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Volumn 65, Issue 2, 2011, Pages 166-176

A general assessment of the physiochemical factors that influence leachables accumulation in pharmaceutical drug products and related solutions

Author keywords

Extractables; Leachables; Material drug product interactions; Suitability for use

Indexed keywords

BENZOIC ACID DERIVATIVE; BENZYL ALCOHOL; DRUG; FATTY ACID; HEXANE; LEACHABLE; OCTANOL; ORGANIC COMPOUND; PHTHALIC ACID DIETHYL ESTER; PLASTIC; POLYOLEFIN; UNCLASSIFIED DRUG; SOLUTION AND SOLUBILITY;

EID: 83755207346     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (20)

References (24)
  • 1
    • 84855348651 scopus 로고    scopus 로고
    • A discussion of the physicochemical factors that regulate the leaching of organic substances from plastic contact materials into aqueous pharmaceutical solutions
    • Available at
    • Jenke, D. A discussion of the physicochemical factors that regulate the leaching of organic substances from plastic contact materials into aqueous pharmaceutical solutions. Am. Pharm. Rev. 2009. Available at http://www.americanpharamceuticalreview.com/ViewArticle.aspx? ContentID-4162&ID-4.
    • (2009) Am. Pharm. Rev.
    • Jenke, D.1
  • 2
    • 33144457121 scopus 로고    scopus 로고
    • A consideration of the impact of solution composition on the accumulation of organic substances leached from plastics used in container/closure systems
    • Jenke, D.; Couch, T. A consideration of the impact of solution composition on the accumulation of organic substances leached from plastics used in container/closure systems. PDA J. Pharm. Sci. Technol. 2006, 60 (1), 60 -71.
    • (2006) PDA J. Pharm. Sci. Technol. , vol.60 , Issue.1 , pp. 60-71
    • Jenke, D.1    Couch, T.2
  • 3
    • 0026808281 scopus 로고
    • Model for estimating the accumulation of solutes leaching from polymeric containers into parenteral solutions
    • Jenke, D. R.; Chess, E. K.; Zietlow, D. C.; Rabinow, B. E. Model for estimating the accumulation of solutes leaching from polymeric containers into parenteral solutions. Int. J. Pharm. 1992, 78 (2-3), 115-122.
    • (1992) Int. J. Pharm. , vol.78 , Issue.2-3 , pp. 115-122
    • Jenke, D.R.1    Chess, E.K.2    Zietlow, D.C.3    Rabinow, B.E.4
  • 4
    • 0027301681 scopus 로고
    • Evaluation of various solvent systems for modeling solute sorption with plasticized polyvinyl chloride materials
    • Jenke, D. R. Evaluation of various solvent systems for modeling solute sorption with plasticized polyvinyl chloride materials. J. Pharm. Sci. 1993, 82 (6), 617- 621.
    • (1993) J. Pharm. Sci. , vol.82 , Issue.6 , pp. 617-621
    • Jenke, D.R.1
  • 5
    • 0028360939 scopus 로고
    • Drug binding by reservoirs in elastomeric infusion devices
    • Jenke, D. R. Drug binding by reservoirs in elastomeric infusion devices. Pharm. Res. 1994, 11 (7), 984 -989.
    • (1994) Pharm. Res. , vol.11 , Issue.7 , pp. 984-989
    • Jenke, D.R.1
  • 6
    • 29244467958 scopus 로고    scopus 로고
    • The effect of solvent polarity on the accumulation of leachables from pharmaceutical product containers
    • Jenke, D. R. The effect of solvent polarity on the accumulation of leachables from pharmaceutical product containers. Eur. J. Pharm. Sci. 2006, 27 (2-3), 133-142.
    • (2006) Eur. J. Pharm. Sci. , vol.27 , Issue.2-3 , pp. 133-142
    • Jenke, D.R.1
  • 8
    • 55749089747 scopus 로고    scopus 로고
    • Strategy for development and characterization of HPLC methods to investigate extractables and leachables
    • Castner, J.; Anderson, J.; Benites, P. Strategy for development and characterization of HPLC methods to investigate extractables and leachables. Am. Pharm. Rev. 2007, 10 (3), 10, 12, 14, 16 -18.
    • (2007) Am. Pharm. Rev. , vol.10 , Issue.3
    • Castner, J.1    Anderson, J.2    Benites, P.3
  • 9
    • 68249101555 scopus 로고    scopus 로고
    • A strategy for determining leachables in liquid drug products
    • Castner, J.; Anderson, J.; Benites, P. A strategy for determining leachables in liquid drug products. Rubber World. 2009, 240 (3), 32-37, 39, 40.
    • (2009) Rubber World , vol.240 , Issue.3
    • Castner, J.1    Anderson, J.2    Benites, P.3
  • 10
    • 1342266260 scopus 로고    scopus 로고
    • Leaching of organic acids from irradiated EVA plastic as a function of solution pH and polarity
    • Jenke, D.; Zietlow, D.; Sadain, S. Leaching of organic acids from irradiated EVA plastic as a function of solution pH and polarity. PDA J. Pharm. Sci. Technol. 2004, 58 (1), 24 -31.
    • (2004) PDA J. Pharm. Sci. Technol. , vol.58 , Issue.1 , pp. 24-31
    • Jenke, D.1    Zietlow, D.2    Sadain, S.3
  • 11
    • 78149289014 scopus 로고    scopus 로고
    • Extraction of stearate salts from plastic materials used in pharmaceutical applications
    • Jenke, D. Extraction of stearate salts from plastic materials used in pharmaceutical applications. PDA J. Pharm. Sci. Technol. 2010, 64 (2), 200-210.
    • (2010) PDA J. Pharm. Sci. Technol. , vol.64 , Issue.2 , pp. 200-210
    • Jenke, D.1
  • 12
    • 0025752589 scopus 로고
    • Effect of solution phase composition on the interaction between aqueous model solutes and polymeric container materials
    • Jenke, D. R. Effect of solution phase composition on the interaction between aqueous model solutes and polymeric container materials. Pharm. Res. 1991, 8 (6), 782-786.
    • (1991) Pharm. Res. , vol.8 , Issue.6 , pp. 782-786
    • Jenke, D.R.1
  • 15
    • 0027292887 scopus 로고
    • Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components
    • Pearson, S. D.; Trissel, L. S. Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components. Am. J. Hosp. Pharm. 1993, 50 (7), 1405-1409.
    • (1993) Am. J. Hosp. Pharm. , vol.50 , Issue.7 , pp. 1405-1409
    • Pearson, S.D.1    Trissel, L.S.2
  • 16
    • 0025806342 scopus 로고
    • Stability, compatibility and plasticizer extraction of Taxol (NSC-125973) injection diluted in infusion solutions and stored in various containers
    • Waugh, W. N.; Trissel, L. A.; Stella, V. J. Stability, compatibility and plasticizer extraction of Taxol (NSC-125973) injection diluted in infusion solutions and stored in various containers. Am. J. Hosp. Pharm. 1991, 48 (7), 1520 -1524.
    • (1991) Am. J. Hosp. Pharm. , vol.48 , Issue.7 , pp. 1520-1524
    • Waugh, W.N.1    Trissel, L.A.2    Stella, V.J.3
  • 18
    • 0031052280 scopus 로고    scopus 로고
    • Compatibility of docetaxel and paclitaxel in intravenous solutions with polyvinyl chloride infusion materials
    • Mazzo, D. J.; Nguyen, J. J.; Pagniez, S.; Denis, P. Compatibility of docetaxel and paclitaxel in intravenous solutions with polyvinyl chloride infusion materials. Am. J. Hosp. Pharm. 1997, 54 (5): 566 -569.
    • (1997) Am. J. Hosp. Pharm. , vol.54 , Issue.5 , pp. 566-569
    • Mazzo, D.J.1    Nguyen, J.J.2    Pagniez, S.3    Denis, P.4
  • 19
    • 0035859990 scopus 로고    scopus 로고
    • Evaluation of model solvent systems for assessing the accumulation of container extractables in drug formulations
    • Jenke, D. R. Evaluation of model solvent systems for assessing the accumulation of container extractables in drug formulations. Int. J. Pharm. 2001, 224 (1-2), 51- 60.
    • (2001) Int. J. Pharm. , vol.224 , Issue.1-2 , pp. 51-60
    • Jenke, D.R.1
  • 20
    • 0027112191 scopus 로고
    • Solute migration through polypropylene blend films
    • Jenke, D. R. Solute migration through polypropylene blend films. J. Appl. Poly. Sci. 1992, 44 (7): 1223-1231.
    • (1992) J. Appl. Poly. Sci. , vol.44 , Issue.7 , pp. 1223-1231
    • Jenke, D.R.1
  • 21
    • 0025089044 scopus 로고
    • Determination of solute-polymer interaction properties and their application to parenteral product container compatibility evaluations
    • Kenley, R. A.; Jenke, D. R. Determination of solute-polymer interaction properties and their application to parenteral product container compatibility evaluations. Pharm. Res. 1990, 7 (9): 911-918. (Pubitemid 20349762)
    • (1990) Pharmaceutical Research , vol.7 , Issue.9 , pp. 911-918
    • Kenley, R.A.1    Jenke, D.R.2
  • 23
    • 83755195217 scopus 로고    scopus 로고
    • Commission Directive No. 2002/72/EC, August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs
    • European Commission, 15.8.2002
    • European Commission, 2002. Commission Directive No. 2002/72/EC, August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs. In Official Journal of the European Communities, L220/18, 15.8.2002.
    • (2002) Official Journal of the European Communities , vol.L220 , Issue.18
  • 24
    • 0025053747 scopus 로고
    • Influence of solute degradation on the accumulation of solutes migrating into solution from polymeric parenteral containers
    • Cruz, L. A.; Jenke, M. P.; Kenley, R. A.; Chen, M. J.; Jenke, D. R. Influence of solute degradation on the accumulation of solutes migrating into solution from polymeric parenteral containers. Pharm. Res. 1990, 7 (9), 967-972.
    • (1990) Pharm. Res. , vol.7 , Issue.9 , pp. 967-972
    • Cruz, L.A.1    Jenke, M.P.2    Kenley, R.A.3    Chen, M.J.4    Jenke, D.R.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.