Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-05-03
2001-07-24
Spivack, Phyllis G. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
Reexamination Certificate
active
06265414
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to treating and/or preventing sleep disorders in a human afflicted with upper airway passage allergi inflammation and congestion by administering a therapeutically effective amount of desloratadine.
BACKGROUND OF THE INVENTION
Sleep disorders are becoming increasingly prevalent in our fast paced, “doing business around the clock” society. It is estimated that 40 million Americans suffer from various sleep disorders. Further, 25 million more Americans suffer from intermittent-sleep-related disorders. Sleep disorders have various etiologies including stress induced by environmental and life style factors, physical factors, such as disease or obesity, and psychiatric disorders, such as depression. Further, allergic rhinitis can cause sleep disorders. Allergic rhinitis is a common cause of breathing disorders associated with nasal congestion which can lead to disordered sleep. Upper airway passage congestion has been observed in over 80% of patients afflicted with seasonal allergic rhinitis and/or perennial allergic rhinitis. The allergic rhinitis congestion may be associated with post nasal drip, sinusitis, nasal polyps, each of which may worsen the upper airway passage air flow (breathing). See, Young, T. et al,
Journal of Allergy Clin. Immunol
., pp. S 757-762, February 1997, and Finn, L. et al.,
Am. J. Respiratory Critical Care Medicine
, Vol. 157, No. 3, p. A61, March 1998. Sleep disorders encompass snoring, sleep apnea, insomnia, narcolepsy, restless legs syndrome, sleep terrors, sleep walking and sleep eating. Possible treatment can be as simple as behavior modification or it can be as involved as mechanical, surgical, or pharmacologic intervention. For example, sleep apnea can be treated by a mechanical device called a pneumatic splint or by allergen proof pillow casings, nasal steroids or pilocarpine. Narcolepsy can be treated with tricyclic anti-depressants, monoamine oxidase inhibitors or amphetamines. Valium® and other benzadiazepines or melatonin may be used to treat insomnia. Restless legs syndrome can be treated with Valium®.
However, the need for improved non-invasive treatment of sleep disorders in patients suffering from upper airway passage congestion is demonstrated by the proliferation of sleep research centers and sleep clinics purporting to offer relief as well as by the proliferation of ENT services (“sinus clinics”) and nasal polyp surgery and upper airway surgery.
SUMMARY OF THE INVENTION
The present invention provides a method of treating and/or preventing sleep disorders in a human afflicted with upper airway passage allergic inflammation and/or congestion comprising administering a therapeutically effective amount of desloratadine.
The present invention also provides a method of treating and/or preventing sleep disorders in a human afflicted with upper airway passage allergic inflammation and/or congestion associated with allergic rhinitis comprising administering a therapeutically effective amount of desloratadine The present invention further provides a method of treating and/or preventing sleep disorders in a human afflicted with upper airway passage allergic inflammation and/or congestion comprising administering a therapeutically effective amount of desloratadine in association with a therapeutically effective amount of an upper airway passage decongestant.
DETAILED DESCRIPTION OF THE INVENTION
The present invention is particularly effective in treating and/or preventing sleep disorders in a patient suffering from upper airway passage allergic inflammation and/or congestion associated with allergic rhinitis and the resultant disordered sleep. The term “allergic rhinitis” as used herein means seasonal allergic rhinitis and perennial allergic rhinitis. The terms “sleep disorders” and “disordered sleep” as used herein mean disordered, interrupted or fragmented sleep characterized by events including, but not limited to, snoring, periods of sleep apnea, insomnia, narcolepsy, restless legs syndrome, sleep terrors, sleep walking, sleep eating and daytime somnolence. The magnitude of a prophylactic or therapeutically effective dose of desloratadine in the acute or chronic management of sleep disorders associated with upper airway passage congestion will vary with the severity of the condition to be treated and the route of administration. The therapeutically effective amount, and perhaps the frequency, will also vary according to the age, body weight, and response of the individual patient. In general, the total daily therapeutically effective amount, for the conditions described herein, is from about 1 mg to about 20 mg administered in single or divided doses orally, topically, transdermally, or locally by inhalation. For example, a preferred oral daily dose range should be from about 5 mg to about 20 mg.
U.S. Pat. No. 4,659,716 discloses desloratadine as a non-sedating antihistamine and methods of making desloratadine, pharmaceutical compositions containing it and methods of using desloratadine compositions to treat allergic reaction in mammals. U.S. Pat. No. 5,595,997 discloses pharmaceutical compositions containing desloratadine and methods of a using desloratadine for treating allergic rhinitis. U.S. Pat. No. 4,659,716 and U.S. Pat. No. 5,595,997 are both incorporated by reference herein.
Desloratadine is available from Schering Corporation, Kenilworth, N.J.
The pharmaceutical compositions of desloratadine can be adapted for any mode of administration, e.g., for oral, parenteral, e.g., subcutaneous (“SC”), intramuscular (“IM”), intravenous (“IV”) and intraperitoneal (“IP”), or by topical, vaginal or rectal administration (e.g. suppositories). Preferably desloratadine is administered orally.
Such compositions may be formulated by combining desloratadine or an equivalent amount of a pharmaceutically acceptable salt thereof with a suitable, inert, pharmaceutically acceptable carrier or diluent which may be either solid or liquid. Desloratadine may be converted into the pharmaceutically acceptable acid addition salts by admixing it with an equivalent amount of a pharmaceutically acceptable acid. Typically suitable pharmaceutically acceptable acids include the mineral acids, e.g., HNO
3
H
2
SO
4
, H
3
PO
4
, HCl, HBr, organic acids, including, but not limited to, acetic, trifluoroacetic, propionic, lactic, maleic, succinic, tartaric, glucuronic and citric acids as well as alkyl or arylsulfonic acids, such as p-toluenesulfonic acid, 2-naphthalenesulfonic acid, or methanesulfonic acid. The preferred pharmaceutically acceptable salts are trifluoroacetate, tosylate, mesylate, and chloride. Desloratadine is more stable as the free base than as an acid addition salt and the use of the desloratadine free base in pharmaceutical compositions of the present invention is preferred.
Solid form preparations include powders, tablets, dispersible granules, capsules, cachets and suppositories. The powders and tablets may include from about 5 to about 95 percent active ingredient. Suitable solid carriers are known in the art, e.g. magnesium carbonate, magnesium stearate, talc, sugar or lactose. Tablets, powders, cachets and capsules can be used as solid dosage forms suitable for oral administration. Examples of pharmaceutically acceptable carriers and methods of manufacture for various compositions may be found in A. Gennaro (ed.),
Remington's Pharmaceutical Sciences
, 18th Ed., Mack Publishing Co., Easton, Pa.
Liquid form preparations include solutions, suspensions and emulsions. As an example may be mentioned water or water-propylene glycol solutions for parenteral injection. Solid form preparations may be converted into liquid preparations shortly before use for either oral or administration. Parenteral forms to be injected intravenously, intramuscularly or subcutaneously are usually in the form of sterile solutions and may contain tonicity agents (salts or glucose), and buffers. Opacifiers may be included in oral solutions, suspensions and emulsions. Liquid form preparations may also include solutions for
Harris Alan G.
Iezzoni Domenic G.
Hoffman Thomas D.
Schering Corporation
Spivack Phyllis G.
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