WO2003013520A1 - Pramipexol destine au traitement de le thada - Google Patents

Pramipexol destine au traitement de le thada Download PDF

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Publication number
WO2003013520A1
WO2003013520A1 PCT/EP2002/008500 EP0208500W WO03013520A1 WO 2003013520 A1 WO2003013520 A1 WO 2003013520A1 EP 0208500 W EP0208500 W EP 0208500W WO 03013520 A1 WO03013520 A1 WO 03013520A1
Authority
WO
WIPO (PCT)
Prior art keywords
acid
pramipexole
use according
treatment
prevention
Prior art date
Application number
PCT/EP2002/008500
Other languages
German (de)
English (en)
Inventor
Jürgen REESS
Franco Borsini
Original Assignee
Boehringer Ingelheim Pharma Gmbh & Co. Kg
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boehringer Ingelheim Pharma Gmbh & Co. Kg filed Critical Boehringer Ingelheim Pharma Gmbh & Co. Kg
Priority to JP2003518529A priority Critical patent/JP2005500368A/ja
Priority to EP02762417A priority patent/EP1416930A1/fr
Priority to CA002453485A priority patent/CA2453485A1/fr
Priority to MXPA04001001A priority patent/MXPA04001001A/es
Publication of WO2003013520A1 publication Critical patent/WO2003013520A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/428—Thiazoles condensed with carbocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the invention relates to the use of 2-amino-4,5,6,7-tetrahydro-6-n-propylamino-benzothiazole, its (+) or (-) enantiomer, its pharmacologically acceptable acid addition salts and hydrates and solvates for the manufacture of a medicament for the prevention and / or treatment of ADHD.
  • the 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzo-thiazole is a dopamine agonist which is also known in the art as pramipexole.
  • Pramipexole and processes for its production are known for example from EP-A-186 087 and US 4,886,812.
  • the utility of pramipexole for the treatment of schizophrenia and in particular for the treatment of Parkinson's is known.
  • the prior art also discloses, for example, that pramipexole lowers the prolactin serum level (DE 38 43 227).
  • pramipexole can be used in therapeutically effective doses for the prevention and / or treatment of ADHD.
  • the present invention relates to the use of 2-amino-4,5,6,7-tetrahydro-6-n-propylamino-benzothiazole, optionally in the form of its (+) or its (-) enantiomer, optionally in the form of the pharmacologically acceptable one Acid addition salts and hydrates and solvates for the manufacture of a medicament for the prevention and / or treatment of ADHD.
  • ADHD stands for "attention deficit hyperactivity disorder”. It describes a disorder that occurs in both children and adults in the form of an attention deficit. ADHD is also understood to be a hyperactivity disorder that can also be observed in both children and adults. Depending on which of the above-mentioned disorders dominates, ADHD can be observed in different forms. There is the mixed type, in which both a deficit in attention and a hyperactivity disorder can be observed, the predominantly inattentive type and the predominantly hyperactive-impulsive type.
  • the mixed type occurs when at least six out of nine symptoms of attention deficit disorder and hyperactivity / impulsivity persist for at least six months. Have at least six symptoms of Attention deficit, but less than six of the hyperactivity / impulsivity persisted for at least six months is the predominantly inattentive type.
  • the predominantly hyperactive-impulsive type is when at least six symptoms from the area of hyperactivity / impulsivity but less than six from the area of inattentiveness have been present over a period of at least six months.
  • Inattentiveness a) often disregards details or makes careless mistakes in school work, work or other activities; (b) often has difficulty keeping attention on tasks or playing for long periods of time; c) often does not seem to listen when others address him / her; d) often does not fully complete instructions from others and cannot complete schoolwork, other work or duties at the workplace; e) often has difficulty organizing tasks and activities; f) often avoids, dislike, or is reluctant to undertake tasks that require prolonged mental effort; (g) often loses items that he / she needs for tasks or activities; h) can easily be distracted by external stimuli; i) is often forgetful in everyday activities;
  • Hyperactivity a) often fidgets with hands or feet or slips around on the chair; b) stands up frequently in class or in other situations where sitting is expected; c) often runs around or climbs excessively in situations where it is inappropriate (in adolescents or adults this can be limited to a subjective feeling of restlessness); d) often has difficulty playing quietly or engaging in leisure activities; e) is often "on the move” or often acts as if he / she was “driven”; (f) often talks excessively; Impulsiveness;
  • the present invention further relates to the use of 2-amino-4,5,6,7-tetrahydro-6-n-propylamino-benzothiazole, optionally in the form of its (+) or its (-) enantiomer, optionally in the form of the pharmacological one compatible acid addition salts and hydrates and solvates for the manufacture of a medicament for the prevention and / or treatment of attention deficits.
  • the present invention further relates to the use of 2-amino-4,5,6,7-tetrahydro-6-n-propylamino-benzothiazole, optionally in the form of its (+) or its (-) enantiomer, optionally in the form of the pharmacologically acceptable one Acid addition salts and hydrates and solvates for the manufacture of a medicament for the prevention and / or treatment of hyperactivity disorders.
  • Another aspect of the present invention relates to the use of 2-amino-4,5,6,7-tetrahydro-6-n-propylamino-benzothiazole, optionally in the form of its (+) or (-) enantiomer, optionally in the form of the pharmacologically acceptable acid addition salts and hydrates and solvates for the manufacture of a medicament for the prevention and / or treatment of hyperactivity disorders associated with attention deficits.
  • a combination therapy of pramipexole with one or more, preferably another, pharmaceutically active compound can alternatively be carried out.
  • the combination with active substances selected from the group consisting of ⁇ -sympatomimetics and antidepressants, preferably tricyclic antidepressants, antidepressants of the SSRI or MAO type can prove to be effective.
  • pramipexole in a sensible manner for the treatment of the aforementioned conditions, preferably with one or more, preferably one of the following substances: Methylphenidate, amphethamine, amphetaminil, metamphetamine, pemoline, tomoxetine, desipramine, imipramine, bupropion and modafinil, methylphenidate, amphetamine, pemolin, tomoxetine and modafinil being particularly preferred.
  • pramipexole can be used as a racemate, in the form of its (+) - or in the form of its (-) - enantiomer. Pramipexole can also be used in the form of its pharmaceutically acceptable acid addition salts and, if appropriate, in the form of its hydrates and / or solvates.
  • pharmaceutically acceptable acid addition salts are understood to be those salts which are selected from the salts of hydrochloric acid, hydrobromic acid, sulfuric acid, phosphoric acid, methanesulfonic acid, acetic acid, fumaric acid, succinic acid, lactic acid, citric acid, tartaric acid and maleic acid, the salts of hydrochloric acid, hydrobromic acid, sulfuric acid , Phosphoric acid, and acetic acid are particularly preferred.
  • the salts of hydrochloric acid are of particular importance here. Accordingly, the hydrochlorides of pramipexole are particularly preferably used in the context of the present invention, the pramipexole dihydrochloride being of particular importance. Of the hydrates of the pramipexole, the pramipexole dihydrochloride monohydrate is particularly preferred.
  • Pramipexole is naturally very dependent on the clinical picture.
  • pramipexole can be used in doses of about 0.05 to 7.5 mg, preferably 0.1 to 5 mg, per day. These dosages are based on pramipexole in the form of its free base. Based on the preferred salt form pramipexole dihydrochloride monohydrate, the above-mentioned dosages correspond to about 0.07 to 10 t 65 mg, preferably 0.14 to 7.1 mg pramipexole dihydrochloride monohydrate per day.
  • Pramipexole can be administered orally, transdermally, intrathecally, by inhalation or parenterally in the context of the use according to the invention. Suitable forms of use are, for example, tablets, capsules, suppositories, solutions, juices, emulsions, dispersible powders or plasters. With regard to possible embodiments of a transdermal one which can be used according to the invention
  • Corresponding tablets can be mixed, for example, by mixing the active ingredient (s) with known auxiliaries, for example inert diluents such as calcium carbonate, calcium phosphate or milk sugar, and disintegrants
  • the tablets can also consist of several layers.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Thiazole And Isothizaole Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne l'utilisation de 2-amino-4,5,6,7-tétrahydro-6-n-propylamino-benzothiazol, son énantiomère (+) ou (-), leurs sels d'addition acide pharmacologiquement tolérables ainsi que des hydrates et solvates destinés à la production d'un médicament permettant de prévenir et/ou traiter le thada.
PCT/EP2002/008500 2001-08-03 2002-07-31 Pramipexol destine au traitement de le thada WO2003013520A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2003518529A JP2005500368A (ja) 2001-08-03 2002-07-31 Ａｄｈｄ治療用プラミペクソール
EP02762417A EP1416930A1 (fr) 2001-08-03 2002-07-31 Pramipexol destine au traitement de le thada
CA002453485A CA2453485A1 (fr) 2001-08-03 2002-07-31 Pramipexol destine au traitement de le thada
MXPA04001001A MXPA04001001A (es) 2001-08-03 2002-07-31 PRAMIPEXOL PARA EL TRATAMIENTO DEL TRASTORNO DE HIPERACTIVIDAD Y DeFICIT DE LA ATENCION.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10137633A DE10137633A1 (de) 2001-08-03 2001-08-03 Pramipexol zur Behandlung von ADHD
DE10137633.2 2001-08-03

Publications (1)

Publication Number Publication Date
WO2003013520A1 true WO2003013520A1 (fr) 2003-02-20

Family

ID=7693957

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2002/008500 WO2003013520A1 (fr) 2001-08-03 2002-07-31 Pramipexol destine au traitement de le thada

Country Status (8)

Country Link
EP (1) EP1416930A1 (fr)
JP (1) JP2005500368A (fr)
AR (1) AR035273A1 (fr)
CA (1) CA2453485A1 (fr)
DE (1) DE10137633A1 (fr)
MX (1) MXPA04001001A (fr)
UY (1) UY27408A1 (fr)
WO (1) WO2003013520A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2308464A1 (fr) * 2009-10-06 2011-04-13 Sanovel Ilac Sanayi ve Ticaret A.S. Compositions orales désintégrables de pramipexole

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TR200906997A1 (tr) 2009-09-11 2011-03-21 Sanovel �La� San. Ve T�C. A. �. Pramipeksol farmasötik bileşimleri.

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5621133A (en) * 1989-05-31 1997-04-15 Deninno; Michael P. Dopamine agonists
WO2001089453A2 (fr) * 2000-05-19 2001-11-29 Wayne State University Derive des 2-aminotetralines et leurs analogues pharmacologiques presentant une activite et un comportement de recepteur du systeme nerveux central differentiels
EP1177798A2 (fr) * 2000-07-31 2002-02-06 Pfizer Products Inc. Compositions destinées au traitement du trouble déficitaire de l'attention avec hyperactivité contenant un agoniste partiel du récepteur à la nicotine et un agent anti-ADHD
US20020058009A1 (en) * 2000-09-19 2002-05-16 Advanced Inhalation Research, Inc. Pulmonary delivery in treating disorders of the central nervous system

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5621133A (en) * 1989-05-31 1997-04-15 Deninno; Michael P. Dopamine agonists
WO2001089453A2 (fr) * 2000-05-19 2001-11-29 Wayne State University Derive des 2-aminotetralines et leurs analogues pharmacologiques presentant une activite et un comportement de recepteur du systeme nerveux central differentiels
EP1177798A2 (fr) * 2000-07-31 2002-02-06 Pfizer Products Inc. Compositions destinées au traitement du trouble déficitaire de l'attention avec hyperactivité contenant un agoniste partiel du récepteur à la nicotine et un agent anti-ADHD
US20020058009A1 (en) * 2000-09-19 2002-05-16 Advanced Inhalation Research, Inc. Pulmonary delivery in treating disorders of the central nervous system

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
EMILIEN ET AL.: "Dopamine D3 agonists", EXPERT OPINION THERAPEUTICS PATENTS, vol. 11, no. 11, pages 1713 - 1728, XP001057496 *
INOUE: "Strategy for Modulation of Central Dopamine Transmission Based on the Partial Agonist Concept in Schizophrenia Therapy", JAPANESE JOURNAL OF PHARMACOLOGY, vol. 86, no. 4, 2001, pages 376 - 380, XP009001165 *
MAJ ET AL.: "Antidepressant effects of pramipexole, a novel dopamine receptor agonist", JOURNAL NEURAL TRANSMISSION, vol. 104, pages 525 - 533, XP002101636 *
MAY ET AL.: "The effect of repeated treatment with pramipexole on the central dopamine D3 system", J NEURAL TRANSMISSION, vol. 107, pages 1369 - 1379, XP002225409 *
See also references of EP1416930A1 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2308464A1 (fr) * 2009-10-06 2011-04-13 Sanovel Ilac Sanayi ve Ticaret A.S. Compositions orales désintégrables de pramipexole
TR200907554A1 (tr) * 2009-10-06 2011-04-21 Sanovel İlaç San.Ve Ti̇c.A.Ş. Oral yolla dağılan pramıpexole bileşimleri.

Also Published As

Publication number Publication date
UY27408A1 (es) 2003-02-28
MXPA04001001A (es) 2004-04-20
EP1416930A1 (fr) 2004-05-12
DE10137633A1 (de) 2003-02-20
AR035273A1 (es) 2004-05-05
CA2453485A1 (fr) 2003-02-20
JP2005500368A (ja) 2005-01-06

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