ME02478B - Čvrste farmaceutske formulacije koje sadrže bibw 2992 - Google Patents

Čvrste farmaceutske formulacije koje sadrže bibw 2992

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Publication number
ME02478B
ME02478B MEP-2016-138A MEP13816A ME02478B ME 02478 B ME02478 B ME 02478B ME P13816 A MEP13816 A ME P13816A ME 02478 B ME02478 B ME 02478B
Authority
ME
Montenegro
Prior art keywords
bibw
dimaleate
per tablet
tablet
pressing
Prior art date
Application number
MEP-2016-138A
Other languages
English (en)
French (fr)
Inventor
Roman Messerschmid
Thomas Friedl
Original Assignee
Boehringer Ingelheim Int
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40941955&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ME02478(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Boehringer Ingelheim Int filed Critical Boehringer Ingelheim Int
Publication of ME02478B publication Critical patent/ME02478B/me

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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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • 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
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • 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
    • 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
    • A61K9/141—Intimate 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
    • A61K9/143—Intimate 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 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
    • A61K9/14—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
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2013—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Plural Heterocyclic Compounds (AREA)

Claims (16)

1. Presovani međuproizvod koji se sastoji od 4-[(3-hloro-4-fluorofenil)amino]-6-{[4-(N,N-dimetilamino)-1-okso-2-buten-1-il]amino}-7-((S)-tetrahidrofuran-3-iloksi)-hinazolin dimaleat (BIBW 2992 dimaleat) u obliku praha dobijen u fazi presovanja valjkom koja je kombinovana sa bar jednom fazom prosejavanja posle presovanja, opciono u smješi sa lubrikantom u količini od 0 do 1.0 % izračunatim u količini BIBW 2992 dimaleata po težini okarakterisanim sa raspodelom veličine čestice od x10 < 200 µm, 1 µm < x50 < 300 µm, 75 µm < x90 < 600 µm.
2. Presovani međuproizvod prema zahtjevu 1, okarakterisan sa gustinom razlivanja (ρp) u opsegu od 0.2 g/mL < ρp < 1.0 g/mL i/ili Hausner Faktorom (HF) u opsegu od 1.00 < HF < 1.30, izračunato formulom zapreminske gustine /gustine stresenog praha, pri čemu je zapreminska gustina izmjerena prema Ph. Eur. 2.9.15 (Evropska Farmakopeja, 4. Izd.) kao gustina razlivanja, a gustina stresenog praha je izmjerena prema Ph. Eur. 2.9.15.
3. Međuproizvod ili finalna smješa dobijena iz presovanog međuproizvoda prema zahtjevu 1 ili 2.
4. Međuproizvod ili finalna smješa prema zahtjevu 3, dalje okarakterisan sadržajima odabranim iz komponenti (a) do (g): (a) presovani međuproizvod BIBW 2992 dimaleat u količini od 1 do 99 % po težini, (b) opciono jedan ili više nosača u količini od 10 do 99 % po težini, (c) jedna ili više vezivnih supstanci u količini od 0 do 99 % po težini, (d) jedna ili više glidanata u količini od 0 do 10 % po težini, (e) jedan ili više dezintegranata u količini od 0 do 10 % po težini, (f) jedan ili više lubrikanata u količini od 0 do 10 % po težini, i (g) 0 do 10 % po težini drugih ekscipijenasa i/ili ađuvanasa, pri čemu prisustvo bar jedne od komponenti (b) do (g) je obavezno, ali takođe je dozvoljeno da bude prisutno dvije do najviše svih šest opcionih komponenti (b) do (g) u odnosu na komponentu (a) u međuproizvodu i finalnoj smješi, suma svih komponenti se dodaje do 100%.
5. Čvrste oralne formulacije koje su spremne za korišćenje/gutanje dobijene iz presovanog međuproizvoda BIBW 2992 dimaleata prema bilo kom od zahtjeva 1 ili 2 ili međuproizvodne smješe prema zahtjevu 3 ili 4.
6. Čvrste oralne formulacije prema zahtjevu 5, odabrane između praha, granula, kuglica, tableta, kapsula, tableta za žvakanje, disperzibilnih tableta, pastila i dražea.
7. Čvrste oralne formulacije prema zahtjevu 5, dobijene direktnim presovanjem finalne smješe prema zahtjevu 3 ili 4 ili tabletiranjem kuglica ili granula dobijene uobičajenom vlažnom, suvom granulacijom ili vrućom granulacijom toplim postupkom međuproizvodne smješe prema zahtjevu 3 ili 4.
8. Tableta prema zahtjevu 7, pri čemu je navedena tableta neobložena ili obložena, npr. oblaganje filmom.
9. Tableta prema zahtjevu 7 ili 8, koja sadrži 1 do 150 mg BIBW 2992 (na osnovu slobodne baze).
10. Tableta prema zahtjevu 7, 8 ili 9, koja sadrži 1 do 150 mg BIBW 2992, 50 do 500 mg nosača, vezivne supstance ili njihovu kombinaciju, 0.1do 5 mg glidanta, 1 do 15 mg dezintegranta, i 1 do 15 mg lubrikanta.
11. Tableta prema zahtjevu 7, 8 ili 9, koja sadrži 20 do 70 mg BIBW 2992, 120 do 500 mg nosača, vezivne supstance ili njihovu kombinaciju, 0.5 do 5 mg glidanta, 2.5 do 15 mg dezintegranta, i 2.5 do 15 mg lubrikanta.
12. Tableta prema zahtjevu 7, 8 ili 9, okarakterisana sa kompozicijom odabranom između formulacija A, B, C, D i E: Formulacija A B C D E Sastojak mg po tableti mg po tableti mg po tableti mg po tableti mg po tableti BIBW 2992 dimaleat, nesamljeven (= BIBW 2992 bazni) 29.5600 (20.0000) 44.3400 (30.0000) 59.1200 (40.0000) 73.9000 (50.0000) 103.4600 (70.0000) Laktoza monohidrat 123.8600 185.7900 247.7200 309.6500 433.5100 Mikrokristalna celuloza 18.4800 27.7200 36.9600 46.2000 64.6800 Krospovidon 3.6000 5.4000 7.2000 9.0000 12.6000 Koloidna anhidrovana silika 0.9000 1.3500 1.8000 2.2500 3.1500 Magnezijum stearat 3.6000 5.4000 7.2000 9.0000 12.6000 Ukupno 180.0000 270.0000 360.0000 450.0000 630.0000 koje su opciono obložene sa filmskom oblogom okarakterisanom sa slijedećim kompozicijama odabrane za formulacije A, B, C, D i E: Prevlaka za Formulacije A B C D E Sastojak mg po tableti Hipromeloza 2.5000 3.5000 4.0000 5.0000 6.0000 Polietilen glikol 400 0.5000 0.7000 0.8000 1.0000 1.2000 Titanijum dioksid 1.1300 0.6825 1.8080 0.9750 1.1700 Indigo Carmin aluminijum lak 0.0700 0.2450 0.1120 0.3500 0.4200 Talk 0.6500 1.6625 1.0400 2.3750 2.8500 Polisorbat 80 0.1500 0.2100 0.2400 0.3000 0.3600 Prečišćena voda (isparljiva komponenta) -- -- -- -- -- Ukupno 5.0000 7.000 8.0000 10.0000 12.0000
13. Tableta prema zahtjevu 7, 8 ili 9, okarakterisana sa kompozicijom odabranom iz formulacija F, G, H, I, J i K: Formulacija F G H I J K Sastojak mg po tableti mg po tableti mg po tableti mg po tableti mg po tableti mg po tableti BIBW 2992 dimaleat, nesamljeven (= BIBW 2992 bazni) 7.390 (5.00) 29.560 (20.0000) 147.800 (100.0000) 7.390 (5.00) 29.560 (20.0000) 147.800 (100.00) Laktoza monohidrat 58.048 232.190 550.200 65.435 261.740 616.200 Mikrokristalna celuloza 7.500 30.000 80.000 - - - Krospovidon 0.750 3.000 8.000 0.750 3.000 16.000 Koloidna anhidrovana silika 0.375 1.500 4.000 0.300 1.200 8.000 Magnezijum stearat 0.937 3.750 10.000 1.125 4.500 12.000 Ukupno 75.00 300.00 800.00 75.00 300.00 800.00 formulacije F, G i H opciono su obložene sa filmskom oblogom okarakterisanom sa slijedećim kompozicijama: Formulacija F G H Sastojak mg po tableti Hipromeloza 1.500 5.000 10.000 Polietilen glikol 400 0.150 0.500 1.000 Titanijum dioksid 0.750 2.500 5.000 Talk 0.600 2.000 4.000 Prečišćena voda (isparljiva komponenta) -- -- -- Ukupno 3.000 10.000 20.000
14. Čvrsta formulacija prema bilo kom od zahtjeva 5 do 13, pakovana u PVC-blistere, PVDC-blistere ili vodootporni materijal za pakovanje kao što su blister pakovanja od aluminijumske folije, alu/alu blister, transparenti ili neprozirni polimerski blister sa kesicom, polipropilenske tube, obojeni blister materijali, tube, braon staklene bočice, staklene bočice i HDPE bočice, koje opciono sadrže elemente zaštite za dijecu, koje opciono sadrže sušač kao što je molekularno sito ili silika gel.
15. Postupak za proizvodnju presovanog međuproizvoda za dobijanje presovanog međuproizvoda 4-[(3-hloro-4-fluorofenil)amino]-6- {[4-(N,N-dimetilamino)-1-okso-2-buten-1-il]amino}-7-((S)-tetrahidrofuran-3-iloks)-hinazolin dimaleata (BIBW 2992 dimaleat) u obliku praha koji sadrži fazu presovanja valjkom, koja je kombinovana sa bar jednom fazom prosejavanja, pri čemu faza presovanja valjkom je izvedena sa - BIBW 2992 dimaleatom, sam ili, opciono, sa - prethodno samljevenim BIBW 2992 dimaleatom sa 0 do 1.0% lubrikanta u mješalici sa slobodnim padom ili dobošu kako bi se sprečilo veliko lijepljenje na valjcima za presovanje.
16. Postupak prema zahtjevu 15, pri čemu faza presovanja valjkom je izvedena na valjku za presovanje - opciono sa horizontalnim postavljanjem, vertikalnim postavljanjem ili postavljanjem pod uglom od 45° valjka za presovanje, - koje može biti glatka ili oblikovana na njihovim površinama; korišćenjem snage presovanja koja se kreće - između 1 kN/cm i 20 kN/cm, pri brzini presovanja na valjcima za presovanje - između 1 rpm i 30 rpm, i širinom proreza između valjaka za presovanje - između 1 mm i 10 mm.
MEP-2016-138A 2008-06-06 2009-06-05 Čvrste farmaceutske formulacije koje sadrže bibw 2992 ME02478B (me)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP08157800 2008-06-06
EP09160297 2009-05-14
PCT/EP2009/056944 WO2009147238A1 (en) 2008-06-06 2009-06-05 Solid pharmaceutical formulations comprising bibw 2992
EP09757619.3A EP2299971B1 (en) 2008-06-06 2009-06-05 Solid pharmaceutical formulations comprising bibw 2992

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ME02478B true ME02478B (me) 2017-02-20

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EP (1) EP2299971B1 (me)
JP (1) JP5632367B2 (me)
KR (1) KR101641517B1 (me)
CN (1) CN102056589B (me)
AR (1) AR072062A1 (me)
AU (1) AU2009254574B2 (me)
BR (1) BRPI0913379C1 (me)
CA (1) CA2726472C (me)
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DK (1) DK2299971T3 (me)
EA (1) EA022168B1 (me)
EC (1) ECSP10010650A (me)
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HR (1) HRP20161061T1 (me)
HU (1) HUE029863T2 (me)
IL (1) IL209054A (me)
MA (1) MA34030B1 (me)
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MX (1) MX2010012939A (me)
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NZ (1) NZ589568A (me)
PE (1) PE20100252A1 (me)
PL (1) PL2299971T3 (me)
PT (1) PT2299971T (me)
RS (1) RS54943B1 (me)
SI (1) SI2299971T1 (me)
TW (1) TWI453203B (me)
UY (1) UY31867A (me)
WO (1) WO2009147238A1 (me)
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