Stabilis - Monographie - Carboplatin

StabilisCarboplatin

Tradename

Acoplasic MexicoAxicarb GermanyBalidon ColombiaBlastocarb Chile, Colombia, Mexico, PeruBoplatex Colombia, Ecuador, MexicoCarbip MexicoCarbodex TurkeyCarboeen IndiaCarbokebir ArgentinaCarbokem IndiaCarbol PeruCarbomedac SwedenCarboplat Argentina, Germany, MexicoCarboplatin Australia, Austria, Belgium, Brazil,

Canada, Denmark, Egypt, Finland,Greece, Iceland, India, Iran, Ireland,Luxembourg, Morocco, New Zealand,Saudi Arabia, United States of America

Carboplatine France, Morocco, SwitzerlandCarboplatino Argentina, Chile, Colombia, SpainCarbosin Belgium, Egypt, Greece, MalaysiaCycloplatin Hungary, PolandEmorzym GreeceMegaplatin GreeceNuvaplast MexicoParaplatin Austria, Belgium, Denmark, Finland,

Great Britain, Greece, Hungary, Italy,Luxembourg, Mexico, Netherlands,Norway, Poland, Spain, Sweden,Switzerland, United Arab Emirates,United States of America

Paraplatine France, Morocco, TunisiaPlatinwas Spain

Stability in solutions

3.2 mg/ml 25°C 30 2244

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1 mg/ml 37°C 14 484

1 mg/ml 4°C 14 484

0,25 mg/ml 2-8°C 3 3830

0,25 mg/ml 25°C 24 3830

2 mg/ml 2-8°C 7 3830

2 mg/ml 25°C 24 3830

4 mg/ml 2-8°C 7 3830

4 mg/ml 25°C 2 3830

0,5 mg/ml 2-8°C 7 3341

0,5 mg/ml 25°C 7 3341

0,5 & 4 mg/ml 25°C 21 486

0,5 & 4 mg/ml 4°C 21 486

1 mg/ml 22°C 28 166

1 mg/ml 35°C 28 166

1 mg/ml 4°C 28 166

2,4 mg/ml 20°C-24°C 9 164

2.15 mg/ml 4°C 84 2203

5 mg/ml 2-8°C 7 3341

5 mg/ml 25°C 7 3341

6 mg/ml 37°C 14 1734

10 mg/ml 37°C 14 1734

0,2 mg/ml 20-25°C 24 4120

3.2 mg/ml 25°C 30 2244

0,72 mg/ml 21-22°C 72 1520

3.2 mg/ml 25°C 30 2244

0.7 & 2.15 mg/ml 4°C 84 2203

2 mg/ml 2-8°C 84 3670

1 mg/ml 22°C 28 166

1 mg/ml 35°C 28 166

1 mg/ml 4°C 28 166

10 mg/ml 37°C 24 645

10 mg/ml 4°C 120 645

10 mg/ml 25°C 8 1667


1 mg/ml 22°C 28 166

1 mg/ml 35°C 28 166

1 mg/ml 4°C 28 166

Stability of mixtures

0,5 mg/ml 20°C-23°C Granisetron hydrochloride : 0,5 mg/ml 4 57

2 mg/ml 25°C Acetyl L-carnitine : 15 mg/ml 4 3277

2,5 mg/ml ? Palonosetron hydrochloride : 25 µg/ml 4 1950

2 mg/ml 23°C Paclitaxel : 0,3 & 1,2 mg/ml 24 872



0,45 mg/ml 20°C-23°C Topotecan : 0,028 mg/ml 4 1026

Factors which affect stability

22422243224532863743

40933413830

2254

2253

3830

4205

Compatibility

Carboplatin : 5 mg/mlAmphotericin B cholesteryl sulfate complex : 0,83 mg/ml 921

Carboplatin : 5 mg/mlCaspofungin acetate : 0,7 mg/ml 2247


Carboplatin : 5 mg/ml 301Carboplatin : 5 mg/ml 1415Carboplatin : 5 mg/mlAllopurinol sodium : 3 mg/ml 307

Carboplatin : 1 mg/mlAmifostine : 10 mg/ml 3

Carboplatin : 5 mg/mlAmifostine : 10 mg/ml 3

Carboplatin : 5 mg/mlAnidulafungin : 0.5 mg/ml 1982

Carboplatin : 5 mg/mlAztreonam : 40 mg/ml 99

Carboplatin : 5 mg/mlCladribine : 0.5 mg/ml 1496

Carboplatin : 5 mg/mlCladribine : 0.015 mg/ml 1496

Carboplatin : 5 mg/mlDoripenem : 5 mg/ml 2262

Carboplatin : 5 mg/mlDoxorubicin hydrochloride liposome peg : 0.4 mg/ml 251

Carboplatin : 5 mg/mlEtoposide phosphate : 5 mg/ml 1410

Carboplatin : 5 mg/mlFilgrastim : 30 µg/ml 244

Carboplatin : 5 mg/mlFludarabine phosphate : 1 mg/ml 492

CarboplatinFluorouracil 3474

Carboplatin 3341Carboplatin 409Carboplatin : 100 mg/mlFluorouracil : 1000 mg/ml 163

Carboplatin : 5 mg/mlGemcitabine hydrochloride : 10 mg/ml 1423

Carboplatin : 1 mg/mlGranisetron hydrochloride : 1 mg/ml 57

Carboplatin : 5 mg/mlLansoprazole : 0.55 mg/ml 1625

Carboplatin : 5 mg/mlLinezolid : 2 mg/ml 1925

Carboplatin : 5 mg/mlMelphalan : 0.1 mg/ml 169

CarboplatinMesna 3602

Carboplatin : 5 mg/mlMicafungin : 1.5 mg/ml 2108

Carboplatin : 5 mg/mlOndansetron hydrochloride : 1 mg/ml 334

Carboplatin : 0,18 >> 9,9 mg/mlOndansetron hydrochloride : 0,016 >> 0,16 mg/ml 3574


Carboplatin : 5 mg/mlOxaliplatin : 0,5 mg/ml 1662

Carboplatin : 5 mg/mlPaclitaxel : 1.2 mg/ml 85

Carboplatin : 2 mg/mlPaclitaxel : 0,3 & 1,2 mg/ml 872

Carboplatin : 2.5 mg/mlPaclitaxel albumin : 5 mg/ml 4310

Carboplatin : 5 mg/mlPalonosetron hydrochloride : 50 µg/ml 1950

Carboplatin : 5 mg/mlPemetrexed disodium : 20 mg/ml 1953

Carboplatin : 5 mg/mlPiperacillin sodium / tazobactam : 40/5 mg/ml 81

Carboplatin : 5 mg/mlPropofol : 10 mg/ml 300

Carboplatin : 5 mg/mlSargramostim : 10 µg/ml 335

Carboplatin : 5 mg/mlTeniposide : 0.1 mg/ml 905

Carboplatin : 5 mg/mlThiotepa : 1 mg/ml 249

Carboplatin : 0.9 mg/mlTopotecan : 0.056 mg/ml 1026

Carboplatin : 5 mg/mlVinorelbine tartrate : 1 mg/ml 84

Route of administration

References

Type Publication3 Journal Trissel LA, Martinez JF.

Compatibility of amifostine with selected drugs during simulated Y-site administration.Am J Health-Syst Pharm 1995 ; 52: 2208-2212.

57 Journal Mayron D, Gennaro AR.Stability and compatibility of granisetron hydrochloride in IV solutions and oral liquids and during simulated Y-siteinjection with selected drugs.Am J Health-Syst Pharm 1996 ; 53: 294-304.

81 Journal Trissel LA, Martinez JF.Compatibility of piperacillin sodium plus tazobactam with selected drugs during simulated Y-site injection.Am J Hosp Pharm 1994 ; 51: 672-678.

84 Journal Trissel LA, Martinez JF.Visual, turbidimetric, and particle-content assessment of compatibility of vinorelbine tartrate with selected drugsduring simulated Y-site injection.Am J Hosp Pharm 1994 ; 51: 495-499.


85 Journal Trissel LA, Bready BB.Turbidimetric assessment of the compatibility of taxol with selected other drugs during simulated Y-site injection.Am J Hosp Pharm 1992 ; 49: 1716-1719.

99 Journal Trissel LA, Martinez JF.Compatibility of aztreonam with selected drugs during simulated Y-site administration.Am J Health-Syst Pharm 1995 ; 52: 1086-1090.

163 Journal Sewell GJ, Allsopp M, Collinson MP, Tyrrell C, Prentice AJ, Copplestone JA.Stability studies on admixtures of 5-fluorouracil with carboplatin and 5-fluorouracil with heparin for administrationin continuous infusion regimens.J Clin Pharm Ther 1994 ; 19: 127-133.

164 Journal Benaji B, Dine T, Luyckx M, Brunet C, Goudaliez F, Mallevais ML, Cazin M, Gressier B, Cazin JC.Stability and compatibility of cisplatin and carboplatin with PVC infusion bags.J Clin Pharm Ther 1994 ; 19: 95-100.

166 Journal Rochard E, Barthes D, Courtois P.Stability and compatibility study of carboplatin with three portable infusion pump reservoirs.Int J Pharm 1994 ; 101: 257-262.

169 Journal Trissel LA, Martinez JF.Physical compatibility of melphalan with selected drugs during simulated Y-site administration.Am J Hosp Pharm 1993 ; 50: 2359-2363.

244 Journal Trissel LA, Martinez JF.Compatibility of filgrastim with selected drugs during simulated Y-site administration.Am J Hosp Pharm 1994 ; 51: 1907-1913.

249 Journal Trissel LA, Martinez JF.Compatibility of thiotepa (lyophilized) with selected drugs during simulated Y-site administration.Am J Health-Syst Pharm 1996 ; 53: 1041-1045.

251 Journal Trissel LA, Gilbert DL, Martinez JF.Compatibility of doxorubicin hydrochloride liposome injection with selected other drugs during simulated Y-siteadministration.Am J Health-Syst Pharm 1997 ; 54: 2708-2713.

300 Journal Trissel LA, Gilbert DL, Martinez JF.Compatibility of propofol injectable emulsion with selected drugs during simulated Y-site administration.Am J Health-Syst Pharm 1997 ; 54: 1287-1292.

301 Journal Trissel LA, Gilbert DL, Martinez JF, Baker MB, Walter WV, Mirtallo JM.Compatibility of parenteral nutrient solutions with selected drugs during simulated Y-site administration.Am J Health-Syst Pharm 1997 ; 54: 1295-1300.

307 Journal Trissel LA, Martinez JF.Compatibility of allopurinol sodium with selected drugs during simulated Y-site administration.Am J Hosp Pharm 1994 ; 51: 1792-1799.

334 Journal Trissel LA, Tramonte SM, Grilley BJ.Visual compatibility of ondansetron hydrochloride with selected drugs during simulated Y-site injection.Am J Hosp Pharm 1991 ; 48: 988-992.

335 Journal Trissel LA, Bready BB, Kwan JW, Santiago NM.Visual compatibility of sargramostim with selected antineoplasic agents, anti-infectives, or other drugs duringsimulated Y-site injection.Am J Hosp Pharm 1992 ; 49: 402-406.

409 Journal Cheung YW, Cradock JC, Vishnuvajjala BR, Flora KP.Stability of cisplatin, iproplatin, carboplatin, and tetraplatin in commonly used intravenous solutions.Am J Hosp Pharm 1987 ; 44: 124-130.

484 Journal Northcott M, Allsopp MA, Powell H, Sewell GJ.The stability of carboplatin, diamorphine, 5-fluorouracil and mitozantrone infusions in an ambulatory pump understorage and prolonged “in use” conditions.J Clin Pharm Ther 1991 ; 16: 123-129.


486 Journal Diaz Amador F, Sevilla Azzati E, Herreros de Tajeda y Lopez-Coterilla A.Stability of carboplatin in polyvinyl chloride bags.Am J Health-Syst Pharm 1998 ; 55: 602, 604.

492 Journal Trissel LA, Parks NPT, Santiago NM.Visual compatibility of fludarabine phosphate with antineoplastic drugs, anti-infectives, and other selected drugsduring simulated Y-site injection.Am J Hosp Pharm 1991 ; 48: 2186-2189.

645 Journal Sewell GJ, Riley CM, Rowland CG.The stability of carboplatin in ambulatory continuous infusion regimes.J Clin Pharm Ther 1987 ; 12: 427-432.

872 Journal Zhang YP, Xu QA, Trissel LA, Gilbert DL, Martinez F.Compatibility and stability of paclitaxel combined with cisplatin and with carboplatin in infusion solutions.Ann Pharmacotherapy 1997 ; 31: 1465-1470.

905 Journal Trissel LA, Martinez JF.Screening teniposide for Y-site physical incompatibilities.Hosp Pharm 1994 ; 29: 1010-1017.

921 Journal Trissel LA, Gilbert DL, Martinez JF.Incompatibility and compatibility of amphotericin B cholesteryl sulfate complex with selected other drugs duringsimulated Y-site administration.Hosp Pharm 1998 ; 33: 284-292.

1026 Journal Mayron D, Gennaro AR.Stability and compatibility of topotecan hydrochloride with selected drugs.Am J Health-Syst Pharm 1999 ; 56: 875-881.

1410 Journal Trissel LA, Martinez JF, Simmons M.Compatibility of etoposide phosphate with selected drugs during simulated Y-site injection.J Am Pharm Assoc 1999 ; 39: 141-145.

1415 Journal Trissel L.A, Gilbert D.L, Martinez J.F, Baker M.B, Walter W.V, Mirtallo J.M.Compatibility of medications with 3-in-1 parenteral nutrition admixtures.JPEN 1999 ; 23: 67-74.

1423 Journal Trissel LA, Martinez JF, Gilbert DL.Compatibility of gemcitabine hyrochloride with 107 selected drugs during simulated Y-site injection.J Am Pharm Assoc 1999 ; 39: 514-518.

1496 Journal Trissel LA, Martinez JF, Gilbert DL.Screening cladribine for Y-site physical compatibility with selected drugs.Hosp Pharm 1996 ; 31: 1425-1428.

1520 Manufacturer Etude de stabilité des médicaments en Ecoflac®B Braun 2001

1625 Journal Trissel LA, Saenz C, Williams YW, Ingram D.Incompatibilities of lansoprazole injection with other drugs during simulated Y-site coadministration.Int J Pharm Compound 2001 ; 5: 314-321.

1662 Journal Trissel LA, Saenz CA, Ingram DS, Ogundele AB.Compatibility screening of oxaliplatin during simulated Y-site administration with other drugs.J Oncol Pharm Practice 2002 ; 8: 33-37.

1667 Journal Vali?re C, Arnaud P, Caroff E, Dauphin JF, Cl?ment G, Brion F.Stability and compatibility study of a carboplatin solution in syringes for continuous ambulatory infusion.Int J Pharm 1996 ; 138: 125-128.

1734 Journal Hadfield JA, McGown AT, Dawson MJ, Thatcher N, Fox BW.The suitability of carboplatin solutions for 14-day continuous infusion by ambulatory pump : an HPLC-dynamic FABstudy.J Pharm Biomed Anal 1993 ; 11: 723-727.


1925 Journal Trissel LA , Williams KY, Gilbert DL.Compatibility screening of linezolid injection during simulated Y-site administration with other drugs and infusionsolutions.J Am Pharm Assoc 2000 ; 40: 515-519.

1950 Journal Trissel LA, Yanping Z.Physical and chemical stability of palonosetron HCl with cisplatin, carboplatin and oxaliplatin during simulatedY-site administration.J Oncol Pharm Practice 2004 ; 10: 191-195.

1953 Journal Trissel LA, Saenz CA, Ogundele AB, Ingram DS.Physical compatibility of pemetrexed disodium with other drugs during simulated Y-site administration.Am J Health-Syst Pharm 2004 ; 61: 2289-2293.

1982 Journal Trissel LA, Ogundele AB.Compatibility of anidulafungin with other drugs during simulated Y-site administration.Am J Health-Syst Pharm 2005 ; 62: 834-837.

2108 Journal Trusley C, Kupiec TC, Trissel LA.Compatibility of micafungin injection with other drugs during simulated Y-site co-administration.Int J Pharm Compound 2006 ; 10: 230-232.

2203 Journal Kaestner S, Sewell G.A sequential temperature cycling study for the investigation of carboplatin infusion stability to facilitate'dose-banding'.J Oncol Pharm Practice 2007 ; 13: 119-126.

2242 Journal Lederer M, Leipzig-Pagani E.A note on the solution chemistry of carboplatin in aqueous solutions.Int J Pharm 1998 ; 167, 1-2: 223-228.

2243 Journal Pujol M, Girona V, Prat J, Munoz M, De Bolos J.Degradation pathway of carboplatin in aqueous solution.Int J Pharm 1997 ; 146: 263-269.

2244 Journal Prat J, Pujol M, Girona V, Munoz M, Sol? L-A.Stability of carboplatin in 5% glucose solution in glass, polyethylene and polypropylene containers.J Pharm Biomed Anal 1994 ; 12, 1: 81-84.

2245 Journal Torres F, Girona V, Puiol M, Prat J, de Bolos J.Stability of carboplatin in 5% glucose solution exposed to light.Int J Pharm 1996 ; 129: 275-277.

2247 Journal Chan P, Heatherly K, Kupiec T.C, Trissel L.A.Compatibility of caspofungin acetate injection with other drugs during simulated Y-site coadministration.Int J Pharm Compound 2008 ; 12, 3: 276-278.

2253 Journal Curis E, Provost K, Bouvet D, Nicolis I, Crauste-manciet S, Brossard D, B?nazeth S.Carboplatin and oxaliplatin decomposition in chloride medium, monitored by XAS.J Synchrotron Rad 2001 ; 8: 716-718.

2254 Journal Curis E, Provost K, Nicolis I, Bouvet D, B?nazeth S, Crauste-Manciet S, Brion F, Brossard D.Carboplatin decomposition in aqueous solution with chloride ions monitored by X-ray absorption spectroscopy.New J Chem 2000 ; 24: 1003-1008.

2262 Journal Brammer MK, Chan P, Heatherly K, Trusley C, Kupiec TC, Trissel LA, Psathas PA, Gilmor T, Schaufelberger D.Compatibility of doripenem with other drugs during simulated Y-site administratioNAm J Health-Syst Pharm 2008 ; 65: 1261-1265.

3277 Journal Yang Z, Cameron S, Paul H.Stability of Carboplatin, Paclitaxel, and Docetaxel with Acetyl-L-carnitine During Simulated Y-site Administration.Int J Pharm Compound 2012 ; 16, 1 : 82-85.

3286 Journal Okamoto Y, Tazumi K, Sanada Y, Tsugane M, Uejima E.Light-induced Deterioration Test of Carboplatin under Clinical Settings.Yakugaku Zasshi 2010 ; 130, 10: 1369-1374.


3341 Journal Trittler R, Jung B, Strehl E.Ist teurer immer auch besser? Analytiklabor der Apotheke unterstütz Einkauf sentcheidungen beiCarboplatin-Präparaten.Krankenhauspharmazie 2001 ; 7: 331-333.

3474 Manufacturer Fluorouracil - Summary of Product CharacteristicsAccord Healthcare Limited 2009

3574 Manufacturer Ondansetron - Résumé des caractéristiques du produitAccord Healthcare France SAS 2013

3602 Manufacturer Mesna (Uromitexan®)- Summary of Product CharacteristicsBaxter SAS 2013

3670 Journal Sewell G, Massimini M.Studies on the stability and compatibility of cytotoxic drug infusion with the Tevadaptor system.EJOP 2014 ; 8, 3: 26-30.

3743 Journal Allsopp M.A, Sewell G.J, Rowland C.G, Riley C.M, Schowen R.L.The degradation of carboplatin in aqueous solutions containing chloride or other selected nucleophiles.Int J Pharm 1991 ; 69: 197-210.

3830 Journal Myers A.Ls, Zhang Y-P, Kawedia L, Trinh V.A, Tran H, Smith J.A, Kramer M.A.Stability study of carboplatin infusion solutions in 0.9% sodium chloride in polyvinyl chloride bags.J Oncol Pharm Practice 2016 ; 22: 31-36.

4120 Journal Vazquez-Sanchez R, Sanchez-Rubio-Ferrandez J, Cordoba-Diaz D, Cordoba-Diaz M, Molina-Garcia T.Stability of carboplatin infusion solutions used in desensitization protocol. J Oncol Pharm Practice 2018 25,5:1076?1081

4205 Journal Choi S, O La H, Kim K, Kim S, Hwangbo S.Stability of Carboplatin in normal saline : dependence on initial dilution concentration and storage time.J Kor Soc Hosp Pharm 2006 ;23,3:219-224

4310 Journal Mizuta N, Nakagawa T, Yamamoto K, Nishioka T, Kume M, Makimoto H, Yano I, Minami H, Hiral M.Compatibility and Stability of Nab-Paclitaxel in Combination with Other Drugs.Kaohsiung J Med Sci 2017 ; 63, 1: E9-E16.


Dictionary

Anticancer drug InjectionTradename Stability in solutionsContainer MoleculeConcentration TemperatureStorage Length of timeBiosimilar Conflicting dataReferences Glass Glucose 5% Protect from lightDay Polyvinyl chlorideWater for Injection Sodium chloride 0,9%Light HourNone PolypropylenePolyethylene Not specifiedPolyolefine Ethylene vinyl acetatePolypropylen Syringe Polyisoprene elastomerStability of mixtures SolventCompound NaCl 0,9% or Glucose 5%Not specified Factors which affect stabilityInduces DegradationReduced stability IncreaseReduced concentration CompatibilityImmediate turbidity IncompatibleCompatible Parenteral nutrition (binary mixture)Parenteral nutrition (with lipids) NaCl 0,9% + antibacterialUnspecified incompatibility Chemical instabilityPrecipitation after 4 hours Route of administrationIntravenous infusion ReferencesDictionary


Documents

Stabilis - Monographie - Carboplatin