HRP20190693T1 - Tekući sastav za upotrebu u postupku liječenja stanja koja reagiraju na bendamustin kod pacijenata kojima su potrebne smanjene zapremnine za davanje - Google Patents
Tekući sastav za upotrebu u postupku liječenja stanja koja reagiraju na bendamustin kod pacijenata kojima su potrebne smanjene zapremnine za davanje Download PDFInfo
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- HRP20190693T1 HRP20190693T1 HRP20190693TT HRP20190693T HRP20190693T1 HR P20190693 T1 HRP20190693 T1 HR P20190693T1 HR P20190693T T HRP20190693T T HR P20190693TT HR P20190693 T HRP20190693 T HR P20190693T HR P20190693 T1 HRP20190693 T1 HR P20190693T1
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- Prior art keywords
- liquid composition
- use according
- bendamustine
- volume
- composition
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- YTKUWDBFDASYHO-UHFFFAOYSA-N bendamustine Chemical compound ClCCN(CCCl)C1=CC=C2N(C)C(CCCC(O)=O)=NC2=C1 YTKUWDBFDASYHO-UHFFFAOYSA-N 0.000 title claims 13
- 229960002707 bendamustine Drugs 0.000 title claims 13
- 239000007788 liquid Substances 0.000 claims 18
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 12
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 7
- 239000002202 Polyethylene glycol Substances 0.000 claims 5
- 229920001223 polyethylene glycol Polymers 0.000 claims 5
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims 4
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims 4
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims 4
- 208000011821 Indolent B-cell non-Hodgkin lymphoma Diseases 0.000 claims 3
- 208000001647 Renal Insufficiency Diseases 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 201000006370 kidney failure Diseases 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- 239000002904 solvent Substances 0.000 claims 3
- 239000003085 diluting agent Substances 0.000 claims 2
- 239000012530 fluid Substances 0.000 claims 2
- QCQCHGYLTSGIGX-GHXANHINSA-N 4-[[(3ar,5ar,5br,7ar,9s,11ar,11br,13as)-5a,5b,8,8,11a-pentamethyl-3a-[(5-methylpyridine-3-carbonyl)amino]-2-oxo-1-propan-2-yl-4,5,6,7,7a,9,10,11,11b,12,13,13a-dodecahydro-3h-cyclopenta[a]chrysen-9-yl]oxy]-2,2-dimethyl-4-oxobutanoic acid Chemical class N([C@@]12CC[C@@]3(C)[C@]4(C)CC[C@H]5C(C)(C)[C@@H](OC(=O)CC(C)(C)C(O)=O)CC[C@]5(C)[C@H]4CC[C@@H]3C1=C(C(C2)=O)C(C)C)C(=O)C1=CN=CC(C)=C1 QCQCHGYLTSGIGX-GHXANHINSA-N 0.000 claims 1
- 206010007559 Cardiac failure congestive Diseases 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims 1
- PJUIMOJAAPLTRJ-UHFFFAOYSA-N monothioglycerol Chemical compound OCC(O)CS PJUIMOJAAPLTRJ-UHFFFAOYSA-N 0.000 claims 1
- 230000004962 physiological condition Effects 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 235000021023 sodium intake Nutrition 0.000 claims 1
- 230000001629 suppression Effects 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
Classifications
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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
- 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
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D235/00—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings
- C07D235/02—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, condensed with other rings condensed with carbocyclic rings or ring systems
- C07D235/04—Benzimidazoles; Hydrogenated benzimidazoles
- C07D235/06—Benzimidazoles; Hydrogenated benzimidazoles with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached in position 2
- C07D235/12—Radicals substituted by oxygen atoms
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Hematology (AREA)
- Oncology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
Claims (17)
1. Tekući sastav koji sadrži:
i) od oko 0,05 do oko 12,5 mg/ml bendamustina ili njegove farmaceutski prihvatljive soli;
ii) solubilizator koji obuhvaća polietilen glikol i propilen glikol, polietilen glikol se nalazi u količini od oko 0,3 do oko 45% zapremnine i propilen glikol se nalazi u količini od oko 0,03 do oko 5% zapremnine; i, opcionalno
iii) parenteralno prihvatljivi razrijeđivač
za upotrebu u postupku liječenja stanja koje reagira na bendamustin kod subjekta kome je potrebno ograničeno unošenje tekućina i/ili natrija, koje obuhvaća
a) identificiranje subjekta kome je potrebna terapija bendamustinom i koji ima fiziološko stanje koje zahtijeva ograničeno unošenje tekućina i/ili natrija;
b) parenteralno davanje spomenutom subjektu zapremnine od oko 120 ml ili manje spomenutog tekućeg sastava tokom suštinski kontinuiranog perioda koji je manji od ili je jednak 30 minuta.
2. Tekući sastav za upotrebu prema zahtjevu 1, pri čemu razrijeđivač obuhvaća 0.9 mas% NaCl ili 0.45 mas% NaCl.
3. Tekući sastav za upotrebu prema zahtjevu 1, pri čemu subjekt ima kongestivnu bolest srca ili insuficijenciju bubrega, poželjno bubrežna insuficijencija je prestanak rada bubrega ili supresija bubrega.
4. Tekući sastav za upotrebu prema zahtjevu 1, pri čemu koncentracija bendamustina ili farmaceutski prihvatljive soli je oko 0,1 do oko 3,2 mg/ml, poželjno od oko 0,5 do oko 5,6 mg/ml.
5. Tekući sastav za upotrebu prema zahtjevu 1, pri čemu je količina solubilizatora od oko 0,5 do oko 26,5% zap, poželjno od oko 2,0 do oko 22,4 % zap.
6. Tekući sastav za upotrebu prema zahtjevu 1, gdje je polietilen glikol PEG 400.
7. Tekući sastav za upotrebu prema zahtjevu 1, gdje je odnos mase polietilen glikola prema propilen glikolu oko 90:10, ili odnos mase polietilen glikola prema propilen glikolu oko 85:15.
8. Tekući sastav za upotrebu prema zahtjevu 1, gdje zapremnina koja se daje je oko 100, 50, 30 ili 15 ml.
9. Tekući sastav za upotrebu prema zahtjevu 1, gdje kompozicija dalje obuhvaća monotioglicerol i NaOH.
10. Tekući sastav za upotrebu prema zahtjevu 4, gdje koncentracija bendamustina ili farmaceutski prihvatljive soli je oko 0,5 do oko 5,6 mg/ml, gdje zapremnina koja se daje je oko 50 ml +/- 15% ili manje i sastav se daje tokom vremenskog perioda od 10 minuta ili manje.
11. Tekući sastav za upotrebu prema zahtjevu 1, gdje je parenteralno prihvatljivi rastvarač 0,9 mas% NaCl (normalni fiziološki rastvor).
12. Tekući sastav za upotrebu prema zahtjevu 1, gdje stanje koje reagira na bendamustin je kronična limfocitna leukemija ili indolentni B-ćelijski ne-Hodgkinov limfom.
13. Tekući sastav za upotrebu prema zahtjevu 12, pri čemu stanje koje reagira na bendamustin je kronična limfocitna leukemija i sastav se primijenjuje intavenozno u zapremnini od oko 50 ml tijekom vremenskog perioda oko 10 minuta ili manje u danima 1 i 2 od 28 dnevnog ciklusa, ili gdje stanje koje reagira na bendamustin je kronična limfocitna leukemija i sastav se primijenjuje intravenozno u zapremnini od oko 100 ml tijekom vremenskog perioda oko 15 minuta ili manje u danima 1 i 2 od 28 dnevnog ciklusa.
14. Tekući sastav za upotrebu prema zahtjevu 12, pri čemu stanje koje reagira na bendamustin je kronična limfocitna leukemija i zapremnina sastava koja se daje subjektu osigurava doznu količinu koja ima opseg od oko 25 mg/m2 do oko 100 mg/m2 prema subjektu, ili gdje stanje koje reagira na bendamustin je indolentni B-ćelijski ne-Hodgkinov limfom i zapremnina sastava koji se primijenjuje subjektu osigurava dozu količinu koja ima opseg od oko 60 mg/m2 do oko 120 mg/m2 prema subjektu.
15. Tekući sastav za upotrebu prema zahtjevu 12, pri čemu stanje koje reagira na bendamustin je indolentni B-ćelijski ne-Hodgkinov limfom, pri čemu sastava koji se primijenjuje intravenozno u zapremnini od oko 50 ml tokom vremenskog perioda od oko 10 minuta ili manje u danima 1 i 2 od ciklusa 21 dana.
16. Tekući sastav za upotrebu prema zahtjevu 1 koja obuhvaća:
a)
ili
b)
17. Tekući sastav za upotrebu prema bilo kojim zahtjevima 1-16, pri čemu se bendamustin nalazi u obliku klorovodonične soli.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261613173P | 2012-03-20 | 2012-03-20 | |
| US201261669889P | 2012-07-10 | 2012-07-10 | |
| US201261678715P | 2012-08-02 | 2012-08-02 | |
| EP13765020.6A EP2827863B1 (en) | 2012-03-20 | 2013-03-15 | Liquid composition for use in a method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration |
| PCT/US2013/032295 WO2013142359A1 (en) | 2012-03-20 | 2013-03-15 | Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20190693T1 true HRP20190693T1 (hr) | 2019-10-04 |
Family
ID=49212373
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230276TT HRP20230276T1 (hr) | 2012-03-20 | 2013-03-15 | Tekući pripravci bendamustina za uporabu u postupku liječenja stanja koja reagiraju na bendamustin kod pacijenata kojima za primjenu trebaju reducirani volumeni |
| HRP20190693TT HRP20190693T1 (hr) | 2012-03-20 | 2019-04-12 | Tekući sastav za upotrebu u postupku liječenja stanja koja reagiraju na bendamustin kod pacijenata kojima su potrebne smanjene zapremnine za davanje |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230276TT HRP20230276T1 (hr) | 2012-03-20 | 2013-03-15 | Tekući pripravci bendamustina za uporabu u postupku liječenja stanja koja reagiraju na bendamustin kod pacijenata kojima za primjenu trebaju reducirani volumeni |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US9000021B2 (hr) |
| EP (3) | EP3533447B1 (hr) |
| JP (6) | JP6224064B2 (hr) |
| CN (2) | CN104271135B (hr) |
| CA (1) | CA2867343C (hr) |
| DK (2) | DK2827863T3 (hr) |
| ES (2) | ES2943668T3 (hr) |
| FI (1) | FI3533447T3 (hr) |
| HK (1) | HK1243346A1 (hr) |
| HR (2) | HRP20230276T1 (hr) |
| HU (2) | HUE044233T2 (hr) |
| LT (1) | LT2827863T (hr) |
| PL (2) | PL2827863T3 (hr) |
| PT (2) | PT3533447T (hr) |
| RS (2) | RS58744B1 (hr) |
| SI (2) | SI3533447T1 (hr) |
| WO (1) | WO2013142359A1 (hr) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HUE054836T2 (hu) | 2010-01-28 | 2021-10-28 | Eagle Pharmaceuticals Inc | Bendamusztin kiszerelései |
| CA2867343C (en) | 2012-03-20 | 2020-08-11 | Eagle Pharmaceuticals, Inc. | Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration |
| WO2013142358A1 (en) * | 2012-03-20 | 2013-09-26 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
| US20230241218A1 (en) * | 2012-07-10 | 2023-08-03 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
| US11826466B2 (en) | 2016-08-31 | 2023-11-28 | Navinta, Llc | Bendamustine solution formulations |
| US10905677B2 (en) | 2016-08-31 | 2021-02-02 | Navinta, Llc | Bendamustine solution formulations |
| US11730815B2 (en) * | 2018-11-26 | 2023-08-22 | Good Health, Llc | Stable liquid pharmaceutical compositions comprising bendamustine |
| JP7235288B2 (ja) * | 2019-01-07 | 2023-03-08 | コーアイセイ株式会社 | ベンダムスチンの液体製剤 |
| CN110123747A (zh) * | 2019-04-26 | 2019-08-16 | 嘉兴市爵拓科技有限公司 | 苯达莫司汀的制剂 |
| WO2021014957A1 (ja) * | 2019-07-22 | 2021-01-28 | 富士フイルム株式会社 | ベンダムスチン注射液製剤 |
| WO2021161876A1 (ja) * | 2020-02-10 | 2021-08-19 | 富士フイルム株式会社 | ベンダムスチン液剤 |
| US20240148696A1 (en) | 2022-10-25 | 2024-05-09 | Softkemo Pharma Inc. | Lyophilized bendamustine-cyclodextrin composition |
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| EP2814487A4 (en) | 2012-02-14 | 2015-07-15 | Eagle Pharmaceuticals Inc | BENDAMUSTIN FORMULATIONS |
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| WO2013142358A1 (en) | 2012-03-20 | 2013-09-26 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
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