DK2367538T3 - Faste doseringsformer af bendamustin - Google Patents

Faste doseringsformer af bendamustin Download PDF

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Publication number
DK2367538T3
DK2367538T3 DK09764462.9T DK09764462T DK2367538T3 DK 2367538 T3 DK2367538 T3 DK 2367538T3 DK 09764462 T DK09764462 T DK 09764462T DK 2367538 T3 DK2367538 T3 DK 2367538T3
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Prior art keywords
pharmaceutical composition
bendamustine
saccharide
tablets
api
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Application number
DK09764462.9T
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English (en)
Inventor
Jeffrey Colledge
Margaretha Olthoff
Thomas Alfred Profitlich
Ulrich Patzak
Taoufik Ouatas
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Astellas Deutschland Gmbh
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Publication of DK2367538T3 publication Critical patent/DK2367538T3/da

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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/4353—Heterocyclic 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
    • A61K31/437—Heterocyclic 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 five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • 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
    • A61K31/57—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
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    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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Claims (15)

1. Farmaceutisk sammensætning i en fast doseringsform, som er egnet til oral indgivelse, hvilken sammensætning omfatter bendamustin eller en farmaceutisk acceptabel ester, salt eller solvat deraf som en aktiv bestanddel, og mindst én farmaceutisk acceptabel excipiens, som er et farmaceutisk acceptabelt saccharid udvalgt fra gruppen bestående af et eller flere af et mo-nosaccharid, et disaccharid, et oligosaccharid, et cyklisk oligosaccharid, et polysaccharid og en saccharid-alkohol, hvor vægtforholdet mellem den aktive bestanddel og saccharid-excipiensen/excipienserne er i området 1:1 -5, kendetegnet ved, at den farmaceutiske sammensætning er i form af en tablet, et granulat eller en pille.
2. Farmaceutisk sammensætning ifølge krav 1, hvor vægtforholdet mellem den aktive bestanddel og saccharidet er 1:2-5.
3. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 2, hvor tabletten eller tabletgranulaterne, granulatet eller pillen er forsynet med en coating.
4. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 3, hvor den aktive bestanddel er bendamustinhydrochlorid.
5. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 6, som omfatter 10 til 1000 mg af den aktive bestanddel og 30 til 5000 mg af saccharid-excipiensen.
6. Farmaceutisk sammensætning ifølge et af kravene 1 til 5, hvor saccharid-excipiensen er udvalgt blandt mannitol, maltitol, erythritol, xylitol, lactose, saccharose, glucose, sorbitol, maltose, trehalose, lactitol og dextrose.
7. Farmaceutisk sammensætning ifølge et af kravene 1 til 5, hvor saccharid-excipiensen er udvalgt blandt vandfri dextrose, dextrosemonohydrat, lacti-tolmonohydrat, trehalose, sorbitol, erythritol, maltosemonohydrat, mannitol, vandfri lactose, lactosemonohydrat, maltitol, xylitol, saccharose, sucrose 97 % + maltodextrin 3 %, β-cyclodextrin, D-raffinose-pentahydrat, D- melezitose-monohydrat og mikrokrystallinsk cellulose.
8. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 7, som yderligere omfattende et farmaceutisk acceptabelt smøremiddel, fyldstof og/eller opløsningsmiddel.
9. Farmaceutisk sammensætning ifølge krav 1, som udviser en opløsning af bendamustin på mindst 60 % på 10 minutter, 70 % på 20 minutter og 80 % på 30 minutter, som målt med en paddle-indretning ved 50 rpm i henhold til den europæiske farmakopé i 500 ml af et opløsningsmiddel med en pH på 1,5.
10. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 9 til anvendelse ved behandling af en medicinsk tilstand, som er udvalgt blandt kronisk lymfatisk leukæmi, akut lymfatisk leukæmi, kronisk myelocytisk leukæmi, akut myelocytisk leukæmi, Hodgkins sygdom, non-Hodgkins lym-fom, myelomatose, brystcancer, ovariecancer, småcellet lungecancer, ikke-småcellet lungecancer og en autoimmun sygdom.
11. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 9 eller farmaceutisk sammensætning til anvendelse ifølge krav 10, som skal indgives i kombination med mindst ét yderligere aktivt stof, hvor det yderligere aktive stof gives før, samtidig med eller efter indgivelsen af den farmaceutiske sammensætning.
12. Farmaceutisk sammensætning ifølge krav 11, hvor det yderligere aktive stof er et antistof, der er specifikt for CD20, et anthracyklin-derivat, et vinca-alkaloid eller et platin-derivat.
13. Farmaceutisk sammensætning ifølge krav 12, hvor antistoffet, der er specifikt for CD20, er rituximab, hvor anthracyclin-derivatet er doxorubicin eller daunorubicin, hvor vinca-alkaloidet er vineristin, og hvor platin-derivatet er cisplatin eller carboplatin.
14. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 9, 11 til 13, eller farmaceutisk sammensætning til anvendelse ifølge krav 10, som skal indgives i kombination med mindst ét kortikosteroid, hvor kortikoste-roidet gives før, samtidig med eller efter indgivelsen af den farmaceutiske sammensætning.
15. Farmaceutisk sammensætning ifølge krav 14, hvor kortikosteroidet er prednison eller prednisolon.
DK09764462.9T 2008-12-03 2009-12-03 Faste doseringsformer af bendamustin DK2367538T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08020996 2008-12-03
PCT/EP2009/008639 WO2010063476A2 (en) 2008-12-03 2009-12-03 Solid dosage forms of bendamustine

Publications (1)

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DK2367538T3 true DK2367538T3 (da) 2017-10-02

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US (4) US20120003309A1 (da)
EP (1) EP2367538B1 (da)
JP (3) JP5658679B2 (da)
KR (1) KR101710935B1 (da)
CN (2) CN102292073B (da)
AU (1) AU2009321728B2 (da)
BR (1) BRPI0922804B8 (da)
CA (1) CA2745509A1 (da)
CO (1) CO6400185A2 (da)
CY (1) CY1119839T1 (da)
DK (1) DK2367538T3 (da)
EA (1) EA028179B1 (da)
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