ME01964B - Sprega agomelatina i timoregulatora i farmaceutske smeše koje je sadrže - Google Patents
Sprega agomelatina i timoregulatora i farmaceutske smeše koje je sadržeInfo
- Publication number
- ME01964B ME01964B MEP-2011-407A MEP40711A ME01964B ME 01964 B ME01964 B ME 01964B ME P40711 A MEP40711 A ME P40711A ME 01964 B ME01964 B ME 01964B
- Authority
- ME
- Montenegro
- Prior art keywords
- disorder
- agomelatine
- mood
- combination
- timoregulatory
- Prior art date
Links
- YJYPHIXNFHFHND-UHFFFAOYSA-N agomelatine Chemical compound C1=CC=C(CCNC(C)=O)C2=CC(OC)=CC=C21 YJYPHIXNFHFHND-UHFFFAOYSA-N 0.000 title claims description 14
- 229960002629 agomelatine Drugs 0.000 title claims description 14
- 239000004050 mood stabilizer Substances 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 208000024732 dysthymic disease Diseases 0.000 claims description 11
- 208000024714 major depressive disease Diseases 0.000 claims description 11
- 238000011282 treatment Methods 0.000 claims description 11
- 208000026725 cyclothymic disease Diseases 0.000 claims description 9
- 239000003795 chemical substances by application Substances 0.000 claims description 8
- 239000000203 mixture Substances 0.000 claims description 8
- 239000002253 acid Substances 0.000 claims description 7
- 150000004677 hydrates Chemical class 0.000 claims description 7
- 150000003839 salts Chemical class 0.000 claims description 7
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 7
- 208000020925 Bipolar disease Diseases 0.000 description 6
- 208000019022 Mood disease Diseases 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 230000036651 mood Effects 0.000 description 6
- 208000035475 disorder Diseases 0.000 description 5
- DLFVBJFMPXGRIB-UHFFFAOYSA-N Acetamide Chemical compound CC(N)=O DLFVBJFMPXGRIB-UHFFFAOYSA-N 0.000 description 4
- 150000001875 compounds Chemical class 0.000 description 4
- 230000003542 behavioural effect Effects 0.000 description 3
- 230000008878 coupling Effects 0.000 description 3
- 238000010168 coupling process Methods 0.000 description 3
- 238000005859 coupling reaction Methods 0.000 description 3
- 229940102566 valproate Drugs 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- 206010026749 Mania Diseases 0.000 description 2
- -1 N-[2-{1-methoxy-1-naphthyl)ethyl]acetamide Chemical compound 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 239000011230 binding agent Substances 0.000 description 2
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- 239000000314 lubricant Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 230000007170 pathology Effects 0.000 description 2
- AEQFSUDEHCCHBT-UHFFFAOYSA-M sodium valproate Chemical compound [Na+].CCCC(C([O-])=O)CCC AEQFSUDEHCCHBT-UHFFFAOYSA-M 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 102000006902 5-HT2C Serotonin Receptor Human genes 0.000 description 1
- 229920001817 Agar Polymers 0.000 description 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- 208000027559 Appetite disease Diseases 0.000 description 1
- 241000416162 Astragalus gummifer Species 0.000 description 1
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- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 206010011971 Decreased interest Diseases 0.000 description 1
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- 108010010803 Gelatin Proteins 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 101150013372 Htr2c gene Proteins 0.000 description 1
- 206010022998 Irritability Diseases 0.000 description 1
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- WHXSMMKQMYFTQS-UHFFFAOYSA-N Lithium Chemical compound [Li] WHXSMMKQMYFTQS-UHFFFAOYSA-N 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 206010027951 Mood swings Diseases 0.000 description 1
- 208000008589 Obesity Diseases 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 description 1
- 206010041243 Social avoidant behaviour Diseases 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 229920001615 Tragacanth Polymers 0.000 description 1
- 239000002250 absorbent Substances 0.000 description 1
- 230000002745 absorbent Effects 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 238000011360 adjunctive therapy Methods 0.000 description 1
- 239000008272 agar Substances 0.000 description 1
- 239000000556 agonist Substances 0.000 description 1
- 239000000783 alginic acid Substances 0.000 description 1
- 235000010443 alginic acid Nutrition 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
- 229960001126 alginic acid Drugs 0.000 description 1
- 150000004781 alginic acids Chemical class 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 235000010210 aluminium Nutrition 0.000 description 1
- 239000005557 antagonist Substances 0.000 description 1
- 230000001430 anti-depressive effect Effects 0.000 description 1
- 230000003561 anti-manic effect Effects 0.000 description 1
- 239000000935 antidepressant agent Substances 0.000 description 1
- 229940005513 antidepressants Drugs 0.000 description 1
- 230000006399 behavior Effects 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 208000028683 bipolar I disease Diseases 0.000 description 1
- 159000000007 calcium salts Chemical class 0.000 description 1
- FFGPTBGBLSHEPO-UHFFFAOYSA-N carbamazepine Chemical compound C1=CC2=CC=CC=C2N(C(=O)N)C2=CC=CC=C21 FFGPTBGBLSHEPO-UHFFFAOYSA-N 0.000 description 1
- 229960000623 carbamazepine Drugs 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
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- 230000001684 chronic effect Effects 0.000 description 1
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- 230000003247 decreasing effect Effects 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 230000003001 depressive effect Effects 0.000 description 1
- 230000000994 depressogenic effect Effects 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 210000002249 digestive system Anatomy 0.000 description 1
- FSBVERYRVPGNGG-UHFFFAOYSA-N dimagnesium dioxido-bis[[oxido(oxo)silyl]oxy]silane hydrate Chemical compound O.[Mg+2].[Mg+2].[O-][Si](=O)O[Si]([O-])([O-])O[Si]([O-])=O FSBVERYRVPGNGG-UHFFFAOYSA-N 0.000 description 1
- 239000008298 dragée Substances 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 230000001544 dysphoric effect Effects 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 235000003599 food sweetener Nutrition 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000007903 gelatin capsule Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
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- 235000011187 glycerol Nutrition 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 206010022437 insomnia Diseases 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- PYZRQGJRPPTADH-UHFFFAOYSA-N lamotrigine Chemical compound NC1=NC(N)=NN=C1C1=CC=CC(Cl)=C1Cl PYZRQGJRPPTADH-UHFFFAOYSA-N 0.000 description 1
- 229960001848 lamotrigine Drugs 0.000 description 1
- 229910052744 lithium Inorganic materials 0.000 description 1
- 229960001078 lithium Drugs 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 239000000391 magnesium silicate Substances 0.000 description 1
- 235000019792 magnesium silicate Nutrition 0.000 description 1
- 229910052919 magnesium silicate Inorganic materials 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 230000001193 melatoninergic effect Effects 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 235000020824 obesity Nutrition 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 230000002085 persistent effect Effects 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 208000020016 psychiatric disease Diseases 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
- 102000005962 receptors Human genes 0.000 description 1
- 208000012672 seasonal affective disease Diseases 0.000 description 1
- 230000009291 secondary effect Effects 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 208000019116 sleep disease Diseases 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 230000000392 somatic effect Effects 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 239000006190 sub-lingual tablet Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 239000000829 suppository Substances 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 239000000196 tragacanth Substances 0.000 description 1
- 235000010487 tragacanth Nutrition 0.000 description 1
- 229940116362 tragacanth Drugs 0.000 description 1
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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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C231/00—Preparation of carboxylic acid amides
- C07C231/08—Preparation of carboxylic acid amides from amides by reaction at nitrogen atoms of carboxamide groups
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- 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
- A61P25/08—Antiepileptics; Anticonvulsants
- A61P25/10—Antiepileptics; Anticonvulsants for petit-mal
-
- 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
- A61P25/08—Antiepileptics; Anticonvulsants
- A61P25/12—Antiepileptics; Anticonvulsants for grand-mal
-
- 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
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- 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
- A61P25/20—Hypnotics; Sedatives
-
- 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
- A61P25/24—Antidepressants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Epidemiology (AREA)
- Pain & Pain Management (AREA)
- Emergency Medicine (AREA)
- Diabetes (AREA)
- Psychiatry (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Endocrinology (AREA)
- Dermatology (AREA)
- Anesthesiology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Description
Opis
Ovaj pronalazak se odnosi na novu spregu agomelatina ili N-[2-{l-metoksi-l-naftil)etil]acetamida formule (I):
ili jednog od njegovih hidrata, kristalnih oblika i adicionih soli sa farmaceutski prihvatljivom kiselinom ili bazom, i regulatora raspoloženja za dobijanje farmaceutskih smeša namenjenih tretmanu poremećaja ponašanja, koji su izdvojeni od: depresivnog major poremećaja, ciklotimijskog poremećaja i distimijskog poremećaja.
Agomelatin ili vV-[2-(7-metoksi-1 -naftil)etil]acetamid ispoljava dvostruku posebnost, da je sa jedne strane agonist na receptorima melatoninergičnog sistema i, daje, sa druge strane, antagonist 5-HT2c receptora. Ove osobine mu daju aktivnost u centralnom nervnom sistemu, a naročito u tretmanu depresivnog major poremećaja, sezonskih depresija, poremećaja spavanja, kardiovaskularnih patologija, patologija digestivnog sistema, nesanice i umora koji je rezultat promene vremenske zone, poremećaja apetita i gojaznosti.
Agomelatin, njegova proizvodnja i korišćenje u terapiji, opisani su u evropskom patentu EP 0 447 285.
Dokument J. D. Guelfija i J. R. Calabrese-a, Bipolar disorders, 7(2), Juin 2005, p.62, objavljuje korišćenje agomelatina u dopunjenoj terapiji sa timoregulatomim sredstvom kod pacijenata koji boluju od bipolamog poremećaja I sa epizodom depresije major.
Zahtevalac je sada otkrio da agomelatin ili A-[2-(7-metoksi-1 -naftiljetil] acetamid ili jedan od njegovih hidrata, kristalnih oblika i adicionih soli sa jednom farmaceutski prihvatljivom kiselinom ili bazom, kada se koristi udružen sa timoregulatornim sredstvom, poseduje korisna svojstva koja mu omogućavaju da se koristi u tretmanu poremećaja raspoloženja, izdvojenih od: depresivnog major poremećaja, ciklotimijskog poremećaja i distimijskog poremećaja.
Poremećaji centralnog nervnog sistema, kao što su poremećaji ponašanja, pogađaju široku populaciju i sve starosne dobi. Tako se oni imenuju uzročnicima uplitanja perzistirajućih pozitivnih ili negativnih osećanja, koja su dovoljno ozbiljnog intenziteta, u prouzrokovanju neprilagođenih ponašanja.
Poremećaj depresije major jeste akutan i težak poremećaj raspoloženja koji se karakteriše tugom, pesimizmom, suicidnim idejama, slabljenjem pokretačkih ideja i različitim somatskim pritužbama. U krajnjem slučaju hendikepirajući, može odvesti u prestanak svih funkcionalnih ili društvenih aktivnosti. Patnji deprimirane osobe se priključuje i patnja celokupne porodice.
Ciklotimijski poremećaj se karakteriše ponavljanim nastupanjem varijacija u raspoloženju, pozitivnom (širenje raspoloženja) i negativnom (depresivno raspoloženje), koje su manje ozbiljnosti nego one kod bipolamog poremećaja, sa jednom manjom funkcionalnom promenom; ipak teškoća dijagnostikovanja je realna i izvesni elementi dopuštaju razmišljanje da ciklotimijski poremećaj čini sloj bipolarnog poremećaja. Sprega jednog antidepresiva sa jednim timoregulatorom omogućava kontrolisanje ovih varijacija raspoloženja i sprečavanje njihovog prelaska u karakterističan bipolarni poremećaj.
Konačno, distimijski poremećaj je hronični i snažan poremećaj raspoloženja, koji se karakteriše dugačkim periodima disforičnog raspoloženja i funkcionalnih promena. Kao i za sindrom profesionalnog iscrpljivanja, ostali simptomi distimije mogu obuhvatiti sledeća osećanja: odsustvo prilagodljivosti, očajanje, intenzivnu razdražljivost ili gnev, osećanje krivice, generalizovani gubitak interesovanja ili zadovoljstva, povlačenje iz društva, hronični umor, pad aktivnosti ili produktivnosti i lošu koncentrisanost. Distimija je jedan podmukli mentalni poremećaj. Nasuprot oslabljenim funkcionalnim simptomima, koji su povezani sa bolestima kao što je poremećaj depresije major, osobe sa distimijom generalno pate od društvenog disfunkcionisanja i slabljenja na profesionalnom planu. Na primer, uprkos tipičnih poremećaja unutar njihovih opštih interpersonalnih odnosa, često se viđaju distimične osobe kako marljivo rade u okviru svoje profesije i održavaju jednu prividnost normalnosti.
Mada postoji veliki broj delotvomih molekula u ovoj oblasti - posebno se mogu navesti timoanaleptici i regulatori raspoloženja - nijedan potpuno ne zadovoljava ova različita patološka stanja i, brojni među njima ispoljavaju značajne sekundarne efekte. Prema tome, pripremanje novih alternativnih tretmana je i danas aktuelno ostaje neophodno.
Zahtevalac je sada iznenađujuće otkrio da agomelatin ili jedan od njegovih hidrata, kristalnih oblika i adicionih soli sa farmaceutski prihvatljivom kiselinom ili bazom, kada se koristi u sprezi sa timoregulatomim sredstvom, ima potpuno prilagođena dejstva za tretman poremećaja ponašanja, a naročito poremećaja depresije major, ciklotimijskog poremećaja i distimijskog poremećaja. Timoregulatori, koji se generalno prepisuju zbog svojih antimanijakalnih svojstava što im omogućava delovanje na lepezu raspoloženja u manijakalnim stanjima, trenutno se koriste u tretmanu bipolamih poremećaja.
Zahtevalac je sada otkrio da ova timoregulatorna sredstva ispoljavaju posebnost da potenciraju dejstva agomelatina u domenu depresivnih poremećaja raspoloženja kao i kod manijakalnih poremećaja.
Ovaj efekat, koji nije predvidiv, omogućava razmatranje korišćenja sprege, u skladu sa pronalaskom, u tretmanu poremećaja raspoloženja, a posebno poremećaja depresije major, ciklotimijskog poremećaja i distimijskog poremećaja.
Od timoregulatomih sredstava prema pronalasku, mogu se navesti pre svega, ali bez ograničavanja na ove, litijum, karbamazepin, valproat i lamotrigin, a pre svih, valproat.
Pronalazak se dakle odnosi na korišćenje sprege agomelatina ili jednog od njegovih hidrata, kristalnih oblika i adicionih soli sa jednom farmaceutski prihvatljivom kiselinom ili bazom i, jednog timoregulatomog jedinjenja, za dobijanje farmaceutskih smeša namenjenih lečenju poremećaja raspoloženja, izdvojenih od: depresivnog major poremećaja, ciklotimijskog poremećaja i distimijskog poremećaja.
Isto tako, pronalazak se odnosi na farmaceutske smeše koje sadrže kombinaciju između agomelatina ili jednog od njegovih hidrata, kristalnih oblika i adicionih soli sa farmaceutski prihvatljivom kiselinom ili bazom i, jednog timoregulatomog jedinjenja, zajedno sa jednom ili više farmaceutski prihvatljivih podloga.
Od farmaceutskih smeša, koje su u skladu sa pronalaskom, mogu se navesti posebno one, koje su prikladne za primenjivanje oralnim putem, parenteralnim, nazalnim, jednostavne pilule ili dražeje, sublingvalne tablete, želatinske kapsule, tablete, supozitorije, kremo vi, masti, kožni gelovi i td...
Sem agomelatina i timoregulatomog jedinjenja, farmaceutske smeše koje su u skladu sa pronalaskom sadrže jednu ili više podloga ili vehikuluma, odabranih od: diluenata, lubrikanasa, sredstava za vezivanje, sredstava za raspadljivost, absorbanata, boja, zasladi vača i td...
U smislu primera i bez cilja ograničavanja, mogu se navesti:
• kao diluenti : laktoza, dekstroza, saharoza, manitol, sorbitol, celuloza, glicerin,
• kao lubrikansi : silika, talk, stearinska kiselina i njene soli magnezijuma i kalcijuma, polietilen glikol,
• kao sredstva za vezivanje : aluminijima i magnezijum silikat, škrob, želatin, tragakanta, metilceluloza, natrij um karboksimetilceluloza i polivinilpirolidon,
• kao sredstva za raspadljivost: agar, alginska kiselina i njena natrij umova so, smeše efervescenata.
Doziranje koje se koristi varira prema polu, starosti i težini pacijenta, od puta primene, prirode bolesti i eventualno pridruženih tretmana i kreće se između 1 mg i 50 mg agomelatina u toku 24 sata, a poželjno, 25 mg na dan. Doza timoregulatomog sredstva biće manja od one koja se koristi kada se primenjuje samo.
Kliničko ispitivanje :
Izvedeno kliničko ispitivanje koristi međunarodnu nomenklaturu, pre svega DSM-IV, kao i potvrđene meme tehnike, kao što je Hamiltonova skala za depresiju, Youngova skala za maniju, globalna klinička skala utiska i sve su tehnike preporučene važećim Vodičima. Sprega agomelatin-valproat u odnosu na placebo-timoregulator, omogućava zaključivanje u boljim metodološkim uslovima kroz nadmoćnost sprege.
Claims (2)
1. Upotreba farmaceutske smese koja sadrzi agomelatin ili jedan od njegovih hidrata, kristalnih oblika i adicionih soli sa farmaceutski prihvatljivom kiselinom ili bazom, u sprezi sa timoregulatomim sredstvom, za proizvodnju leka za lecenje depresivnog major poremecaja, ciklotimijskog poremecaja ili distimijskog poremecaja.
2. Upotreba sprege koja se sastoji od agomelatina ili jednog od njegovih hidrata, kristalnih oblika i adicionih soli sa farmaceutski prihvatljivom kiselinom ili bazom i timoregulatornog sredstva za dobijanje farmaceutskih smesa namenjenih za lecenje depresivnog major poremecaja, ciklotimijskog poremecaja ili distimijskog poremecaja. Izdaje i stampa: Zavod za intelektualnu svojinu, Beograd, Kneginje Ljubice 5 7
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR0509208A FR2890563B1 (fr) | 2005-09-09 | 2005-09-09 | Nouvelle association entre l'agomelatine et un agent thymoregulateur et les compositions pharmaceutiques qui la contiennent |
| EP06291423A EP1762238B1 (fr) | 2005-09-09 | 2006-09-08 | Association entre l'agomélatine et un agent thymorégulateur et compositions pharmaceutiques les contenant |
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| Publication Number | Publication Date |
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| ME01964B true ME01964B (me) | 2012-04-30 |
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| Application Number | Title | Priority Date | Filing Date |
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| MEP-2011-407A ME01964B (me) | 2005-09-09 | 2006-09-08 | Sprega agomelatina i timoregulatora i farmaceutske smeše koje je sadrže |
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| FR2658818B1 (fr) | 1990-02-27 | 1993-12-31 | Adir Cie | Nouveaux derives a structure naphtalenique, leur procede de preparation et les compositions pharmaceutiques qui les contiennent. |
| EP1185259A1 (en) * | 1999-04-29 | 2002-03-13 | MERCK PATENT GmbH | Glycine cleavage system inhibitors as potential antipsychotics |
| RO121085B1 (ro) * | 1999-12-01 | 2006-12-29 | Ucb, S.A., | Utilizarea levetiracetamului, în tratamentul bolilor sistemului nervos central |
| AR047553A1 (es) * | 2003-07-04 | 2006-01-25 | Lundbeck & Co As H | La combinacion de un inhibidor de reabsorcion de serotonina y agomelatina |
| FR2884714B1 (fr) * | 2005-04-20 | 2011-05-06 | Servier Lab | Utilisation de l'agomelatine pour l'obtention de medicaments destines au traitement des troubles bipolaires |
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