HRP20230655T1 - Metode liječenja artritisa - Google Patents

Metode liječenja artritisa Download PDF

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Publication number
HRP20230655T1
HRP20230655T1 HRP20230655TT HRP20230655T HRP20230655T1 HR P20230655 T1 HRP20230655 T1 HR P20230655T1 HR P20230655T T HRP20230655T T HR P20230655TT HR P20230655 T HRP20230655 T HR P20230655T HR P20230655 T1 HRP20230655 T1 HR P20230655T1
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HR
Croatia
Prior art keywords
sustained
use according
release preparation
release
phospholipid
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HRP20230655TT
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English (en)
Inventor
Keelung Hong
Luke S.S. Guo
Yun-Long Tseng
Sheue-Fang Shih
Po-Chun Chang
Chih-Chiang Tsai
Hong-hui LIN
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Taiwan Liposome Company, Ltd.
Tlc Biopharmaceuticals, Inc.
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Application filed by Taiwan Liposome Company, Ltd., Tlc Biopharmaceuticals, Inc. filed Critical Taiwan Liposome Company, Ltd.
Publication of HRP20230655T1 publication Critical patent/HRP20230655T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • 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
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404Indoles, e.g. pindolol
    • A61K31/405Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/28Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/127Liposomes
    • 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
    • A61K9/19Particulate 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
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Rheumatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cell Biology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)

Claims (16)

1. Pripravak s produljenim otpuštanjem za uporabu u liječenju artritisa, koji sadrži: liposome; i jedno ili više terapijskih sredstava, naznačen time što liposomi sadrže mješavinu prvog fosfolipida i drugog fosfolipida i kolesterola, prvi fosfolipid je DOPC i drugi fosfolipid DOPG, pri čemu je molarni postotak DOPC:DOPG:kolesterola liposoma oko 56.25 do 72.5: 7.5 do 18.75 : 20 do 25, pri čemu su liposomi u vodenoj suspenziji, i pri čemu terapeutsko sredstvo nije kovalentno vezano na fosfolipid, i pripravak s produljenim otpuštanjem se intraartikularno ubrizgava u zglob subjekta kojem je potrebno liječenje artritisa.
2. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 1, naznačen time što je pripravak s produljenim otpuštanjem pripravljen rekonstitucijom lipidnog kolača koji je liofiliziran s vodenom otopinom koja sadrži navedeno jedno ili više terapijskih sredstava da se formira vodena suspenzija.
3. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 1, naznačen time što je pripravak za produljeno otpuštanje pripremljen rekonstitucijom liofilizirane kombinacije navedenog jednog ili više terapijskih sredstava i lipidnog kolača s vodenom otopinom da se dobije vodena suspenzija.
4. Pripravak s produljenim otpuštanjem za uporabu prema bilo kojem od zahtjeva 1 do 3, naznačen time što terapeutsko sredstvo sadrži otopinu steroida topljivu u vodi koja sadrži učinkovitu količinu steroida topljivog u vodi ili njegove farmaceutski prihvatljive soli.
5. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 4, naznačen time što je steroid topljiv u vodi deksametazon natrijev fosfat.
6. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 4, naznačen time što otopina steroida topljivog u vodi ima snagu koja je ekvivalentna dozi od oko 2 mg do oko 8 mg doze deksametazona.
7. Pripravak s produljenim otpuštanjem za uporabu prema bilo kojem od zahtjeva 1 do 3, naznačen time što terapeutsko sredstvo sadrži nesteroidni protuupalni lijek ili njegovu farmaceutski prihvatljivu sol.
8. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 7, naznačen time što je nesteroidni protuupalni lijek indometacin.
9. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 8, naznačen time što farmaceutski prihvatljiva sol indometacina je indometacin natrij.
10. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 8, naznačen time što je doza nesteroidnog protuupalnog lijeka 4.65 do 5 mg/ml.
11. Pripravak s produljenim otpuštanjem za uporabu prema bilo kojem od zahtjeva 1 do 3, naznačen time što terapeutsko sredstvo sadrži anti-reumatski lijek koji modificira bolest (DMARD).
12. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 11, naznačen time što DMARD sadrži antagonist TNF-α ili metotreksat.
13. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 12, naznačen time što je antagonist TNF-α etanercept ili Humira.
14. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 13, naznačen time što je doza etanercepta 42.8 mg/ml do 50 mg/ml.
15. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 12, naznačen time što je DMARD natrijev metotreksat.
16. Pripravak s produljenim otpuštanjem za uporabu prema zahtjevu 12, naznačen time što je doza metotreksata 2.3 do 2.5 mg/ml.
HRP20230655TT 2012-07-05 2013-07-05 Metode liječenja artritisa HRP20230655T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201261668446P 2012-07-05 2012-07-05
US201361791650P 2013-03-15 2013-03-15
EP13813286.5A EP2854769B1 (en) 2012-07-05 2013-07-05 Methods of treating arthritis
PCT/US2013/049442 WO2014008469A2 (en) 2012-07-05 2013-07-05 Methods of treating arthritis

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HRP20230655T1 true HRP20230655T1 (hr) 2023-10-13

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US (5) US9789062B2 (hr)
EP (1) EP2854769B1 (hr)
JP (2) JP6535281B2 (hr)
KR (2) KR102176971B1 (hr)
CN (1) CN105377238B (hr)
AU (1) AU2013286575B2 (hr)
BR (1) BR112015000174A2 (hr)
CA (1) CA2878152C (hr)
CY (1) CY1126136T1 (hr)
DK (1) DK2854769T3 (hr)
ES (1) ES2949093T3 (hr)
FI (1) FI2854769T3 (hr)
HK (1) HK1219414A1 (hr)
HR (1) HRP20230655T1 (hr)
HU (1) HUE062466T2 (hr)
LT (1) LT2854769T (hr)
NZ (1) NZ703532A (hr)
PL (1) PL2854769T3 (hr)
PT (1) PT2854769T (hr)
RU (1) RU2677658C2 (hr)
SG (2) SG11201408810TA (hr)
SI (1) SI2854769T1 (hr)
TW (1) TWI556838B (hr)
WO (1) WO2014008469A2 (hr)
ZA (1) ZA201500152B (hr)

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Publication number Publication date
AU2013286575A1 (en) 2015-02-26
EP2854769A2 (en) 2015-04-08
KR102176971B1 (ko) 2020-11-11
CY1126136T1 (el) 2023-11-15
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