DK2968351T3 - Opioid receptormodulator-doseringsformuleringer - Google Patents
Opioid receptormodulator-doseringsformuleringer Download PDFInfo
- Publication number
- DK2968351T3 DK2968351T3 DK14774006.2T DK14774006T DK2968351T3 DK 2968351 T3 DK2968351 T3 DK 2968351T3 DK 14774006 T DK14774006 T DK 14774006T DK 2968351 T3 DK2968351 T3 DK 2968351T3
- Authority
- DK
- Denmark
- Prior art keywords
- amino
- phenyl
- pharmaceutically acceptable
- propionyl
- carbamoyl
- Prior art date
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
-
- 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
-
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/501—Inorganic compounds
-
- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
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)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Pain & Pain Management (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (12)
1. Fast farmaceutisk doseringsformulering der er en misbrugs-præventiv formulering omfattende fra ca. 5-20 vægtprocent 5-({[2-amino-3-(4-carbamoyl- 2,6-dimethyl-phenyl)-propionyl]-[l-(4-phenyl-lH-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoesyre, fra ca. 60-80 vægtprocent silificeret mikrokrystallinsk cellulose, fra ca. 0,45-1,0 vægtprocent kolloid silica, fra ca. 2-8 vægtprocent crospovidon, fra ca. 1-20 vægtprocent mannitol, og fra ca. 0,45-1 vægtprocent magnesiumstearat, hvor formuleringen eventuelt yderligere omfatter (i) en filmcoating, og/eller (ii) mindst én inert farmaceutisk excipiens valgt fra et farmaceutisk acceptabelt opløsningshastigheds-modificerende middel, et farmaceutisk acceptabelt blødgøringsmiddel, et farmaceutisk acceptabelt farvestof, et farmaceutisk acceptabelt opakiseringsmiddel, farmaceutisk acceptabel antioxidant, et farmaceutisk acceptabelt konserveringsmiddel, et smagsstof, et neutraliseringsmiddel, et buffermiddel og kombinationer deraf.
2. Fast farmaceutisk doseringsformulering ifølge krav 1, formuleret som en tablet eller som en kapsel.
3. Fast farmaceutisk doseringsformulering ifølge et hvilket som helst af de foregående krav, yderligere omfattende en filmcoating.
4. Fast farmaceutisk doseringsformulering ifølge krav 1, hvor den faste farmaceutiske doseringsformulering er en misbrugs præventiv, mono-fasisk farmaceutisk sammensætning egnet til enkeltdosisadministration til behandling af en tilstand medieret af en opioidreceptor bestående i det væsentlige af ca. 20 mg/dosis til ca. 200 mg/dosis af 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[l-(4-phenyl-lH-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxybenzoesyre, fra ca. 60-80 vægtprocent silificeret mikrokrystallinsk cellulose, fra ca. 0,55-0,95 vægtprocent kolloid silica, fra ca. 5-15 vægtprocent mannitol, fra ca. 3-7 vægtprocent crospovidon, og fra ca. 0,55-0,95 vægtprocent magnesiumstearat, hvor formuleringen eventuelt yderligere omfatter (i) en filmcoating, og/eller (ii) mindst én inert farmaceutisk excipiens valgt fra et farmaceutisk acceptabelt opløsningshastigheds-modificerende middel, et farmaceutisk acceptabelt blødgøringsmiddel, et farmaceutisk acceptabelt farvestof, et farmaceutisk acceptabelt opakiseringsmiddel, farmaceutisk acceptabel antioxidant, et farmaceutisk acceptabelt konserveringsmiddel, et smagsstof, et neutraliseringsmiddel, et buffermiddel og kombinationer deraf.
5. Fast farmaceutisk doseringsformulering ifølge krav 4, hvor den misbrugspræventive, mono-fasiske farmaceutisk sammensætning består i det væsentlige afca. 20 mg/dosis til ca. 200 mg/dosis af5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[l-(4-phenyl-lH-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoesyre, ca. 71 vægtprocent silificeret mikrokrystallinsk cellulose, ca. 0,75 vægtprocent kolloid silica, ca. 10 vægtprocent mannitol, ca. 5 vægtprocent crospovidon, og ca. 0,75 vægtprocent magnesiumstearat, hvor formuleringen eventuelt yderligere omfatter (i) en filmcoating, og/eller (ii) mindst én inert farmaceutisk excipiens valgt fra et farmaceutisk acceptabelt opløsningshastigheds-modificerende middel, et farmaceutisk acceptabelt blødgøringsmiddel, et farmaceutisk acceptabelt farvestof, et farmaceutisk acceptabelt opakiseringsmiddel, farmaceutisk acceptabelanti-oxidant, et farmaceutisk acceptabelt konserveringsmiddel, et smagsstof, et neutraliseringsmiddel, et buffermiddel og kombinationer deraf.
6. Fast farmaceutisk doseringsformulering ifølge et hvilket som helst af de foregående krav til anvendelse i en fremgangsmåde til behandling eller lindring af en tilstand medieret af en opioidreceptor omfattende administrering af den faste farmaceutisk doseringsformulering ifølge et hvilket som helst af de foregående krav til et individ med behov for en sådan behandling.
7. Fast farmaceutisk doseringsformulering til anvendelse ifølge krav 6, hvor administrationen omfatter administrering af 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[l-(4-phenyl-lH-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoesyre til individet i) mellem to administrationer pr. dag og otte administrationer pr. dag; eller ii) én gang daglig.
8. Fremgangsmåde til fremstilling af en fast farmaceutisk doseringsformulering ifølge et hvilket som helst af de foregående krav omfattende: i) blanding af 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[l-(4-phenyl-lH-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoesyre med silificeret mikrokrystallinsk cellulose, mannitol, kolloid silica og crospovidon; og ii) blanding af den tørre blanding til en fast doseringsformulering.
9. Misbrugs præventiv-, mono-fasisk farmaceutisk sammensætning egnet til enkeltdosisadministration til behandling afen tilstand medieret afen opioidreceptor bestående i det væsentlige af: ca. 75 mg 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]- [l-(4-phenyl-lH-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy- benzoesyre; ca. 426 mg silificeret mikrokrystallinsk cellulose; ca. 4,5mg kolloid silica; ca. 60 mg mannitol; ca. 30 mg crospovidon; og, ca. 4,5 mg ved vægt magnesiumstearat, hvor formuleringen eventuelt yderligere omfatter (i) en filmcoating, og/eller (ii) mindst én inert farmaceutisk excipiens valgt fra et farmaceutisk acceptabelt opløsningshastigheds-modificerende middel, et farmaceutisk acceptabelt blødgøringsmiddel, et farmaceutisk acceptabelt farvestof, et farmaceutisk acceptabelt opakiseringsmiddel, farmaceutisk acceptabel antioxidant, et farmaceutisk acceptabelt konserveringsmiddel, et smagsstof, et neutraliseringsmiddel, et buffermiddel og kombinationer deraf.
10. Misbrugs præventiv, mono-fasisk farmaceutisk sammensætning egnet til enkeltdosisadministration til behandling afen tilstand medieret afen opioidreceptor bestående i det væsentlige af: ca. 100 mg 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]- [l-(4-phenyl-lH-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy- benzoesyre; ca. 568 mg silificeret mikrokrystallinsk cellulose; ca. 6 mg kolloid silica; ca. 80 mg mannitol; ca. 40 mg crospovidon; og, ca. 6 mg ved vægt magnesiumstearat, hvor formuleringen eventuelt yderligere omfatter (i) en filmcoating, og/eller (ii) mindst én inert farmaceutisk excipiens valgt fra et farmaceutisk acceptabelt opløsningshastigheds-modificerende middel, et farmaceutisk acceptabelt blødgøringsmiddel, et farmaceutisk acceptabelt farvestof, et farmaceutisk acceptabelt opakiseringsmiddel, farmaceutisk acceptabel antioxidant, et farmaceutisk acceptabelt konserveringsmiddel, et smagsstof, et neutraliseringsmiddel, et buffermiddel og kombinationer deraf.
11. Fast farmaceutisk doseringsformulering ifølge et hvilket som helst af kravene 1-5 og 9-10, hvor formuleringen omfatter en filmcoating der er en vand-opløselig, pH-uafhængig filmcoating.
12. Fast farmaceutisk doseringsformulering ifølge et hvilket som helst af kravene 1-5 og 9-11, hvor formuleringen omfatter en filmcoating der er udgør ca. 3 vægtprocent af den farmaceutiske sammensætning.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US13/829,984 US9675587B2 (en) | 2013-03-14 | 2013-03-14 | Opioid receptor modulator dosage formulations |
| PCT/US2014/022666 WO2014159245A1 (en) | 2013-03-14 | 2014-03-10 | Opioid receptor modulator dosage formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2968351T3 true DK2968351T3 (da) | 2018-11-26 |
Family
ID=51528071
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK14774006.2T DK2968351T3 (da) | 2013-03-14 | 2014-03-10 | Opioid receptormodulator-doseringsformuleringer |
Country Status (20)
| Country | Link |
|---|---|
| US (9) | US9675587B2 (da) |
| EP (3) | EP2968351B1 (da) |
| JP (2) | JP6449225B2 (da) |
| KR (1) | KR102435440B1 (da) |
| CN (2) | CN105228629A (da) |
| AU (1) | AU2014241076B2 (da) |
| BR (1) | BR112015022753A8 (da) |
| CA (2) | CA3254178A1 (da) |
| CY (1) | CY1120892T1 (da) |
| DK (1) | DK2968351T3 (da) |
| EA (1) | EA031559B1 (da) |
| ES (1) | ES2693374T3 (da) |
| HU (1) | HUE042748T2 (da) |
| IL (2) | IL241561B (da) |
| PL (1) | PL2968351T3 (da) |
| PT (1) | PT2968351T (da) |
| SI (1) | SI2968351T1 (da) |
| TR (1) | TR201815953T4 (da) |
| TW (1) | TWI648071B (da) |
| WO (1) | WO2014159245A1 (da) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9675587B2 (en) | 2013-03-14 | 2017-06-13 | Allergan Holdings Unlimited Company | Opioid receptor modulator dosage formulations |
| MX2017014987A (es) * | 2015-05-22 | 2018-04-13 | Novartis Ag | Composiciones farmaceuticas. |
| CN105250232B (zh) * | 2015-09-29 | 2018-08-14 | 江苏汇智知识产权服务有限公司 | 一种伊卢多啉肠溶片及其制备方法 |
| WO2018055528A2 (en) * | 2016-09-20 | 2018-03-29 | Sun Pharmaceutical Industries Limited | Processes for the preparation of eluxadoline |
| WO2018069770A1 (en) * | 2016-10-14 | 2018-04-19 | Allergan Holdings Unlimited Company | Methods of treatment using eluxadoline |
| US12285411B2 (en) * | 2019-09-10 | 2025-04-29 | Aurobindo Pharma Ltd | Pharmaceutical composition comprising eluxadoline, process of preparation and use thereof |
| CA3166250A1 (en) | 2020-02-05 | 2021-08-12 | Gregory G. Plucinski | Drug products for intranasal administration and uses thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US553266A (en) | 1896-01-21 | Car-fender | ||
| US3980766A (en) | 1973-08-13 | 1976-09-14 | West Laboratories, Inc. | Orally administered drug composition for therapy in the treatment of narcotic drug addiction |
| JP2711759B2 (ja) | 1990-10-24 | 1998-02-10 | エスエス製薬 株式会社 | 止瀉剤組成物 |
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| US12285411B2 (en) | 2019-09-10 | 2025-04-29 | Aurobindo Pharma Ltd | Pharmaceutical composition comprising eluxadoline, process of preparation and use thereof |
| US20220016034A1 (en) | 2020-07-17 | 2022-01-20 | Allergan Holdings Unlimited Company | Opioid receptor modulator dosage formulations |
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2013
- 2013-03-14 US US13/829,984 patent/US9675587B2/en active Active
-
2014
- 2014-02-26 TW TW103106575A patent/TWI648071B/zh not_active IP Right Cessation
- 2014-03-10 KR KR1020157028735A patent/KR102435440B1/ko active Active
- 2014-03-10 HU HUE14774006A patent/HUE042748T2/hu unknown
- 2014-03-10 SI SI201430934T patent/SI2968351T1/sl unknown
- 2014-03-10 BR BR112015022753A patent/BR112015022753A8/pt not_active Application Discontinuation
- 2014-03-10 ES ES14774006.2T patent/ES2693374T3/es active Active
- 2014-03-10 EP EP14774006.2A patent/EP2968351B1/en active Active
- 2014-03-10 EP EP20215626.1A patent/EP3865131A1/en not_active Withdrawn
- 2014-03-10 CA CA3254178A patent/CA3254178A1/en active Pending
- 2014-03-10 CN CN201480026522.7A patent/CN105228629A/zh active Pending
- 2014-03-10 CN CN201911036853.XA patent/CN110917159A/zh active Pending
- 2014-03-10 AU AU2014241076A patent/AU2014241076B2/en not_active Ceased
- 2014-03-10 EA EA201591768A patent/EA031559B1/ru not_active IP Right Cessation
- 2014-03-10 EP EP18187598.0A patent/EP3456321A1/en not_active Withdrawn
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- 2014-03-10 JP JP2016501031A patent/JP6449225B2/ja not_active Expired - Fee Related
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- 2014-03-10 WO PCT/US2014/022666 patent/WO2014159245A1/en not_active Ceased
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2015
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