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LIU Xiaohui, YIN Hui, YAN Fang, DI Bin. Compatibility of pre-filled syringes with pharmaceutical products[J]. Journal of China Pharmaceutical University, 2016, 47(3): 275-281. DOI: 10.11665/j.issn.1000-5048.20160304
Citation: LIU Xiaohui, YIN Hui, YAN Fang, DI Bin. Compatibility of pre-filled syringes with pharmaceutical products[J]. Journal of China Pharmaceutical University, 2016, 47(3): 275-281. DOI: 10.11665/j.issn.1000-5048.20160304
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Compatibility of pre-filled syringes with pharmaceutical products

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    • Abstract
  • Pre-filled syringes are becoming increasingly popular for packaging and delivering system of pharmaceutical products. However, their compatibility with biotherapeutics needs to be carefully assessed. This review highlights and makes critically review on the extractables and leachables, the safety evaluation and analytical methods related to the compatibility study.
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  • [1]
    Roots Analysis.Prefilled syringes market,2015-2025[EB/OL].http://www.rootsanalysis.com/reports/view_document/prefilled-syringes-market-3rd-edition-2015-2025/99.html.
    [2]
    Ingle RG, Agarwal AS. Pre-filled syringe—a ready-to-use drug delivery system:a review[J].Expert Opin Drug Deliv,2014,11(9):1391-1399.
    [3]
    FDA.Guidance for industry container closure systems for packaging human drugs and biologics[EB/OL].http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070551.pdf.
    [4]
    Wang W,Ignatius AA,Thakkar SV.Impact of residual impurities and contaminants on protein stability[J].J Pharm Sci,2014,103(5):1315-1330.
    [5]
    China Food and Drug Administraion.Technical guidelines for the research on the compatibility of chemical medicine injection and plastic packing materials(化学药品注射剂与塑料包装材料相容性研究技术指导原则)[S].2012.
    [6]
    Jenke D,Castner J,Egert T,et al.Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products[J].PDA J Pharm Sci Technol,2013,67(5):448-511.
    [7]
    EMEA.Guideline on plastic immediate packaging materials[EB/OL].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003448.pdf.
    [8]
    Jenke D,Liu N,Hua Y,et al.A means of establishing and justifying binary ethanol/water mixtures as simulating solvents in extractables studies[J].PDA J Pharm Sci Technol,2015,69(3):366-382.
    [9]
    Zhou SX, Schoneich C, Singh SK. Biologics formulation factors affecting metal leachables from stainless steel[J].AAPS PharmSci Tech,2011,12(1):411-421.
    [10]
    Jenke D.The Prototype Stage[M].John Wiley & Sons Inc,2008:157-190.
    [11]
    Jenke DR.Extractables and leachables considerations for prefilled syringes[J].Expert Opin Drug Deliv,2014,11(10):1591-1600.
    [12]
    Jenke D,Odufu A,Couch T,et al.Evaluation of the general solution compatibility of polymer materials used in medical devices such as syringes[J].PDA J Pharm Sci Technol,2012,66(4):286-306.
    [13]
    Jenke D.Safety risk categorization of organic extractables associated with polymers used in packaging,delivery and manufacturing systems for parenteral drug products[J].Pharm Res,2015,32(3):1105-1127.
    [14]
    Paskiet D,Jenke D,Ball D,et al.The product quality research institute(PQRI)leachables and extractables working group initiatives for parenteral and ophthalmic drug product(PODP)[J].PDA J Pharm Sci Technol,2013,67(5):430-447.
    [15]
    China Food and Drug Administraion.Technical guidelines for the research on the compatibility of chemical medicine injection and glass packing container(化学药品注射剂与药用玻璃包装容器相容性研究技术指导原则)[S].2015.
    [16]
    Norwood DL,Stults CLM,Nagao LM.Analytical Best Practices for The Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products[M].John Wiley & Sons,Inc.,2012:153-183.
    [17]
    Jiang YJ,Nashed-Samuel Y,Ll C,et al.Tungsten-induced protein aggregation:solution behavior[J].J Pharm Sci,2009,98(12):4695-4710.
    [18]
    Seidl A,Hainzl O,Richter M,et al.Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity[J].Pharm Res,2012,29(6):1454-1467.
    [19]
    Jezek J,Darton NJ,Derham BK,et al.Biopharmaceutical formulations for pre-filled delivery devices[J].Expert Opin Drug Deliv,2013,10(6):811-828.
    [20]
    Mensch CD, Davis HB. Inhibition of tungsten-induced protein aggregation by cetyl trimethyl ammonium bromide[J].PDA J Pharm Sci Technol,2012,66(1):2-11.
    [21]
    Felsovalyi F,Janvier S,Jouffray S,et al.Silicone-oil-based subvisible particles:their detection,interactions,and regulation in prefilled container closure systems for biopharmaceuticals[J].J Pharm Sci,2012,101(12):4569-4583.
    [22]
    Chisholm CF,Nguyen BH,Soucie KR,et al.In vivo analysis of the potency of silicone oil microdroplets as immunological adjuvants in protein formulations[J].J Pharm Sci,2015,104(11):3681-3690.
    [23]
    Gerhardt A,Nguyen BH,Lewus R,et al.Effect of the siliconization method on particle generation in a monoclonal antibody formulation in pre-filled syringes[J].J Pharm Sci,2015,104(5):1601-1609.
    [24]
    Majumdar S,Ford BM,Mar KD,et al.Evaluation of the effect of syringe surfaces on protein formulations[J].J Pharm Sci,2011,100(7):2563-2573.
    [25]
    Varmette E,Strony B,Haines D,et al.An assay for measurement of protein adsorption to glass vials[J].PDA J Pharm Sci Technol,2010,64(4):305-315.
    [26]
    Becherer T,Grunewald C,Engelschalt V,et al.Polyglycerol based coatings to reduce non-specific protein adsorption in sample vials and on spr sensors[J].Anal Chim Acta,2015,867:47-55.
    [27]
    Eu B, Cairns A, Ding G, et al. Direct visualization of protein adsorption to primary containers by gold nanoparticles[J].J Pharm Sci,2011,100(5):1663-1670.
    [28]
    Joshi O,McGuire J,Wang DQ.Adsorption and function of recombinant factor viii at solid-water interfaces in the presence of tween-80[J].J Pharm Sci,2008,97(11):4741-4755.
    [29]
    Ball D,Blanchard J,Jacobson-Kram D,et al.Development of safety qualification thresholds and their use in orally inhaled and nasal drug product evaluation[J].Toxicol Sci,2007,97(2):226-236.
    [30]
    Norwood DL, Nagao LM, Stults CLM. Perspectives on the pqri extractables and leachables “safety thresholds and best practices” recommendations for inhalation drug products[J].PDA J Pharm Sci Technol,2013,67(5):413-429.
    [31]
    EMEA.Guideline on the limits of genotoxic impurities[EB/OL].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002903.pdf.
    [32]
    Ma Y,Ma L,Jiang Y.Interpretation of the guideline of compatibility study of pharmaceutical products and packaging materials-the assessment of experimental data[J].Chin New Drugs J(中国新药杂志),2014,23(8):940-943.
    [33]
    Markovic I.Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products:a risk-based perspective[J].Expert Opin Drug Saf,2007,6(5):487-491.
    [34]
    Mueller R,Karle A,Vogt A,et al.Evaluation of the immuno-stimulatory potential of stopper extractables and leachables by using dendritic cells as readout[J].J Pharm Sci,2009,98(10):3548-3561.
    [35]
    Fan NQ,Lin YH.Study on measuring method of medicinal media materials by total organic carbon meter[J].Chin J Pharm Anal(药物分析杂志),2011,31(7):1330-1332.
    [36]
    Fujimori K,Lee H,Phillips J,et al.Development of an inductively coupled plasma mass spectrometry method for quantification of extracted tungsten from glass prefilled syringes used as a primary packaging for pharmaceutical and therapeutic protein products[J].PDA J Pharm Sci Technol,2013,67(6):670-679.
    [37]
    Zhou SX,Evans B,Schoneich C,et al.Biotherapeutic formulation factors affecting metal leachables from stainless steel studied by design of experiments[J].AAPS PharmSciTech,2012,13(1):284-294.
    [38]
    Manta B,Obal G,Ricciardi A,et al.Tools to evaluate the conformation of protein products[J].Biotechnol J,2011,6(6):731-741.
    [39]
    Jones LS,Kaufmann A,Middaugh CR.Silicone oil induced aggregation of proteins[J].J Pharm Sci,2005,94(4):918-927.
    [40]
    Yuan Y, Zhang W, Dai JH, et al. Studies on the interaction between malanin and metal ions by fluorescence spectra methods[J].Spectrosc Spect Anal,2014,34(12):3297-3300.
    [41]
    Gerhardt A,Bonam K,Bee JS,et al.Ionic strength affects tertiary structure and aggregation propensity of a monoclonal antibody adsorbed to silicone oil-water interfaces[J].J Pharm Sci,2013,102(2):429-440.
    [42]
    Atici EB,Karliga B.Quantitative determination of two polymorphic forms of imatinib mesylate in a drug substance and tablet formulation by X-ray powder diffraction,differential scanning calorimetry and attenuated total reflectance fourier transform infrared spectroscopy[J].J Pharm Biomed,2015,114:330-340.
    [43]
    Narhi LO,Schmit J,Bechtold-Peters K,et al.Classification of protein aggregates[J].J Pharm Sci,2012,101(2):493-498.
    [44]
    Narhi LO,Jiang Y,Cao S,et al.A critical review of analytical methods for subvisible and visible particles[J].Curr Pharm Biotechnol,2009,10(4):373-381.
    [45]
    Philo JS.A critical review of methods for size characterization of non-particulate protein aggregates[J].Curr Pharm Biotechnol,2009,10(4):359-372.
    [46]
    Sitar S,Kejzar A,Pahovnik D,et al.Size characterization and quantification of exosomes by asymmetrical-flow field-flow fractionation[J].Anal Chem,2015,87(18):9225-9233.
    [47]
    U.S.Pharmacopeial Convention.The United States Pharmacopeia 36-The National Formulary 31:volume 1[M].Baltimore:United Book Press Inc,2013:350-353.
    [48]
    Chinese Pharmacopoeia Commission.China Pharmacopoeia:part 4(中华人民共和国药典:四部)[S].Beijing:China Medical Science Press,2015:114-115.
    [49]
    Levin I,Zigman S,Komlosh A,et al.Development of flow imaging analysis for subvisible particle characterization in glatiramer acetate[J].J Pharm Sci,2015,104(11):3977-3983.
    [50]
    Yusko EC,Prangkio P,Sept D,et al.Single-particle characterization of a beta oligomers in solution[J].ACS Nano,2012,6(7):5909-5919.
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