HRP20230276T1 - Tekući pripravci bendamustina za uporabu u postupku liječenja stanja koja reagiraju na bendamustin kod pacijenata kojima za primjenu trebaju reducirani volumeni - Google Patents
Tekući pripravci bendamustina za uporabu u postupku liječenja stanja koja reagiraju na bendamustin kod pacijenata kojima za primjenu trebaju reducirani volumeni Download PDFInfo
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- HRP20230276T1 HRP20230276T1 HRP20230276TT HRP20230276T HRP20230276T1 HR P20230276 T1 HRP20230276 T1 HR P20230276T1 HR P20230276T T HRP20230276T T HR P20230276TT HR P20230276 T HRP20230276 T HR P20230276T HR P20230276 T1 HRP20230276 T1 HR P20230276T1
- Authority
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- Croatia
- Prior art keywords
- bendamustine
- use according
- liquid preparation
- volume
- individual
- Prior art date
Links
- 239000007788 liquid Substances 0.000 title claims 19
- 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 14
- 229960002707 bendamustine Drugs 0.000 title claims 14
- 239000000203 mixture Substances 0.000 title claims 4
- 238000000034 method Methods 0.000 title claims 2
- 238000002360 preparation method Methods 0.000 claims 23
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 12
- 239000002202 Polyethylene glycol Substances 0.000 claims 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 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
- 150000003839 salts Chemical class 0.000 claims 4
- 208000028564 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
- 239000003085 diluting agent Substances 0.000 claims 3
- 201000006370 kidney failure Diseases 0.000 claims 3
- 239000002904 solvent Substances 0.000 claims 3
- 239000012530 fluid Substances 0.000 claims 2
- 238000001802 infusion Methods 0.000 claims 2
- 238000001990 intravenous administration Methods 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
- 239000003963 antioxidant agent Substances 0.000 claims 1
- 230000003078 antioxidant effect Effects 0.000 claims 1
- PJUIMOJAAPLTRJ-UHFFFAOYSA-N monothioglycerol Chemical compound OCC(O)CS PJUIMOJAAPLTRJ-UHFFFAOYSA-N 0.000 claims 1
- 238000007911 parenteral administration Methods 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 239000011780 sodium chloride 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
Claims (17)
1. Tekući pripravak, naznačen time, da sadrži:
(i) od oko 0,05 do oko 12,5 mg/ml bendamustina ili njegove farmaceutski prihvatljive soli;
(ii) otapalo koje sadrži polietilen glikol i propilen glikol, dok se polietilen glikol nalazi u količini od oko 0,3 do oko 45% volumena i propilen glikol se nalazu u količini od oko 0,03 do oko 5% volumena; i, opcionalno
(iii) parenteralno prihvatljiv razrjeđivač;
i time, da je za uporabu u postupku liječenja stanja koje reagira na bendamustin kod pojedinca kojemu treba smanjeni unos fluida i/ili natrija; pri čemu postupak obuhvaća:
a) prepoznavanje pojedinca kojemu trebaju obje terapije bendamustinom i koji će imati dobrobiti od manjih unosa jednog ili više fluida i/ili natrija; i
b) parenteralnu primjenu na navedenom pojedincu volumena od oko 120 ml ili manje od navedenog tekućeg pripravka,
većinom u kontinuiranom vremenskom periodu od manje od ili od oko 30 minuta; i pri čemu pojedinac je čovjek.
2. Tekući pripravak ili njegova farmaceutski prihvatljiva sol za uporabu prema patentnom zahtjevu 1, naznačen time, da otapalo nadalje sadrži antioksidant.
3. Tekući pripravak za uporabu prema patentnom zahtjevu 1 ili 2, naznačen time, da se pripravci primjenjuju infuzijom intravenozno u vremenskom periodu od oko 10 minuta ili manje kada je volumen oko 50 ml; i u vremenskom periodu od oko 15 minuta ili manje, kada je intravenozni infuzijski volumen oko 100 ml.
4. Tekući pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da razrjeđivač sadrži 0,9%-tni NaCl ili 0,45%-tni NaCl.
5. Tekući pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, da pojedinac ima kongestivnu srčanu bolest ili bubrežnu insuficijenciju, pretpostavljeno, bubrežna insuficijencija je zastoj bubrega ili supresija bubrega.
6. Tekući pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da:
i) koncentracija bendamustina ili njegove farmaceutski prihvatljive soli iznosi od oko 0,1 do oko 3,2 mg/ml, poželjno od oko 0,5 do oko 5,6 mg/ml; i/ili
ii) količina otapala iznosi od oko 0,5 do oko 26,5% volumena, poželjno od oko 2,0 do oko 22,4% volumena; i/ili
iii) volumen koji se primjenjuje iznosi oko 100, 50, 30, ili 15 ml.
7. Tekući pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da polietilen glikol je PEG 400.
8. Tekući pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da je maseni omjer polietilen glikola prema propilen glikolu oko 90:10, ili je maseni omjer polietilen glikola prema propilen glikolu oko 85:15.
9. Tekući pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time, da pripravak nadalje sadrži monotioglicerol i NaOH.
10. Tekući pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time, da koncentracija bendamustina ili njegove farmaceutski prihvatljive soli iznosi od oko 0,5 do oko 5,6 mg/ml, pri čemu volumen koji se primjenjuje iznosi oko 50 ml +/- 15% ili manje i pripravak se primjenjuje u vremenskom periodu od oko 10 minuta ili manje.
11. Tekući pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 10, naznačen time, da parenteralno prihvatljiv razrjeđivač je 0,9%-tni NaCl (normalna slana otopina).
12. Tekući pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 11, naznačen time, da stanje koje reagira na bendamustin je kronična limfocitna leukemija ili indolentni ne-Hodgkinov limfom B-stanica.
13. Tekući pripravak za uporabu prema patentnom zahtjevu 12, naznačen time, da stanje koje reagira na bendamustin je kronična limfocitna leukemija i pripravak se primjenjuje intravenozno u volumenu od oko 50 ml u vremenskom periodu od oko 10 minuta ili manje na dane 1 i 2 u ciklusu od 28 dana, ili time, da stanje koje reagira na bendamustin je kronična limfocitna leukemija i pripravak se primjenjuje intravenozno u volumenu od oko 100 ml u vremenskom periodu od oko 15 minuta ili manje na dane 1 i 2 u ciklusu od 28 dana.
14. Tekući pripravak za uporabu prema patentnom zahtjevu 12, naznačen time, da stanje koje reagira na bendamustin je kronična limfocitna leukemija i volumen pripravka koji se primjenjuje na pojedincu, omogućava količinu za doziranje koja se nalazi u rasponu od oko 25 mg/m2 do oko 100 mg/m2 za pojedinca, ili time, da stanje koje reagira na bendamustin je indolentni ne-Hodgkinov limfom B-stanica i volumen pripravka koji se primjenjuje na pojedincu, omogućava količinu za doziranje koja se nalazi u rasponu od oko 60 mg/m2 do oko 120 mg/m2 za pojedinca.
15. Tekući pripravak za uporabu prema patentnom zahtjevu 12, naznačen time, da stanje koje reagira na bendamustin je indolentni ne-Hodgkinov limfom B-stanica, pri čemu se pripravak primjenjuje intravenozno u volumenu od oko 50 ml u vremenskom periodu od oko 10 minuta ili manje na dane 1 i 2 u ciklusu od 21 dana.
16. Tekući pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 15, naznačen time, da sadrži:
a)
[image]
ili
b)
[image]
17. Tekući pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1 do 16, naznačen time, da se bendamustin nalazi u obliku hidrokloridne soli.
Applications Claiming Priority (4)
| 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 | |
| EP19151152.6A EP3533447B1 (en) | 2012-03-20 | 2013-03-15 | Bendamustine liquid compositions for use in method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230276T1 true HRP20230276T1 (hr) | 2023-04-28 |
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 After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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 |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US9000021B2 (hr) |
| EP (3) | EP4218756A1 (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) | PT2827863T (hr) |
| RS (2) | RS64137B1 (hr) |
| SI (2) | SI3533447T1 (hr) |
| WO (1) | WO2013142359A1 (hr) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SI3158991T1 (sl) | 2010-01-28 | 2021-10-29 | Eagle Pharmaceuticals Inc | Formulacije bendamustina |
| FI2827862T3 (fi) * | 2012-03-20 | 2024-02-13 | Eagle Pharmaceuticals Inc | Bendamustiinin formulaatioita |
| ES2943668T3 (es) | 2012-03-20 | 2023-06-15 | Eagle Pharmaceuticals Inc | Composiciones líquidas de bendamustina para su uso en un método para tratar afecciones que responden a la bendamustina en pacientes que requieren volúmenes reducidos para administración |
| US20230241218A1 (en) * | 2012-07-10 | 2023-08-03 | Eagle Pharmaceuticals, Inc. | Formulations of bendamustine |
| US10905677B2 (en) | 2016-08-31 | 2021-02-02 | Navinta, Llc | Bendamustine solution formulations |
| US11826466B2 (en) | 2016-08-31 | 2023-11-28 | 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 |
| JPWO2021014957A1 (hr) * | 2019-07-22 | 2021-01-28 | ||
| JPWO2021161876A1 (hr) * | 2020-02-10 | 2021-08-19 |
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| EP2814487A4 (en) | 2012-02-14 | 2015-07-15 | Eagle Pharmaceuticals Inc | BENDAMUSTIN FORMULATIONS |
| FI2827862T3 (fi) | 2012-03-20 | 2024-02-13 | Eagle Pharmaceuticals Inc | Bendamustiinin formulaatioita |
| ES2943668T3 (es) | 2012-03-20 | 2023-06-15 | Eagle Pharmaceuticals Inc | Composiciones líquidas de bendamustina para su uso en un método para tratar afecciones que responden a la bendamustina en pacientes que requieren volúmenes reducidos para administración |
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