ES478272A1 - Un procedimiento para la preparacion de una solucion acuosa esteril y estable de cisplatina. - Google Patents
Un procedimiento para la preparacion de una solucion acuosa esteril y estable de cisplatina.Info
- Publication number
- ES478272A1 ES478272A1 ES478272A ES478272A ES478272A1 ES 478272 A1 ES478272 A1 ES 478272A1 ES 478272 A ES478272 A ES 478272A ES 478272 A ES478272 A ES 478272A ES 478272 A1 ES478272 A1 ES 478272A1
- Authority
- ES
- Spain
- Prior art keywords
- stable
- sterile aqueous
- procedure
- preparation
- cisplatin solution
- 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.)
- Expired
Links
- DQLATGHUWYMOKM-UHFFFAOYSA-L cisplatin Chemical compound N[Pt](N)(Cl)Cl DQLATGHUWYMOKM-UHFFFAOYSA-L 0.000 title abstract 4
- 229960004316 cisplatin Drugs 0.000 title abstract 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract 2
- 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 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- 239000003708 ampul Substances 0.000 abstract 1
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 238000001990 intravenous administration Methods 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 239000011780 sodium chloride Substances 0.000 abstract 1
- 239000000243 solution Substances 0.000 abstract 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)
Abstract
Un procedimiento para la preparación de una solución acuosa estéril y estable de cisplatina en un envase sellado, en forma de dosis unitaria, adecuada para la administración al hombre, teniendo esta solución una concentración de cisplatina comprendida entre aproximadamente 0,1 y 1,0 mg/ml y un pH del orden de 2,0 a 3,0 y opcionalmente una fuente inorgánica de iones cloruro y/o un excipiente; cuyo procedimiento comprende: a)introducir el 80% del volumen del lote de agua para inyección, en una vasija adecuada; b)agregar la fuente de iones cloruro, con agitación durante tiempo necesario para que se disuelva; c)ajustar cuidadosamente el pH de la solución procedente de la etapa anterior a 2,0 - 3,0, con la cantidad apropiada de un ácido no tóxico y terapéuticamente aceptable, y buena agitación; d) agregar a la solución obtenida, con agitación, el excipiente; e) con buena agitación y adoptando precauciones especiales contra la formación de polvo y la exposición agregar la cisplatina; f) agitar durante el tiempo necesario para que la cisplatina se disuelva completamente, comprobar el pH y agregar una cantidad adicional de ácido, si es necesario, para mantener el pH a 2,0 - 3,0; g) ajustar cuidadosamente el volumen al volumen teórico del lote con agua para inyección y realizar una comprobación final del pH; y h) pasar la solución por un filtro Millipore limpio estéril a la línea de llenado estéril
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US91032578A | 1978-05-30 | 1978-05-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES478272A1 true ES478272A1 (es) | 1980-06-16 |
Family
ID=25428626
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES478272A Expired ES478272A1 (es) | 1978-05-30 | 1979-03-02 | Un procedimiento para la preparacion de una solucion acuosa esteril y estable de cisplatina. |
Country Status (32)
| Country | Link |
|---|---|
| JP (1) | JPS54157817A (es) |
| AR (1) | AR218134A1 (es) |
| AT (1) | AT362052B (es) |
| AU (1) | AU519873B2 (es) |
| BE (1) | BE874596A (es) |
| CA (1) | CA1119954A (es) |
| CH (1) | CH619141A5 (es) |
| CS (1) | CS226002B2 (es) |
| CY (1) | CY1159A (es) |
| DD (1) | DD142293A5 (es) |
| DE (1) | DE2906700C2 (es) |
| DK (1) | DK149192C (es) |
| ES (1) | ES478272A1 (es) |
| FI (1) | FI66121C (es) |
| FR (1) | FR2427097A1 (es) |
| GB (1) | GB2021946A (es) |
| HK (1) | HK37982A (es) |
| HU (1) | HU177557B (es) |
| IE (1) | IE48177B1 (es) |
| IL (1) | IL56540A (es) |
| IT (1) | IT1116893B (es) |
| KE (1) | KE3230A (es) |
| LU (1) | LU81056A1 (es) |
| MY (1) | MY8300152A (es) |
| NL (1) | NL191108C (es) |
| NO (1) | NO149914C (es) |
| NZ (1) | NZ189556A (es) |
| PH (1) | PH18056A (es) |
| PT (1) | PT69207A (es) |
| SE (1) | SE445172B (es) |
| SU (1) | SU1192596A3 (es) |
| ZA (1) | ZA79395B (es) |
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 |
| AU541056B2 (en) * | 1980-03-31 | 1984-12-13 | Bristol-Myers Company | Pharmaceuticals formulations |
| 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 CA CA000320412A patent/CA1119954A/en not_active Expired
- 1979-01-29 SE SE7900774A patent/SE445172B/sv not_active IP Right Cessation
- 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 NO NO790313A patent/NO149914C/no unknown
- 1979-01-31 CY CY1159A patent/CY1159A/en unknown
- 1979-01-31 GB GB7903379A patent/GB2021946A/en not_active Expired - Lifetime
- 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 PT PT7969207A patent/PT69207A/pt unknown
- 1979-02-09 CS CS79901A patent/CS226002B2/cs unknown
- 1979-02-09 JP JP1345479A patent/JPS54157817A/ja active Granted
- 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 FR FR7905349A patent/FR2427097A1/fr active Granted
- 1979-03-01 CH CH201479A patent/CH619141A5/de not_active IP Right Cessation
- 1979-03-02 BE BE0/193822A patent/BE874596A/xx not_active IP Right Cessation
- 1979-03-02 ES ES478272A patent/ES478272A1/es not_active Expired
- 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
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