Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Patent
1993-05-21
1994-12-06
Richter, Johann
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
A61K 314.35
Patent
active
053710924
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a method for the treatment of senile dementia, bulimia, migraine or anorexia and to a compound for use in such methods.
U.S. Pat. No. 4 007 196 discloses the compound, (-)-trans-4-(4'-fluorophenyl)-3-(3'4'-methylenedioxyphenoxymethyl)piperidi ne, and, in Example 2, a process by which it can be prepared. The compound, which is referred to herein by its common name, paroxetine, is described in the patent as an inhibitor of 5-hydroxytryptamine uptake and, therefore, is of use in the treatment of depression. The patent also mentions that paroxetine is useful in the treatment of Parkinson's disease.
It has now been discovered that paroxetine also has potential therapeutic utility for treating senile dementia, bulimia, migraine or anorexia.
Accordingly, the present invention provides a method for treating senile dementia, bulimia, migraine or anorexia in human or non-human animals, which method comprises administering an effective, non-toxic amount of paroxetine or a pharmaceutically acceptable salt thereof, to human or non-human animals suffering from senile dementia, bulimia, migraine or anorexia.
The present invention also provides the use of paroxetine or a pharmaceutically acceptable salt thereof in the manufacture of a medicament for use in the treatment of senile dementia, bulimia, migraine or anorexia.
Examples of pharmaceutically acceptable salts of paroxetine are paroxetine hydrochloride, paroxetine hydrobromide, paroxetine acetate and paroxetine maleate. A preferred salt is crystalline paroxetine hydrochloride hemi-hydrate.
A paroxetine medicament, for use in the treatment of senile dementia, bulimia, migraine or anorexia may be prepared by admixture of paroxetine or salt thereof with an appropriate carrier, which may contain a diluent, binder, filler, disintegrant, flavouring agent, colouring agent, lubricant or preservative in conventional manner.
Preferably, the medicament is in unit dosage form and in a form adapted for use in the medical or veterinarial fields. For example, such preparations may be in a pack form accompanied by written or printed instructions for use as an agent in the treatment of senile dementia, bulimia, migraine or anorexia.
The suitable dosage range for paroxetine or a salt depends on the severity of the senile dementia, bulimia, migraine or anorexia and on the condition of the patient. It will also depend, inter alia, upon the relation of potency to absorbability and the frequency and route of administration.
Paroxetine or a salt thereof may be formulated for administration by any route, and examples are oral, rectal, topical, parenteral, intravenous or intramuscular administration. Preparations may, if desired, be designed to give slow release of paroxetine.
The medicaments may, for example, be in the form of tablets, capsules, sachets, vials, powders, granules, lozenges, reconstitutable powders, or liquid preparations, for example solutions or suspensions, or suppositories.
The medicaments, for example those suitable for oral administration, may contain conventional excipients such binding agents, for example syrup, acacia, gelatin, sorbitol, tragacanth, or polyvinylpyrrolidone; fillers, for example lactose, sugar, maize-starch, calcium phosphate, sorbitol or glycerine; tabletting lubricants, for example magnesium stearate; disintegrants, for example starch, polyvinylpyrrolidone, sodium starch glycollate or microcrystalline cellulose; or pharmaceutically acceptable setting agents such as sodium lauryl sulphate.
Solid medicaments may be obtained by conventional methods of blending, filling, tabletting or the like. Repeated blending operations may be used to distribute paroxetine or a salt thereof throughout those medicaments employing large quantities of fillers. When the medicament is in the form of a tablet, powder, or lozenge, any carrier suitable for formulating solid pharmaceutical compositions may be used, examples being magnesium stearate, starch, glucose, lactose, sucrose, rice flour and chalk. Tablets may be coated according to met
REFERENCES:
patent: 4007196 (1977-02-01), Christensen et al.
patent: 5169856 (1992-12-01), Goto et al.
International Journal of Geriatric Psychiatry, vol. 3, 1988, John Wiley & Sons, Ltd, J. Balldin et al.: "Relationship between DST and the serotonergic system. Results from treatments with two 5-HT reuptake blockers in dementia disorders", pp. 17-26, see p. 18, col. 2, lines 15-39; p. 19, col. 2, lines 25-38.
Annals of the New York Academy of Sciences, vol. 600, Oct. 1990, (New York, US), A. J. Cross: "Serotonin in Alzheimer-type dementia and other dementing illnesses", pp. 405-417, see p. 406, table 1; pp. 412-413.
Current Therapeutic Research, vol. 25, No. 2, Feb. 1979, E. Syvalahti et al.: "Migraine headache and blood serotonin levels after administration of zimelidine, a selective inhibitor of serotonin uptake", pp. 299-310, see the whole document.
Progress in Drug Research, vol. 35, 1990, (Basel, CH), R. W. Fuller: "Drugs affecting serotonin neurons", pp. 85-108, see p. 87, paragraph 3--p. 88; p. 89, paragraph 9; p. 99, paragraph 2.
European Journal of Pharmacology, vol. 183, No. 5, Jul. 1990, M. D. Cotrim et al.: "Migraine and serotonin uptake, 3Hdelta--paroxetine and 3H--imipramine binding", p. 1917, see the whole document.
International Journal of Obesity, vol. 11, suppl. 3, Dec. 1987, C. P. L. Freeman et al.: "Fluoxetine as a treatment for bulimia nervosa", pp. 171-177, see the whole document.
Beecham Group p.l.c.
Lentz Edward T.
Peabody John
Richter Johann
Suter Stuart R.
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