FI3650081T3 - Syklobentsapriinihydrokloridin ja mannitolin eutektiset formulaatiot - Google Patents
Syklobentsapriinihydrokloridin ja mannitolin eutektiset formulaatiot Download PDFInfo
- Publication number
- FI3650081T3 FI3650081T3 FIEP19214535.7T FI19214535T FI3650081T3 FI 3650081 T3 FI3650081 T3 FI 3650081T3 FI 19214535 T FI19214535 T FI 19214535T FI 3650081 T3 FI3650081 T3 FI 3650081T3
- Authority
- FI
- Finland
- Prior art keywords
- mannitol
- cyclobenzaprine
- hcl
- eutectic
- cyclobenzaprine hydrochloride
- Prior art date
Links
- 239000000594 mannitol Substances 0.000 title claims 14
- 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 title claims 13
- 229930195725 Mannitol Natural products 0.000 title claims 13
- 235000010355 mannitol Nutrition 0.000 title claims 13
- 230000005496 eutectics Effects 0.000 title claims 10
- 229960000500 cyclobenzaprine hydrochloride Drugs 0.000 title 1
- VXEAYBOGHINOKW-UHFFFAOYSA-N cyclobenzaprine hydrochloride Chemical compound Cl.C1=CC2=CC=CC=C2C(=CCCN(C)C)C2=CC=CC=C21 VXEAYBOGHINOKW-UHFFFAOYSA-N 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 229960003572 cyclobenzaprine Drugs 0.000 claims 13
- JURKNVYFZMSNLP-UHFFFAOYSA-N cyclobenzaprine Chemical compound C1=CC2=CC=CC=C2C(=CCCN(C)C)C2=CC=CC=C21 JURKNVYFZMSNLP-UHFFFAOYSA-N 0.000 claims 13
- 238000000034 method Methods 0.000 claims 6
- 238000004519 manufacturing process Methods 0.000 claims 2
- 238000003825 pressing Methods 0.000 claims 2
- 238000000227 grinding Methods 0.000 claims 1
- 239000000155 melt Substances 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 238000001694 spray drying Methods 0.000 claims 1
Classifications
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- 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
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
-
- 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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
-
- 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
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- 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
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- 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
- A61P25/22—Anxiolytics
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- 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
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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- A—HUMAN NECESSITIES
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- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Emergency Medicine (AREA)
- Biophysics (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Inorganic Chemistry (AREA)
- Anesthesiology (AREA)
- Rheumatology (AREA)
- Psychiatry (AREA)
- Toxicology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361792757P | 2013-03-15 | 2013-03-15 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| FI3650081T3 true FI3650081T3 (fi) | 2024-05-16 |
Family
ID=51538423
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FIEP19214535.7T FI3650081T3 (fi) | 2013-03-15 | 2014-03-14 | Syklobentsapriinihydrokloridin ja mannitolin eutektiset formulaatiot |
Country Status (27)
| Country | Link |
|---|---|
| US (11) | US9636408B2 (enExample) |
| EP (2) | EP3650081B1 (enExample) |
| JP (5) | JP6310542B2 (enExample) |
| CN (2) | CN105142730B (enExample) |
| AU (1) | AU2014233277B2 (enExample) |
| BR (1) | BR112015022095B1 (enExample) |
| CA (2) | CA2904812C (enExample) |
| CY (1) | CY1122740T1 (enExample) |
| DK (2) | DK2968992T3 (enExample) |
| ES (2) | ES2769879T3 (enExample) |
| FI (1) | FI3650081T3 (enExample) |
| HR (2) | HRP20200055T1 (enExample) |
| HU (2) | HUE047547T2 (enExample) |
| IL (1) | IL241353B (enExample) |
| LT (2) | LT3650081T (enExample) |
| MX (2) | MX388137B (enExample) |
| MY (1) | MY196014A (enExample) |
| NZ (2) | NZ631152A (enExample) |
| PL (2) | PL2968992T3 (enExample) |
| PT (2) | PT3650081T (enExample) |
| RS (2) | RS60015B1 (enExample) |
| SA (1) | SA515361124B1 (enExample) |
| SG (2) | SG11201507124XA (enExample) |
| SI (2) | SI2968992T1 (enExample) |
| SM (2) | SMT202400324T1 (enExample) |
| TW (2) | TWI661825B (enExample) |
| WO (1) | WO2014145156A2 (enExample) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8483821B2 (en) | 2009-07-27 | 2013-07-09 | Cardiac Pacemakers, Inc. | Blood volume redistribution therapy for heart failure |
| HUE037281T2 (hu) | 2009-11-20 | 2018-08-28 | Tonix Pharma Holdings Ltd | Eljárás és készítmény poszt-traumás stressz rendellenesség tüneteinek kezelésére ciklobenzaprin alkalmazásával |
| US20110319389A1 (en) | 2010-06-24 | 2011-12-29 | Tonix Pharmaceuticals, Inc. | Methods and compositions for treating fatigue associated with disordered sleep using very low dose cyclobenzaprine |
| US11998516B2 (en) | 2011-03-07 | 2024-06-04 | Tonix Pharma Holdings Limited | Methods and compositions for treating depression using cyclobenzaprine |
| MX382516B (es) * | 2012-06-15 | 2025-03-13 | Tonix Pharmaceuticals Inc | Composiciones y metodos para absorcion transmucosa. |
| NZ631152A (en) | 2013-03-15 | 2017-05-26 | Tonix Pharmaceuticals Inc | Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride |
| MX383378B (es) | 2014-02-05 | 2025-03-13 | Merck Sharp & Dohme Llc | Formulación de tableta para compuestos activos de péptido relacionado con el gen de calcitonina. |
| US12168004B2 (en) | 2014-02-05 | 2024-12-17 | Merck Sharp & Dohme Llc | Treatment of migraine |
| US10357465B2 (en) * | 2014-09-18 | 2019-07-23 | Tonix Pharma Holdings Limited | Eutectic formulations of cyclobenzaprine hydrochloride |
| JP2021505629A (ja) * | 2017-12-11 | 2021-02-18 | トニックス ファーマ ホールディングス リミテッド | 認知症および神経変性状態における興奮、精神病および認知機能低下のためのシクロベンザプリン処置 |
| US12383545B1 (en) | 2018-06-08 | 2025-08-12 | Allergan Pharmaceuticals International Limited | Treatment of migraine |
| US12090148B2 (en) | 2020-07-29 | 2024-09-17 | Allergan Pharmaceuticals International Limited | Treatment of migraine |
| MX2021002012A (es) * | 2018-08-20 | 2021-04-28 | Tonix Pharma Holdings Ltd | Metodos de tratamiento del trastorno por estres agudo y trastorno por estres postraumatico. |
| NL2023661B1 (en) * | 2019-08-19 | 2021-04-21 | Seranovo Holding B V | Pharmaceutical Eutectic Salt Formulation |
| JP7088153B2 (ja) * | 2019-09-19 | 2022-06-21 | カシオ計算機株式会社 | Ｃａｐ（周期性脳波活動）検出装置、ｃａｐ（周期性脳波活動）検出方法及びプログラム |
| WO2021207561A1 (en) | 2020-04-08 | 2021-10-14 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine treatment for sexual dysfunction |
| EP4247370A1 (en) * | 2020-11-20 | 2023-09-27 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine treatment for alcohol use disorder |
| JP2023554692A (ja) | 2020-12-07 | 2023-12-28 | トニックス ファーマシューティカルズ ホールディング コーポレイション | 線維筋痛症のためのシクロベンザプリン処置 |
| WO2022140537A1 (en) | 2020-12-22 | 2022-06-30 | Allergan Pharmaceuticals International Limited | Treatment of migraine |
| WO2022170107A2 (en) | 2021-02-04 | 2022-08-11 | Tonix Pharmaceuticals Holding Corp. | An improved method of assessing clinical response in the treatment of ptsd symptoms |
| CN113116843A (zh) * | 2021-05-11 | 2021-07-16 | 福建海西新药创制有限公司 | 一种含有缬沙坦的药物组合物及其制备方法 |
| AU2022353124A1 (en) | 2021-09-27 | 2024-04-11 | Allergan Pharmaceuticals International Limited | Combination comprising atogepant for treating migraine |
| WO2023059728A1 (en) | 2021-10-06 | 2023-04-13 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine for treatment or prevention of sexual dysfunction associated with mental health conditions in female patients |
| CN120379655A (zh) | 2022-06-21 | 2025-07-25 | 通尼克斯医药控股公司 | (sars)-cov-2感染的急性后后遗症(pasc)的环苯扎林治疗 |
| WO2025160302A1 (en) | 2024-01-25 | 2025-07-31 | Tonix Pharmaceuticals Holding Corp. | Cyclobenzaprine treatment for acute stress reaction or acute stress disorder |
| CN120059783B (zh) * | 2025-04-24 | 2025-07-04 | 太原理工大学 | 一种低共熔溶剂循环萃取促进沥青快速氧化的方法 |
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| JP2551754B2 (ja) * | 1986-04-17 | 1996-11-06 | 内橋エステック 株式会社 | ペレツト型温度ヒユ−ズ |
| US5073543A (en) | 1988-07-21 | 1991-12-17 | G. D. Searle & Co. | Controlled release formulations of trophic factors in ganglioside-lipsome vehicle |
| FR2635461B1 (fr) | 1988-08-18 | 1992-01-17 | Adir | Utilisation de derives tricycliques pour l'obtention de medicaments destines au traitement du stress |
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| WO1999018937A1 (en) | 1997-10-16 | 1999-04-22 | Merck & Co., Inc. | New cyclobenzaprine composition |
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