HRP20200055T1 - Eutektičke formulacije ciklobenzaprin-klorovodika i manitola - Google Patents

Eutektičke formulacije ciklobenzaprin-klorovodika i manitola Download PDF

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Publication number
HRP20200055T1
HRP20200055T1 HRP20200055TT HRP20200055T HRP20200055T1 HR P20200055 T1 HRP20200055 T1 HR P20200055T1 HR P20200055T T HRP20200055T T HR P20200055TT HR P20200055 T HRP20200055 T HR P20200055T HR P20200055 T1 HRP20200055 T1 HR P20200055T1
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Croatia
Prior art keywords
mannitol
cyclobenzaprine
hydrochloride
eutectic
optionally
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HRP20200055TT
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English (en)
Inventor
Marino Nebuloni
Patrizia COLOMBO
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Tonix Pharma Holdings Limited
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Application filed by Tonix Pharma Holdings Limited filed Critical Tonix Pharma Holdings Limited
Publication of HRP20200055T1 publication Critical patent/HRP20200055T1/hr

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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
    • 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
    • A61K47/06—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
    • A61K9/14—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
    • 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
    • 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
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • 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
    • 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
    • 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]
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
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    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Anesthesiology (AREA)
  • Rheumatology (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)

Claims (14)

1. Farmaceutski sastav, naznačen time, da obuhvaća eutektik od manitola i ciklobenzaprin-klorovodika.
2. Farmaceutski sastav prema zahtjevu 1, naznačen time, da obuhvaća eutektik od 75% ± 2% ciklobenzaprin-klorovodika i od 25% ± 2% manitola.
3. Farmaceutski sastav prema zahtjevu 1, naznačen time, da eutektički molarni omjer ciklobenzaprin-klorovodika prema manitolu iznosi 1,76 ± 0,1.
4. Farmaceutski sastav prema zahtjevu 1, naznačen time, da manitol u eutektiku je β manitol, opcionalno gdje se eutektik tali na 143,6 ± 3 °C; ili time, da je manitol u eutektiku δ manitol, opcionalno gdje se eutektik tali na 134 ± 3 °C.
5. Farmaceutski sastav prema bilo kojem od patentnih zahtjeva 1-4, naznačen time, da ciklobenzaprin-klorovodik je mikronizirani ciklobenzaprin-klorovodik.
6. Farmaceutski sastav prema bilo kojem od patentnih zahtjeva 1-5, naznačen time, da dalje obuhvaća alkalizacijsko sredstvo, opcionalno gdje je alkalizacijsko sredstvo K2HPO4, ili gdje je alkalizacijsko sredstvo Na2HPO4, ili gdje je alkalizacijsko sredstvo bezvodni trinatrijev citrat.
7. Postupak proizvodnje farmaceutskg sastava, naznačen time, da obuhvaća eutektik od manitola i ciklobenzaprin-klorovodika u skladu s bilo kojim od patentnih zahtjeva 1-6, gdje navedeni postupak obuhvaća sljedeće: miješanje ciklobenzaprin-klorovodika i manitola, ili mljevenje ciklobenzaprin-klorovodika i manitola, ili sušenje raspršivanjem ciklobenzaprin-klorovodika i manitola.
8. Postupak prema patentnom zahtjevu 7, naznačen time, da obuhvaća mljevenje ciklobenzaprin-klorovodika i manitola, opcionalno s time, da se ciklobenzaprin-klorovodik i manitol melju u granulatoru velike brzine.
9. Postupak prema patentnom zahtjevu 7, naznačen time, da obuhvaća miješanje ciklobenzaprin-klorovodika i manitola, opcionalno s time, da se ciklobenzaprin-klorovodik i manitol miješaju putem kompresije, poželjno gdje se ciklobenzaprin-klorovodik i manitol komprimiraju preko sabijanja valjcima.
10. Postupak prema patentnom zahtjevu 7, naznačen time, da obuhvaća sušenje raspršivanjem ciklobenzaprin-klorovodika i manitola.
11. Postupak prema bilo kojem od patentnih zahtjeva 7-10, naznačen time, da ciklobenzaprin-klorovodik je mikronizirani ciklobenzaprin-klorovodik.
12. Postupak prema bilo kojem od patentnih zahtjeva 7-11, naznačen time, da farmaceutsko sredstvo obuhvaća alkalizacijsko sredstvo, opcionalno gdje je alkalizacijsko sredstvo K2HPO4, ili gdje je alkalizacijsko sredstvo Na2HPO4, ili gdje je alkalizacijsko sredstvo bezvodni trinatrijev citrat.
13. Postupak prema bilo kojem od patentnih zahtjeva 7-12, naznačen time, da eutektik obuhvaća β manitol, opcionalno gdje se eutektik tali na 143,6 ± 3 °C; ili time, da eutektik obuhvaća δ manitol, opcionalno gdje se eutektik tali na 134 ± 3 °C.
14. Postupak prema patentnom zahtjevu 13, naznačen time, da eutektik obuhvaća β manitol, opcionalno gdje se eutektik tali na 143,6 ± 3 °C.
HRP20200055TT 2013-03-15 2014-03-14 Eutektičke formulacije ciklobenzaprin-klorovodika i manitola HRP20200055T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361792757P 2013-03-15 2013-03-15
EP14762323.5A EP2968992B8 (en) 2013-03-15 2014-03-14 Eutectic formulations of cyclobenzaprine hydrochloride and mannitol
PCT/US2014/029872 WO2014145156A2 (en) 2013-03-15 2014-03-14 Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride

Publications (1)

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HRP20200055T1 true HRP20200055T1 (hr) 2020-04-03

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Application Number Title Priority Date Filing Date
HRP20240648TT HRP20240648T1 (hr) 2013-03-15 2014-03-14 Eutektičke formulacije ciklobenzaprin hidroklorida i manitola
HRP20200055TT HRP20200055T1 (hr) 2013-03-15 2014-03-14 Eutektičke formulacije ciklobenzaprin-klorovodika i manitola

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HRP20240648TT HRP20240648T1 (hr) 2013-03-15 2014-03-14 Eutektičke formulacije ciklobenzaprin hidroklorida i manitola

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US (11) US9636408B2 (hr)
EP (2) EP3650081B1 (hr)
JP (5) JP6310542B2 (hr)
CN (2) CN105142730B (hr)
AU (1) AU2014233277B2 (hr)
BR (1) BR112015022095B1 (hr)
CA (2) CA3119755C (hr)
CY (1) CY1122740T1 (hr)
DK (2) DK3650081T3 (hr)
ES (2) ES2769879T3 (hr)
FI (1) FI3650081T3 (hr)
HR (2) HRP20240648T1 (hr)
HU (2) HUE066883T2 (hr)
IL (1) IL241353B (hr)
LT (2) LT3650081T (hr)
MX (2) MX388137B (hr)
MY (1) MY196014A (hr)
NZ (2) NZ747040A (hr)
PL (2) PL2968992T3 (hr)
PT (2) PT3650081T (hr)
RS (2) RS60015B1 (hr)
SA (1) SA515361124B1 (hr)
SG (2) SG11201507124XA (hr)
SI (2) SI3650081T1 (hr)
SM (2) SMT202400324T1 (hr)
TW (2) TWI661825B (hr)
WO (1) WO2014145156A2 (hr)

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