DK2575784T3 - Orale doseringsformer af bendamustin - Google Patents
Orale doseringsformer af bendamustin Download PDFInfo
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- DK2575784T3 DK2575784T3 DK11727396.1T DK11727396T DK2575784T3 DK 2575784 T3 DK2575784 T3 DK 2575784T3 DK 11727396 T DK11727396 T DK 11727396T DK 2575784 T3 DK2575784 T3 DK 2575784T3
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- bendamustine
- pharmaceutical composition
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- 229960002707 bendamustine Drugs 0.000 claims description 127
- ZHSKUOZOLHMKEA-UHFFFAOYSA-N 4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid;hydron;chloride Chemical group Cl.ClCCN(CCCl)C1=CC=C2N(C)C(CCCC(O)=O)=NC2=C1 ZHSKUOZOLHMKEA-UHFFFAOYSA-N 0.000 claims description 125
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- OGWKCGZFUXNPDA-XQKSVPLYSA-N vincristine Chemical group C([N@]1C[C@@H](C[C@]2(C(=O)OC)C=3C(=CC4=C([C@]56[C@H]([C@@]([C@H](OC(C)=O)[C@]7(CC)C=CCN([C@H]67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)C[C@@](C1)(O)CC)CC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-XQKSVPLYSA-N 0.000 description 1
- 229960004528 vincristine Drugs 0.000 description 1
- OGWKCGZFUXNPDA-UHFFFAOYSA-N vincristine Natural products C1C(CC)(O)CC(CC2(C(=O)OC)C=3C(=CC4=C(C56C(C(C(OC(C)=O)C7(CC)C=CCN(C67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)CN1CCC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-UHFFFAOYSA-N 0.000 description 1
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- 229960002675 xylitol Drugs 0.000 description 1
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Classifications
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61K9/145—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 organic compounds
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (14)
1. Farmaceutisk sammensætning til oral indgivelse, hvilken sammensætning omfatter bendamustin eller en farmaceutisk acceptabel ester, salt eller solvat deraf som en aktiv bestanddel og en farmaceutisk acceptabel excipiens, som er et farmaceutisk acceptabelt ikke-ionisk hydrofilt overfladeaktivt stof, udvalgt fra gruppen bestående af propylenglycoldicaprylocaprat (Labrafac® PG), pro-pylenglycolmonolaurat (Lauroglycol® 90), linoleoylmacrogolglycerider (Labrafil® M2125), oleoylmacrogolglycerider (Labrafil® M 1944CS), diethylenglycol-monobutylether, diethylenglycolmonoethylether (Transcutol® HP), propy-lenglycolcaprylat (Capryol® PGMC), diethylenglycolmonomethylether, poly-sorbat 20 (Tween® 20), macrogolglycerylcocoater (Glycerox® HE), polysorbat 40 (Tween® 40) og macrogol-23-laurylether (Brij® L23).
2. Farmaceutisk sammensætning ifølge krav 1, kendetegnet ved, at den aktive bestanddel er bendamustinhydrochlorid.
3. Farmaceutisk sammensætning ifølge krav 1 eller krav 2, kendetegnet ved, at den omfatter 10 til 1000 mg, fortrinsvis 25 til 600 mg, mere foretrukket 50 til 200 mg og mere foretrukket ca. 100 mg af den aktive bestanddel.
4. Farmaceutisk sammensætning ifølge krav 1,2 eller 3, kendetegnet ved, at den yderligere omfatter kolloid siliciumdioxid.
5. Farmaceutisk sammensætning ifølge krav 1,2 eller 3, kendetegnet ved, at den yderligere omfatter lauroylmacrogolglycerider (Gelucire® 44/14).
6. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, kendetegnet ved, at sammensætningen er i en hård gelatinekapsel.
7. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, kendetegnet ved, at den udviser en opløsning af bendamustin på mindst 80 % efter 60 minutter, målt med en paddle-indretning ved 50 rpm i løbet af 30 minutter, efterfulgt af 200 rpm i løbet af yderligere 30 minutter, i henhold til den Europæiske Farmakopé, i 500 ml af et opløsningsmiddel ved en pH på 1,5.
8. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1-6, kendetegnet ved, at den udviser en opløsningsprofil af bendamustin på mindst 60 % opløst efter 20 minutter, 70 % efter 40 minutter og 80 % efter 60 minutter, målt med en paddle-indretning ved 50 rpm i henhold til den Europæiske Farmakopé i 500 ml af et opløsningsmiddel ved en pH på 1,5.
9. Farmaceutisk sammensætning ifølge krav 8, kendetegnet ved, at opløsningen af bendamustin er mindst 80 % efter 30 minutter, og fortrinsvis opløsningsprofilen på mindst 60 % bendamustin opløst efter 10 minutter, 70 % efter 20 minutter og 80 % efter 30 minutter.
10. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav kendetegnet ved, at den anvendes til præparatet til en medicinsk tilstand, som er udvalgt blandt kronisk lymfatisk leukæmi, akut lymfatisk leukæmi, kronisk myelocytisk leukæmi, akut myelocytisk leukæmi, Hodgkins sygdom, non-Hodgkins lymfom, myelomatose, brystcancer, ovariecancer, småcellet lungecancer og ikke-småcellet lungecancer.
11. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, kendetegnet ved, at den skal indgives i kombination med mindst et yderligere aktivt stof, hvor det yderligere aktive stof gives før, samtidig med eller efter indgivelsen af den farmaceutiske sammensætning og er udvalgt fra gruppen bestående af et antistof, der er specifikt for CD20, et anthracyclin-derivat, et vinca-alkaloid eller et platin-derivat.
12. Farmaceutisk sammensætning ifølge krav 11, kendetegnet ved, at antistoffet, der er specifikt for CD20, er rituximab; anthracyclin-derivatet er doxorubicin eller daunorubicin; vinca-alkaloidet er vineristin, og platin-derivatet er cisplatin eller carboplatin.
13. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 12, som skal indgives i kombination med mindst ét kortikosteroid, hvor kortiko-steroidet gives før, samtidig med eller efter indgivelsen af den farmaceutiske sammensætning.
14. Farmaceutisk sammensætning ifølge krav 13, kendetegnet ved, at korti-kosteroidet er prednison eller prednisolon.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10075231 | 2010-06-02 | ||
| EP11075047 | 2011-03-14 | ||
| PCT/EP2011/002764 WO2011151087A1 (en) | 2010-06-02 | 2011-06-01 | Oral dosage forms of bendamustine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2575784T3 true DK2575784T3 (da) | 2018-10-15 |
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| US20130210879A1 (en) * | 2012-02-14 | 2013-08-15 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
| EP2641592A1 (en) | 2012-03-23 | 2013-09-25 | Salmon Pharma GmbH | Pharmaceutical formulation comprising bendamustine |
| CA2873646C (en) * | 2012-05-18 | 2022-04-26 | Genentech, Inc. | High-concentration monoclonal antibody formulations |
| GB201212010D0 (en) * | 2012-07-05 | 2012-08-22 | Sigmoid Pharma Ltd | Formulations |
| CA2890462A1 (en) | 2012-11-12 | 2014-05-15 | Ignyta, Inc. | Bendamustine derivatives and methods of using same |
| HK1216240A1 (zh) | 2012-11-14 | 2016-10-28 | W. R. Grace & Co.-Conn. | 含有生物活性材料与无序无机氧化物的组合物 |
| GB201304662D0 (en) | 2013-03-14 | 2013-05-01 | Sigmoid Pharma Ltd | Compositions |
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| DE159289C (da) * | 1903-10-08 | 1905-03-16 | ||
| US20030044434A1 (en) * | 1997-07-29 | 2003-03-06 | Ping Gao | Self-emulsifying formulation for lipophilic compounds |
| FR2781373B1 (fr) * | 1998-07-07 | 2001-09-21 | Pf Medicament | Formulations thixotropes pour le remplissage de gelules |
| US7374779B2 (en) * | 1999-02-26 | 2008-05-20 | Lipocine, Inc. | Pharmaceutical formulations and systems for improved absorption and multistage release of active agents |
| AU2002258013A1 (en) | 2001-04-10 | 2002-10-28 | Fakhreddin Jamali | Animal model for evaluating analgesics |
| US20030105141A1 (en) * | 2001-04-17 | 2003-06-05 | Ping Gao | Finely self-emulsifiable pharmaceutical composition |
| UA80682C2 (en) * | 2001-08-06 | 2007-10-25 | Pharmacia Corp | Orally deliverable stabilized oral suspension formulation and process for the incresaing physical stability of thixotropic pharmaceutical composition |
| US7423004B2 (en) | 2003-01-31 | 2008-09-09 | Smithkline Beecham Corporation | Solid dispersion compositions |
| JP2006514119A (ja) | 2003-02-12 | 2006-04-27 | アール アンド ピー コリア カンパニー リミテッド | 溶解率が向上した難溶性薬剤の溶媒系 |
| US7871607B2 (en) * | 2003-03-05 | 2011-01-18 | Halozyme, Inc. | Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases |
| CN101052396A (zh) * | 2004-11-05 | 2007-10-10 | 赛福伦公司 | 癌症治疗 |
| TW200621240A (en) * | 2004-11-05 | 2006-07-01 | Salmedix Inc | Cancer treatments |
| EP1674082A1 (de) * | 2004-12-22 | 2006-06-28 | Zentaris GmbH | Verfahren zur Herstellung von sterilen Suspensionen oder Lyophilisaten schwerlöslicher basischer Peptidkomplexe, diese enthaltende pharmazeutische Formulierungen sowie ihre Verwendung als Arzneimittel |
| US8436190B2 (en) * | 2005-01-14 | 2013-05-07 | Cephalon, Inc. | Bendamustine pharmaceutical compositions |
| GB0526419D0 (en) | 2005-12-23 | 2006-02-08 | Cyclacel Ltd | Formulation |
| CA2656540A1 (en) * | 2006-06-30 | 2008-01-10 | Mcneil-Ppc, Inc. | Ibuprofen-containing liquid filled hard capsules |
| EP2144601A4 (en) * | 2007-04-05 | 2012-10-10 | Univ Kansas | RAPID DISSOLVING PHARMACEUTICAL COMPOSITIONS COMPRISING PULLULANE |
| CA2692977A1 (en) * | 2007-07-12 | 2009-01-15 | Tragara Pharmaceuticals, Inc. | Methods and compositions for the treatment of cancer, tumors, and tumor-related disorders |
| US20100310661A1 (en) * | 2007-07-16 | 2010-12-09 | Poniard Pharmaceuticals, Inc. | Oral formulations for picoplatin |
| KR100913644B1 (ko) | 2007-10-09 | 2009-08-24 | 제일약품주식회사 | 활성성분으로 시부트라민 유리염기를 함유하는 약제학적조성물 및 그 제조방법 |
| AR072777A1 (es) | 2008-03-26 | 2010-09-22 | Cephalon Inc | Formas solidas de clorhidrato de bendamustina |
| RS57142B1 (sr) * | 2008-06-06 | 2018-07-31 | Boehringer Ingelheim Int | Farmaceutski dozni oblik u vidu kapsule koji sadrži formulaciju suspenzije indolinon derivata |
| US8349353B2 (en) * | 2008-06-27 | 2013-01-08 | Otonomy, Inc. | Controlled release cytotoxic agent compositions and methods for the treatment of otic disorders |
| UA107186C2 (xx) * | 2008-12-03 | 2014-12-10 | Тверді форми дозування бендамустину | |
| BRPI0922806B8 (pt) * | 2008-12-03 | 2021-05-25 | Astellas Deutschland Gmbh | composição farmacêutica oral compreendendo bendamustina |
| US20100273730A1 (en) * | 2009-04-27 | 2010-10-28 | Innopharmax, Inc. | Self-emulsifying pharmaceutical compositions of hydrophilic drugs and preparation thereof |
| CN102413816A (zh) * | 2009-04-28 | 2012-04-11 | 赛福伦公司 | 苯达莫司汀的口服制剂 |
| US20100297194A1 (en) * | 2009-04-30 | 2010-11-25 | Nathaniel Catron | Formulation for oral administration of apoptosis promoter |
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