Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Patent
2000-01-03
2000-07-18
Henley, III, Raymond
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
A61K 31135
Patent
active
060908564
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
This invention relates to a therapeutic or prophylactic composition for urinary frequency or a therapeutic or prophylactic composition for urinary incontinence, which comprises tramadol or a salt thereof as an active ingredient.
BACKGROUND ART
Tramadol is an opioid non-narcotic analgesic drug having the chemical name of trans-(.+-.)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol and has heretofore been used broadly in the form of hydrochloride for the management of intense to moderate pain.
Urinary incontinence is a disease generally considered to occur when the intravesical pressure involuntarily exceeds the urethral closure pressure and is suspected to involve, as an etiologic factor, an increase in intravesical pressure (which chiefly causes urge urinary incontinence or urinary frequency) or a decrease in urethral closure pressure (which chiefly causes stress urinary incontinence).
The current pharmacotherapeutic regimen in urinary frequency or urinary incontinence includes the drugs adapted to lower intravesical pressure, i.e. decrease the contractility of the detrusor muscle, such as anticholinergic drugs (e.g. oxybutynin, propiverine), tricyclic antidepressants (e.g. imipramine), smooth muscle direct relaxants (e.g. flavoxate), etc., and the drugs adapted to increase the urethral closure pressure, i.e. increase the resistance of bladder neck or the urethra, such as .alpha.-adrenergic agonists (e.g. ephedrine), .beta.-adrenergic agonists (e.g. clenbuterol) and female hormones (e.g. estradiol). Opioid analgesics are not included in this therapeutic regimen.
Up to the present, there is no report indicating that any drug belonging to the established and clinically accepted class of opioid analgesics, represented by morphine, is ever effective in the treatment of urinary frequency or urinary incontinence. In addition, as to tramadol, it is not known at all that, as a main efficacy, this drug is effective in the therapy of urinary frequency or urinary incontinence.
DISCLOSURE OF INVENTION
The object of this invention is to provide a novel medicinal use for tramadol the safety, among other properties, of which has already been established.
The inventors of this invention did intensive investigations and found that tramadol is effective in the treatment of urinary frequency or urinary incontinence as a main efficacy. This invention has come forth from the above finding.
This invention is directed to a therapeutic or prophylactic composition for urinary frequency and a therapeutic or prophylactic composition for urinary incontinence, both comprising tramadol or a salt thereof [hereinafter referred to as the drug of the invention] as an active ingredient [both compositions are collectively referred to herein as the pharmaceutical composition of this invention]. This invention may be defined also as the use of the drug of the invention for the manufacture of said pharmaceutical composition for the therapy or prophylaxis of urinary frequency or said pharmaceutical composition for the therapy or prophylaxis of urinary incontinence, which contain the drug of the invention as an active ingredient. Furthermore, this invention may also be defined as a method for the therapy or prophylaxis of urinary frequency or urinary incontinence which comprises using the drug of the invention.
The salt of tramadol is not particularly restricted as far as it is a pharmaceutically acceptable acid addition salt, thus including salts with inorganic acid, e.g. hydrochloride, sulfate, nitrate, phosphate, hydrofluoride, hydrobromide, etc. and salts with organic acids such as acetate, tartrate, lactate, citrate, fumarate, maleate, succinate, methanesulfonate, benzenesulfonate, toluenesulfonate, naphthalenesulfonate, camphorsulfonate and so forth. Particularly preferred is tramadol hydrochloride which is in broad use as an analgesic.
BEST MODE FOR CARRYING OUT THE INVENTION
The pharmaceutical composition of the invention or the drug of the invention can be used in the therapy or prophylaxis of urinary
REFERENCES:
The Department of Biochemical Pharmacology and Pharmacology, Grunethal GmbH, Aachen (Fed. Rep. of Germany) entitled Receptor Binding, Analgesic and Antitussive Potency of Tramadol and Other Selected Opioids ( Publication date not available).
Henley III Raymond
Nippon Shinyaku Co. Ltd.
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