HRP20211515T1 - Stabilni farmaceutski pripravak u fiksnoj dozi koji sadrži mometazon i olopatadin, namijenjen nazalnoj primjeni - Google Patents

Stabilni farmaceutski pripravak u fiksnoj dozi koji sadrži mometazon i olopatadin, namijenjen nazalnoj primjeni Download PDF

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HRP20211515T1
HRP20211515T1 HRP20211515TT HRP20211515T HRP20211515T1 HR P20211515 T1 HRP20211515 T1 HR P20211515T1 HR P20211515T T HRP20211515T T HR P20211515TT HR P20211515 T HRP20211515 T HR P20211515T HR P20211515 T1 HRP20211515 T1 HR P20211515T1
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mometasone
sodium
preparation
olopatadine
pharmaceutical preparation
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HRP20211515TT
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Ulhas Dhuppad
Ashok KATKURWAR
Yashwant GUPTA
Rajesh ANKAM
Chandrakant DHATRAK
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Glenmark Specialty S.A.
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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
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    • 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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds 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
    • A61K31/573—Compounds 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
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K47/26—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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
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    • 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
    • A61K9/0043—Nose
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/44—Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids

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Claims (17)

1. Stabilni vodeni farmaceutski pripravak u fiksnoj dozi, namijenjen nazalnoj primjeni na čovjeku, gdje je navedeni pripravak suspenzija koja sadrži a) 0.001 % tež./tež. do 0.075 % tež./tež. mometazona ili njegove soli u obliku čestica; b) 0.5 % tež./tež. do 0.8 % tež./tež. olopatadina ili njegove soli u otopljenom obliku; i c) hidrokoloid u količini od najmanje 0.1 % tež./tež. i dovoljnoj za sprječavanje razdvajanja faza u trajanju od najmanje 24 sata u okolišnim uvjetima.
2. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, pri čemu su mometazon ili njegova sol i olopatadin ili njegova sol prisutni u težinskom omjeru od 1:3 do 1:106.
3. Farmaceutski pripravak u skladu s patentnim zahtjevom 1 ili 2, pri čemu je sol mometazona mometazon-furoat, a sol olopatadina je olopatadin-hidroklorid.
4. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1-3, pri čemu mometazon ili njegova sol imaju prosječnu veličinu čestica u rasponu od 1 µm do 20 µm.
5. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1-4, pri čemu pripravak ima pH od 3.3-4.1, te osmolalnost u rasponu od 200 mOsm/kg do 400 mOsm/kg.
6. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, navedeni pripravak sadrži 0.025 % tež./tež. do 0.05 % tež./tež. mometazona ili njegove soli, te 0.6 % tež./tež. do 0.7 % tež./tež. olopatadina ili njegove soli, pri čemu se hidrokoloid bira s popisa koji sadrži karboksimetilcelulozu-natrij i ksantansku gumu.
7. Farmaceutski pripravak u skladu s patentnim zahtjevom 6, pri čemu pripravak sadrži bilo 0.025 % tež./tež. mometazon-furoata ili 0.05 % tež./tež. mometazon-furoata i 0.665 % tež./tež. olopatadin-hidroklorida; a navedeni hidrokoloid sadrži ksantansku gumu, karboksimetilcelulozu-natrij, ili oboje.
8. Farmaceutski pripravak u skladu s patentnim zahtjevom 6 ili patentnim zahtjevom 7, pri čemu pripravak dodatno sadrži farmaceutski prihvatljivo pomoćno sredstvo kojeg se bira iz skupine koju čine kelirajuća sredstva, konzervansi, puferi, tenzidi, sredstva za reguliranje izotoničnosti, sredstva za prikrivanje okusa, antioksidansi, sredstva za ovlaživanje, sredstva za podešavanje pH, te njihove mješavine.
9. Farmaceutski pripravak u skladu s patentnim zahtjevom 8, pri čemu: A) kelirajuće sredstvo se bira iz skupine koju čine dinatrijev edetat (EDTA), trinatrijev edetat, tetranatrijev edetat, dietilenamin-pentaacetat, te bilo koja kombinacija bilo kojeg od gore navedenog, gdje je navedeno kelirajuće sredstvo prisutno u rasponu od 0.002 % tež./tež. do 0.5 % tež./tež.; B) konzervans se bira iz skupine koju čine benzil-alkohol, kvaternarni amonijevi halogenidi, fenilkarbinol, tiomersal, te bilo koja kombinacija bilo kojeg od gore navedenog, gdje je navedeni konzervans prisutan u rasponu od 0.005 do 0.2 % tež./tež.; C) pufer se bira iz skupine koju čine limunska kiselina, octena kiselina, fumarna kiselina, klorovodična kiselina, jabučna kiselina, dušična kiselina, fosforna kiselina, propionska kiselina, sumporna kiselina, vinska kiselina, fosfatne soli, te bilo koja kombinacija bilo kojeg od gore navedenog; i D) tenzid se bira iz skupine koju čine polietoksilirani derivati sorbitana, polioksietilenirano biljno ulje, polioksietilen-sorbitan-monolaurat, natrijev oleat, te bilo koja kombinacija bilo kojeg od gore navedenog.
10. Farmaceutski pripravak u skladu s patentnim zahtjevom 6, pri čemu bilo: pripravak sadrži (1) 0.025 % tež./tež. mometazon-furoata monohidrata, (2) 0.665 % tež./tež. olopatadin-hidroklorida, (3) hidrokoloid kojeg se bira s popisa koji sadrži 0.3 % tež./tež. ksantanske gume i 0.5 % tež./tež. karboksimetilceluloze-natrija, (4) 0.02 % tež./tež. benzalkonijevog klorida, (5) 0.4 % tež./tež. natrijevog klorida, (6) 0.01 % tež./tež. dinatrijevog edetata, (7) 0.94 % tež./tež. natrijevog fosfata heptahidrata, te (8) 0.01 % tež./tež. polisorbata 80; ili pripravak sadrži (1) 0.050 % tež./tež. mometazon-furoata monohidrata, (2) 0.665 % tež./tež. olopatadin-hidroklorida, (3) hidrokoloid koji je 0.3 % tež./tež. ksantanske gume ili 0.5 % tež./tež. karboksimetilceluloze-natrija, (4) 0.02 % tež./tež. benzalkonijevog klorida, (5) 0.4 % tež./tež. natrijevog klorida, (6) 0.01 % tež./tež. dinatrijevog edetata, (7) 0.94 % tež./tež. natrijevog fosfata heptahidrata, te (8) 0.01 % tež./tež. polisorbata 80.
11. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1-10, pri čemu je pripravak vodeni pripravak koji sadrži: (1) 0.025 % tež./tež. mometazon-furoata monohidrata, (2) 0.665 % tež./tež. olopatadin-hidroklorida, (3) 1.2 % tež./tež. mješavine mikrokristalne celuloze i karboksimetilceluloze-natrija, (4) 0.5 % tež./tež. karboksimetilceluloze-natrija, (5) 0.02 % tež./tež. benzalkonijevog klorida, (6) 0.41 % tež./tež. natrijevog klorida, (7) 0.01 % tež./tež. dinatrijevog edetata, (8) 0.94 % tež./tež. natrijevog fosfata heptahidrata, te (9) 0.01 % tež./tež. polisorbata 80.
12. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 6-11, pri čemu pripravak ima pH od 3.5-3.9, i osmolalnost u rasponu od 250 mOsm/kg do 350 mOsm/kg.
13. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 6-12, pri čemu pripravak ima prosječnu veličinu čestica u rasponu od 1 µm do 20 µm.
14. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1-13, pri čemu pripravak ima viskoznost u rasponu od 20 cps do 150 cps.
15. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1-14, pri čemu se pripravak nalazi u spremniku, gdje prilikom unosa u obliku nazalnog spreja ima uzorak prskanja koji ima najdulju os od 15-75 mm, najkraću os od 10-65 mm, te eliptičnost od 1-2.
16. Stabilna suspenzija, pogodna za nazalnu primjenu na čovjeku, koja sadrži (a) vodeno otapalo, (b) čestice mometazon-furoata, suspendirane u otapalu, gdje čestice imaju prosječnu veličinu čestica od 1 do 20 µm, (c) olopatadin-hidroklorid, otopljen u otapalu, te (d) hidrokoloid prisutan u količini od najmanje 0.1 % tež./tež. i dovoljnoj za sprječavanje razdvajanja faza u trajanju od najmanje 24 sata u okolišnim uvjetima, gdje suspenzija ima viskoznost u rasponu od 20 cps do 150 cps; te može dodatno sadržavati kelirajuće sredstvo, konzervans, pufer, tenzid, sredstvo za reguliranje izotoničnosti, te izborno sredstvo za podešavanje pH.
17. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1-3 i 5-15 ili suspenzija u skladu s patentnim zahtjevom 16, namijenjeni uporabi u liječenju rinitisa kod čovjeka.
HRP20211515TT 2013-09-13 2014-09-04 Stabilni farmaceutski pripravak u fiksnoj dozi koji sadrži mometazon i olopatadin, namijenjen nazalnoj primjeni HRP20211515T1 (hr)

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Application Number Priority Date Filing Date Title
IN2975MU2013 2013-09-13
EP14781946.0A EP3043773B1 (en) 2013-09-13 2014-09-04 Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine for nasal administration
PCT/IB2014/064251 WO2015036902A1 (en) 2013-09-13 2014-09-04 Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine

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HRP20211515T1 true HRP20211515T1 (hr) 2021-12-24

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US (1) US9078923B2 (hr)
EP (2) EP3718533A1 (hr)
JP (2) JP6203967B2 (hr)
BR (1) BR112015018252B1 (hr)
CY (1) CY1124675T1 (hr)
DK (1) DK3043773T3 (hr)
ES (1) ES2891729T3 (hr)
FR (1) FR21C1057I2 (hr)
HR (1) HRP20211515T1 (hr)
HU (1) HUE056448T2 (hr)
LT (1) LT3043773T (hr)
MX (1) MX367674B (hr)
MY (1) MY191380A (hr)
NL (1) NL301154I2 (hr)
NO (1) NO2021045I1 (hr)
PH (1) PH12016500433A1 (hr)
PL (1) PL3043773T3 (hr)
PT (1) PT3043773T (hr)
RS (1) RS62383B1 (hr)
SI (1) SI3043773T1 (hr)
UA (1) UA116793C2 (hr)
WO (1) WO2015036902A1 (hr)

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