HRP20200222T1 - Nazalna praškasta formulacija, namijenjena liječenju hipoglikemije - Google Patents

Nazalna praškasta formulacija, namijenjena liječenju hipoglikemije Download PDF

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Publication number
HRP20200222T1
HRP20200222T1 HRP20200222TT HRP20200222T HRP20200222T1 HR P20200222 T1 HRP20200222 T1 HR P20200222T1 HR P20200222T T HRP20200222T T HR P20200222TT HR P20200222 T HRP20200222 T HR P20200222T HR P20200222 T1 HRP20200222 T1 HR P20200222T1
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Croatia
Prior art keywords
preparation
powder
preparation according
mixture
weight
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Application number
HRP20200222TT
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English (en)
Inventor
Sankaram B. Mantripragada
Claude A. PICHE
Jo Jan Filip VAN BETSBRUGGE
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Eli Lilly And Company
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Application filed by Eli Lilly And Company filed Critical Eli Lilly And Company
Publication of HRP20200222T1 publication Critical patent/HRP20200222T1/hr
Publication of HRP20200222T4 publication Critical patent/HRP20200222T4/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
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/724Cyclodextrins
    • 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
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • 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
    • A61K47/30Macromolecular 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
    • A61K47/40Cyclodextrins; 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
    • A61K9/0043Nose
    • 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
    • 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
    • A61K9/146Intimate 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 macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/02Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0043Non-destructive separation of the package, e.g. peeling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/08Inhaling devices inserted into the nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/06Solids
    • A61M2202/064Powder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/07General characteristics of the apparatus having air pumping means
    • A61M2205/071General characteristics of the apparatus having air pumping means hand operated
    • A61M2205/073Syringe, piston type

Claims (14)

1. Praškasti pripravak koji sadrži glukagon (SEQ ID NO:1), β-ciklodekstrin, te dodecilfosfokolin, gdje je u najmanju ruku dio praha prisutan u fazi naznačenoj time što ima XRPD međusignal kao što je određen difrakcijom rendgenskih zraka na prahu.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što je glukagon prisutan u količini od 5 to 15 posto, težinski.
3. Pripravak u skladu s patentnim zahtjevom 1 ili patentnim zahtjevom 2, naznačen time što dodatno sadrži aditiv kojeg se bira između niskomolekulskih organskih kiselina ili njihovih farmaceutski prihvatljivih soli i estera topljivih u vodi.
4. Pripravak u skladu s patentnim zahtjevom 3, naznačen time što je aditiv limunska kiselina ili natrijev citrat.
5. Pripravak u skladu s patentnim zahtjevom 3 ili patentnim zahtjevom 4, naznačen time što je količina aditiva do 10 posto, težinski.
6. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što se količina β-ciklodekstrina kreće između 44 i 90 posto, težinski.
7. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što se količina dodecilfosfokolina kreće između 5 i 51 posto, težinski.
8. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je sadržaj vode u pripravku ispod 5 posto, težinski, od ukupne težine pripravka.
9. Nazalni aplikator za praškastu formulaciju, naznačen time što navedeni aplikator sadrži spremnik praškaste formulacije, te praškastu formulaciju koja se nalazi u spremniku, gdje je praškasta formulacija pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 8.
10. Postupak priprave praškastog pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 8, gdje se navedeni postupak sastoji u koracima a. dobivanja prve smjese glukagona s dodecilfosfokolinom u vodenom nosaču, gdje je dodecilfosfokolin prisutan u koncentraciji većoj od ili jednakoj koncentraciji kritičnoj za stvaranje micela; b. dodavanja β-ciklodekstrina u prvu smjesu kako bi se dobilo drugu smjesu; c. sušenja druge smjese kako bi se dobilo čvrstu formulaciju; i d. obrade čvrste formulacije kako bi se dobilo jednolični prah, gdje navedeni jednolični prah sadrži u najmanju ruku dio praha u fazi naznačenoj time što ima XRPD međusignal.
11. Postupak u skladu s patentnim zahtjevom 10, naznačen time što se sušenje druge smjese provodi sušenjem smrzavanjem ili sušenjem raspršivanjem druge smjese.
12. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što je namijenjen upotrebi u liječenju hipoglikemije.
13. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 12, naznačen time što se pripravak primjenjuje u terapijski djelotvornoj količini u obliku praha na sluznicu nosa pacijenta kojeg treba liječiti.
14. Pripravak namijenjen upotrebi u skladu s patentnim zahtjevom 13, naznačen time što se pripravak primjenjuje u samo jednu pacijentovu nosnicu.
HRP20200222TT 2015-02-17 2016-02-16 Nazalna praškasta formulacija, namijenjena liječenju hipoglikemije HRP20200222T4 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562117031P 2015-02-17 2015-02-17
EP16710352.2A EP3258919B2 (en) 2015-02-17 2016-02-16 Nasal powder formulation for treatment of hypoglycemia
PCT/US2016/018003 WO2016133863A1 (en) 2015-02-17 2016-02-16 Nasal powder formulation for treatment of hypoglycemia

Publications (2)

Publication Number Publication Date
HRP20200222T1 true HRP20200222T1 (hr) 2020-05-29
HRP20200222T4 HRP20200222T4 (hr) 2022-12-23

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ID=55538593

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HRP20200222TT HRP20200222T4 (hr) 2015-02-17 2016-02-16 Nazalna praškasta formulacija, namijenjena liječenju hipoglikemije

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US (3) US10213487B2 (hr)
EP (3) EP3673899A1 (hr)
JP (3) JP6522144B2 (hr)
KR (1) KR102121443B1 (hr)
CN (1) CN107278154B (hr)
AU (2) AU2016220235B2 (hr)
BR (1) BR112017014994B1 (hr)
CA (1) CA2975562C (hr)
CL (1) CL2017002031A1 (hr)
CO (1) CO2017008148A2 (hr)
CR (1) CR20170373A (hr)
CY (1) CY1122716T1 (hr)
DK (1) DK3258919T4 (hr)
DO (1) DOP2017000179A (hr)
EA (1) EA034820B1 (hr)
EC (1) ECSP17053843A (hr)
ES (1) ES2775498T5 (hr)
FI (1) FI3258919T4 (hr)
GT (1) GT201700179A (hr)
HR (1) HRP20200222T4 (hr)
HU (1) HUE049413T2 (hr)
IL (1) IL253273B (hr)
LT (1) LT3258919T (hr)
MA (3) MA41547B1 (hr)
MD (1) MD3258919T3 (hr)
MX (1) MX2017010572A (hr)
MY (1) MY175669A (hr)
NZ (1) NZ734035A (hr)
PE (1) PE20171334A1 (hr)
PH (1) PH12017501486A1 (hr)
PL (1) PL3258919T5 (hr)
PT (1) PT3258919T (hr)
RS (1) RS59918B2 (hr)
SA (1) SA517382068B1 (hr)
SG (1) SG11201705640PA (hr)
SI (1) SI3258919T2 (hr)
SV (1) SV2017005515A (hr)
TN (1) TN2017000349A1 (hr)
UA (1) UA121874C2 (hr)
WO (1) WO2016133863A1 (hr)
ZA (2) ZA201704944B (hr)

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US10213487B2 (en) 2019-02-26
CA2975562C (en) 2020-04-28
PH12017501486A1 (en) 2018-01-15
SI3258919T1 (sl) 2020-03-31
AU2016220235B2 (en) 2021-04-29
SG11201705640PA (en) 2017-08-30
CO2017008148A2 (es) 2017-11-30
NZ734035A (en) 2019-06-28
TN2017000349A1 (en) 2019-01-16
EP3258919A1 (en) 2017-12-27
EP3673899A1 (en) 2020-07-01
HUE049413T2 (hu) 2020-09-28
EP3258919B1 (en) 2020-01-15
DOP2017000179A (es) 2017-08-31
PE20171334A1 (es) 2017-09-13
US20230302093A1 (en) 2023-09-28
PT3258919T (pt) 2020-03-26
US20180000904A1 (en) 2018-01-04
MX2017010572A (es) 2017-12-07
IL253273A0 (en) 2017-08-31
CN107278154A (zh) 2017-10-20
CA2975562A1 (en) 2016-08-25
JP2021107418A (ja) 2021-07-29
US20190282666A1 (en) 2019-09-19
SA517382068B1 (ar) 2020-10-26
MA41547B1 (fr) 2020-04-30
IL253273B (en) 2019-08-29
CR20170373A (es) 2017-09-18
AU2016220235A1 (en) 2017-07-20
JP2018507852A (ja) 2018-03-22
GT201700179A (es) 2018-11-23
MY175669A (en) 2020-07-03
KR20170103934A (ko) 2017-09-13
WO2016133863A1 (en) 2016-08-25
ZA201901241B (en) 2020-10-28
CY1122716T1 (el) 2021-03-12
MD3258919T3 (ro) 2023-04-30
LT3258919T (lt) 2020-02-25
EA201791560A1 (ru) 2018-02-28
MA52253A (fr) 2021-02-17
JP6522144B2 (ja) 2019-05-29
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