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HRP20151021T1 - Formulacije na osnovi nalbufina i njihove uporabe - Google Patents

Formulacije na osnovi nalbufina i njihove uporabe Download PDF

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Publication number
HRP20151021T1
HRP20151021T1 HRP20151021TT HRP20151021T HRP20151021T1 HR P20151021 T1 HRP20151021 T1 HR P20151021T1 HR P20151021T T HRP20151021T T HR P20151021TT HR P20151021 T HRP20151021 T HR P20151021T HR P20151021 T1 HRP20151021 T1 HR P20151021T1
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HR
Croatia
Prior art keywords
nalbuphine
pharmaceutical formulation
oral pharmaceutical
povidone
hcl
Prior art date
Application number
HRP20151021TT
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English (en)
Inventor
Christophe Lebon
Pascal Suplie
David Olivier Paul
Original Assignee
Debregeas Et Associes Pharma
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43426302&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20151021(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Debregeas Et Associes Pharma filed Critical Debregeas Et Associes Pharma
Publication of HRP20151021T1 publication Critical patent/HRP20151021T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36Opioid-abuse
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Nutrition Science (AREA)
  • Inorganic Chemistry (AREA)
  • Physiology (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (7)

1. Oralna farmaceutska formulacija s trenutnim otpuštanjem, naznačena time, da je u obliku tablete od 30 mg, koja sadrži po masi: - 4,69 % nalbufina/HCl, - 54,58 % manitola, - 37,8 % povidona, - 2% krospovidona, - 0,10 % koloidne anhidridne silike, - 0,50 % natrijevog stearil-fumarata, - 0,33 % talka.
2. Oralna farmaceutska formulacija s trenutnim otpuštanjem, naznačena time, da je u obliku tablete od 30 mg, koja sadrži po masi: - 18,65 % nalbufina/HCl, - 48 % aglomeriranog α-laktoza-monohidrata (Tablettose® 80), - 14 % mikrokristalne celuloze (Avicel® PH200), - 4,50 % povidona, - 2,25% krospovidona, - 0,45 % koloidne anhidridne silike, - 0,45 % magnezijevog stearata, - 2,70 % talka, - 9 % Sepifilm® LP014.
3. Oralna farmaceutska formulacija s trenutnim otpuštanjem, naznačena time, da je u obliku tablete od 10 mg, koja sadrži po masi: - 11,86 % nalbufina/HCl, - 53,28 % aglomeriranog α-laktoza-monohidrata (Tablettose® 80), - 18,43 % mikrokristalne celuloze (Avicel® PH200), - 4,56 % povidona (PVP K30), - 0,46 % silike (Aerosil® 200), - 0,46 % magnezijevog stearata, - 1,83 % talka, - 9,13 % Sepifilm® LP014.
4. Oralna farmaceutska formulacija s trenutnim otpuštanjem, naznačena time, da je u obliku tablete od 50 mg, koja sadrži po masi: - 20,55 % nalbufina/HCl, - 22,02 % laktoze, - 47,53 % mikrokristalne celuloze (Avicel® PH200), - 4,98 % povidona (PVP CL), - 0,50 % magnezijevog stearata, - 3,98 % arome, - 0,44 % Sepifilm® IR777.
5. Oralna farmaceutska formulacija s trenutnim otpuštanjem, naznačena time, da je u obliku granulata od 10 mg, koji sadrži po masi: - 1,99 % nalbufina/HCl, - 27,80 % polietilen glikola (PEG 400), - 21,29 % magnezijevog aluminosilikata (Neusilin® UFL2), - 6,49 % povidona K30, - 0,50 % talka, - 3,69 % suklraloze (zaslađivača), - 29,20 % arome za maskiranje okusa, - 2,56 % okusa karamele, - 6,49 % Sepifilm® LP014.
6. Oralna farmaceutska formulacija s trenutnim otpuštanjem, naznačena time, da je u obliku tablete od 30 mg, koja sadrži po masi: - 20,31 % nalbufina/HCl, - 62,16 % aglomeriranog α-laktoza-monohidrata (Tablettose® 80), - 6,65 % povidona (PVP K30), - 2,38% krospovidona (Polyplasdone XL), - 1,76 % mikrokristalne celuloze (Avicel® PH200), - 0,10 % silike (Aerosil® 200), - 0,48 % magnezijevog stearata, - 1,92 % talka, - 4,81 % Sepifilm® LP014.
7. Oralna farmaceutska formulacija s trenutnim otpuštanjem, naznačena time, da ona odgovara prema bilo kojem od zahtjeva 1 do 6, te se takva upotrebljava u obradi bolova koji se generiraju putem liječenja ovisnosti od opijata.
HRP20151021TT 2010-08-20 2015-09-28 Formulacije na osnovi nalbufina i njihove uporabe HRP20151021T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR1056689A FR2963889B1 (fr) 2010-08-20 2010-08-20 Formulations a base de nalbuphine et leurs utilisations
PCT/FR2011/051929 WO2012022919A2 (fr) 2010-08-20 2011-08-18 Formulations à base de nalbuphine et leurs utilisations
EP11758519.0A EP2605757B1 (fr) 2010-08-20 2011-08-18 Formulations a base de nalbuphine et leurs utilisations

Publications (1)

Publication Number Publication Date
HRP20151021T1 true HRP20151021T1 (hr) 2015-11-06

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Application Number Title Priority Date Filing Date
HRP20151021TT HRP20151021T1 (hr) 2010-08-20 2015-09-28 Formulacije na osnovi nalbufina i njihove uporabe

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US (2) US20130123294A1 (hr)
EP (1) EP2605757B1 (hr)
JP (2) JP2013534242A (hr)
KR (1) KR101801424B1 (hr)
CN (1) CN103025317B (hr)
AR (1) AR082493A1 (hr)
AU (1) AU2011290614B2 (hr)
BR (1) BR112013004016A2 (hr)
CA (1) CA2804333C (hr)
CL (1) CL2013000477A1 (hr)
CY (1) CY1116729T1 (hr)
DK (1) DK2605757T3 (hr)
EA (1) EA024945B1 (hr)
ES (1) ES2548535T3 (hr)
FR (1) FR2963889B1 (hr)
HR (1) HRP20151021T1 (hr)
HU (1) HUE027664T2 (hr)
IL (1) IL224230A (hr)
MA (1) MA34484B1 (hr)
MX (1) MX354416B (hr)
NZ (1) NZ605469A (hr)
PH (1) PH12013500289A1 (hr)
PL (1) PL2605757T3 (hr)
PT (1) PT2605757E (hr)
RS (1) RS54244B1 (hr)
SG (1) SG187566A1 (hr)
SI (1) SI2605757T1 (hr)
SM (1) SMT201500257B (hr)
TW (1) TWI522100B (hr)
UA (1) UA110945C2 (hr)
WO (1) WO2012022919A2 (hr)

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Publication number Publication date
CN103025317A (zh) 2013-04-03
NZ605469A (en) 2015-01-30
PT2605757E (pt) 2015-10-19
HUE027664T2 (en) 2016-10-28
CA2804333A1 (fr) 2012-02-23
SG187566A1 (en) 2013-03-28
JP2016166230A (ja) 2016-09-15
WO2012022919A2 (fr) 2012-02-23
BR112013004016A2 (pt) 2016-06-28
FR2963889B1 (fr) 2013-04-12
UA110945C2 (uk) 2016-03-10
WO2012022919A3 (fr) 2012-05-10
AU2011290614B2 (en) 2015-11-19
EA024945B1 (ru) 2016-11-30
JP2013534242A (ja) 2013-09-02
MA34484B1 (fr) 2013-08-01
RS54244B1 (en) 2015-12-31
PH12013500289A1 (en) 2016-10-26
CL2013000477A1 (es) 2013-06-28
KR101801424B1 (ko) 2017-11-24
IL224230A (en) 2017-03-30
TWI522100B (zh) 2016-02-21
DK2605757T3 (en) 2015-10-05
MX2013001985A (es) 2013-05-09
AU2011290614A1 (en) 2013-01-31
EP2605757A2 (fr) 2013-06-26
CN103025317B (zh) 2016-08-17
PL2605757T3 (pl) 2015-12-31
EA201300258A1 (ru) 2013-06-28
TW201302198A (zh) 2013-01-16
US20160271124A1 (en) 2016-09-22
US20130123294A1 (en) 2013-05-16
FR2963889A1 (fr) 2012-02-24
KR20130099914A (ko) 2013-09-06
MX354416B (es) 2018-03-05
JP6173521B2 (ja) 2017-08-02
US10441585B2 (en) 2019-10-15
ES2548535T3 (es) 2015-10-19
EP2605757B1 (fr) 2015-07-01
AR082493A1 (es) 2012-12-12
SMT201500257B (it) 2016-01-08
SI2605757T1 (sl) 2015-11-30
CY1116729T1 (el) 2017-03-15
CA2804333C (fr) 2019-03-19

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