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HRP20210025T1 - Farmaceutske kompozicije koje sadrže levodop, inhibitor dopaminske dekarboksilaze i komt inhibitor i metoda administracije istih - Google Patents

Farmaceutske kompozicije koje sadrže levodop, inhibitor dopaminske dekarboksilaze i komt inhibitor i metoda administracije istih Download PDF

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Publication number
HRP20210025T1
HRP20210025T1 HRP20210025TT HRP20210025T HRP20210025T1 HR P20210025 T1 HRP20210025 T1 HR P20210025T1 HR P20210025T T HRP20210025T T HR P20210025TT HR P20210025 T HRP20210025 T HR P20210025T HR P20210025 T1 HRP20210025 T1 HR P20210025T1
Authority
HR
Croatia
Prior art keywords
inhibitor
gel composition
composition according
komt
levodopa
Prior art date
Application number
HRP20210025TT
Other languages
English (en)
Inventor
Roger BOLSÖY
Original Assignee
Lobsor Pharmaceuticals Aktiebolag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from SE1451034A external-priority patent/SE538425C2/en
Application filed by Lobsor Pharmaceuticals Aktiebolag filed Critical Lobsor Pharmaceuticals Aktiebolag
Publication of HRP20210025T1 publication Critical patent/HRP20210025T1/hr

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Classifications

    • 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
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/275Nitriles; Isonitriles
    • A61K31/277Nitriles; Isonitriles having a ring, e.g. verapamil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K9/0012Galenical 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
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Landscapes

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

Claims (14)

1. Farmaceutska gel kompozicija za intra-intestinalnu administraciju, koja sadrži agens za zamjenu dopamina izabran od levodopa, melevodopa, etilevodopa i njihovih kombinacija, inhibitor dopaminske dekarboksilaze (IDD) pri čemu je inhibitor dopaminske dekarboksilaze karbidopa, a katehol-O-metiltransferazni (KOMT) inhibitor izabran od entakapona, tolkapona, opikapona i njihovih kombinacija.
2. Farmaceutska gel kompozicija iz patentnog zahtjeva 1, pri čemu je levodop agens za zamjenu dopamina i poželjno pri čemu je maseni odnos KOMT inhibitora prema levodopu oko 10:1 do oko 2:1, ili 5:1 do 3:1.
3. Farmaceutska gel kompozicija prema patentnim zahtjevima 1-2, pri čemu entakapon je KOMT inhibitor.
4. Farmaceutska gel kompozicija prema bilo kojem od patentnih zahtjeva 1 do 3, pri čemu gel kompozicija ima pH vrijednost jednaku ili nižu od oko 5.7, poželjno od oko 4.5 do oko 5.5.
5. Farmaceutska gel kompozicija prema bilo kojem od patentnih zahtjeva 1 do 4, pri čemu gel kompozicija dalje sadrži antioksidans.
6. Farmaceutska gel kompozicija prema patentnom zahtjevu 5, pri čemu askorbinska kiselina ili limunska kiselina je antioksidans.
7. Farmaceutska gel kompozicija prema bilo kojem od patentnih zahtjeva 1 do 6, pri čemu su levodop, IDD i KOMT inhibitor u formi čestica; čestice su suspendirane u vodenom nosaču, i imaju veličinu čestica ne veću od 80 µm; i nosač ima viskozitet od najmanje 300 mPas pri umjerenoj brzini smicanja.
8. Farmaceutska gel kompozicija prema patentnom zahtjevu 7, pri čemu je nosač polisaharid izabran iz grupe koja se sastoji od celuloze, metil celuloze, etil celuloze, karboksmetil celuloze, njihovih soli, i njihovih kombinacija.
9. Farmaceutska gel kompozicija prema bilo kojem od patentnih zahtjeva 1 do 8, pri čemu gel kompozicija sadrži oko 1.0 do oko 15 % (m/m) mikroniziranog levodopa, oko 0.1 do oko 2.0 % (m/m) mikroniziranog karbidopa, oko 1.0 do oko 5.0 % (m/m) mikroniziranog entakapona, i oko 1.0 do oko 7.5 % (m/m) natrij karboksmetil celuloze.
10. Farmaceutska gel kompozicija prema bilo kojem od patentnih zahtjeva 7 do 9, pri čemu je pH vrijednost gela veća od oko 5.0 i viskozitet vodenog nosača nakon 12 dana na 25°C je najmanje oko 300 mPas pri umjerenoj brzini smicanja.
11. Farmaceutska gel kompozicija prema patentnom zahtjevu 2, pri čemu je maseni odnos inhibitora dopaminske dekarboksilaze naspram levodopa oko 1:10 do oko 1:2, ili oko 1:5 do oko 1:3.
12. Farmaceutska gel kompozicija prema patentnom zahtjevu 2, pri čemu kompozicija sadrži najmanje oko 10 mg/ml levodopa, najmanje oko 2.5 mg/ml inhibitora dopaminske dekarboksilaze, i najmanje oko 10 mg/ml KOMT inhibitora.
13. Farmaceutska gel kompozicija prema patentnom zahtjevu 1 za intra-intestinalnu administraciju koja sadrži levodopu, inhibitor dopaminske dekarboksilaze i KOMT inhibitor, pri čemu je maseni odnos KOMT inhibitora naspram inhibitora dopaminske dekarboksilaze oko 10:1 do oko 2:1, ili oko 5:1 do oko 3:1.
14. Metoda za produžavanje roka trajanja farmaceutskog gela koja obuhvaća: osiguravanje prvog gela koji sadrži levodop i inhibitor dopaminske dekarboksilaze; i - uključivanje KOMT inhibitora u prvi gel; pri čemu karbidop je inhibitor dopaminske dekarboksilaze, a katehol-O-metiltransferazni (KOMT) inhibitor je izabran od entakapona, tolkapona, opikapona i njihovih kombinacija.
HRP20210025TT 2014-09-04 2021-01-07 Farmaceutske kompozicije koje sadrže levodop, inhibitor dopaminske dekarboksilaze i komt inhibitor i metoda administracije istih HRP20210025T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
SE1451034A SE538425C2 (en) 2014-09-04 2014-09-04 Pharmaceutical compositions comprising levodopa, carbidopa and a comt inhibitor and method of administration thereof
SE1550344 2015-03-24
EP15838800.9A EP3188725B1 (en) 2014-09-04 2015-09-04 Pharmaceutical compositions comprising levodopa, a dopamine decarboxylase inhibitor and a comt inhibitor and method of administration thereof
PCT/SE2015/050939 WO2016036308A1 (en) 2014-09-04 2015-09-04 Pharmaceutical compositions comprising levodopa, a dopamine decarboxylase inhibitor and a comt inhibitor and method of administration thereof

Publications (1)

Publication Number Publication Date
HRP20210025T1 true HRP20210025T1 (hr) 2021-03-05

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20240314TT HRP20240314T1 (hr) 2014-09-04 2015-09-04 Farmaceutske gel kompozicije koje sadrže levodopu, karbidopu i entakapon
HRP20210025TT HRP20210025T1 (hr) 2014-09-04 2021-01-07 Farmaceutske kompozicije koje sadrže levodop, inhibitor dopaminske dekarboksilaze i komt inhibitor i metoda administracije istih

Family Applications Before (1)

Application Number Title Priority Date Filing Date
HRP20240314TT HRP20240314T1 (hr) 2014-09-04 2015-09-04 Farmaceutske gel kompozicije koje sadrže levodopu, karbidopu i entakapon

Country Status (16)

Country Link
US (4) US10071069B2 (hr)
EP (3) EP3782617B1 (hr)
JP (2) JP6622310B2 (hr)
CN (1) CN107072973A (hr)
AU (3) AU2015312430B2 (hr)
CA (2) CA2959307C (hr)
DK (2) DK3782617T3 (hr)
ES (2) ES2844500T3 (hr)
FI (1) FI3782617T3 (hr)
HR (2) HRP20240314T1 (hr)
HU (2) HUE052857T2 (hr)
PL (2) PL3782617T3 (hr)
PT (2) PT3188725T (hr)
RS (1) RS65337B1 (hr)
SI (2) SI3782617T1 (hr)
WO (1) WO2016036308A1 (hr)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2844500T3 (es) 2014-09-04 2021-07-22 Lobsor Pharmaceuticals Ab Composiciones farmacéuticas que comprenden levodopa, un inhibidor de dopamina decarboxilasa y un inhibidor de COMT, y método de administración de las mismas
JP2018500300A (ja) * 2014-11-28 2018-01-11 ノヴィファーマ,エス.アー. パーキンソン病を遅延させるための医薬
CN113197851A (zh) 2015-05-06 2021-08-03 辛纳吉勒公司 包含药物粒子的药用悬浮液、用于其配给的装置、以及其使用方法
US10555922B2 (en) 2015-09-04 2020-02-11 Lobsor Pharmaceuticals Aktiebolag Method of treating a dopamine related disorder in a subject by administering levodopa, in combination with a dopamine decarboxylase inhibitor and a catechol-o-methyltransferase inhibitor
WO2017177262A1 (en) * 2016-04-11 2017-10-19 University Of Canberra Ophthalmic compositions comprising levodopa, an antioxidant and an aqueous carrier
AU2017299710A1 (en) * 2016-07-20 2019-01-31 Abbvie Inc. Levodopa and carbidopa intestinal gel and methods of use
EP3275433A1 (en) * 2016-07-29 2018-01-31 Som Innovation Biotech S.L. Sustained release composition comprising micronized tolcapone
UA124124C2 (uk) * 2017-02-13 2021-07-21 Баєр Енімал Хелс Гмбх Рідка композиція, що містить прадофлоксацин
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ES2844500T3 (es) 2014-09-04 2021-07-22 Lobsor Pharmaceuticals Ab Composiciones farmacéuticas que comprenden levodopa, un inhibidor de dopamina decarboxilasa y un inhibidor de COMT, y método de administración de las mismas
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Also Published As

Publication number Publication date
AU2022200291B2 (en) 2024-01-25
ES2973289T3 (es) 2024-06-19
US20170231937A1 (en) 2017-08-17
EP3782617A1 (en) 2021-02-24
HRP20240314T1 (hr) 2024-05-24
DK3782617T3 (da) 2024-03-04
EP4356907A1 (en) 2024-04-24
US20220362193A1 (en) 2022-11-17
JP6622310B2 (ja) 2019-12-18
DK3188725T3 (da) 2021-01-18
US11413262B2 (en) 2022-08-16
EP3188725B1 (en) 2020-10-28
AU2020239682B2 (en) 2021-12-23
PT3782617T (pt) 2024-02-29
PL3188725T3 (pl) 2021-08-02
PL3782617T3 (pl) 2024-06-24
EP3782617B1 (en) 2024-01-03
FI3782617T3 (fi) 2024-03-13
SI3188725T1 (sl) 2021-04-30
US20180338944A1 (en) 2018-11-29
HUE052857T2 (hu) 2021-05-28
AU2015312430B2 (en) 2020-06-25
US20210023033A1 (en) 2021-01-28
CA3175785A1 (en) 2016-03-10
AU2020239682A1 (en) 2020-10-15
RS65337B1 (sr) 2024-04-30
AU2015312430A1 (en) 2017-03-30
PT3188725T (pt) 2021-01-27
EP3188725A1 (en) 2017-07-12
AU2022200291A1 (en) 2022-02-10
JP2017527623A (ja) 2017-09-21
US10786472B2 (en) 2020-09-29
CA2959307A1 (en) 2016-03-10
ES2844500T3 (es) 2021-07-22
JP2020045353A (ja) 2020-03-26
JP6889231B2 (ja) 2021-06-18
HUE066097T2 (hu) 2024-07-28
CA2959307C (en) 2023-03-28
SI3782617T1 (sl) 2024-04-30
WO2016036308A1 (en) 2016-03-10
EP3188725A4 (en) 2018-04-25
US10071069B2 (en) 2018-09-11
CN107072973A (zh) 2017-08-18

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