HRP20211040T1 - Poticanje apetita, upravljanje gubitkom težine, i liječenje anoreksije kod pasa i mačaka - Google Patents

Poticanje apetita, upravljanje gubitkom težine, i liječenje anoreksije kod pasa i mačaka Download PDF

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HRP20211040T1
HRP20211040T1 HRP20211040TT HRP20211040T HRP20211040T1 HR P20211040 T1 HRP20211040 T1 HR P20211040T1 HR P20211040T T HRP20211040T T HR P20211040TT HR P20211040 T HRP20211040 T HR P20211040T HR P20211040 T1 HRP20211040 T1 HR P20211040T1
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polyethylene glycol
flo
dry
formulation
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William BUHLES
Richard CORTEZ
Kristin MAAS
Geeta Srivastava
Daniel Perez
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Dechra Limited
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    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A61K9/0017—Non-human animal skin, e.g. pour-on, spot-on
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • 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
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • 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
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nutrition Science (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
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Claims (13)

1. Farmaceutska formulacija, naznačena time, da je za uporabu u liječenju anoreksije i/ili u upravljanju gubitkom težine zbog starosti ili bolesti kod pasa i mačaka, gdje navedena formulacija sadrži terapijski učinkovitu dozu mirtazapina za topikalnu primjenu putem transdermalne apsorpcije, pri čemu navedena formulacija sadrži 0,2-4% po masi mirtazapina, 20-80% po masi polietilen glikola, najmanje 25% po masi smjese od pojačivača prodiranja i sredstava za otapanje, 0,5-3% polidimetilsiloksanskog fluida, i 1-4% po masi polimetilsilsekvioksana škroba tapioke (Dry-Flo TS) ili aluminijevog škrobnog oktenilsukcinata (Dry-Flo AF).
2. Farmaceutska formulacija za uporabu prema patentnom zahtjevu 1, naznačena time, da navedena formulacija jest pomada.
3. Farmaceutska formulacija za uporabu prema patentnom zahtjevu 1 ili zahtjevu 2, naznačena time, da se bira iz skupine koju čine: (a) Formulacija G koja sadrži mirtazapin s 2% po masi, polietilen glikol 400 s 40% po masi, polietilen glikol 3350 s 20% po masi, C12-15 alkoholni laktat s 3,5% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, i aluminijev škrobni oktenilsukcinat (Dry-Flo AF) s 2,5% po masi, (b) Formulacija H koja uključuje Dry-Flo AF i sadrži mirtazapin s 4% po masi, polietilen glikol 400 s 40% po masi, polietilen glikol 3350 s 20% po masi, C12-15 alkoholni laktat s 1,5% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, i aluminijev škrobni oktenilsukcinat (Dry-Flo AF) s 2,5% po masi, (c) Formulacija H koja uključuje Dry-Flo TS i sadrži mirtazapin s 4% po masi, polietilen glikol 400 s 40% po masi, polietilen glikol 3350 s 20% po masi, C12-15 alkoholni laktat s 1,5% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, i polimetilsilsekvioksan škroba tapioke (Dry-Flo TS) s 2,5% po masi, (d) Formulacija O koja sadrži mirtazapin s 2% po masi, polietilen glikol 400 s 40% po masi, polietilen glikol 3350 s 20% po masi, C12-15 alkoholni laktat s 3,49% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, aluminijev škrobni oktenilsukcinat (Dry-Flo AF) ili polimetilsilsekvioksan škroba tapioke (Dry-Flo TS) s 2,5% po masi, i butilirani hidroksitoluen s 0,01% po masi, (e) Formulacija T koja uključuje Dry-Flo AF i sadrži mirtazapin s 2% po masi, polietilen glikol 400 s 42,01% po masi, polietilen glikol 3350 s 21,48% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, aluminijev škrobni oktenilsukcinat (Dry-Flo AF) s 2,5% po masi, i butilirani hidroksitoluen s 0,01% po masi, i (f) Formulacija T koja uključuje Dry-Flo TS i sadrži mirtazapin s 2% po masi, polietilen glikol 400 s 42,01% po masi, polietilen glikol 3350 s 21,48% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, polimetilsilsekvioksan škroba tapioke (Dry-Flo TS) s 2,5% po masi, i butilirani hidroksitoluen s 0,01% po masi.
4. Farmaceutska formulacija za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, da se formulacija nudi u spremniku koji štiti formulaciju od vlage, zraka i/ili svjetla, i time, da je spremnik takav uređaj koji je osposobljen za doziranje volumena ljekovitog proizvoda u rasponu između 0,05 i 2,0 ml ponavljano i dosljedno putem aktiviranja uređaja od strane korisnika.
5. Pomada, naznačena time, da je za uporabu u liječenju anoreksije i/ili u upravljanju gubitkom težine zbog starosti ili bolesti kod psa ili mačke, pri čemu ona sadrži terapijski učinkovitu dozu mirtazapina za topikalnu primjenu putem transdermalne apsorpcije na koži psa ili mačke, pri čemu formulacija sadrži 0,2-4% po masi mirtazapina, 20-80% po masi polietilen glikola, najmanje 25% po masi smjese od pojačivača prodiranja i sredstava za otapanje, 0,5-3% polidimetilsiloksanskog fluida, 1-4% po masi polimetilsilsekvioksana škroba tapioke (Dry-Flo TS) ili aluminijevog škrobnog oktenilsukcinata (Dry-Flo AF).
6. Pomada za uporabu prema patentnom zahtjevu 5, naznačena time, da je za davanje mirtazapina u jednostrukoj dnevnoj dozi u rasponu od 0,05 do 2 mg/kg težine psa ili mačke.
7. Pomada za uporabu prema patentnom zahtjevu 5 ili zahtjevu 6, naznačena time, da je pomada za nanošenje u volumenu od 0,05 do 2,0 ml po dozi.
8. Pomada za uporabu prema bilo kojem od patentnih zahtjeva 5 do 7, naznačena time, da je pomada za davanje doze između 0,2 i 5 mg za jednu mačku, ili između 0,5 i 50 mg za jednog psa.
9. Pomada za uporabu prema bilo kojem od patentnih zahtjeva 5 do 8, naznačena time, da je pomada za nanošenje na ušku.
10. Pomada za uporabu prema bilo kojem od patentnih zahtjeva 5 do 9, naznačena time, da se pomada bira iz skupine koju čine: (a) Formulacija G koja sadrži mirtazapin s 2% po masi, polietilen glikol 400 s 40% po masi, polietilen glikol 3350 s 20% po masi, C12-15 alkoholni laktat s 3,5% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, i aluminijev škrobni oktenilsukcinat (Dry-Flo AF) s 2,5% po masi, (b) Formulacija H koja uključuje Dry-Flo AF i sadrži mirtazapin s 4% po masi, polietilen glikol 400 s 40% po masi, polietilen glikol 3350 s 20% po masi, C12-15 alkoholni laktat s 1,5% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, i aluminijev škrobni oktenilsukcinat (Dry-Flo AF) s 2,5% po masi, (c) Formulacija H koja uključuje Dry-Flo TS i sadrži mirtazapin s 4% po masi, polietilen glikol 400 s 40% po masi, polietilen glikol 3350 s 20% po masi, C12-15 alkoholni laktat s 1,5% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, i polimetilsilsekvioksan škroba tapioke (Dry-Flo TS) s 2,5% po masi, (d) Formulacija O koja sadrži mirtazapin s 2% po masi, polietilen glikol 400 s 40% po masi, polietilen glikol 3350 s 20% po masi, C12-15 alkoholni laktat s 3,49% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, aluminijev škrobni oktenilsukcinat (Dry-Flo AF) ili polimetilsilsekvioksan škroba tapioke (Dry-Flo TS) s 2,5% po masi, i butilirani hidroksitoluen s 0,01% po masi, (e) Formulacija T koja uključuje Dry-Flo AF i sadrži mirtazapin s 2% po masi, polietilen glikol 400 s 42,01% po masi, polietilen glikol 3350 s 21,48% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, aluminijev škrobni oktenilsukcinat (Dry-Flo AF) s 2,5% po masi, i butilirani hidroksitoluen s 0,01% po masi, i (f) Formulacija T koja uključuje Dry-Flo TS i sadrži mirtazapin s 2% po masi, polietilen glikol 400 s 42,01% po masi, polietilen glikol 3350 s 21,48% po masi, dietilen glikol monoetil eter (DGME) s 19% po masi, PEG-8 kaprilne/kaprinske gliceride s 6,5% po masi, oleilni alkohol s 5% po masi, polidimetilsiloksanski fluid s 1,5% po masi, polimetilsilsekvioksan škroba tapioke (Dry-Flo TS) s 2,5% po masi, i butilirani hidroksitoluen s 0,01% po masi.
11. Farmaceutska formulacija za uporabu prema patentnom zahtjevu 1 ili zahtjevu 2, naznačena time, da formulacija sadrži 20-70% , ili 30-80%, ili 30-70%, ili 40-80%, ili 40-70%, ili 50-80%, ili 50-70% polietilen glikola, pri čemu polietilen glikoli uključuju jedan ili više polietilen glikola 400, polietilen glikola 3350, polietilen glikola 4000, polietilen glikola 2000, ili polietilen glikola 6000.
12. Farmaceutska formulacija za uporabu prema patentnom zahtjevu 11, naznačena time, da formulacija sadrži 30-45% polietilen glikola 400 i 20-25% polietilen glikola 3350, 15-25% dietilen glikol monoetil etera (DGME), 5-10% PEG-8 kaprilnih/kaprinskih glicerida, 3-8% oleilnih alkohola, 0,5-3% polidimetilsiloksanskog fluida, i 1-4% polimetilsilsekvioksana škroba tapioke (Dry-Flo TS).
13. Farmaceutska formulacija za uporabu prema bilo kojem od patentnih zahtjeva 10 do 12, naznačena time, da formulacija ne sadrži etanol ili hidroksipropilcelulozu.
HRP20211040TT 2015-02-27 2021-06-30 Poticanje apetita, upravljanje gubitkom težine, i liječenje anoreksije kod pasa i mačaka HRP20211040T1 (hr)

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US201562126188P 2015-02-27 2015-02-27
EP16756426.9A EP3261645B1 (en) 2015-02-27 2016-02-26 Stimulation of appetite, management of weight loss, and treatment of anorexia in dogs and cats
PCT/US2016/019730 WO2016138357A1 (en) 2015-02-27 2016-02-26 Stimulation of appetite, management of weight loss, and treatment of anorexia in dogs and cats

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US (1) US10603272B2 (hr)
EP (1) EP3261645B1 (hr)
JP (1) JP6876003B2 (hr)
AU (1) AU2016222550B2 (hr)
CA (1) CA3013771C (hr)
DK (1) DK3261645T3 (hr)
ES (1) ES2874549T3 (hr)
HR (1) HRP20211040T1 (hr)
HU (1) HUE055000T2 (hr)
PL (1) PL3261645T3 (hr)
PT (1) PT3261645T (hr)
RS (1) RS62055B1 (hr)
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