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EP1521590A1 - Nouvelles combinaisons medicamenteuses a base de sels de magnesium et d'agents fibrinolytiques - Google Patents

Nouvelles combinaisons medicamenteuses a base de sels de magnesium et d'agents fibrinolytiques

Info

Publication number
EP1521590A1
EP1521590A1 EP03740328A EP03740328A EP1521590A1 EP 1521590 A1 EP1521590 A1 EP 1521590A1 EP 03740328 A EP03740328 A EP 03740328A EP 03740328 A EP03740328 A EP 03740328A EP 1521590 A1 EP1521590 A1 EP 1521590A1
Authority
EP
European Patent Office
Prior art keywords
magnesium
group
treatment
drug combinations
fibrinolytic
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Withdrawn
Application number
EP03740328A
Other languages
German (de)
English (en)
Inventor
Hermann Duettmann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boehringer Ingelheim Pharma GmbH and Co KG
Boehringer Ingelheim Pharmaceuticals Inc
Original Assignee
Boehringer Ingelheim Pharma GmbH and Co KG
Boehringer Ingelheim Pharmaceuticals Inc
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 and Co KG, Boehringer Ingelheim Pharmaceuticals Inc filed Critical Boehringer Ingelheim Pharma GmbH and Co KG
Publication of EP1521590A1 publication Critical patent/EP1521590A1/fr
Withdrawn legal-status Critical Current

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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/164—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • A61K38/166—Streptokinase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/49—Urokinase; Tissue plasminogen activator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Definitions

  • the invention relates to new drug combinations based on magnesium salts 1 and fibrinolytics 2, processes for their preparation and their
  • the invention relates to drug combinations containing one or more, preferably a magnesium salt 1 and one or more, preferably a fibrinolytic
  • magnesium salts 1 which can be used according to the invention:
  • the magnesium salts 1 are preferably selected from the group consisting of magnesium adipate, magnesium L-aspartate, magnesium carbonate, magnesium L-hydrogen aspartate, magnesium hydrogen citrate, magnesium hydrogen glutamate, magnesium sulfate, magnesium chloride, trimagnesium dicitrate and magnesium acetate ,
  • Magnesium salts 1 selected from the group consisting of magnesium sulfate, magnesium chloride and magnesium acetate, the magnesium sulfate being of particular importance in the context of the present invention.
  • fibrinolytics 2 are preferably selected from the group of plasminogen activators.
  • plasminogen activators human tissue plasminogen activator, t-PA
  • tenecteplase reteplase
  • streptokinase urokinase
  • urokinase anistreplase
  • monteplase nateplase
  • duteplase lanoteplase
  • silteplase amediplase and desmoteplase. All of these fibrinolytics are known in the art.
  • Alteplase (amino acid sequence: GenBank Accession No. AAB59510) is a fibrinolytic approved as a medicinal product, the production of which by recombinant expression, preferably in cell linens of the Chinese hamster Cricetulus griseus (CHO cells), as well as its pharmaceutical formulation and medical use are described in detail in the prior art (Pennica et al., Nature 301, 214-221 (1983); EP 0 093619; Andersen et al., Biotechnol Bioeng 70 (1), 25-31 (2000); Dowd et al., Biotechnol Prog 16 (5 ), 786-794 (2000); Fann et al., Biotechnol Bioeng 69 (2), 204-212 (2000); Werner et al., Pharmaceutical Research 48 (8), 870-880 (1998); Wemicke et Will, Anal Biochem 203 (1), 146-150 (1992); Bos et al., Biochim Biophys Acta 11
  • Tenecteplase (TNK-tPA; T103N, N117Q, KHRR (296-299) AAAA-tPA) is also a drug approved fibrinolytic. Its preparation and use is described in references WO 93/24635; Keyt et al., Proc Natl Acad Sei U S. A. 1994 Apr 26; 91 (9): 3670-4; Turcasso et Nappi, Ann Pharmacother. 2001 Oct; 35 (10): 1233-40; MacGahan, Issues Emerg Health Technol. 2001 Jan; (13): 1-6; Davydov et Cheng, Clin Ther. 2001 Jul; 23 (7): 982-97; The Assent II investigators, Lancet. 1999 Aug 28; 354 (9180): 716-22 described in detail.
  • fibrinolytics 2 are particularly preferably selected from the group consisting of old plase (t-PA), tenecteplase, reteplase, streptokinase, urokinase, anistreplase, monoplase and nateplase.
  • Fibrinolytics 2 which are particularly preferred according to the invention are selected from the group of old plase (t-PA), tenecteplase, reteplase, urokinase and anistreplase, oldplase, tenecteplase and reteplase, particularly preferably oldplase, being of outstanding importance according to the invention.
  • t-PA old plase
  • tenecteplase tenecteplase
  • reteplase urokinase and anistreplase
  • oldplase tenecteplase
  • reteplase urokinase and anistreplase
  • oldplase tenecteplase
  • reteplase urokinase and anistreplase
  • oldplase tenecteplase
  • reteplase urokinase and anistreplase
  • the present invention further relates to the use of the combinations according to the invention of one or more, preferably a magnesium salt 1 and one or more, preferably a fibrinolytic 2 for the production of a medicament for the treatment of ischemic conditions of different origins ,
  • the present invention preferably relates to the use of the combinations according to the invention of one or more, preferably a magnesium salt, and one or more, preferably a fibrinolytic, 2 for the manufacture of a medicament for the treatment of cardiac or cerebral ischemia, particularly preferably for the treatment of stroke.
  • the present invention further relates to a method for the treatment of ischemic conditions of different origins, which is characterized in that a combination according to the invention of one or more, preferably a magnesium salt 1 and one or more, preferably a fibrinolytic 2 is applied.
  • the present invention preferably relates to a method for the treatment of cardiac or brain ischemia, particularly preferably stroke, according to the invention preferably furthermore ischemic stroke, particularly preferably acute, ischemic stroke, which is characterized in that a combination according to the invention of one or more, preferably one Magnesium salt 1 and one or more, preferably a fibrinolytic 2 is applied.
  • the present invention further relates to the use of one or more, preferably a magnesium salt, for the production of a medicament for the combined treatment of ischemic conditions of different origins with one or more, preferably a fibrinolytic 2.
  • the present invention relates to the use mentioned above for the manufacture of a medicament for the combined treatment of cardiac or brain ischemia, particularly preferably for the treatment of stroke with one or more, preferably a fibrinolytic 2.
  • the above use for the combined treatment of ischemic stroke particularly preferred of acute, ischemic stroke with one or more, preferably a fibrinolytic 2.
  • the present invention further relates to a method for the treatment of ischemic conditions of different origins, which is characterized in that one or more, preferably a magnesium salt 1 and one or more, preferably a fibrinolytic 2, simultaneously or sequentially in a single or two separate, preferably in two separate dosage forms can be applied.
  • the present invention preferably relates to a method for the treatment of cardiac or brain ischemia, particularly preferably of stroke, according to the invention preferably further of ischemic stroke, particularly preferably of acute, ischemic stroke, which is characterized in that one or more, preferably a magnesium salt 1 and a or more, preferably one fibrinolytic 2, can be administered simultaneously or sequentially in a single or two separate, preferably in two separate, dosage forms.
  • the pharmaceutical combinations according to the invention can contain the active constituents 1 and 2 in a single or in two separate administration forms.
  • the two components are preferably in two separate dosage forms, for example in the form of a so-called Kits. Separate dosage forms of the two components 1 and 2 are described in detail in the following sections.
  • the application of the combination of 1 and 2 according to the invention in the context of the abovementioned use and in the context of the abovementioned method can be achieved by simultaneous administration of the combination of ⁇ and 2 or, if 1 and 2 are present, in different administration forms by simultaneous administration or sequential administration of components 1 and 2.
  • sequential is to be understood as any application of components 1 or 2 that does not take place simultaneously.
  • Simultaneous application is understood to mean in particular the type of application in which at least one of components 1 and 2 is administered over a longer period of time, for example by means of an infusion, and the other component is also used during this application interval. If both components 1 and 2 are administered by infusion over a longer period of time, it also means in the sense of the present invention that the infusion intervals overlap at least briefly.
  • components 1 and 2 are preferably administered simultaneously or at least at short intervals, i.e. for example within an hour.
  • Treatment with the pharmaceutical combinations according to the invention is particularly effective here if it takes place within a very short time after the onset of the stroke.
  • the therapy is particularly preferably started at the latest within about 5 hours, particularly preferably within 4 hours, further preferably within 3 hours after the onset of the stroke.
  • the magnesium salt 1 used in the combination according to the invention can be administered orally or parenterally in the context of the present invention, the parenteral application being of particular importance.
  • Parenteral administration can be carried out in particular by intravenous, intraarterial, intramuscular, intra- or subcutaneous injection.
  • Typical formulations here are aqueous infusion solutions or injection solutions containing the magnesium salt, which may be the usual ones
  • Stabilizers, solubilizers and preservatives may contain other ingredients.
  • a total of between 30 to 120 mmol, preferably about 50 to 100 mmol, particularly preferably about 70 to 90 mmol of magnesium are administered per dose.
  • the application takes place, for example, in the form of an infusion which is applied over a period of about 6 to 48 hours, preferably about 12 to 36 hours, particularly preferably about 18 to 30 hours.
  • the respective dose per time interval can be designed variably within this period.
  • a first Interval between about 5 and 25 mmol, preferably between about 10 and 20 mmol magnesium over a period of about 5 minutes to 1 hour, preferably over a period of about 10 to 30 minutes, and then in a second interval between, for example, 25 and 100 mmol, preferably between about 40 and 80 mmol, particularly preferably between about 50 and 70 mmol of magnesium over a period of about 5 to 48 hours, preferably about 12 to 36 hours, particularly preferably about 20 to 28 hours.
  • the dosage and duration of application may deviate from the above-mentioned values used for orientation.
  • component 1 can also be administered by means of one or more injections.
  • the amount stated for magnesium sulfate relates to the anhydrous form of the magnesium sulfate.
  • the fibrinolytic 2 used in the combination according to the invention is generally a polypeptide that must be administered parenterally.
  • the application can be done in particular by intravenous, intraarterial, intramuscular, intra- or subcutaneous injection, but also Administration by inhalation of a powder or aerosol is possible.
  • Typical formulations are freeze-dried preparations (lyophilisates) of the polypeptide, which are reconstituted with a solution for injection or infusion immediately before administration.
  • the reconstitution solution can be water or a buffered aqueous solution.
  • the formulation can also consist of an aqueous solution, which is preferably buffered with a physiologically compatible buffer and can additionally contain conventional stabilizers, solubilizers, and preservatives.
  • auxiliaries for such solid or liquid formulations are alkali hydrogen phosphate / alkali dihydrogen phosphate, sodium chloride, serum albumin, polyoxyethylene sorbitan monolaurate (Tween ® 20), polyoxyethylene sorbitan monooleate (Tween ® 80), ethylenediamine tetraacetate (EDTA), sucrose, mannitol Dextran, amino acid, and benzyl alcohol (the latter only for liquid formulations).
  • the application is usually parenteral, preferably by intravenous injection or infusion.
  • the mode of application and dosage depend on the fibrinolytic chosen, in particular on its specific biological activity and half-life in the blood plasma.
  • Alteplase which has a relatively short half-life, is typically administered in a total dose of 100 mg as follows: 10-15 mg as an intravenous bolus, followed by an intravenous infusion of 50 mg over a period of 30 to 60 minutes, followed by one further infusion from 60-180 minutes to the maximum dose. Tenecteplase has a longer half-life and can therefore be administered as a single bolus based on body weight up to a maximum dose of 50 mg.
  • Reteplase which has a medium half-life and a lower specific activity, is administered as an intravenous double bolus every 30 minutes at a dose of 10 units (560 mg) per bolus.
  • the person skilled in the art knows how to find suitable dosages for a new medicament. For the palsminogen activators mentioned by name, the person skilled in the art can obtain formulation and dosage information from the literature references mentioned above.
  • component 2 Formulations of component 2 are known in the prior art and are available on the market. Some commercially available formulations which can be used according to the invention are listed below by way of example and for clarification. Alteplase: (powder and solvent for solution for injection / infusion)
  • Composition Alteplase 10 mg / 20 mg / 50 mg / 100 mg. further components: arginine, phosphoric acid, polysorbate 80. water for injections.
  • Tenecteplase (powder and solvent for solution for injection) Composition: Tenecteplase 8,000 U / 10,000 U (40 mg / 50 mg). further components: arginine, phosphoric acid, polysorbate 20.
  • Reteplase (powder and solvent for solution for injection) Composition: Reteplase 0.56 g (equivalent to 10 units). further components: tranexamic acid, potassium monohydrogen phosphate,
  • Phosphoric acid sucrose, polysorbate 80. Water for injections 10 ml.
  • Streptokinase (dry substance for infusion solution) Composition: highly purified streptokinase 250,000 IU / 750,000 IU /
  • Streptokinase (oral tablets)
  • composition streptokinase 10,000 IU, streptodomase 2500-
  • magnesium stearate 10,000 IU other ingredients: magnesium stearate, calcium hydrogen phosphate,
  • Composition urokinase 500,000 IU further components: sodium monohydrogen phosphate,
  • Urokinase human
  • 500,000 IU further components: sodium dihydrogen phosphate, sodium monohydrogen phosphate, sodium chloride, dextran 40.
  • Anistreplase (dry substance and solvent for iv injection)
  • Composition . 209-230 mg dry substance with anistreplase 29.55-

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne de nouvelles combinaisons médicamenteuses à base de sels de magnésium (1) et d'agents fibrinolytiques (2). L'invention concerne également leurs procédés de préparation et leur utilisation pour la production de médicaments destinés au traitement d'états ischémiques
EP03740328A 2002-07-09 2003-06-25 Nouvelles combinaisons medicamenteuses a base de sels de magnesium et d'agents fibrinolytiques Withdrawn EP1521590A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10230752 2002-07-09
DE10230752A DE10230752A1 (de) 2002-07-09 2002-07-09 Neue Arzneimittelkompositionen auf der Basis von Magnesiumsalzen und Fibrinolytika
PCT/EP2003/006666 WO2004004754A1 (fr) 2002-07-09 2003-06-25 Nouvelles combinaisons medicamenteuses a base de sels de magnesium et d'agents fibrinolytiques

Publications (1)

Publication Number Publication Date
EP1521590A1 true EP1521590A1 (fr) 2005-04-13

Family

ID=29761747

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03740328A Withdrawn EP1521590A1 (fr) 2002-07-09 2003-06-25 Nouvelles combinaisons medicamenteuses a base de sels de magnesium et d'agents fibrinolytiques

Country Status (6)

Country Link
EP (1) EP1521590A1 (fr)
JP (1) JP2005532377A (fr)
AU (1) AU2003281249A1 (fr)
CA (1) CA2491712A1 (fr)
DE (1) DE10230752A1 (fr)
WO (1) WO2004004754A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1902708A1 (fr) * 2006-09-25 2008-03-26 Losan Pharma GmbH Compositions pharmaceutiques stabilisées et solides contenant au moins un médicament et procédé d'élaboration
CN103391785A (zh) * 2010-12-23 2013-11-13 热诺瓦生物制药有限公司 替萘普酶的药用组合物

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB872146A (en) * 1958-01-06 1961-07-05 Innerfield Irving Emzymic composition
SU1084024A1 (ru) * 1982-06-25 1984-04-07 Ленинградский научно-исследовательский институт вакцин и сывороток Состав дл стабилизации стрептокиназы
AU2213197A (en) * 1996-03-05 1997-09-22 Medinox, Inc. Combinational therapeutic methods employing nitric oxide scavengers and compositions useful therefor
CA2265877A1 (fr) * 1996-09-10 1998-03-19 Medinox, Inc. Macromolecules contenant du polydithiocarbamate, et leur utilisation dans des applications therapeutiques et diagnostiques

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2004004754A1 *

Also Published As

Publication number Publication date
DE10230752A1 (de) 2004-01-22
JP2005532377A (ja) 2005-10-27
CA2491712A1 (fr) 2004-01-15
WO2004004754A1 (fr) 2004-01-15
AU2003281249A1 (en) 2004-01-23

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