HRP20230863T1 - Inhalacijska formulacija rapamicina, namijenjena liječenju stanja povezanih sa starenjem - Google Patents

Inhalacijska formulacija rapamicina, namijenjena liječenju stanja povezanih sa starenjem Download PDF

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Publication number
HRP20230863T1
HRP20230863T1 HRP20230863TT HRP20230863T HRP20230863T1 HR P20230863 T1 HRP20230863 T1 HR P20230863T1 HR P20230863T T HRP20230863T T HR P20230863TT HR P20230863 T HRP20230863 T HR P20230863T HR P20230863 T1 HRP20230863 T1 HR P20230863T1
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Croatia
Prior art keywords
micrometers
preparation
carrier
intended
accordance
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HRP20230863TT
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English (en)
Inventor
Thomas ARMER
Lawrence S. Melvin
Jonathan M. Rothberg
Henri Lichenstein
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AI Therapeutics, Inc.
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Publication of HRP20230863T1 publication Critical patent/HRP20230863T1/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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K9/141Intimate 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
    • A61K9/145Intimate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00General protective or antinoxious agents
    • A61P39/06Free radical scavengers or antioxidants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Nutrition Science (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)

Claims (9)

1. Farmaceutski aerosolni pripravak u obliku suhog praha namijenjenog plućnom unosu koji sadrži čestice mikroniziranog rapamicina koje imaju maseni srednji aerodinamički promjer (MMAD) od 0,5 do 5 mikrometara (µm) i čestice nosača namijenjenog upotrebi u postupku liječenja kronične plućne bolesti, gdje se postupak sastoji u unosu pripravka u obliku suhog praha u ljudskog subjekta kojem je to potrebno inhalacijom, naznačen time što je formulacija djelotvorno unosi terapijsku količinu rapamicina u pluća, te što kronična plućna bolest nije limfangioleiomiomatoza (LAM).
2. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 1, naznačen time što se postupak sastoji u primjeni ukupne dnevne doze od 20 do 250 mikrograma rapamicina.
3. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 1 ili 2, naznačen time što se količina rapamicina u pripravku kreće od 0,1% do 20% (tež./tež.) ili od 0,25% do 2% (tež./tež.), na osnovi ukupne težine pripravka.
4. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 1 ili 3, naznačen time što čestice mikroniziranog rapamicina imaju MMAD od 1 do 5 µm (mikrometara), od 1,5 do 4 µm (mikrometara) ili od 1,5 do 3,5 µm (mikrometara).
5. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što se nosač bira iz skupine koju čine arabinoza, glukoza, fruktoza, riboza, manoza, saharoza, trehaloza, laktoza, maltoza, škrobovi, dekstran, te manitol.
6. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što čestice nosača imaju promjere u rasponu od 1 do 200 µm (mikrometara), od 30 do 100 µm (mikrometara), ili manje od 10 µm (mikrometara).
7. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što nosač sadrži ili se sastoji od smjese dva različita nosača, prvog nosača i drugog nosača, gdje se nosač može sastojati od smjese dva različita laktozna nosača.
8. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 7, naznačen time što se prvi nosač sastoji od čestica koje imaju promjere u rasponu od 30-100 µm (mikrometara), a drugi nosač se sastoji od čestica koje imaju promjere manje od 10 µm (mikrometara).
9. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1-8, naznačen time što je subjekt gerijatrijski subjekt.
HRP20230863TT 2014-04-04 2015-04-06 Inhalacijska formulacija rapamicina, namijenjena liječenju stanja povezanih sa starenjem HRP20230863T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461975127P 2014-04-04 2014-04-04
PCT/US2015/024551 WO2015154084A1 (en) 2014-04-04 2015-04-06 An inhalable rapamycin formulation for treating age-related conditions
EP15718687.5A EP3125875B1 (en) 2014-04-04 2015-04-06 An inhalable rapamycin formulation for treating age-related conditions

Publications (1)

Publication Number Publication Date
HRP20230863T1 true HRP20230863T1 (hr) 2023-11-10

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HRP20230863TT HRP20230863T1 (hr) 2014-04-04 2015-04-06 Inhalacijska formulacija rapamicina, namijenjena liječenju stanja povezanih sa starenjem

Country Status (21)

Country Link
US (5) US20170014341A1 (hr)
EP (2) EP3125875B1 (hr)
JP (2) JP6525285B2 (hr)
KR (1) KR102352249B1 (hr)
CN (1) CN106659686A (hr)
AU (1) AU2015240485B2 (hr)
BR (1) BR112016022598A8 (hr)
CA (1) CA2944075C (hr)
DK (1) DK3125875T3 (hr)
ES (1) ES2952025T3 (hr)
FI (1) FI3125875T3 (hr)
HR (1) HRP20230863T1 (hr)
HU (1) HUE062742T2 (hr)
IL (1) IL248048A0 (hr)
MX (2) MX2016012712A (hr)
NZ (1) NZ724756A (hr)
PL (1) PL3125875T3 (hr)
PT (1) PT3125875T (hr)
RS (1) RS64482B1 (hr)
RU (1) RU2718583C2 (hr)
WO (1) WO2015154084A1 (hr)

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