CZ302196B6 - Stabilní prípravek na bázi roztoku oxaliplatiny, použití oxaliplatiny pri získávání tohoto prípravku, zpusob stabilizace vodného roztoku oxaliplatiny, zpusob získání tohoto prípravku, a balený farmaceutický produkt - Google Patents
Stabilní prípravek na bázi roztoku oxaliplatiny, použití oxaliplatiny pri získávání tohoto prípravku, zpusob stabilizace vodného roztoku oxaliplatiny, zpusob získání tohoto prípravku, a balený farmaceutický produkt Download PDFInfo
- Publication number
- CZ302196B6 CZ302196B6 CZ20003089A CZ20003089A CZ302196B6 CZ 302196 B6 CZ302196 B6 CZ 302196B6 CZ 20003089 A CZ20003089 A CZ 20003089A CZ 20003089 A CZ20003089 A CZ 20003089A CZ 302196 B6 CZ302196 B6 CZ 302196B6
- Authority
- CZ
- Czechia
- Prior art keywords
- oxaliplatin
- buffer
- formulation
- solution
- oxalic acid
- Prior art date
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- DWAFYCQODLXJNR-BNTLRKBRSA-L oxaliplatin Chemical compound O1C(=O)C(=O)O[Pt]11N[C@@H]2CCCC[C@H]2N1 DWAFYCQODLXJNR-BNTLRKBRSA-L 0.000 title claims abstract description 109
- 229960001756 oxaliplatin Drugs 0.000 title claims abstract description 108
- 239000000203 mixture Substances 0.000 title claims abstract description 99
- 238000009472 formulation Methods 0.000 title claims abstract description 51
- 238000000034 method Methods 0.000 title claims abstract description 30
- 230000000087 stabilizing effect Effects 0.000 title claims abstract description 15
- 238000004519 manufacturing process Methods 0.000 title claims description 11
- 239000000243 solution Substances 0.000 title abstract description 81
- 239000007864 aqueous solution Substances 0.000 title abstract description 7
- 239000008194 pharmaceutical composition Substances 0.000 title description 2
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 claims abstract description 147
- 235000006408 oxalic acid Nutrition 0.000 claims abstract description 48
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 38
- 238000002360 preparation method Methods 0.000 claims abstract description 27
- 206010028980 Neoplasm Diseases 0.000 claims abstract description 16
- 239000003937 drug carrier Substances 0.000 claims abstract description 16
- 229910052783 alkali metal Inorganic materials 0.000 claims abstract description 13
- -1 alkali metal salt Chemical class 0.000 claims abstract description 13
- 201000011510 cancer Diseases 0.000 claims abstract description 4
- 239000000872 buffer Substances 0.000 claims description 35
- ZNCPFRVNHGOPAG-UHFFFAOYSA-L sodium oxalate Chemical compound [Na+].[Na+].[O-]C(=O)C([O-])=O ZNCPFRVNHGOPAG-UHFFFAOYSA-L 0.000 claims description 23
- 229940039790 sodium oxalate Drugs 0.000 claims description 23
- 238000002156 mixing Methods 0.000 claims description 8
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 8
- 229940127557 pharmaceutical product Drugs 0.000 claims description 7
- 230000001954 sterilising effect Effects 0.000 claims description 7
- 239000012298 atmosphere Substances 0.000 claims description 6
- 238000001914 filtration Methods 0.000 claims description 6
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- 238000001802 infusion Methods 0.000 claims description 4
- 150000001340 alkali metals Chemical class 0.000 claims description 3
- 239000003708 ampul Substances 0.000 claims description 3
- 239000006172 buffering agent Substances 0.000 abstract description 4
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Substances [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 36
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 32
- 229910052757 nitrogen Inorganic materials 0.000 description 24
- 239000012535 impurity Substances 0.000 description 21
- 229910052697 platinum Inorganic materials 0.000 description 20
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- 150000003058 platinum compounds Chemical class 0.000 description 12
- 229940045985 antineoplastic platinum compound Drugs 0.000 description 7
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- 238000010438 heat treatment Methods 0.000 description 7
- 229910052760 oxygen Inorganic materials 0.000 description 7
- HRGDZIGMBDGFTC-UHFFFAOYSA-N platinum(2+) Chemical compound [Pt+2] HRGDZIGMBDGFTC-UHFFFAOYSA-N 0.000 description 7
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 6
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 6
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- 239000000126 substance Substances 0.000 description 6
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 5
- 150000001875 compounds Chemical class 0.000 description 5
- SSJXIUAHEKJCMH-UHFFFAOYSA-N cyclohexane-1,2-diamine Chemical class NC1CCCCC1N SSJXIUAHEKJCMH-UHFFFAOYSA-N 0.000 description 5
- 239000012299 nitrogen atmosphere Substances 0.000 description 5
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- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 3
- 102100028735 Dachshund homolog 1 Human genes 0.000 description 3
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- GVNVAWHJIKLAGL-UHFFFAOYSA-N 2-(cyclohexen-1-yl)cyclohexan-1-one Chemical compound O=C1CCCCC1C1=CCCCC1 GVNVAWHJIKLAGL-UHFFFAOYSA-N 0.000 description 2
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- DQLATGHUWYMOKM-UHFFFAOYSA-L cisplatin Chemical compound N[Pt](N)(Cl)Cl DQLATGHUWYMOKM-UHFFFAOYSA-L 0.000 description 2
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- MUTQTHUBSRXFQO-UHFFFAOYSA-L oxalate;platinum(2+) Chemical compound [Pt+2].[O-]C(=O)C([O-])=O MUTQTHUBSRXFQO-UHFFFAOYSA-L 0.000 description 1
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Classifications
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- 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
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- 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
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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
- A61K31/28—Compounds containing heavy metals
- A61K31/282—Platinum compounds
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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
- A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
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- Oil, Petroleum & Natural Gas (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Rešení se týká stabilního prípravku na bázi roztoku oxaliplatiny, který obsahuje oxaliplatinu, úcinné stabilizující množství pufru, kterým je kyselina štavelová nebo sul kyseliny štavelové a alkalického kovu, a farmaceuticky prijatelný nosic, kterým je voda. Do rozsahu tohoto rešení rovnež náleží použití oxaliplatiny pri získávání tohoto prípravku pro lécbu rakoviny, zpusob stabilizace vodného roztoku oxaliplatiny pridáním úcinného stabilizujícího množství kyseliny štavelové nebo soli alkalického kovu této kyseliny do tohoto roztoku a zpusob získání uvedeného prípravku.
Claims (21)
- PATENTOVÉ NÁROKY1. Stabilní přípravek na bázi roztoku oxaliplatiny, vyznačující se tím, že obsahuje oxaliplatinu, účinné stabilizující množství pufru, kterým je kyselina šťavelová nebo sůl kyseliny šťavelové a alkalického kovu, a farmaceuticky přijatelný nosič, kterým je voda, přičemž toto účinné stabilizující množství pufru se pri vyjádření v molámí koncentraci pohybuje v rozmezí od 1 x ΚΓ4 M do 5 x ΙΟ*4 M a přípravek je stabilní po dobu alespoň 15 měsíců.
- 2. Přípravek podle nároku 1, vyznačující se tím, že tímto pufrem je kyselina šťavelová nebo oxalát sodný.
- 3. Přípravek podle nároku 2, vyznačující se tím, že tímto pufrem je kyselina Šťavelová.
- 4. Přípravek podle nároku kteréhokoliv z nároků 1 až 3, vyznačující se tím, že množství pufru pri vyjádření v molámí koncentraci činí 2 x 101 M.-26CZ 302196 B6
- 5. Přípravek podle kteréhokoliv z nároků 1 až 3, vyznačující se tím, pufru při vyjádření v molámí koncentraci činí 4 x ΙΟ4 M.
- 6. Přípravek podle kteréhokoli z nároků 1 až 5, vyznačující se tím, oxaliplatiny se pohybuje v rozmezí od 1 mg/ml do 7 mg/ml.
- 7. Přípravek podle kteréhokoli z nároků laž5, vyznačující se tím, oxaliplatiny se pohybuje v rozmezí od 1 mg/ml do 5 mg/ml.
- 8. Přípravek podle kteréhokoli z nároků 1 až 5, vyznačující se tím, oxaliplatiny se pohybuje v rozmezí od 2 mg/ml do 5 mg/ml.
- 9. Přípravek podle kteréhokoli z nároků 1 až 5, vyznačující se tím, oxaliplatiny činí 5 mg/ml.že množství že množství že množství že množství že množství
- 10. Přípravek podle nároku 3, vyznačující se tím, že množství oxaliplatiny činí 5 mg/ml a množství pufru pri vyjádření v molámí koncentraci činí 2 x ΚΓ4 M.
- 11. Přípravek podle nároku 3, vyznačující se tím, že množství oxaliplatiny činí 5 mg/ml a množství pufru pri vyjádření v molámí koncentraci činí 4 x ΚΓ4 M.
- 12. Přípravek podle kteréhokoli z nároků 1 až 11 pro použití v oblasti medicíny.
- 13. Použití oxaliplatiny pro výrobu přípravku podle kteréhokoli z nároků 1 až 11 pro léčbu rakoviny.
- 14. Použití oxaliplatiny pro výrobu přípravku podle kteréhokoli z nároků 1 až 11 pro léčbu pevného tumoru.
- 15. Způsob výroby přípravku definovaného v kterémkoli z nároků lažll, vyznačující setím, že zahrnuje smíchání farmaceuticky přijatelného nosiče, kterým je voda, pufru, kterým je kyselina šťavelová nebo sůl alkalického kovu této kyseliny, a oxaliplatiny.
- 16. Způsob výroby přípravku definovaného v kterémkoli z nároků lažll, vyznačující setím, že zahrnuje kroky:smíchání farmaceuticky přijatelného nosiče, kterým je voda, a pufru, kterým je kyselina šťavelová nebo sůl alkalického kovu této kyseliny; rozpuštění oxaliplatiny v této směsi;ochlazení směsi vytvořené v kroku (b) a doplnění na konečný objem s pomocí farmaceuticky přijatelného nosiče;zfiltrování roztoku vytvořeného v kroku (c); a případná sterilizace produktu vytvořeného v kroku (d).
- 17. Způsob podle nároku 16, vyznačující se tím, že tento způsob je realizován v inertní atmosféře.
- 18. Způsob podle nároku 16, vyznačující se tím, že produkt vytvořený v rámci kroku (d) je sterilizován vystavením účinku tepla.
- 19. Balený farmaceutický produkt, vyznačující se tím, že zahrnuje přípravek podle kteréhokoli z nároků 1 až 11 v utěsnitelné nádobě.
- 20. Balený farmaceutický produkt podle nároku 19, vyznačující se tím, že touto nádobou je ampulka, lékovka, infúzní vak nebo injekční stříkačka.-27CZ 302196 B6
- 21. Balený farmaceutický produkt podle nároku 20, vyznačující se tím, nádobou je dělená injekční stříkačka.
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GBGB9804013.2A GB9804013D0 (en) | 1998-02-25 | 1998-02-25 | Formulations |
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CZ20003089A CZ302196B6 (cs) | 1998-02-25 | 1999-02-25 | Stabilní prípravek na bázi roztoku oxaliplatiny, použití oxaliplatiny pri získávání tohoto prípravku, zpusob stabilizace vodného roztoku oxaliplatiny, zpusob získání tohoto prípravku, a balený farmaceutický produkt |
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US (1) | US6306902B1 (cs) |
EP (1) | EP0943331B1 (cs) |
JP (1) | JP4430229B2 (cs) |
KR (1) | KR20010041182A (cs) |
CN (1) | CN1152718C (cs) |
AR (1) | AR015524A1 (cs) |
AT (1) | ATE202472T1 (cs) |
AU (1) | AU757101B2 (cs) |
BR (1) | BR9908273A (cs) |
CA (1) | CA2261500C (cs) |
CZ (1) | CZ302196B6 (cs) |
DE (1) | DE69900162T2 (cs) |
DK (1) | DK0943331T3 (cs) |
ES (1) | ES2161085T3 (cs) |
GB (1) | GB9804013D0 (cs) |
GR (1) | GR3036646T3 (cs) |
GT (1) | GT199900019A (cs) |
HU (1) | HU224611B1 (cs) |
IL (1) | IL137772A (cs) |
MX (1) | MXPA00008195A (cs) |
NO (1) | NO329900B1 (cs) |
PL (1) | PL197948B1 (cs) |
PT (1) | PT943331E (cs) |
RU (1) | RU2207857C2 (cs) |
UA (1) | UA70316C2 (cs) |
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