HRP20191016T1 - Farmaceutska otopina pemetrekseda - Google Patents
Farmaceutska otopina pemetrekseda Download PDFInfo
- Publication number
- HRP20191016T1 HRP20191016T1 HRP20191016TT HRP20191016T HRP20191016T1 HR P20191016 T1 HRP20191016 T1 HR P20191016T1 HR P20191016T T HRP20191016T T HR P20191016TT HR P20191016 T HRP20191016 T HR P20191016T HR P20191016 T1 HRP20191016 T1 HR P20191016T1
- Authority
- HR
- Croatia
- Prior art keywords
- solution
- solution according
- range
- antioxidant
- preparation
- Prior art date
Links
- 229960005079 pemetrexed Drugs 0.000 title claims 6
- QOFFJEBXNKRSPX-ZDUSSCGKSA-N pemetrexed Chemical compound C1=N[C]2NC(N)=NC(=O)C2=C1CCC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 QOFFJEBXNKRSPX-ZDUSSCGKSA-N 0.000 title claims 5
- 239000000243 solution Substances 0.000 claims 21
- 239000003963 antioxidant agent Substances 0.000 claims 6
- 230000003078 antioxidant effect Effects 0.000 claims 6
- 150000003839 salts Chemical class 0.000 claims 5
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 claims 3
- XOGTZOOQQBDUSI-UHFFFAOYSA-M Mesna Chemical compound [Na+].[O-]S(=O)(=O)CCS XOGTZOOQQBDUSI-UHFFFAOYSA-M 0.000 claims 3
- 229960004308 acetylcysteine Drugs 0.000 claims 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 239000003186 pharmaceutical solution Substances 0.000 claims 2
- 239000002904 solvent Substances 0.000 claims 2
- QXNVGIXVLWOKEQ-UHFFFAOYSA-N Disodium Chemical class [Na][Na] QXNVGIXVLWOKEQ-UHFFFAOYSA-N 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 150000007513 acids Chemical class 0.000 claims 1
- 150000001720 carbohydrates Chemical class 0.000 claims 1
- 235000014633 carbohydrates Nutrition 0.000 claims 1
- 239000002738 chelating agent Substances 0.000 claims 1
- 230000000536 complexating effect Effects 0.000 claims 1
- 229910001385 heavy metal Inorganic materials 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 230000002906 microbiologic effect Effects 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 238000007911 parenteral administration Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 229940124531 pharmaceutical excipient Drugs 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Classifications
-
- 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
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61K47/20—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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (15)
1. Tekuća farmaceutska otopina za parenteralnu primjenu, koja sadrži
- otapalo
- pemetreksed ili njegovu farmaceutsku prihvatljivu sol; i
- antioksidans
naznačena time da je antioksidans odabran iz skupine koja se sastoji od acetilcisteina i natrijevog 2-merkaptoetansulfonata.
2. Otopina prema patentnom zahtjevu 1, naznačena time da je otapalo odabrano iz skupine koja se sastoji od vode, polietilen glikola i etanola, i od smjese dviju ili više spomenutih otopina.
3. Otopina prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time da je pemetreksed prisutan u otopini otopljen u obliku njegove dinatrijeve soli.
4. Otopina prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time da je sadržaj pemetrekseda ili njegove farmaceutski prihvatljive soli u otopini 0.1 mg/ml do 100 mg ml, poželjnije 5 mg/ml do 80 mg/ml, još poželjnije 10 mg/ml do 50 mg/ml i dodatno poželjnije 20 mg/ml do 40 mg/ml.
5. Otopina prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time da sadržaj otopine pemetrekseda ili njegove farmaceutski prihvatljive soli u otopini je 10 mg/ml, 20 mg/ml, 25 mg/ml, 40 mg/ml ili 50 mg/ml.
6. Otopina prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time da je antioksidans acetilcistein.
7. Otopina prema patentnom zahtjevu 6, naznačena time da otopina ima pH u rasponu od 7,5 do 11,5, poželjnije pH u rasponu 8,0 do 10,5 i čak poželjnije pH u rasponu od 8,5 do 10,5.
8. Otopina prema patentnom zahtjevu 1 do 5, naznačena time da je antioksidans natrijev 2-merkaptoetansulfonat.
9. Otopina prema patentnom zahtjevu 8, naznačena time da otopina ima pH u rasponu od 7,5 do 11,5, poželjno pH u rasponu od 8,0 do 10,5, poželjnije pH u rasponu od 8,0 do 10,0 i dodatno poželjnije pH u rasponu od 8,3 do 9,3.
10. Otopina prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time da, sadržaj antioksidansa u otopini je 0,1 mg/ml do 100 mg/ml, poželjno 0,5 mg/ml do 20 mg/ml, čak poželjnije 1.0 mg/ml do 5 mg/ml i dodatnomerk poželjnije od 1 mg/ml do 3 mg/ml.
11. Otopina prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time da otopina nadalje sadrži jedan ili više farmaceutskih ekscipijenata, odabranih iz skupine koja se sastoji od soli, ugljikohidrata za toniranje, kelatnih sredstava za kompleksiranje teških metala, kiselina za podešavanje pH, baza za podešavanje pH, puferskih tvari, konzervansa za mikrobiološku konzervaciju otopine.
12. Farmaceutski pripravak za pripremu otopine prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time da sadrži pemetreksed ili njegovu farmaceutski prihvatljivu sol i antioksidans odabran iz skupine koja se sastoji od acetilcisteina i natrijevog 2-merkaptoetansulfonata.
13. Pripravak prema patentnom zahtjevu 12, naznačen time da je pripravak u krutom obliku.
14. Pripravak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time da je pripravak liofilizat.
15. Hermetički zatvoreni spremnik, naznačen time da sadrži farmaceutsku otopinu ili farmaceutski pripravak prema bilo kojem od prethodnih patentnih zahtjeva.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102012010774A DE102012010774A1 (de) | 2012-05-31 | 2012-05-31 | Pharmazeutische Pemetrexed-Lösung |
| EP13737527.5A EP2854765B1 (de) | 2012-05-31 | 2013-05-29 | Pharmazeutische pemetrexed-lösung |
| PCT/DE2013/000292 WO2013178214A1 (de) | 2012-05-31 | 2013-05-29 | Pharmazeutische pemetrexed-lösung |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20191016T1 true HRP20191016T1 (hr) | 2019-08-23 |
Family
ID=48793847
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20191016TT HRP20191016T1 (hr) | 2012-05-31 | 2019-06-04 | Farmaceutska otopina pemetrekseda |
Country Status (9)
| Country | Link |
|---|---|
| EP (1) | EP2854765B1 (hr) |
| KR (2) | KR101843613B1 (hr) |
| DE (1) | DE102012010774A1 (hr) |
| DK (1) | DK2854765T3 (hr) |
| ES (1) | ES2731526T3 (hr) |
| HR (1) | HRP20191016T1 (hr) |
| PL (1) | PL2854765T3 (hr) |
| PT (1) | PT2854765T (hr) |
| WO (1) | WO2013178214A1 (hr) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101260636B1 (ko) * | 2012-11-29 | 2013-05-13 | 씨제이제일제당 (주) | 안정화된 페메트렉시드 제제 |
| RS60183B1 (sr) | 2014-10-16 | 2020-06-30 | Synthon Bv | Tečna farmaceutska kompozicija koja sadrži pemetreksed |
| WO2016159684A1 (ko) * | 2015-04-01 | 2016-10-06 | 주식회사 아모레퍼시픽 | 소듐 2-메르캅토에탄 설포네이트를 함유하는 피부 재생 촉진용 조성물 |
| KR101693675B1 (ko) | 2015-12-14 | 2017-01-06 | 주식회사 종근당 | 페메트렉시드 또는 그의 약제학적으로 허용가능한 염을 함유하는 안정화된 약학조성물 |
| US20170239250A1 (en) * | 2016-02-19 | 2017-08-24 | Eagle Pharmaceuticals, Inc. | Pemetrexed formulations |
| KR102040034B1 (ko) | 2017-12-13 | 2019-11-05 | 주식회사 아이큐어비앤피 | 페메트렉시드를 포함하는 경구용 약학 조성물 및 이의 제조방법 |
| EP4046626A1 (de) | 2021-02-21 | 2022-08-24 | STADA Arzneimittel AG | Verwendung einer pemetrexed-konzentratlösung |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL150475A0 (en) | 2000-02-04 | 2002-12-01 | Lilly Co Eli | Pharmaceutical composition comprising pemetrexed together with monothioglycerol l-cystein or thioglycolic acid |
| WO2012015810A2 (en) | 2010-07-28 | 2012-02-02 | Eagle Pharmaceuticals, Inc. | Pharmaceutical compositions containing pemetrexed having extended storage stability |
| KR20130122065A (ko) * | 2012-04-30 | 2013-11-07 | 씨제이제일제당 (주) | 페메트렉시드를 함유하는 안정화된 주사용 액상 제제 |
| KR101260636B1 (ko) | 2012-11-29 | 2013-05-13 | 씨제이제일제당 (주) | 안정화된 페메트렉시드 제제 |
-
2012
- 2012-05-31 DE DE102012010774A patent/DE102012010774A1/de not_active Ceased
-
2013
- 2013-05-29 KR KR1020147031312A patent/KR101843613B1/ko active IP Right Grant
- 2013-05-29 PT PT13737527T patent/PT2854765T/pt unknown
- 2013-05-29 KR KR1020177021453A patent/KR102004341B1/ko active IP Right Grant
- 2013-05-29 WO PCT/DE2013/000292 patent/WO2013178214A1/de active Application Filing
- 2013-05-29 PL PL13737527T patent/PL2854765T3/pl unknown
- 2013-05-29 ES ES13737527T patent/ES2731526T3/es active Active
- 2013-05-29 DK DK13737527.5T patent/DK2854765T3/da active
- 2013-05-29 EP EP13737527.5A patent/EP2854765B1/de active Active
-
2019
- 2019-06-04 HR HRP20191016TT patent/HRP20191016T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| DK2854765T3 (da) | 2019-07-01 |
| KR20170091778A (ko) | 2017-08-09 |
| EP2854765A1 (de) | 2015-04-08 |
| PL2854765T3 (pl) | 2019-11-29 |
| PT2854765T (pt) | 2019-06-25 |
| EP2854765B1 (de) | 2019-03-27 |
| KR20150020266A (ko) | 2015-02-25 |
| KR102004341B1 (ko) | 2019-07-26 |
| KR101843613B1 (ko) | 2018-03-29 |
| WO2013178214A1 (de) | 2013-12-05 |
| ES2731526T3 (es) | 2019-11-15 |
| DE102012010774A1 (de) | 2013-12-05 |
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