CA2537610A1 - Pharmaceutical composition, method of manufacturing and therapeutic use thereof - Google Patents
Pharmaceutical composition, method of manufacturing and therapeutic use thereof Download PDFInfo
- Publication number
- CA2537610A1 CA2537610A1 CA002537610A CA2537610A CA2537610A1 CA 2537610 A1 CA2537610 A1 CA 2537610A1 CA 002537610 A CA002537610 A CA 002537610A CA 2537610 A CA2537610 A CA 2537610A CA 2537610 A1 CA2537610 A1 CA 2537610A1
- Authority
- CA
- Canada
- Prior art keywords
- oxaliplatin
- animal origin
- alcoholic
- pharmaceutical composition
- freeze
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 20
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 5
- 230000001225 therapeutic effect Effects 0.000 title description 2
- DWAFYCQODLXJNR-BNTLRKBRSA-L oxaliplatin Chemical compound O1C(=O)C(=O)O[Pt]11N[C@@H]2CCCC[C@H]2N1 DWAFYCQODLXJNR-BNTLRKBRSA-L 0.000 claims abstract description 34
- 229960001756 oxaliplatin Drugs 0.000 claims abstract description 34
- 241001465754 Metazoa Species 0.000 claims abstract description 23
- 230000001476 alcoholic effect Effects 0.000 claims abstract description 22
- 238000004108 freeze drying Methods 0.000 claims abstract description 22
- 235000000346 sugar Nutrition 0.000 claims abstract description 21
- 150000008163 sugars Chemical class 0.000 claims abstract description 7
- 206010028980 Neoplasm Diseases 0.000 claims abstract description 5
- 239000003937 drug carrier Substances 0.000 claims abstract description 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 7
- 229930195725 Mannitol Natural products 0.000 claims description 7
- 239000007864 aqueous solution Substances 0.000 claims description 7
- 239000000594 mannitol Substances 0.000 claims description 7
- 235000010355 mannitol Nutrition 0.000 claims description 7
- 150000001875 compounds Chemical class 0.000 claims description 2
- 239000000203 mixture Substances 0.000 abstract description 8
- 239000000243 solution Substances 0.000 description 20
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 8
- 239000008101 lactose Substances 0.000 description 8
- 238000011109 contamination Methods 0.000 description 7
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 238000004090 dissolution Methods 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 230000003612 virological effect Effects 0.000 description 5
- 229940079593 drug Drugs 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 238000003860 storage Methods 0.000 description 4
- 238000005336 cracking Methods 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 208000024777 Prion disease Diseases 0.000 description 2
- 239000003242 anti bacterial agent Substances 0.000 description 2
- 229940088710 antibiotic agent Drugs 0.000 description 2
- 238000011067 equilibration Methods 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 230000003301 hydrolyzing effect Effects 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 235000006408 oxalic acid Nutrition 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 241000283690 Bos taurus Species 0.000 description 1
- 206010009944 Colon cancer Diseases 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 208000003362 bronchogenic carcinoma Diseases 0.000 description 1
- 230000000959 cryoprotective effect Effects 0.000 description 1
- 208000035250 cutaneous malignant susceptibility to 1 melanoma Diseases 0.000 description 1
- 239000000824 cytostatic agent Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 150000005699 fluoropyrimidines Chemical class 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000003978 infusion fluid Substances 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 201000001441 melanoma Diseases 0.000 description 1
- SYSQUGFVNFXIIT-UHFFFAOYSA-N n-[4-(1,3-benzoxazol-2-yl)phenyl]-4-nitrobenzenesulfonamide Chemical class C1=CC([N+](=O)[O-])=CC=C1S(=O)(=O)NC1=CC=C(C=2OC3=CC=CC=C3N=2)C=C1 SYSQUGFVNFXIIT-UHFFFAOYSA-N 0.000 description 1
- 231100000417 nephrotoxicity Toxicity 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- HRGDZIGMBDGFTC-UHFFFAOYSA-N platinum(2+) Chemical compound [Pt+2] HRGDZIGMBDGFTC-UHFFFAOYSA-N 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 239000008174 sterile solution Substances 0.000 description 1
- 230000002381 testicular Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 238000010626 work up procedure Methods 0.000 description 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
- A61K9/0012—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
- 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
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Virology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CZ20032367A CZ300795B6 (cs) | 2003-09-02 | 2003-09-02 | Farmaceutická kompozice a zpusob její výroby |
| CZPV2003-2367 | 2003-09-02 | ||
| PCT/CZ2004/000053 WO2005020876A2 (en) | 2003-09-02 | 2004-08-31 | Pharmaceutical composition, method of manufacturing and therapeutic use thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2537610A1 true CA2537610A1 (en) | 2005-03-10 |
Family
ID=34256928
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002537610A Abandoned CA2537610A1 (en) | 2003-09-02 | 2004-08-31 | Pharmaceutical composition, method of manufacturing and therapeutic use thereof |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP1663106A2 (cs) |
| CA (1) | CA2537610A1 (cs) |
| CZ (1) | CZ300795B6 (cs) |
| PL (1) | PL366975A1 (cs) |
| RU (1) | RU2329052C2 (cs) |
| WO (1) | WO2005020876A2 (cs) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CZ300664B6 (cs) * | 2007-01-22 | 2009-07-15 | Pliva-Lachema A. S. | Sterilní kapalná farmaceutická kompozice a zpusob její výroby |
| US20100093849A1 (en) * | 2007-01-22 | 2010-04-15 | Borek Zaludek | Oxaliplatin pharmaceutical composition with alcoholic sugar-based buffer |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB8810173D0 (en) * | 1988-04-29 | 1988-06-02 | Norsk Hydro As | Pharmaceutical compositions with anti-cancer activity & method for treatment of cancer |
| AU5416394A (en) * | 1992-11-24 | 1994-06-22 | Debiopharm S.A. | Cisplatinum/oxaliplatinum combination |
| FR2740686B1 (fr) * | 1995-11-03 | 1998-01-16 | Sanofi Sa | Formulation pharmaceutique lyophilisee stable |
| GB9804013D0 (en) * | 1998-02-25 | 1998-04-22 | Sanofi Sa | Formulations |
| DK1154796T3 (da) * | 1999-02-22 | 2007-09-24 | Univ Connecticut | Nye albuminfrie Faktor VIII-formuleringer |
| KR100688217B1 (ko) * | 1999-08-30 | 2007-02-28 | 데비오 팜 소시에떼 아노님 | 비경구 투여용의 약학적으로 안정된 옥살리백금 약학제제 및 그 조제방법 |
| DE10314377A1 (de) * | 2003-03-28 | 2004-10-07 | Stada Arzneimittel Ag | Gebrauchsfertige Oxaliplatin-Lösungen |
-
2003
- 2003-09-02 CZ CZ20032367A patent/CZ300795B6/cs not_active IP Right Cessation
-
2004
- 2004-04-05 PL PL04366975A patent/PL366975A1/xx not_active Application Discontinuation
- 2004-08-31 EP EP04762305A patent/EP1663106A2/en not_active Withdrawn
- 2004-08-31 CA CA002537610A patent/CA2537610A1/en not_active Abandoned
- 2004-08-31 WO PCT/CZ2004/000053 patent/WO2005020876A2/en active Application Filing
- 2004-08-31 RU RU2006110563/15A patent/RU2329052C2/ru active
Also Published As
| Publication number | Publication date |
|---|---|
| WO2005020876A3 (en) | 2005-06-09 |
| WO2005020876A2 (en) | 2005-03-10 |
| PL366975A1 (en) | 2005-03-07 |
| RU2006110563A (ru) | 2006-08-10 |
| EP1663106A2 (en) | 2006-06-07 |
| CZ300795B6 (cs) | 2009-08-12 |
| RU2329052C2 (ru) | 2008-07-20 |
| CZ20032367A3 (cs) | 2005-04-13 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Dead |