HRP20230305T1 - Pripravci za ileo-jejunalnu dostavu lijeka - Google Patents

Pripravci za ileo-jejunalnu dostavu lijeka Download PDF

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HRP20230305T1
HRP20230305T1 HRP20230305TT HRP20230305T HRP20230305T1 HR P20230305 T1 HRP20230305 T1 HR P20230305T1 HR P20230305T T HRP20230305T T HR P20230305TT HR P20230305 T HRP20230305 T HR P20230305T HR P20230305 T1 HRP20230305 T1 HR P20230305T1
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dosage form
oral dosage
solid oral
pharmaceutically acceptable
compound
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HRP20230305TT
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Philip A. Nunn
Bret Berner
Mohammad Reza MASJEDIZADEH
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Principia Biopharma Inc.
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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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia

Claims (15)

1. Kruti oralni oblik doziranja, koji je tableta ili kapsula, koji sadrži: (A) jezgru koja sadrži spoj odabran između: [image] [image] [image] [image] [image] [image] i/ili njihovu farmaceutski prihvatljivu sol; (B) enteričku ovojnicu; (C) podsloj između enteričke ovojnice i jezgre, pri čemu je podsloj: (1) vodotopljivi ili hidrofilni erodibilni polimer, navedeni polimer je polimer niske molekularne težine odabran između hidroksimetil celuloze (HPMC), hidroksietil celuloze, hidroksimetil celuloze, hidroksipropil celuloze, mikrokristalne celuloze, polivinilpirolidiona, polisaharida (ili derivata polisaharida), polivinil alkohola, polietilen glikola (PEG), polipropilen glikola (PPG) i PEG-PPG blok kopolimera; ili (2) pripravak netopljiv u vodi koji sadrži: (i) čestice spoja topljivog u vodi koje mogu oblikovati kanale u pripravku netopljivom u vodi; ili (ii) hidrofilne čestice netopljive u vodi koje uzrokuju bubrenje podsloja kada su u kontaktu s vodenim medijem; i (D) farmaceutski prihvatljivu pomoćnu tvar, pri čemu kruti oralni oblik doziranja nakon oralnog gutanja oblika doziranja od strane sisavca ima početak otpuštanja spoja i/ili njegove farmaceutski prihvatljive soli iz jezgre (A) u ileo-jejunalni dio tankog crijeva sisavca; i pri čemu kruti oralni oblik doziranja može otpustiti najmanje 80% težine navedenog spoja i/ili njegove farmaceutski prihvatljive soli u 120 minuta u posudi za otapanje koja sadrži vodenu otopinu pri pH od 6,4 do 7,4.
2. Kruti oralni oblik doziranja prema zahtjevu 1, naznačen time što kruti oralni oblik doziranja može otpustiti manje od 10% težine navedenog spoja i/ili njegove farmaceutski prihvatljive soli jezgre (A) u 1,5 sati u posudi za otapanje koja sadrži vodenu otopinu s pH manjim od 3 ili pH od 4,5 do 5,5.
3. Kruti oralni oblik doziranja prema zahtjevu 1 ili zahtjevu 2, naznačen time što kruti oralni oblik doziranja oslobađa spoj i/ili njegovu farmaceutski prihvatljivu sol iz jezgre (A) kao bolus u ileum i/ili jejunum tankog crijeva sisavca.
4. Kruti oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 3, naznačen time što je spoj jezgre (A) odabran između: [image] [image] [image] [image] [image] [image] i/ili njihova farmaceutski prihvatljiva sol.
5. Kruti oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 4, naznačen time što podsloj (C) sadrži: (i) čestice spoja topljivog u vodi; ili (ii) hidrofilne čestice netopljive u vodi koje uzrokuju bubrenje podsloja kada su u kontaktu s vodenim medijem.
6. Kruti oralni oblik doziranja prema kojem od zahtjeva 1 do 4, naznačen time što je podsloj (C) pripravak netopiv u vodi koji sadrži čestice spoja topljivog u vodi koje tvore kanale koji dopuštaju dotok vode u kruti oralni oblik doziranja i difuziju spoja i/ili njegove farmaceutski prihvatljive soli u crijeva.
7. Kruti oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 4, naznačen time što je podsloj (C) pripravak netopiv u vodi koji sadrži čestice spoja topljivog u vodi sposobne za stvaranje kanala koji su nepropusni za spoj i/ili njegovu farmaceutski prihvatljivu sol, ali dopuštaju ulazak vode i bubrenje i pucanje podsloja, uzrokujući otpuštanje spoja i/ili njegove farmaceutski prihvatljive soli.
8. Kruti oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 7, naznačen time što je vodena otopina simulirana crijevna tekućina na pH od 6,4 do 7,4.
9. Kruti oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 8, naznačen time što kruti oralni oblik doziranja sadrži farmaceutski prihvatljivu kiselu sol spoja.
10. Kruti oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 9, naznačen time što jezgra (A) nadalje sadrži: (a) farmaceutski prihvatljivu kiselinu u količini dovoljnoj za proizvodnju kisele vodene otopine unutar krutog oralnog oblika doziranja prije otpuštanja spoja i/ili njegove farmaceutski prihvatljive soli jezgre iz krutog oralnog oblika doziranja; i/ili (b) površinski aktivnu tvar koja je prisutna u koncentraciji iznad njezine kritične micelarne koncentracije nakon raspadanja u 50 mL vodenog medija.
11. Kruti oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 10, naznačen time što je srednja veličina čestica spoja i/ili njegove farmaceutski prihvatljive soli od 0,3 mikrona do 100 mikrona.
12. Kruti oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 11, naznačen time što je enterička ovojnica (B): (a) od 10% do 150% težine jezgre; (b) debljine od 5 do 500 mikrona; (c) odabrana od polimerizirane želatine, šelaka, kopolimera metakrilne kiseline tipa CNF, celuloznog butirat ftalata, celuloznog hidrogen ftalata, celuloznog proprionat ftalata, polivinil acetat ftalata (PVAP), celuloznog acetat ftalata (CAP), celuloznog acetat trimelitata (CAT), hidroksipropil metilceluloza ftalata, hidroksipropil metilceluloza acetata, dioksipropil metilceluloza sukcinata, karboksimetil etilceluloze (CMEC), hidroksipropil metilceluloza acetat sukcinata (HPMCAS), te polimera i kopolimera (met)akrilne kiseline, pri čemu su navedeni polimeri napravljeni od jednog monomera i navedeni kopolimeri su napravljeni od dva ili više monomera, pri čemu su navedeni monomeri odabrani između metil akrilata, etil akrilata, metil metakrilata, i etil metakrilata, poželjno pri čemu crijevna ovojnica sadrži poli(met)akrilatni polimer, izborno pri čemu je crijevna ovojnica Eudragit® L ili S serije, i dalje po izboru pri čemu je crijevna ovojnica Eudragit® L100, L12.5, S100, S12.5, ili FS 30D; (d) sadrži derivat celuloze, poželjno pri čemu je derivat celuloze odabran između metilceluloze, celuloza acetat ftalata, hidroksimetil celuloze ftalata (HPMCP), hidroksipropil metil celuloze sukcinata (HPMCS), i hidroksimetil celuloze acetat sukcinata (HPMCAS); i/ili (e) sadrži polimer polivinil acetat ftalata (PVAP).
13. Kruti oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 12, naznačen time što je farmaceutski prihvatljiva pomoćna tvar (D) neovisno odabrana između veziva, surfaktanata, razrjeđivača, pufera, sredstava protiv prianjanja, sredstava za klizanje, dezintegratora, antioksidanata, sredstava protiv pjenjenja, punila, aroma, boja, maziva, sorbenata, konzervansa, plastifikatora, i sladila.
14. Kruti oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 13 za upotrebu u postupka liječenja bolesti koja se može liječiti inhibicijom BTK, kod pacijenata kod kojih je prepoznata potreba za tim, pri čemu navedeni postupak obuhvaća davanje pacijentu terapeutski učinkovite količine spoja i/ili njegove farmaceutski prihvatljive soli jezgre (A) u jednoj ili više doza.
15. Kruti oralni oblik doziranja za upotrebu prema zahtjevu 14, naznačen time što je bolest odabrana od autoimune bolesti, raka, i upalne bolesti, poželjno leukemije ili limfoma, te dalje po izboru pri čemu je leukemija odabrana između kronične limfocitne leukemije ( CLL), male limfocitne leukemije (SLL), multiplog mijeloma, limfoma plaštenih stanica, i B-staničnog ne-Hodgkinovog limfoma.
HRP20230305TT 2014-12-24 2015-12-23 Pripravci za ileo-jejunalnu dostavu lijeka HRP20230305T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462096812P 2014-12-24 2014-12-24
EP15834774.0A EP3236943B1 (en) 2014-12-24 2015-12-23 Compositions for ileo-jejunal drug delivery
PCT/US2015/000515 WO2016105582A1 (en) 2014-12-24 2015-12-23 Compositions for ileo-jejunal drug delivery

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HRP20230305T1 true HRP20230305T1 (hr) 2023-05-26

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US (1) US20180193274A1 (hr)
EP (1) EP3236943B1 (hr)
JP (1) JP6687248B2 (hr)
DK (1) DK3236943T3 (hr)
ES (1) ES2942642T3 (hr)
FI (1) FI3236943T3 (hr)
HK (1) HK1245071A1 (hr)
HR (1) HRP20230305T1 (hr)
HU (1) HUE061809T2 (hr)
LT (1) LT3236943T (hr)
MA (1) MA41265B1 (hr)
PL (1) PL3236943T3 (hr)
PT (1) PT3236943T (hr)
RS (1) RS64139B1 (hr)
SI (1) SI3236943T1 (hr)
WO (1) WO2016105582A1 (hr)

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