HRP20200015T1 - Pripravci oralno dezintegrirajuće tablete koji sadrže koritikosteroid za eozinofilni ezofagitis - Google Patents

Pripravci oralno dezintegrirajuće tablete koji sadrže koritikosteroid za eozinofilni ezofagitis Download PDF

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HRP20200015T1
HRP20200015T1 HRP20200015TT HRP20200015T HRP20200015T1 HR P20200015 T1 HRP20200015 T1 HR P20200015T1 HR P20200015T T HRP20200015T T HR P20200015TT HR P20200015 T HRP20200015 T HR P20200015T HR P20200015 T1 HRP20200015 T1 HR P20200015T1
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Croatia
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corticosteroid
disintegrant
pharmaceutically acceptable
pharmaceutical preparation
optionally
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HRP20200015TT
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English (en)
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Michael A. Gosselin
Jin-Wang Lai
Gopi M. Venkatesh
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Adare Pharmaceuticals Us, L.P.
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Publication of HRP20200015T1 publication Critical patent/HRP20200015T1/hr

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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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • A61K31/57—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
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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
    • A61K31/58—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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
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    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/003—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor characterised by the choice of material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/006—Pressing and sintering powders, granules or fibres

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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (19)

1. Farmaceutski pripravak u obliku oralno dezintegrirajuće tablete koja sadrži: a. kortikosteroid topikalnog djelovanja ili farmaceutski prihvatljivu sol, ester, ili polimorf u količini od oko 5% ili manje po težini u pripravku; b. farmaceutski prihvatljiv nosač; i c. brzo dispergirajuće mikrogranule; naznačen time što je kortikosteroid ili farmaceutski prihvatljiva sol, ester, ili polimorf adsorbiran na farmaceutski prihvatljiv nosač, i pri čemu je farmaceutski prihvatljiv nosač odabran iz grupe koja se sastoji od mikrokristalne celuloze, silicificirane mikrokristalne celuloze, preželatiniziranog škroba, kukuruznog škroba, koloidnog silicij dioksida, i amorfnog magnezij aluminij silikata.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što se oralno dezintegrirajuća tableta dezintegrira u roku od 30 sekundi kada se testira uporabom USP <701> postupka za vrijeme dezintegracije ili u roku od 60 sekundi pri kontaktu sa slinom u usnoj duplji pacijenta kome je potrebna.
3. Farmaceutski pripravak prema patentnim zahtjevima 1 ili 2, naznačen time što je farmaceutski prihvatljiv nosač silicificirana mikrokristalna celuloza.
4. Farmaceutski pripravak prema patentnim zahtjevima 1, 2, ili 3, naznačen time što brzo dispergirajuće mikrogranule sadrže šećerni alkohol, ili saharid, ili njihovu smjesu i najmanje jedan dezintegrant, izborno pri čemu su šećerni alkohol ili saharid i dezintegrant prisutni u težinskom odnosu šećernog alkohola ili saharida prema dezintegrantu od 90:10 do 99:1.
5. Farmaceutski pripravak prema patentnim zahtjevima 1, 2, 3, ili 4, naznačen time što je navedeni kortikosteroid odabran iz grupe koja se sastoji od budesonida, flutikazona, flunizolida, ciklesonida, mometazona, beklometazona, i soli, solvata, estera, i njihovih smjesa.
6. Farmaceutski pripravak prema patentnim zahtjevima 1, 2, 3, 4, ili 5, naznačen time što je kortikosteroid prisutan u količini oko 3% ili manje po težini u kompoziciji, oko 1.5% ili manje po težini pripravka, oko 1% ili manje po težini pripravka , ili oko 0.5% ili manje pripravka.
7. Farmaceutski pripravak prema patentnim zahtjevima 1, 2, 3, 4, 5, ili 6, naznačen time što je kortikosteroid prisutan u količini od oko 0.75 mg do oko 12 mg u kompoziciji.
8. Farmaceutski pripravak prema patentnim zahtjevima 1, 2, 3, 4, 5, 6, ili 7, naznačen time što je kortikosteroid flutikazon propionat u rasponu od 0.05 do oko 15 mg u kompoziciji sa sadržajem lijeka od oko 0.16% do 5% po težini pripravka.
9. Farmaceutski pripravak prema patentnim zahtjevima 1, 2, 3, 4, 5, 6, 7, ili 8, naznačen time što je kortikosteroid mikroniziran sa veličinom čestice ne većom od 50 mikrona.
10. Farmaceutski pripravak prema patentnim zahtjevima 1, 2, 3, 4, 5, 6, 7, 8, ili 9, naznačen time što kompozicija dalje sadrži adhezivni agens odabran iz grupe koja se sastoji od saharoza aluminij sulfatnog kompleksa, kitozana i njegovih derivata, polivinilpirolidona, metilceluloze, hidroksipropil celuloze, hidroksipropil metilceluloze, hidroksietil etilceluloze, natrij karboksimetilceluloze, umrežene poliakrilne kiseline, umreženih poliakrilata, aminoalkil metakrilat kopolimera, karbopol polimera, hidrofilnih polisaharidnih guma, maltodekstrina, pektina, ksantan guma, alginske kiseline, modificiranih alginskih kiselina, i njihovih kombinacija.
11. Farmaceutski pripravak prema patentnim zahtjevima 4, 5, 6, 7, 8, 9, ili 10, naznačen time što je dezintegrant odabran iz grupe koji se sastoji od krospovidona, natrij škrob glikolata, umrežene karboksimetil celuloze, i nisko-supstituisane hidroksipropil celuloze, i pri čemu je šećerni alkohol ili saharid odabran iz grupe koja se sastoji od sukraloze, laktoze, saharoze, maltoze, manitola, sorbitola, ksilitola, maltitola, i njihovih smjesa.
12. Farmaceutski pripravak prema patentnim zahtjevima 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, ili 11, koja dalje sadrži slobodno tekući šećerni alkohol ili saharid odabran iz grupe koja se sastoji od manitola osušenog raspršivanjem, laktoze osušene raspršivanjem, i njihovih kombinacija.
13. Farmaceutski pripravak prema patentnim zahtjevima 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, ili 12, koji dalje sadrži lubrikant odabran iz grupe koja se sastoji od magnezij stearata, stearinske kiseline, natrij stearil fumarata, gliceril behenata, i njihove smjese.
14. Farmaceutski pripravak prema patentnim zahtjevima 4, 5, 6, 7, 8, 9, 10, 11, 12, ili 13, naznačen time što brzo dispergirajuće mikrogranule dalje sadrže aditiv odabran iz grupe koja se sastoji od preželatiniziranog škroba i hidroksipropil celuloze i pri čemu je težinski odnos šećernog alkohola ili saharida prema dezintegrantu prema aditivu od 88:10:2 do 98.5:1:0.5.
15. Farmaceutski pripravak u skladu s patentnim zahtjevima 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, ili 14, za uporabu u liječenju inflamatornog stanja gastrointestinalnog trakta.
16. Pripravak za uporabu prema patentnom zahtjevu 15, naznačen time što navedeno stanje gastrointestinalnog trakta sadrži inflamaciju jednjaka, glotisa, epiglotisa, krajnika, ili orofarinksa, izborno pri čemu je navedeno stanje eozinofilni ezofagitis, virusni ili bakterijski faringitis, gastroezofagealna refluksna bolest (GERD), neerozivna refluksna bolest (NERD) ili erozivni ezofagitis.
17. Postupak pripremanja farmaceutskog pripravka prema patentnim zahtjevima 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, ili 15, naznačen time što sadrži korake: a) pripremanje brzo dispergujućih mikrogranula; b) pripremanje pred-mješavine 1 miješanjem farmaceutski prihvatljivog nosača, kortikosteroida, i glidanta, izborno pri čemu je farmaceutski prihvatljiv nosač silicificirana mikrokristalna celuloza, kortikosteroid je mikroniziran flutikazon propionat i glidant je koloidni silicij dioksid; c) pripremanje pred-mješavine 2 miješanjem filera, pred-mješavine 1 iz koraka b), dezintegranta, i zaslađivača, izborno pri čemu je filer manitol, dezintegrant je krospovidon i zaslađivač je sukraloza u prahu; d) pripremanje konačne mješavine pogodne za komprimiranje, miješanjem brzo dispergirajućih granula iz koraka a), lubrikanta, pred-mješavine 2 iz koraka c), i filera, izborno pri čemu je lubrikant natrij stearil fumarat i filer je šećerni alkohol ili isprani manitol; e) pripremanje tablete komprimiranjem mješavine iz koraka d.
18. Postupak prema patentnom zahtjevu 17, naznačen time što sadrži korake: a) pripremanje brzo dispergirajućih mikrogranula; b) pripremanje pred-mješavine 1 koje sadrži punjenje blendera jednom četvrtinom ukupne količine farmaceutski prihvatljivog nosača, kortikosteroidom, glidantom, i još jednom četvrtinom ukupne količine farmaceutski prihvatljivog nosača i miješanjem rezultirajuće kombinacije, izborno pri čemu je farmaceutski prihvatljiv nosač silicificirana mikrokristalna celuloza (SMCC), kortikosteroid je mikroniziran flutikazon propionat i glidant je koloidni silicij dioksid; c) pripremanje pred-mješavine 2 punjenjem granulatora sa visokim klizanjem slobodno tekućim filerom, pred-mješavinom 1, preostalom polovinom ukupne količine farmaceutski prihvatljivog nosača, dezintegrantom, i zaslađivačem i miješanjem rezultirajuće kombinacije, izborno pri čemu je filer manitol osušen raspršivanjem, dezintegrant je krospovidon i zaslađivač je sukraloza u prahu; d) pripremanje konačne mješavine pogodne za komprimiranje punjenjem blendera jednom polovinom ukupne količine brzo dispergirajućih granula iz koraka a), lubrikantom, pred-mješavinom 2 iz koraka c), i preostalom polovinom brzo dispergirajućih granula iz koraka a) i miješanjem rezultirajuće kombinacije kako bi se osigurala mješavina pogodna za komprimiranje, izborno pri čemu je blender V-blender i lubrikant je natrijstearil fumarat; i e) pripremanje oralno dezintegrirajućih tableta komprimiranjem mješavine pogodne za komprimiranje iz koraka d).
19. Postupak prema patentnom zahtjevu 17, naznačen time što sadrži korake: a) pripremanje brzo dispergirajućih mikrogranula sa prosječnom veličinom čestice ne većom od oko 400 μm granulacijom jednog ili više šećernih alkohola i/ili saharida, od kojih svaki ima prosječni promjer čestice ne veći od oko 30 μm, sa dezintegrantom u prisustvu vode ili smjese alkohol-voda i zatim sušenjem granulata, izborno pri čemu je dezintegrant krospovidon; b) pripremanje mljevene pred-mješavine 1 miješanjem farmaceutski prihvatljivog nosača, kortikosteroida, i glidanta u blenderu i zatim mljevenjem rezultirajuće smjese kroz mlin za fino mljevenje opremljen sitom sa otvorom mreže 30, izborno pri čemu je farmaceutski nosač silicificirana mikrokristalna celuloza, kortikosteroid je mikronizirani flutikazon propionat i glidant je koloidni silicij dioksid; c) pripremanje mljevene pred-mješavine 2 miješanjem polovine ukupne količine filera koji je slobodno tekući manitol, pred-mješavine 1 iz koraka b), dezintegranta, i zaslađivača u blenderu i zatim mljevenjem rezultirajuće smjese kroz mlin za fino mljevenje opremljen sitom sa otvorom mreže 30, i ispiranjem mlina preostalom polovinom ukupne količine slobodno tekućeg manitola, izborno pri čemu je dezintegrant krospovidon i zaslađivač je sukraloza u prahu; d) pripremanje mješavine pogodne za komprimiranje miješanjem brzo dispergirajućih granula iz koraka a), lubrikanta, mljevene pred-mješavine 2 iz koraka c), i ispranog slobodno tekućeg manitola, izborno pri čemu je lubrikant natrij stearil fumarat; e) pripremanje oralno dezintegrirajućih tableta komprimiranjem mješavine pogodne za komprimiranje iz koraka d).
HRP20200015TT 2013-09-06 2020-01-07 Pripravci oralno dezintegrirajuće tablete koji sadrže koritikosteroid za eozinofilni ezofagitis HRP20200015T1 (hr)

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