EP1617831A1 - Combination of desoxypeganine and mecamylamine for the treatment of alcohol abuse - Google Patents
Combination of desoxypeganine and mecamylamine for the treatment of alcohol abuseInfo
- Publication number
- EP1617831A1 EP1617831A1 EP04727830A EP04727830A EP1617831A1 EP 1617831 A1 EP1617831 A1 EP 1617831A1 EP 04727830 A EP04727830 A EP 04727830A EP 04727830 A EP04727830 A EP 04727830A EP 1617831 A1 EP1617831 A1 EP 1617831A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- active ingredient
- mecamylamine
- ingredient combination
- pharmaceutically acceptable
- combination according
- Prior art date
- Legal status (The legal status 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 status listed.)
- Withdrawn
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K31/13—Amines
-
- 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
- A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/32—Alcohol-abuse
-
- 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 present invention relates to pharmaceutical preparations which contain 3-deoxypeganine and / or ecamylamine.
- the invention further relates to the use of this combination of active substances for the therapy of harmful alcohol consumption and alcohol addiction,
- alcohol is the oldest, most widespread and by far the most important in terms of its health, social and economic effects.
- alcohol is the oldest, most widespread and by far the most important in terms of its health, social and economic effects.
- Germany there are around 1.6 million clinically dependent on alcohol and 2.7 million people with medically harmful alcohol consumption.
- tiapride an antagonist of dopamine that acts on the receptor subtypes D2 and D3, has gained little practical importance, the opiate receptor antagonist naltrexone (ReVia®, DuPont; Trexan®) and the acamprosate (N-acetylhomotaurin), which has a complex anti-excitatory effect, ; Ca pral®, Merck AG; Aotal®), which also influences noradrenergic and dopaminergic conduction pathways, is used to a much greater extent after acute withdrawal to prevent relapses in alcohol abuse.
- the anti-excitatory gamma-hydroxybutyrate eg Alcover®, Gerot Pharmaceuticals
- Alcover® Gerot Pharmaceuticals
- naltrexone and gamma-hydroxybutyrate produce significant gastrointestinal and psychomotor side effects that impair compliance with the therapy.
- Naltrexone is also characterized by low oral bioavailability (approx. 5% of the amount taken is effective) moreover hepatotoxic, while gamma-hydroxybutyrate itself has addictive potential.
- Dopaminergic therapy can either be done directly (by dopamine receptor agonists such as lisuride or bromocriptine), or indirectly by increasing the dopamine concentration locally available in the synaptic cleft (for example by inhibiting the breakdown of the neurotransmitters by monoamine oxidases).
- dopamine receptor agonists such as lisuride or bromocriptine
- the pharmacology of alcohol is complicated, which is also reflected in the variety of therapeutic approaches described above.
- cholinergic neurotransmission which include cholinesterase inhibitors in particular, occupy a special position in alcoholism therapy that has received little attention.
- cholinergic drugs can improve cognition that is impaired by alcohol-related damage to the cholinergic conduction pathways, thereby increasing insight into the problem.
- cholinergic therapies can also bring about an immediate, non-cognitive reduction in the desire for alcohol. According to the current state of knowledge, this is mediated by the neuronal nicotinic acetylcholine receptors (nAChR), which are located not only on cholinergic but also on dopaminergic neurons in the mesolimbic system.
- nAChR neuronal nicotinic acetylcholine receptors
- Deoxypeganine (1,2,3, 9-tetrahydropyrrollo [2, 1-b] quinazoline) is a cholinesterase inhibitor that does not bind to nAChR in pharmacologically relevant concentrations and additionally inhibits monooxidase A (but not monoamine oxidase B). This substance is also extremely suitable for the therapy of alcohol abuse, as described in DE 199 06 974 and the documents WO 00/48600 and EP 1 154 776 derived therefrom.
- This racemic mixture of the optical isomers exo-S (+) and exo-R (-) -mecamylamine is an almost 100% orally bioavailable, centralized, non-subtype-specific and non-competitive antagonist of neuronal nAChR, which was established in the United States in 1956 Brand names Inversene® and Inversine® were introduced as antihypertensive agents in therapy.
- the two stereoisomers show differentiated, but essentially comparable behavior on the individual nAChR subtypes, whereby the exo-S (+) isomer has a certain selectivity for neuronal nAChR and could therefore have reduced peripheral side effects, particularly on the muscles.
- mecamylamine causes a substantial blockade of the parasympathetic nervous system at the effective doses of at least 25 mg / day in the treatment of essential hypertension and thus leads to an abundance of corresponding side effects, it has only been used since 1977 in exceptional cases. In year In 2000, mecamylamine was reintroduced to the United States for experimental therapy of certain neuropsychiatric disorders.
- mecamylamine administered two hours before drinking alcoholic beverages, reduced the central stimulating psychotropic effects and presumably also the pharmacokinetics of alcohol. Neither of these three works mentions the combination and / or simultaneous administration of mecamylamine with other pharmacologically active substances, in particular not with cholinesterase inhibitors or nicotinic agonists.
- the invention thus relates to the combined use of deoxypeganine and mecamylamine to reduce alcohol consumption.
- the treatment can be carried out either by the simultaneous administration of the two active substances or by the sole administration of mecamylamine, immediately followed by a combination of the active substances according to the invention.
- the rat strain "AA”, bred in Finland, has a genetically determined preference for alcohol, ie the animals prefer alcohol-free liquids to alcohol-free liquids to satisfy their fluid needs, even without pretreatment with alcohol. This strain has therefore been used in numerous studies on the pharmacology of alcohol and is characterized excellently.
- Ambient temperature 24 +/- 1 ° C and the light / dark change was 12/12 hours (dark period from 6 p.m. to 6 a.m.).
- Each cage contained two identical drinking vessels, one containing pure water and the other aqueous ethanol (10% v / v).
- the animals were given access to the vessels during the 12-hour dark phase and were free to choose between the two solutions during this time.
- Deoxypeganine hydrochloride (hereinafter referred to as "DOP") was obtained from the Institute of Plant Pharmacology (Tashkent, Uzbekistan) and provided by LTS Lohmann Therapie-Systeme (Andernach, Germany) after checking its identity and purity. Mecamylamine was considered to be commercial preparation obtained from Sig a-Aldrich GmbH (Munich).
- Mecamylamine was dissolved in 0.9% saline and administered in a volume of 5 ml / kg body weight by intraperitoneal injection.
- DOP was applied as an aqueous solution in a volume of 10 ml / kg using a pharyngeal tube. In the case of combination treatments, these administrations were carried out within a period of less than 10 minutes. At least two treatment-free days were always interposed before and after the treatment days.
- the target parameters were monitored during the 12 hours of the dark period following the treatment, with intermediate results after the first 4 hours and final results after 12 hours.
- the statistical Evaluation of the test data was carried out with the t-test for dependent values.
- the results with regard to alcohol consumption and alcohol preference are summarized in Figures 1 and 2 and in Tables 1 and 2.
- DOP reduced alcohol consumption and alcohol preference, preferably within the first four hours after administration.
- Table 2 Synergy between deoxpeganine po (DOP) and mecamylamine ip (Mec) in reducing the consumption of 10% aqueous ethanol solution by female AA rats.
- the administration according to the invention can take place either in the form of a single medicament with a fixed combination of both active ingredients, or else by administration in separate administration forms.
- deoxypeganine HCl can be administered orally in the form of tablets or capsules, the daily dose being 50 to 750 mg and a daily dose of 100 to 400 mg being preferred, which can be divided into any number of individual doses.
- deoxypeganm-containing transdermal therapeutic systems and oral and parenteral administration forms with delayed release, as described in DE-199 06 974 and the documents WO 00/48600 and EP-1 154 776 derived therefrom be used, usable; the preferred daily dose is 50-250 mg and is preferably given in a single dose.
- mecamylamine can be administered orally, for example in the form of the Inversin TM preparation (Targacept, Inc., USA; tablets containing 2.5 mg of racemic mecamylamine hydrochloride), the daily dose being 2.5-20 mg and a daily dose of 2.5 - 7.5 mg is preferred.
- transdermal systems or oral dosage forms with delayed release formulated according to the usual galenical methods can be used, the daily dose being 0.5-10 mg and preferably being administered in a single dose.
- deoxypeganm and mecamylamine can also be administered in the form of medicaments which contain fixed combinations of the two active compounds, which, depending on the type of administration, are designed such that the daily dose of deoxypeganine is 50 to 750 mg and that of mecamylamine is 0.5 - Can be 20 mg.
- salts is to be understood as meaning, but not exclusively, the salts of the compounds according to the invention with hydrohalic acids and with simple organic acids, such as tartaric acid (tartrates), succinic acid (succinates), maleic acid (maleates), etc.
- the treatment described above with combinations of deoxypeganm and mecamylamine can be preceded by a pretreatment which is carried out exclusively with racing ischemic mecamylamine or its individual isomers and is carried out with daily doses between 0.5 and 20 mg and between one day and five days can take.
- compositions which are used according to the present invention for the administration of a combination of 3-deoxypeganm or one of its pharmaceutically acceptable derivatives with mecamylamine or one of its pharmaceutically acceptable derivatives can contain one or more of the following additives:
- surfactants emulsifiers, solubilizers, wetting agents, defoamers
- a combination of 3-deoxypeganm or one of its pharmaceutically acceptable derivatives with mecamylamine or one of its pharmaceutically acceptable derivatives can be administered orally or parenterally.
- drugs can be produced in known dosage forms, such as tablets, coated tablets or lozenges.
- liquid or semi-liquid dosage forms are also suitable, the active ingredient being present as a solution or suspension.
- Water, aqueous media or pharmacologically acceptable oils can be used as solvents or suspending agents.
- the medicaments containing a combination of 3-deoxypegane or one of its pharmaceutically acceptable derivatives with mecamylamine or one of its pharmaceutically acceptable derivatives are preferably formulated as depot medicaments which are able to release these active substances to the organism in a controlled manner over a longer period of time .
- the administration of a combination of 3-deoxypeganm or one of its pharmaceutically acceptable derivatives with mecamylamine or one of its pharmaceutically acceptable derivatives according to the invention can also be carried out parenterally.
- transdermal or transmucosal dosage forms can be used particularly advantageously for the administration according to the invention of a combination of 3-deoxypeganm or one of its pharmaceutically acceptable derivatives with mecamylamine or one of its pharmaceutically acceptable derivatives, in particular adhesive transdermal therapeutic systems (active substance plasters).
- adhesive transdermal therapeutic systems active substance plasters
- transdermal dosage forms are very advantageous due to other properties, e.g. B. Avoiding the first pass effect or better, more even control of blood levels.
- transdermal systems a combination of 3-deoxypeganine or one of its pharmaceutically acceptable derivatives with mecamylamine or one of its pharmaceutically acceptable derivatives, usually have an active substance-containing, pressure-sensitive polymer matrix which is covered on the side remote from the skin by an active substance-impermeable backing layer, and the adhesive, active ingredient-releasing surface is covered with a removable protective layer before application.
- So-called reservoir systems can be considered as alternative embodiments of transdermal therapeutic systems in plaster form for the administration of the active substance combination according to the invention, in which the active substances are present in a pouch consisting at least on the skin side of a membrane permeable to the active substances.
- the combination of 3-deoxypeganm or one of its pharmaceutically acceptable derivatives with mecamylamine or one of its pharmaceutically acceptable derivatives according to the invention can be used in the therapy of harmful alcohol consumption and alcohol addiction in order to reduce the consumption of alcohol.
- the combination according to the invention of 3-deoxypeganm or one of its pharmaceutically acceptable derivatives with mecamylamine or one of its pharmaceutically acceptable derivatives can be used for the production of medicaments for the therapy of alcohol abuse and / or alcohol addiction, in particular in order to reduce the consumption of the alcohol.
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Addiction (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Psychiatry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Cephalosporin Compounds (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10318714A DE10318714B4 (en) | 2003-04-25 | 2003-04-25 | Drug combinations and therapies to combat alcohol abuse |
PCT/EP2004/004033 WO2004096200A1 (en) | 2003-04-25 | 2004-04-16 | Combination of desoxypeganine and mecamylamine for the treatment of alcohol abuse |
Publications (1)
Publication Number | Publication Date |
---|---|
EP1617831A1 true EP1617831A1 (en) | 2006-01-25 |
Family
ID=33304936
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP04727830A Withdrawn EP1617831A1 (en) | 2003-04-25 | 2004-04-16 | Combination of desoxypeganine and mecamylamine for the treatment of alcohol abuse |
Country Status (18)
Country | Link |
---|---|
US (1) | US20060199866A1 (en) |
EP (1) | EP1617831A1 (en) |
JP (1) | JP2006524647A (en) |
KR (1) | KR20060006946A (en) |
CN (1) | CN1771029A (en) |
AR (1) | AR044067A1 (en) |
AU (1) | AU2004233564A1 (en) |
BR (1) | BRPI0410507A (en) |
CA (1) | CA2523331A1 (en) |
CL (1) | CL2004000881A1 (en) |
DE (1) | DE10318714B4 (en) |
EA (1) | EA200501514A1 (en) |
MX (1) | MXPA05011249A (en) |
MY (1) | MY136408A (en) |
NO (1) | NO20054243L (en) |
TW (1) | TW200427452A (en) |
WO (1) | WO2004096200A1 (en) |
ZA (1) | ZA200507213B (en) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2008045641A2 (en) * | 2006-10-10 | 2008-04-17 | The University Of Chicago | Composition s comprising a benzodiazepine, an alcohol aversive agent and an abuse aversive agent |
CN108498493A (en) * | 2017-02-27 | 2018-09-07 | 中国人民解放军第二军医大学 | Mecamylamine prevents motion sickness or the medical usage of vertigo |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3797494A (en) * | 1969-04-01 | 1974-03-19 | Alza Corp | Bandage for the administration of drug by controlled metering through microporous materials |
US3742951A (en) * | 1971-08-09 | 1973-07-03 | Alza Corp | Bandage for controlled release of vasodilators |
US3996934A (en) * | 1971-08-09 | 1976-12-14 | Alza Corporation | Medical bandage |
US4031894A (en) * | 1975-12-08 | 1977-06-28 | Alza Corporation | Bandage for transdermally administering scopolamine to prevent nausea |
DE3315272C2 (en) * | 1983-04-27 | 1986-03-27 | Lohmann Gmbh & Co Kg, 5450 Neuwied | Pharmaceutical product and process for its manufacture |
US5316759A (en) * | 1986-03-17 | 1994-05-31 | Robert J. Schaap | Agonist-antagonist combination to reduce the use of nicotine and other drugs |
DE3843239C1 (en) * | 1988-12-22 | 1990-02-22 | Lohmann Therapie Syst Lts | |
DE69811378T2 (en) * | 1997-10-03 | 2004-02-12 | Cary Pharmaceuticals Inc. (n.d.Ges.d. Staates Delaware) | COMPOSITIONS FOR TREATING NICOTINE DEPENDENCY, CONTAINING MECAMYLAMINE AND BUPROPION |
ES2313187T3 (en) * | 1998-12-16 | 2009-03-01 | University Of South Florida | FORMULATION OF EXO-S-MECAMILAMINE. |
DE19906974C2 (en) * | 1999-02-19 | 2003-10-09 | Lohmann Therapie Syst Lts | Use of deoxypeganine for the treatment of alcoholism |
DE10129265A1 (en) * | 2001-06-18 | 2003-01-02 | Hf Arzneimittelforsch Gmbh | Active ingredient combination for drug addiction or intoxicant therapy |
-
2003
- 2003-04-25 DE DE10318714A patent/DE10318714B4/en not_active Expired - Fee Related
-
2004
- 2004-04-16 CN CNA2004800094893A patent/CN1771029A/en active Pending
- 2004-04-16 WO PCT/EP2004/004033 patent/WO2004096200A1/en not_active Application Discontinuation
- 2004-04-16 MX MXPA05011249A patent/MXPA05011249A/en not_active Application Discontinuation
- 2004-04-16 EA EA200501514A patent/EA200501514A1/en unknown
- 2004-04-16 JP JP2006505158A patent/JP2006524647A/en active Pending
- 2004-04-16 US US10/554,350 patent/US20060199866A1/en not_active Abandoned
- 2004-04-16 EP EP04727830A patent/EP1617831A1/en not_active Withdrawn
- 2004-04-16 KR KR1020057020318A patent/KR20060006946A/en not_active Application Discontinuation
- 2004-04-16 BR BRPI0410507-9A patent/BRPI0410507A/en not_active Application Discontinuation
- 2004-04-16 CA CA002523331A patent/CA2523331A1/en not_active Abandoned
- 2004-04-16 AU AU2004233564A patent/AU2004233564A1/en not_active Abandoned
- 2004-04-22 MY MYPI20041476A patent/MY136408A/en unknown
- 2004-04-23 AR ARP040101378A patent/AR044067A1/en unknown
- 2004-04-23 TW TW093111538A patent/TW200427452A/en unknown
- 2004-04-26 CL CL200400881A patent/CL2004000881A1/en unknown
-
2005
- 2005-09-08 ZA ZA200507213A patent/ZA200507213B/en unknown
- 2005-09-13 NO NO20054243A patent/NO20054243L/en not_active Application Discontinuation
Non-Patent Citations (1)
Title |
---|
See references of WO2004096200A1 * |
Also Published As
Publication number | Publication date |
---|---|
EA200501514A1 (en) | 2006-04-28 |
MY136408A (en) | 2008-09-30 |
DE10318714B4 (en) | 2006-03-23 |
ZA200507213B (en) | 2006-05-31 |
US20060199866A1 (en) | 2006-09-07 |
DE10318714A1 (en) | 2004-11-18 |
TW200427452A (en) | 2004-12-16 |
JP2006524647A (en) | 2006-11-02 |
MXPA05011249A (en) | 2005-12-14 |
WO2004096200A1 (en) | 2004-11-11 |
KR20060006946A (en) | 2006-01-20 |
CN1771029A (en) | 2006-05-10 |
CA2523331A1 (en) | 2004-11-11 |
BRPI0410507A (en) | 2006-06-20 |
AR044067A1 (en) | 2005-08-24 |
NO20054243L (en) | 2005-09-13 |
CL2004000881A1 (en) | 2005-01-21 |
AU2004233564A1 (en) | 2004-11-11 |
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