SI2852389T1 - Sestavki, obsegajoči kratkotrajno-delujoče benzodiazepine - Google Patents
Sestavki, obsegajoči kratkotrajno-delujoče benzodiazepine Download PDFInfo
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- SI2852389T1 SI2852389T1 SI201330840T SI201330840T SI2852389T1 SI 2852389 T1 SI2852389 T1 SI 2852389T1 SI 201330840 T SI201330840 T SI 201330840T SI 201330840 T SI201330840 T SI 201330840T SI 2852389 T1 SI2852389 T1 SI 2852389T1
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- dextran
- benzodiazepine
- pharmaceutically acceptable
- hygroscopic excipient
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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
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
- A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
- A61K31/5517—1,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
-
- 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
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
- A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
-
- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
- A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P23/00—Anaesthetics
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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
-
- 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
-
- 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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D243/00—Heterocyclic compounds containing seven-membered rings having two nitrogen atoms as the only ring hetero atoms
- C07D243/06—Heterocyclic compounds containing seven-membered rings having two nitrogen atoms as the only ring hetero atoms having the nitrogen atoms in positions 1 and 4
- C07D243/10—Heterocyclic compounds containing seven-membered rings having two nitrogen atoms as the only ring hetero atoms having the nitrogen atoms in positions 1 and 4 condensed with carbocyclic rings or ring systems
- C07D243/14—1,4-Benzodiazepines; Hydrogenated 1,4-benzodiazepines
- C07D243/16—1,4-Benzodiazepines; Hydrogenated 1,4-benzodiazepines substituted in position 5 by aryl radicals
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D243/00—Heterocyclic compounds containing seven-membered rings having two nitrogen atoms as the only ring hetero atoms
- C07D243/06—Heterocyclic compounds containing seven-membered rings having two nitrogen atoms as the only ring hetero atoms having the nitrogen atoms in positions 1 and 4
- C07D243/10—Heterocyclic compounds containing seven-membered rings having two nitrogen atoms as the only ring hetero atoms having the nitrogen atoms in positions 1 and 4 condensed with carbocyclic rings or ring systems
- C07D243/14—1,4-Benzodiazepines; Hydrogenated 1,4-benzodiazepines
- C07D243/16—1,4-Benzodiazepines; Hydrogenated 1,4-benzodiazepines substituted in position 5 by aryl radicals
- C07D243/18—1,4-Benzodiazepines; Hydrogenated 1,4-benzodiazepines substituted in position 5 by aryl radicals substituted in position 2 by nitrogen, oxygen or sulfur atoms
- C07D243/24—Oxygen atoms
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
- C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
- C07D401/04—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings directly linked by a ring-member-to-ring-member bond
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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
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Anesthesiology (AREA)
- Pain & Pain Management (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Plural Heterocyclic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Claims (12)
- SESTAVKI, OBSEGAJOČI KRATKOTRAJNO-DELUJOČE BENZODIAZEPINE EP2852389 Patentni zahtevki1. Liofiliziran ali pršno-posušen sestavek, obsegajoč vsaj en benzodiazepin po formuli (I)z Wje H; X je CH2; n je 1; Yje CH2; m je 1; Z je O; R1 je CH3, CH2CH3, CH2CH2CH3, CH(CH3)2 ali CH2CH(CH3)2; R2 je 2-fluorofenil, 2-klorofenil ali 2-piridil; R3 je Cl ali Br; R4, R5 in R8 tvorijo skupino-CR8=U-V= pri čemer je R8 vodik, C1-4 alkil ali C1-3 hidroksialkil, U je N ali CR9 pri čemer je R9 H, C1-4 alkil, C1-3 hidroksialkil ali C1-4 alkoksi, V je N ali CH in je p nič ali njega farmacevtsko sprejemljiva sol, pri čemer sestavek obsega vsaj en farmacevtsko sprejemljiv higroskopski ekscipient, pri čemer je higroskopski ekscipient ogljikov hidrat, izbran izmed skupine, ki jo sestavljajo disaharidi in dekstran, in je opcijsko sestavek vsaj delno amorfen.
- 2. Sestavek po zahtevku 1, pri čemer je benzodiazepin po formuli (I) metil 3-[(4S)-8-bromo-1 -metil-6-(piridin-2-il)-4H-imidazo[1,2-a][1,4]benzadiazepin-4-iljprapanoat (remimazolam).
- 3. Sestavek po zahtevku 2, pri čemer je v farmacevtsko sprejemljivi soli benzodiazepin formuliran v kationski obliki in je nasprotni ion benzen sulfonat (besilat).
- 4. Sestavek po kateremkoli od zahtevkov 1 do 3, pri čemer ima dekstran molekulsko maso manj kot 150 kD.
- 5. Sestavek po kateremkoli od zahtevkov 1 do 3, pri čemer je disaharid izbran izmed skupine, ki jo sestavljajo laktoza, maltoza, saharoza in trehaloza.
- 6. Sestavek po kateremkoli od zahtevkov 1 do 3, pri čemer sestavek obsega zmes prvega higroskopskega ekscipienta in drugega higroskopskega ekscipienta.
- 7. Sestavek po zahtevku 6, pri čemer sestavek obsega zmes disaharida in dekstrana, prednostno zmesi laktoze in dekstrana.
- 8. Sestavek po zahtevku 7, pri čemer je utežno % razmerje med laktozo in dekstranom od 1: 1,0 do 1:10, prednostno od 1: 1,2 do 1: 5 in bolj prednostno 1: 1,5 ali 1:4.
- 9. Sestavek po kateremkoli od zahtevkov 1 do 3, pri čemer je utežno % razmerje med celotno količino higroskopskih ekscipientov in celotno količino benzodiazepinov ali njih soli, izračunano za bazo, v sestavku, od 20:1 do 1 : 1, prednostno od 12: 1 do 3: 1, najbolj prednostno od 9: 1 do 3: 1.
- 10. Sestavek po kateremkoli od zahtevkov 1 do 3, ki je farmacevtska formulacija.
- 11. Uporaba zmesi vsaj enega disaharida in vsaj enega dekstrana za pripravo liofiliziranega ali pršno posušenega farmacevtskega sestavka, ki obsega benzodiazepin z ester karboksilne kisline delom po zahtevku 1 ali njega farmacevtsko sprejemljivo sol, zlasti remimazolam.
- 12. Postopek za pripravo farmacevtskega sestavka, ki obsega korake a) dobava raztopine, ki obsega benzodiazepin po zahtevku 1 ali njega farmacevtsko sprejemljivo sol, zlasti remimazolam; b) dodajanje vsaj enega higroskopskega ekscipienta, ki je ogljikov hidrat, izbran izmed skupine, ki jo sestavljajo disaharidi in dekstran ali njih zmes z vsaj še enim higroskopskim ekscipientom; c) sušenje raztopine iz koraka b) z liofilizacijo ali pršnim sušenjem.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP12168968 | 2012-05-22 | ||
EP13730128.9A EP2852389B1 (en) | 2012-05-22 | 2013-05-22 | Compositions comprising short-acting benzodiazepines |
PCT/EP2013/060543 WO2013174883A1 (en) | 2012-05-22 | 2013-05-22 | Compositions comprising short-acting benzodiazepines |
Publications (1)
Publication Number | Publication Date |
---|---|
SI2852389T1 true SI2852389T1 (sl) | 2018-02-28 |
Family
ID=48669863
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
SI201330840T SI2852389T1 (sl) | 2012-05-22 | 2013-05-22 | Sestavki, obsegajoči kratkotrajno-delujoče benzodiazepine |
Country Status (42)
Families Citing this family (21)
Publication number | Priority date | Publication date | Assignee | Title |
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DE602007009128D1 (de) | 2006-07-10 | 2010-10-21 | Paion Uk Ltd | Benzodiazepinsalze mit kurzzeitwirkung und polymorphe formen davon |
EP2305647A1 (en) | 2009-09-18 | 2011-04-06 | PAION UK Limited | Process for preparing 3-[(4S)-8-bromo-1-methyl-6-(2-pyridinyl)-4 H-imidazo[1,2-a][1,4]benzodiazepine-4-yl] propionic acid methyl ester or the benzene sulfonate salt thereof, and compounds useful in that process |
EP2450039A1 (en) | 2010-11-08 | 2012-05-09 | PAION UK Ltd. | Dosing regimen for sedation with CNS 7056 (Remimazolam) |
AR094963A1 (es) | 2013-03-04 | 2015-09-09 | Ono Pharmaceutical Co | Reacción de oxidación excelente en el índice de conversión |
WO2015076340A1 (ja) * | 2013-11-21 | 2015-05-28 | 小野薬品工業株式会社 | 全身麻酔および/または鎮静のための注射用組成物 |
WO2015119510A1 (en) | 2014-02-10 | 2015-08-13 | Biolumic Limited | Improvements in and relating to controlling characteristics of photosynthetic organisms |
ES2807220T3 (es) | 2014-03-14 | 2021-02-22 | Biolumic Ltd | Método para mejorar el rendimiento y/o la resistencia al estrés de los cultivos |
WO2016011943A1 (zh) * | 2014-07-23 | 2016-01-28 | 李勤耕 | 新的苯并二氮杂䓬类衍生物及其用途 |
EP4091440A1 (en) | 2014-09-17 | 2022-11-23 | Biolumic Limited | Method of seed treatments and resulting products |
CN105726495B (zh) * | 2014-12-12 | 2019-03-29 | 宜昌人福药业有限责任公司 | 一种注射用短效苯并二氮杂卓盐药物组合物及其制备方法 |
CN107198691A (zh) * | 2016-03-17 | 2017-09-26 | 江苏恒瑞医药股份有限公司 | 一种瑞马唑仑的药物组合物 |
BR112018071082A2 (pt) * | 2016-04-14 | 2019-02-05 | Paion Uk Ltd | benzodiazepinas nasais e inaladas oralmente |
CN108289897B (zh) * | 2016-05-20 | 2020-07-28 | 江苏恒瑞医药股份有限公司 | 一种瑞马唑仑的药物组合物 |
CA3034739A1 (en) | 2016-08-22 | 2018-03-01 | Biolumic Limited | System, device and methods of seed treatment |
CN108503644B (zh) | 2016-12-09 | 2019-06-14 | 成都倍特药业有限公司 | 一种苯并二氮杂*衍生物的氢溴酸盐及其制备方法和用途 |
EP3714884A1 (en) | 2019-03-27 | 2020-09-30 | Paion UK Limited | Medical uses for benzodiazepines with a particular eeg pattern |
CN112209932B (zh) * | 2019-07-12 | 2023-03-24 | 成都倍特药业股份有限公司 | 一种化合物氢溴酸盐的新固体形态及其制备方法和用途 |
ES2803099B2 (es) | 2019-07-22 | 2021-11-08 | Moehs Iberica Sl | Procedimiento de obtención de besilato de remimazolam amorfo |
CN114478535B (zh) * | 2020-10-23 | 2024-02-09 | 成都苑东生物制药股份有限公司 | 一种苯磺酸瑞马唑仑ii晶型的制备方法 |
CN112462015B (zh) * | 2020-11-18 | 2022-07-12 | 海南倍特药业有限公司 | 一种氢溴酸瑞马唑仑细菌内毒素的检测方法 |
CN114624351B (zh) * | 2020-12-14 | 2024-04-09 | 宜昌人福药业有限责任公司 | 苯磺酸瑞马唑仑原料药中(r)-(-)-1-氨基-2-丙醇残留的分析方法 |
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2013
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- 2013-05-22 WO PCT/EP2013/060543 patent/WO2013174883A1/en active Application Filing
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- 2013-05-22 KR KR1020147036021A patent/KR102116737B1/ko active Protection Beyond IP Right Term
- 2013-05-22 NO NO13730128A patent/NO2852389T3/no unknown
- 2013-05-22 ES ES13730128.9T patent/ES2651389T3/es active Active
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- 2013-05-22 PE PE2014002207A patent/PE20150683A1/es active IP Right Grant
- 2013-05-22 AR ARP130101779A patent/AR092008A1/es not_active Application Discontinuation
- 2013-05-22 MA MA37581A patent/MA37581B1/fr unknown
- 2013-05-22 US US14/402,590 patent/US20150148338A1/en not_active Abandoned
- 2013-05-22 UA UAA201413655A patent/UA115063C2/uk unknown
- 2013-05-22 DK DK13730128.9T patent/DK2852389T3/en active
- 2013-05-22 LT LTEP13730128.9T patent/LT2852389T/lt unknown
- 2013-05-22 EP EP13730128.9A patent/EP2852389B1/en active Active
- 2013-05-22 CN CN201380036582.2A patent/CN104968348B/zh active Active
- 2013-05-22 CN CN201810206738.1A patent/CN108578413A/zh active Pending
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2014
- 2014-11-18 TN TN2014000479A patent/TN2014000479A1/fr unknown
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- 2014-11-19 IL IL235789A patent/IL235789B/en active IP Right Grant
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2015
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2017
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2021
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