliet, “Voltage- and Time-Dependent Block of the Delayed K+ Current in Cardiac Myocytes by Dofetilide”, The J. of Pharm. And Experimental Therapeutics, 1992, vol. 262, No. 2, pp. 809-817.
Castello, et al., “Discoloration of tablets containing amines and lactose”, J. of Pharm. Sciences, Feb., 1962, vol. 51, No. 2, pp. 106-108.
Cheung, et al., “Investigation of anti-motion sickness drugs in the squirrel monkey”, J. Clin. Pharmacol, 1992, vol. No. 32, pp. 163-175.
Clissold, et al., “Loratadine: A preliminary review of its pharmacodynamic properties and therapeutic efficacy”, Drugs, 1989,vol. 37, pp. 42-57.
Cooke, “Glycopyrrolate in bladder dysfunction”, SA Medical Journal, Jan. 1, 1983, p. 3.
Craft, “Torsade de pointes after astemizole overdose”, Br. Medical Journal, 1986,, vol. 292, p. 660.
Dorje, et al., “Antagonist Binding Profiles of Five Cloned Human Muscarinic Receptor Subtypes”, The J. of Pharm. And Experimental Therapeutics, 1991, vol. 256, pp. 727-733.
Drug Facts and Comparisons, 1998 Ed., Facts and Comparisons, St. Louis, Missouri, p. 2832.
Ebert, “Soft elastic gelatin capsules: a unique dosage form”, Pharmaceutical Technology, 1977, pp. 44-50.
Gengo, “Dilemma: Antihistamine Selection: Use vs. Side Effects”, U.S. Pharmacist, Nov., 1990, vol. 15, No. 22, pp. 59-60,62,24,68,70 & 72.
Hartauer, et al., A Comparison of Diffuse Reflectance FT-IR Spectroscopy and DSC in the Characterization of a Drug-Excipient Interaction, “Drug Development and industrial Pharmacy”, 1991, vol. 17, No. 4, pp. 617-630.
Herron, et al, “Dose Proportionality, Linearity, and Pharmacokiinetics of Desloratadine in Healthy Volunteers” (Abstract 1126), J. Allergy Clin. Immunol., Jan., 2000, vol. 105, No. 1, Part 2, p. S385.
Herzog, et al., “Urinary Incontinence: medical and Psychosocial Aspects”,Annual Review of Gerontology and Geriatrics,1989, vol. 9, pp. 74-119.
Hilbert, et al., “Pharmacokinetics and Dose Proportionality of Loratadine”, J. Clin. Pharmacol. 1987, vol. 27, pp. 694-698
Housley, et al., “Histamine and related substances influence neurotransmission in the semicircular canal”, Hearing Research, May 1, 1988, vol. 35, pp. 87-97.
Jankowski, et al., “Effect of Terfenadine on Nnasal Provocation”, Int. Arch. Allergy Immunolog., 1993, vol. 101, pp. 311-317.
Kaliner, “Nonsedating Antihistamines: Pharmacology, Clinical Efficacy and Adverse Effects”, American Family Physician, Mar., 1992, vol. 45, No. 3, pp. 1337-1342.
Kleine-Tebbe, et al., “Inhibition of IgE- and non-IgE-mediated histamine release from human basophil leukocytes in vitro by a histamine H1-antagonist, desethoxycarbonyl-loratadine”, J. Allergy Clin. Immunol., 1994, vol. 93, pp. 494-500.
Knowles, “Astemizole and Terfenadine-Induced Cardiovascular Effects”, The Canadian J. of Hospital Pharmacy, Feb., 1992, vol. 45, No. 1, pp. 33 & 37.
Kohl, et al., “Lack of Effects of Astemizole on Vestibular Ocular Reflex, Motion Sickness, and Cognitive Performance in Man”, Aviation, Space, and Environmental Medicine, Dec. 1987, pp. 1171-1174.
Kohl, et al., “New Pharmacologic Approaches to the Prevention of Space/Motion Sickness”, J. Clin. Pharmacol., 1991, vol. 31, pp. 934-946.
Kohl., et al., “Control of Nausea and autonomic dysfunction with terfenadine, a peripherally acting antihistamine”
Covington & Burling
Hoffman Thomas D.
Howard Sharon
Lipka Robert J.
Page Thurman K.
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