HRP20161771T4 - Formulacije bendamustina - Google Patents
Formulacije bendamustina Download PDFInfo
- Publication number
- HRP20161771T4 HRP20161771T4 HRP20161771TT HRP20161771T HRP20161771T4 HR P20161771 T4 HRP20161771 T4 HR P20161771T4 HR P20161771T T HRP20161771T T HR P20161771TT HR P20161771 T HRP20161771 T HR P20161771T HR P20161771 T4 HRP20161771 T4 HR P20161771T4
- Authority
- HR
- Croatia
- Prior art keywords
- bendamustine
- pharmaceutically acceptable
- term storage
- liquid composition
- long
- Prior art date
Links
- 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 19
- 229960002707 bendamustine Drugs 0.000 title claims 19
- 239000000203 mixture Substances 0.000 title claims 15
- 238000009472 formulation Methods 0.000 title 1
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 30
- 239000007788 liquid Substances 0.000 claims 15
- 230000007774 longterm Effects 0.000 claims 14
- 239000002202 Polyethylene glycol Substances 0.000 claims 10
- 229920001223 polyethylene glycol Polymers 0.000 claims 10
- 239000012530 fluid Substances 0.000 claims 9
- 239000003963 antioxidant agent Substances 0.000 claims 4
- 235000006708 antioxidants Nutrition 0.000 claims 4
- PJUIMOJAAPLTRJ-UHFFFAOYSA-N monothioglycerol Chemical compound OCC(O)CS PJUIMOJAAPLTRJ-UHFFFAOYSA-N 0.000 claims 4
- 230000000087 stabilizing effect Effects 0.000 claims 4
- 230000003078 antioxidant effect Effects 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 229940035024 thioglycerol Drugs 0.000 claims 3
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 claims 2
- IZFHEQBZOYJLPK-SSDOTTSWSA-N (R)-dihydrolipoic acid Chemical compound OC(=O)CCCC[C@@H](S)CCS IZFHEQBZOYJLPK-SSDOTTSWSA-N 0.000 claims 1
- XUJNEKJLAYXESH-REOHCLBHSA-N L-Cysteine Chemical compound SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 claims 1
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 1
- 241000124008 Mammalia Species 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims 1
- 150000007824 aliphatic compounds Chemical class 0.000 claims 1
- 150000001491 aromatic compounds Chemical class 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- XUJNEKJLAYXESH-UHFFFAOYSA-N cysteine Natural products SCC(N)C(O)=O XUJNEKJLAYXESH-UHFFFAOYSA-N 0.000 claims 1
- 235000018417 cysteine Nutrition 0.000 claims 1
- 229960002433 cysteine Drugs 0.000 claims 1
- AGBQKNBQESQNJD-UHFFFAOYSA-M lipoate Chemical compound [O-]C(=O)CCCCC1CCSS1 AGBQKNBQESQNJD-UHFFFAOYSA-M 0.000 claims 1
- 235000019136 lipoic acid Nutrition 0.000 claims 1
- -1 metabisulfites Chemical compound 0.000 claims 1
- 229930182817 methionine Natural products 0.000 claims 1
- 229960004452 methionine Drugs 0.000 claims 1
- 235000006109 methionine Nutrition 0.000 claims 1
- 239000000473 propyl gallate Substances 0.000 claims 1
- 229940075579 propyl gallate Drugs 0.000 claims 1
- 235000010388 propyl gallate Nutrition 0.000 claims 1
- XWGJFPHUCFXLBL-UHFFFAOYSA-M rongalite Chemical compound [Na+].OCS([O-])=O XWGJFPHUCFXLBL-UHFFFAOYSA-M 0.000 claims 1
- 229960002663 thioctic acid Drugs 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
- A61K47/06—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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
-
- 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
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K9/08—Solutions
-
- 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
- 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
Claims (14)
1. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju, koji sadrži:
a) bendamustin ili njegovu farmaceutski prihvatljivu sol; i
b) farmaceutski prihvatljiv fluid koji sadrži:
i) polietilen glikol i propilen glikol, gdje je odnos polietilen glikol:propilen glikol u farmaceutski prihvatljivoj tekućini od 95:5 do 50:50; i
ii) stablilizirajuću količinu antioksidanta.
2. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema zahtjevu 1, gdje je koncentracija bendamustina od 20 mg/ml do 60 mg/ml, poželjno od 25 mg/ml do 50 mg/ml.
3. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema bilo kojem od prethodnih zahtjeva, gdje farmaceutski prihvatljiv fluid sadrži 95% polietilen glikola i 5% propilen glikola.
4. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema bilo kojem od zahtjeva 1 ili 2, gdje farmaceutski prihvatljiv fluid sadrži 90% polietilen glikola i 10% propilen glikola.
5. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema bilo kojem od zahtjeva 1 ili 2, gdje farmaceutski prihvatljiv fluid sadrži 85% polietilen glikola i 15% propilen glikola.
6. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema bilo kojem od prethodnih zahtjeva, gdje je antioksidans izabran iz grupe koju čine tioglicerol, monotioglicerol, lipoična kiselina, propil galat, metionin, cistein, metabisulfiti, natrijev formaldehid sulfoksilat, fenol koji sadrži aromatične i alifatične spojeve i dihidrolipoična kiselina.
7. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema bilo kojem od prethodnih zahtjeva, gdje stabilizirajuća količina antioksidansa je od 2,5 mg/ml do 35 mg/ml.
8. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema zahtjevu 7, gdje je stabilizirajuća količina antioksidansa od 5 mg/ml do 20 mg/ml.
9. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema zahtjevu 1, koji sadrži
a) bendamustin ili njegovu farmaceutski prihvatljivu sol; i
b) farmaceutski prihvatljiv fluid koji sadrži
i) 90% polietilen glikola i 10% propilen glikola; i
ii) stablilizirajuću količinu tioglicerola.
10. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema zahtjevu 1, koji sadrži
a) bendamustin ili njegovu farmaceutski prihvatljivu sol pri koncentraciji od 50 mg/ml; i
b) farmaceutski prihvatljiv fluid koji sadrži
i) 90% polietilen glikola i 10% propilen glikola; i
ii) tioglicerola pri koncentraciji od 2,5 mg/ml
11. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema bilo kojem od prethodnih zahtjeva, za upotrebu u liječenju karcinoma kod sisavaca.
12. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema zahtjevu 1, gdje farmaceutski prihvatljiv fluid sadrži 80% polietilen glikola i 20% propilen glikola.
13. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema zahtjevu 1, gdje farmaceutski prihvatljiv fluid sadrži 75% polietilen glikola i 25% propilen glikola.
14. Nevodeni tekući sastav bendamustina stabilan pri dugotrajnom čuvanju prema zahtjevu 1, gdje farmaceutski prihvatljiv fluid sadrži 50% polietilen glikola i 50% propilen glikola.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US29910010P | 2010-01-28 | 2010-01-28 | |
| EP11737745.7A EP2528602B2 (en) | 2010-01-28 | 2011-01-28 | Formulations of bendamustine |
| PCT/US2011/022958 WO2011094565A1 (en) | 2010-01-28 | 2011-01-28 | Formulations of bendamustine |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20161771T1 HRP20161771T1 (hr) | 2017-02-24 |
| HRP20161771T4 true HRP20161771T4 (hr) | 2020-08-07 |
Family
ID=44309429
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161771TT HRP20161771T4 (hr) | 2010-01-28 | 2016-12-22 | Formulacije bendamustina |
| HRP20210915TT HRP20210915T1 (hr) | 2010-01-28 | 2021-06-09 | Formulacije bendamustina |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20210915TT HRP20210915T1 (hr) | 2010-01-28 | 2021-06-09 | Formulacije bendamustina |
Country Status (16)
| Country | Link |
|---|---|
| US (12) | US8609707B2 (hr) |
| EP (3) | EP2528602B2 (hr) |
| JP (2) | JP5795600B2 (hr) |
| CA (1) | CA2787568C (hr) |
| CY (2) | CY1118769T1 (hr) |
| DK (2) | DK2528602T4 (hr) |
| ES (2) | ES2609106T5 (hr) |
| HR (2) | HRP20161771T4 (hr) |
| HU (2) | HUE054836T2 (hr) |
| LT (2) | LT3158991T (hr) |
| PL (2) | PL2528602T5 (hr) |
| PT (2) | PT2528602T (hr) |
| RS (2) | RS62327B1 (hr) |
| SI (2) | SI3158991T1 (hr) |
| SM (1) | SMT201700043B (hr) |
| WO (1) | WO2011094565A1 (hr) |
Families Citing this family (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| LT3158991T (lt) | 2010-01-28 | 2021-07-12 | Eagle Pharmaceuticals, Inc. | Bendamustino kompozicijos |
| US20120237492A1 (en) | 2011-02-18 | 2012-09-20 | Kythera Biopharmaceuticals, Inc. | Treatment of submental fat |
| EP2806872A1 (en) * | 2012-01-24 | 2014-12-03 | Innopharma, Inc. | Bendamustine compositions and methods therefore |
| JP2015506989A (ja) * | 2012-02-14 | 2015-03-05 | イーグル・ファーマシューティカルズ・インコーポレーテッド | ベンダムスチン製剤 |
| DK3533447T3 (da) * | 2012-03-20 | 2023-04-24 | Eagle Pharmaceuticals Inc | Flydende bendamustinsammensætninger til anvendelse i fremgangsmåde til behandling af bendamustin-responsive tilstande hos patienter som kræver reducerede volumener til indgivelse |
| PT2827862T (pt) * | 2012-03-20 | 2024-03-06 | Eagle Pharmaceuticals Inc | Formulações de bendamustina |
| JP6571657B2 (ja) | 2013-08-27 | 2019-09-04 | ボウドウリス バシリオス | ベンダムスチンの薬学的組成物 |
| CA2924628A1 (en) * | 2013-09-20 | 2015-03-26 | Santen Pharmaceutical Co., Ltd. | Polyethylene glycol-containing composition |
| WO2015054550A1 (en) * | 2013-10-11 | 2015-04-16 | Luitpold Pharmaceuticals, Inc. | Bendamustine pharmaceutical compositions |
| CN106102722A (zh) | 2014-03-13 | 2016-11-09 | V·沃道里斯 | 苯达莫司汀固体分散体和连续输液 |
| WO2016005995A2 (en) * | 2014-07-10 | 2016-01-14 | Leiutis Pharmaceuticals Pvt. Ltd. | Glycol free stable liquid compositions of bendamustine |
| US9603930B2 (en) | 2014-12-04 | 2017-03-28 | Navinta, Llc | Liquid bendamustine formulation |
| EP3370710A1 (en) * | 2015-11-04 | 2018-09-12 | Kythera Biopharmaceuticals, Inc. | Treatments of accumulated fat with deoxycholic acid and salts thereof |
| 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 |
| ES2928931T3 (es) | 2018-03-29 | 2022-11-23 | Project Pharmaceutics Gmbh | Formulación farmacéutica líquida |
| AU2019321089A1 (en) * | 2018-08-17 | 2021-02-11 | Hospira Australia Pty Ltd | Liquid bendamustine pharmaceutical compositions |
| US11730815B2 (en) | 2018-11-26 | 2023-08-22 | Good Health, Llc | Stable liquid pharmaceutical compositions comprising bendamustine |
| JP2020090481A (ja) * | 2018-11-27 | 2020-06-11 | 日本化薬株式会社 | ベンダムスチンを含有する溶液製剤 |
| 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 |
| WO2020170104A1 (en) * | 2019-02-18 | 2020-08-27 | Shilpa Medicare Limited | Liquid bendamustine parenteral compositions |
| 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 |
| WO2023067188A1 (en) | 2021-10-22 | 2023-04-27 | Project Pharmaceutics Gmbh | Liquid pharmaceutical formulation |
| GB202118175D0 (en) | 2021-12-15 | 2022-01-26 | Arecor Ltd | Novel composition |
| US11707450B1 (en) * | 2022-03-03 | 2023-07-25 | Slayback Pharma Llc | Stable pharmaceutical compositions of bendamustine |
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