HRP20200387T1 - Tekući farmaceutski pripravak koji sadrži pemetreksed - Google Patents
Tekući farmaceutski pripravak koji sadrži pemetreksed Download PDFInfo
- Publication number
- HRP20200387T1 HRP20200387T1 HRP20200387TT HRP20200387T HRP20200387T1 HR P20200387 T1 HRP20200387 T1 HR P20200387T1 HR P20200387T T HRP20200387T T HR P20200387TT HR P20200387 T HRP20200387 T HR P20200387T HR P20200387 T1 HRP20200387 T1 HR P20200387T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation according
- preparation
- arginine
- parenteral
- pemetrexed diacid
- Prior art date
Links
- 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
- 229960005079 pemetrexed Drugs 0.000 title claims 5
- 239000007788 liquid Substances 0.000 title claims 2
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 238000002360 preparation method Methods 0.000 claims 13
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 9
- 239000004475 Arginine Substances 0.000 claims 4
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 4
- 239000002904 solvent Substances 0.000 claims 4
- YTPLMLYBLZKORZ-UHFFFAOYSA-N Divinylene sulfide Natural products C=1C=CSC=1 YTPLMLYBLZKORZ-UHFFFAOYSA-N 0.000 claims 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 3
- ZMXDDKWLCZADIW-UHFFFAOYSA-N N,N-Dimethylformamide Chemical compound CN(C)C=O ZMXDDKWLCZADIW-UHFFFAOYSA-N 0.000 claims 3
- 239000003963 antioxidant agent Substances 0.000 claims 3
- 230000003078 antioxidant effect Effects 0.000 claims 3
- 239000002738 chelating agent Substances 0.000 claims 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid group Chemical group C(CC(O)(C(=O)O)CC(=O)O)(=O)O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 3
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims 2
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims 2
- XUJNEKJLAYXESH-REOHCLBHSA-N L-Cysteine Chemical compound SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- 125000000415 L-cysteinyl group Chemical group O=C([*])[C@@](N([H])[H])([H])C([H])([H])S[H] 0.000 claims 1
- 206010023774 Large cell lung cancer Diseases 0.000 claims 1
- FXHOOIRPVKKKFG-UHFFFAOYSA-N N,N-Dimethylacetamide Chemical compound CN(C)C(C)=O FXHOOIRPVKKKFG-UHFFFAOYSA-N 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 239000011521 glass Substances 0.000 claims 1
- 239000011261 inert gas Substances 0.000 claims 1
- 201000009546 lung large cell carcinoma Diseases 0.000 claims 1
- 208000006178 malignant mesothelioma Diseases 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 238000007911 parenteral administration Methods 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 230000001954 sterilising effect Effects 0.000 claims 1
- 238000004659 sterilization and disinfection Methods 0.000 claims 1
Classifications
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- 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
- A61K47/08—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
- A61K47/16—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
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (13)
1. Tekući farmaceutski pripravak pogodan za parenteralnu primjenu, naznačen time što sadrži:
a. dikiselinu pemetreksed;
b. arginin;
c. najmanje jedan monotiolni antioksidans;
d. 10-200 mg/ml propilen-glikola; i
e. jedno ili više parenteralnih otapala;
gdje se njegovu pripravu provodi u atmosferi od inertnog plina, a arginin je prisutan u količini dovoljnoj za postizanje pH pripravka u rasponu od 8,3 do 9,1.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što je monotiolni antioksidans l-cistein.
3. Pripravak u skladu s patentnim zahtjevom 2, naznačen time što je l-cistein prisutan u koncentraciji od 0,5-4 mg/ml.
4. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što je koncentracija propilen-glikola u rasponu od 20-50 mg/ml.
5. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što se parenteralno otapalo bira između: etanola, izopropanola, dimetil-sulfoksida, dimetilformamida, dimetilacetamida, glicerola i vode ili njihovih smjesa.
6. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što je parenteralno otapalo voda.
7. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što je arginin prisutan u najmanje 2,5 ekvivalenata (mol/mol) u odnosu na dikiselinu pemetreksed.
8. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što može sadržavati najmanje jedno kelirajuće sredstvo.
9. Pripravak u skladu s patentnim zahtjevom 8, naznačen time što je kelirajuće sredstvo limunska kiselina.
10. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što je koncentracija dikiseline pemetrekseda 25-50 mg/ml.
11. Postupak priprave pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačen time što se sastoji u otapanju arginina, dikiseline pemetrekseda, monotiolnog antioksidansa, izborno kelirajućeg sredstva i propilen-glikola u otapalu, dopunjavanju volumena vodom, filtriranju i punjenju staklenih bočica.
12. Postupak u skladu s patentnim zahtjevom 11, naznačen time što se sastoji u koraku terminalne sterilizacije.
13. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačen time što je namijenjen upotrebi u liječenju zloćudnog mezotelioma poprsnice i raka velikih stanica pluća.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14189222 | 2014-10-16 | ||
| PCT/EP2015/073385 WO2015193517A2 (en) | 2014-10-16 | 2015-10-09 | Liquid pharmaceutical composition comprising pemetrexed |
| EP15778927.2A EP3206666B1 (en) | 2014-10-16 | 2015-10-09 | Liquid pharmaceutical composition comprising pemetrexed |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20200387T1 true HRP20200387T1 (hr) | 2020-06-12 |
Family
ID=51844505
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20200387TT HRP20200387T1 (hr) | 2014-10-16 | 2020-03-09 | Tekući farmaceutski pripravak koji sadrži pemetreksed |
Country Status (12)
| Country | Link |
|---|---|
| US (3) | US20180235969A1 (hr) |
| EP (1) | EP3206666B1 (hr) |
| EA (1) | EA034559B1 (hr) |
| ES (1) | ES2775582T3 (hr) |
| HR (1) | HRP20200387T1 (hr) |
| HU (1) | HUE048357T2 (hr) |
| LT (1) | LT3206666T (hr) |
| PL (1) | PL3206666T3 (hr) |
| PT (1) | PT3206666T (hr) |
| RS (1) | RS60183B1 (hr) |
| SI (1) | SI3206666T1 (hr) |
| WO (1) | WO2015193517A2 (hr) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20180132643A (ko) * | 2016-02-19 | 2018-12-12 | 이글 파마슈티컬즈 인코포레이티드 | 페메트렉시드 제제 |
| US20170239250A1 (en) * | 2016-02-19 | 2017-08-24 | Eagle Pharmaceuticals, Inc. | Pemetrexed formulations |
| JP6854710B2 (ja) * | 2017-06-14 | 2021-04-07 | 日本化薬株式会社 | ペメトレキセドを含有する注射用溶液製剤 |
| JP2019094284A (ja) * | 2017-11-21 | 2019-06-20 | 日本化薬株式会社 | ペメトレキセドを含有する注射用溶液製剤 |
| CA3137265A1 (en) * | 2019-05-01 | 2020-11-05 | Intas Pharmaceuticals Ltd. | A stable, ready to use aqueous pharmaceutical composition of pemetrexed |
| JP7282065B2 (ja) | 2020-10-05 | 2023-05-26 | イーグル ファーマシューティカルズ， インコーポレイテッド | ペメトレキセド製剤 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL96531A (en) | 1989-12-11 | 1995-08-31 | Univ Princeton | History of Acid N- (Diomeric-H1-Pyrolo] D-2,3 [Pyrimidine-3-Ilacyl (-glutamic, preparation and pharmaceutical preparations containing them) |
| US6686365B2 (en) * | 2000-02-04 | 2004-02-03 | Eli Lilly And Company | Pharmaceutical composition |
| DK1265612T3 (da) | 2000-02-04 | 2004-08-09 | Lilly Co Eli | Farmaceutisk præparat omfattende pemetrexed samt monothioglycerol, l-cystein eller thioglycolsyre |
| CN101081301A (zh) * | 2006-05-29 | 2007-12-05 | 海南天源康泽医药科技有限公司 | 含有培美曲塞的药物组合物 |
| CN100522173C (zh) | 2006-07-28 | 2009-08-05 | 南京依诺维医药科技有限公司 | 含有培美曲塞的药物组合物 |
| CA2804855A1 (en) * | 2010-07-28 | 2012-02-02 | Eagle Pharmaceuticals, Inc. | Pharmaceutical compositions containing pemetrexed having extended storage stability |
| KR101069128B1 (ko) | 2011-03-10 | 2011-09-30 | 건일제약 주식회사 | 페메트렉시드 또는 그의 염을 포함하는 항산화제-비함유 주사용 용액 형태의 약학적 제제의 제조방법 |
| IN2012DE00912A (hr) | 2012-03-27 | 2015-09-11 | Fresenius Kabi Oncology Ltd | |
| EP2666463A1 (en) * | 2012-05-21 | 2013-11-27 | Synthon BV | Stabilized liquid composition comprising pemetrexed |
| DK2854768T3 (en) * | 2012-05-30 | 2017-06-12 | Fresenius Kabi Oncology Ltd | PHARMACEUTICAL COMPOSITIONS OF PEMETREXED |
| DE102012010774A1 (de) | 2012-05-31 | 2013-12-05 | Stada Arzneimittel Ag | Pharmazeutische Pemetrexed-Lösung |
| ES2657944T3 (es) | 2013-06-14 | 2018-03-07 | Synthon B.V. | Sal estable de arginina de pemetrexed y composiciones que la comprenden |
-
2015
- 2015-10-09 EA EA201790788A patent/EA034559B1/ru not_active IP Right Cessation
- 2015-10-09 RS RS20200261A patent/RS60183B1/sr unknown
- 2015-10-09 PT PT157789272T patent/PT3206666T/pt unknown
- 2015-10-09 US US15/518,201 patent/US20180235969A1/en not_active Abandoned
- 2015-10-09 ES ES15778927T patent/ES2775582T3/es active Active
- 2015-10-09 LT LTEP15778927.2T patent/LT3206666T/lt unknown
- 2015-10-09 HU HUE15778927A patent/HUE048357T2/hu unknown
- 2015-10-09 WO PCT/EP2015/073385 patent/WO2015193517A2/en active Application Filing
- 2015-10-09 EP EP15778927.2A patent/EP3206666B1/en active Active
- 2015-10-09 PL PL15778927T patent/PL3206666T3/pl unknown
- 2015-10-09 SI SI201531124T patent/SI3206666T1/sl unknown
-
2018
- 2018-05-25 US US15/990,035 patent/US10188655B2/en active Active
- 2018-12-10 US US16/215,029 patent/US10272090B1/en active Active
-
2020
- 2020-03-09 HR HRP20200387TT patent/HRP20200387T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US10272090B1 (en) | 2019-04-30 |
| EA201790788A1 (ru) | 2017-08-31 |
| RS60183B1 (sr) | 2020-06-30 |
| US10188655B2 (en) | 2019-01-29 |
| PL3206666T3 (pl) | 2020-09-21 |
| EP3206666B1 (en) | 2019-12-11 |
| EA034559B1 (ru) | 2020-02-20 |
| LT3206666T (lt) | 2020-03-10 |
| US20180271872A1 (en) | 2018-09-27 |
| EP3206666A2 (en) | 2017-08-23 |
| WO2015193517A2 (en) | 2015-12-23 |
| SI3206666T1 (sl) | 2020-04-30 |
| ES2775582T3 (es) | 2020-07-27 |
| US20190105325A1 (en) | 2019-04-11 |
| HUE048357T2 (hu) | 2020-08-28 |
| WO2015193517A3 (en) | 2016-03-10 |
| US20180235969A1 (en) | 2018-08-23 |
| PT3206666T (pt) | 2020-03-11 |
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