SE445172B - Stabil, steril vattenlosning av cisplatin i enhetsdoseringsform - Google Patents
Stabil, steril vattenlosning av cisplatin i enhetsdoseringsformInfo
- Publication number
- SE445172B SE445172B SE7900774A SE7900774A SE445172B SE 445172 B SE445172 B SE 445172B SE 7900774 A SE7900774 A SE 7900774A SE 7900774 A SE7900774 A SE 7900774A SE 445172 B SE445172 B SE 445172B
- Authority
- SE
- Sweden
- Prior art keywords
- cisplatin
- concentration
- stable
- cis
- sterile
- Prior art date
Links
- DQLATGHUWYMOKM-UHFFFAOYSA-L cisplatin Chemical compound N[Pt](N)(Cl)Cl DQLATGHUWYMOKM-UHFFFAOYSA-L 0.000 title claims description 35
- 229960004316 cisplatin Drugs 0.000 title claims description 16
- 239000002552 dosage form Substances 0.000 title claims description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 title description 20
- 239000008223 sterile water Substances 0.000 title description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 31
- 239000000243 solution Substances 0.000 claims description 28
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 16
- 239000011780 sodium chloride Substances 0.000 claims description 16
- 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 14
- 229930195725 Mannitol Natural products 0.000 claims description 13
- 239000000594 mannitol Substances 0.000 claims description 13
- 235000010355 mannitol Nutrition 0.000 claims description 13
- 239000007864 aqueous solution Substances 0.000 claims description 6
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims description 2
- 231100000252 nontoxic Toxicity 0.000 claims description 2
- 230000003000 nontoxic effect Effects 0.000 claims description 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 2
- 239000003708 ampul Substances 0.000 description 16
- 238000002360 preparation method Methods 0.000 description 11
- 239000000047 product Substances 0.000 description 10
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 9
- ZMXDDKWLCZADIW-UHFFFAOYSA-N N,N-Dimethylformamide Chemical compound CN(C)C=O ZMXDDKWLCZADIW-UHFFFAOYSA-N 0.000 description 9
- 239000012299 nitrogen atmosphere Substances 0.000 description 9
- 239000000203 mixture Substances 0.000 description 8
- 239000000523 sample Substances 0.000 description 8
- 238000003860 storage Methods 0.000 description 8
- 206010028980 Neoplasm Diseases 0.000 description 7
- 238000000034 method Methods 0.000 description 7
- 238000004458 analytical method Methods 0.000 description 6
- 239000004809 Teflon Substances 0.000 description 5
- 229920006362 Teflon® Polymers 0.000 description 5
- 201000011510 cancer Diseases 0.000 description 5
- 239000012153 distilled water Substances 0.000 description 5
- 238000011049 filling Methods 0.000 description 5
- 238000004128 high performance liquid chromatography Methods 0.000 description 5
- 238000002347 injection Methods 0.000 description 5
- 239000007924 injection Substances 0.000 description 5
- 230000036515 potency Effects 0.000 description 5
- 238000003756 stirring Methods 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 4
- 239000008215 water for injection Substances 0.000 description 4
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 229910052782 aluminium Inorganic materials 0.000 description 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 3
- 238000002512 chemotherapy Methods 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 238000002425 crystallisation Methods 0.000 description 3
- 230000008025 crystallization Effects 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 238000011275 oncology therapy Methods 0.000 description 3
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Natural products CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 2
- 238000002835 absorbance Methods 0.000 description 2
- 239000002246 antineoplastic agent Substances 0.000 description 2
- 230000033228 biological regulation Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 238000004364 calculation method Methods 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 239000013078 crystal Substances 0.000 description 2
- 229940127089 cytotoxic agent Drugs 0.000 description 2
- -1 diamine tetrachloride Chemical class 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229940000406 drug candidate Drugs 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 238000004108 freeze drying Methods 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000002547 new drug Substances 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Substances [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 150000003058 platinum compounds Chemical class 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 239000003755 preservative agent Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 239000008227 sterile water for injection Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 231100000419 toxicity Toxicity 0.000 description 2
- 230000001988 toxicity Effects 0.000 description 2
- 238000013519 translation Methods 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- 206010065553 Bone marrow failure Diseases 0.000 description 1
- 206010006187 Breast cancer Diseases 0.000 description 1
- 201000000274 Carcinosarcoma Diseases 0.000 description 1
- 230000006820 DNA synthesis Effects 0.000 description 1
- 241000588724 Escherichia coli Species 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
- 238000010268 HPLC based assay Methods 0.000 description 1
- 206010025323 Lymphomas Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 208000001647 Renal Insufficiency Diseases 0.000 description 1
- 206010038540 Renal tubular necrosis Diseases 0.000 description 1
- 206010039491 Sarcoma Diseases 0.000 description 1
- 208000006268 Sarcoma 180 Diseases 0.000 description 1
- 231100000230 acceptable toxicity Toxicity 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 125000003277 amino group Chemical group 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 210000001185 bone marrow Anatomy 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
- 238000011088 calibration curve Methods 0.000 description 1
- 239000003183 carcinogenic agent Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- HGAZMNJKRQFZKS-UHFFFAOYSA-N chloroethene;ethenyl acetate Chemical compound ClC=C.CC(=O)OC=C HGAZMNJKRQFZKS-UHFFFAOYSA-N 0.000 description 1
- 229940048477 cisplatin 1 mg/ml Drugs 0.000 description 1
- 229940121657 clinical drug Drugs 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 238000011970 concomitant therapy Methods 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 150000004985 diamines Chemical class 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000009509 drug development Methods 0.000 description 1
- 238000009513 drug distribution Methods 0.000 description 1
- 239000000428 dust Substances 0.000 description 1
- 238000010410 dusting Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 208000010227 enterocolitis Diseases 0.000 description 1
- 239000005308 flint glass Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000003517 fume Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 201000003911 head and neck carcinoma Diseases 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 150000002484 inorganic compounds Chemical class 0.000 description 1
- 229910010272 inorganic material Inorganic materials 0.000 description 1
- 230000002452 interceptive effect Effects 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 201000006370 kidney failure Diseases 0.000 description 1
- 239000008176 lyophilized powder Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 229940126601 medicinal product Drugs 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- CLSUSRZJUQMOHH-UHFFFAOYSA-L platinum dichloride Chemical compound Cl[Pt]Cl CLSUSRZJUQMOHH-UHFFFAOYSA-L 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 238000011045 prefiltration Methods 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000001698 pyrogenic effect Effects 0.000 description 1
- 238000013139 quantization Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 238000005464 sample preparation method Methods 0.000 description 1
- 239000012488 sample solution Substances 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000012859 sterile filling Methods 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 231100000167 toxic agent Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 239000003440 toxic substance Substances 0.000 description 1
- 231100000041 toxicology testing Toxicity 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/243—Platinum; Compounds thereof
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US91032578A | 1978-05-30 | 1978-05-30 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SE7900774L SE7900774L (sv) | 1979-12-01 |
| SE445172B true SE445172B (sv) | 1986-06-09 |
Family
ID=25428626
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SE7900774A SE445172B (sv) | 1978-05-30 | 1979-01-29 | Stabil, steril vattenlosning av cisplatin i enhetsdoseringsform |
Country Status (32)
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4302446A (en) * | 1979-10-02 | 1981-11-24 | Bristol-Myers Company | Pharmaceutical compositions |
| CA1162479A (en) * | 1980-03-31 | 1984-02-21 | Murray A. Kaplan | Pharmaceutical formulations containing cisplatin |
| JPS5851959B2 (ja) * | 1980-06-11 | 1983-11-19 | 呉羽化学工業株式会社 | プラチナ化合物とその医薬組成物 |
| DE3046927A1 (de) | 1980-12-11 | 1982-07-15 | Josef Dipl.-Chem.Dr.rer.nat. 1000 Berlin Klosa | 8-dialkylaminoalkylaether-coffein-platin-komplexe , verfahren zu ihrer herstellung und sie enthaltende arzneimittel |
| IT1153974B (it) * | 1982-09-23 | 1987-01-21 | Erba Farmitalia | Composizioni farmacologiche a base di cisplatino e metodo per il loro ottenimento |
| DE3305248C2 (de) * | 1983-02-16 | 1987-04-09 | Degussa Ag, 6000 Frankfurt | Verfahren zur Reinigung von cis-Platin-(II)-diammin-dichlorid |
| NL8303657A (nl) * | 1983-10-24 | 1985-05-17 | Pharmachemie Bv | Voor injectie geschikte, stabiele, waterige, zoutzuur bevattende oplossing van cisplatine, alsmede werkwijze ter bereiding daarvan. |
| GB8501354D0 (en) * | 1985-01-18 | 1985-02-20 | Ici Plc | Effecting gas-liquid contact |
| IL85790A0 (en) * | 1988-03-20 | 1988-09-30 | Abic Ltd | Solution of carboplatin |
| FI895340A7 (fi) * | 1988-11-14 | 1990-05-15 | Bristol Myers Squibb Co | Hypertoninen cisplatin-liuos |
| FI904752A7 (fi) * | 1989-02-01 | 1990-09-27 | Kievsky Gosudarstvenny Inst | Kahden arvoisen platinan ja polymetyylisiloksaanin johdannaisia, menet elmä niiden valmistamiseksi ja johdannaisiin perustuva tuumorinvastain en lääkeaine |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4053587A (en) * | 1973-04-13 | 1977-10-11 | Research Corporation | Method of treating viral infections |
-
1979
- 1979-01-29 SE SE7900774A patent/SE445172B/sv not_active IP Right Cessation
- 1979-01-29 CA CA000320412A patent/CA1119954A/en not_active Expired
- 1979-01-30 DK DK39079A patent/DK149192C/da active
- 1979-01-30 IL IL56540A patent/IL56540A/xx unknown
- 1979-01-30 ZA ZA79395A patent/ZA79395B/xx unknown
- 1979-01-31 GB GB7903379A patent/GB2021946A/en not_active Expired - Lifetime
- 1979-01-31 CY CY1159A patent/CY1159A/en unknown
- 1979-01-31 NO NO790313A patent/NO149914C/no unknown
- 1979-02-01 IE IE194/79A patent/IE48177B1/en not_active IP Right Cessation
- 1979-02-01 AU AU43833/79A patent/AU519873B2/en not_active Expired
- 1979-02-02 PH PH22160A patent/PH18056A/en unknown
- 1979-02-02 NZ NZ189556A patent/NZ189556A/en unknown
- 1979-02-07 FI FI790404A patent/FI66121C/fi not_active IP Right Cessation
- 1979-02-09 CS CS79901A patent/CS226002B2/cs unknown
- 1979-02-09 JP JP1345479A patent/JPS54157817A/ja active Granted
- 1979-02-09 PT PT7969207A patent/PT69207A/pt unknown
- 1979-02-12 HU HU79BI583A patent/HU177557B/hu unknown
- 1979-02-19 NL NL7901283A patent/NL191108C/xx not_active IP Right Cessation
- 1979-02-21 DE DE2906700A patent/DE2906700C2/de not_active Expired
- 1979-03-01 CH CH201479A patent/CH619141A5/de not_active IP Right Cessation
- 1979-03-01 FR FR7905349A patent/FR2427097A1/fr active Granted
- 1979-03-02 ES ES478272A patent/ES478272A1/es not_active Expired
- 1979-03-02 BE BE0/193822A patent/BE874596A/xx not_active IP Right Cessation
- 1979-03-05 AT AT164879A patent/AT362052B/de not_active IP Right Cessation
- 1979-03-09 DD DD79211496A patent/DD142293A5/de not_active IP Right Cessation
- 1979-03-16 LU LU81056A patent/LU81056A1/xx unknown
- 1979-04-05 SU SU792747852A patent/SU1192596A3/ru active
- 1979-05-16 AR AR276542A patent/AR218134A1/es active
- 1979-05-29 IT IT49215/79A patent/IT1116893B/it active
-
1982
- 1982-08-14 KE KE3230A patent/KE3230A/xx unknown
- 1982-08-26 HK HK379/82A patent/HK37982A/en not_active IP Right Cessation
-
1983
- 1983-12-30 MY MY152/83A patent/MY8300152A/xx unknown
Also Published As
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