Stabilization of Pharmaceuticals to Oxidative Degradation

REFERENCES

• Solomons T.W.G. Organic Chemistry. 5th Ed., John Wiley and Sons, New York 1992; 449
   Google Scholar
• March J. Advanced Organic Chemistry. 4th Ed., John Wiley and Sons, New York 1992; 1158
   Google Scholar
• Menger F.M., Mandell L. Electronic Interpretation of Organic Chemistry. Plenum Press, New York 1980; 27
   Google Scholar
• , Brittain, H. Personal communication.
   Google Scholar
• Singh S., Bakshi M. Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs. Pharmacol. Technol. 2000; 1–14, (General references to stress tests, http://www.pharmaportal.com/articles)
   Google Scholar
• Alsante K.M., Friedmann R.C., Hatajik T.D., Lohr L.L., Sharp T.S., Snyder K.D., Szczesny E.J. S. Ahuja, S. ScypinskiDegradation and Impurity Analysis for Pharmaceutical Drug Candidates. Handbook of Modern Pharmaceutical Analysis, . Academic Press, Boston 2002, (General references to stress tests, Chapter 4)
   Google Scholar
• Carstensen J.T. Drug Stability Principles and Practices. 2nd Ed., Marcel Dekker, Inc., New York 1995; Vol. 68
   Google Scholar
• Hudlicky M. Oxidations in Organic Chemistry—186. American Chemical Society, Washington, DC 1990
   Google Scholar
• Boccardi G. Autoxidation of Drugs: Prediction of Degradation Impurities from Results with Radical Chain Initiators. Farmaco 1994; 49(6)431–435
   PubMedGoogle Scholar
• Howard J.A. Free Radicals. John Wiley and Sons, New York 1973; Vol. 2
   Google Scholar
• Porter N.A. Membrane Lipid Oxidation. CRC Press, Boca Raton 1990; Vol. 1
   Google Scholar
• Huyser E.S. Free Radical Chain Reactions. Wiley–Interscience, New York 1970
   Google Scholar
• Bard A.J., Faulkner L. Electrochemical Methods: Fundamentals and Applications. 2nd Ed., John Wiley and Sons, New York 2000; 479–480
   Google Scholar
• Wilson T.D. Structural Influences on the Amperometric Detection of Opiates in High Performance Liquid Chromatography. J. Chromatogr. 1984; 301: 39–46, Note that this potential is a polarographic half-wave potential
   PubMed Web of Science ®Google Scholar
• , Ryan, E.; Gamache, P.; Acworth, I.; ESA, Inc. Poster presented at the 43rd Pittsburgh Conference and Exposition, New Orleans, March 1992.
   Google Scholar
• Blessel K.W., Rudy B.C., Senkowski B.Z. Analytical Profiles of Drug Substances. Academic Press, New York 1974; Vol. 3: 127–147
   Google Scholar
• Risley D.S., Bopp R.J. Analytical Profiles of Drug Substances. Academic Press, New York 1990; Vol. 19: 193–219
   Google Scholar
• Rudy B.C., Senkowski B.Z. Analytical Profiles of Drug Substances. Academic Press, New York 1974; Vol. 3: 307–331
   Google Scholar
• Ranta V.-P., Urtti A., Auriola S. Gradient High-Performance Liquid Chromatography Analysis of Enkephalin Peptides, Their Metabolites and Enzyme Inhibitors Using Combined Ultraviolet and Electrochemical Detection. J. Chromatogr. Anal. 1997; 766: 85–97
   Google Scholar
• Connors K.A., Amidon G.L., Stella V.J. Chemical Stability of Pharmaceuticals: A Handbook for Pharmacists. 2nd Ed., John Wiley and Sons, New York 1986; 93–94, see also pp 161–808
   Google Scholar
• , Lombardo, F.; Campos, G.; Caldwell, C.J. Pfizer Corporation, unpublished results.
   Google Scholar
• Chan H.K., Fogg A.G. Voltammetric Determination of Phenylbutazone and Oxyphenylbutazone at a Glassy Carbon Electrode. Anal. Chim. Acta 1979; 109: 341–349
   Web of Science ®Google Scholar
• Oungpipat W., Southwell-Keely P., Alexander P.W. Flow Injection Detection of Tetracyclines by Electrocatalytic Oxidation at a Nickel-Modified Glassy Carbon Electrode. Analyst 1995; 120: 1559–1565
   Google Scholar
• Leeson L.J., Weidenheimer J.F. Stability of Tetracycline and Riboflavin. J. Pharm. Sci. 1969; 58: 355–357
   PubMedGoogle Scholar
• Kerr J.A. Bond Dissociation Energies by Kinetic Methods. Chem. Rev. 1966; 66(5)465–500
   Google Scholar
• Lowry T.H., Richardson K.S. Mechanism and Theory in Organic Chemistry. 3rd Ed., Harper and Row, New York 1987; 161–162
   Google Scholar
• Hoellering R., Gasteiger J., Steinhauer L., Schultz P.-P., Herwig A. Simulation of Organic Reactions from the Degradation of Chemicals to Combinatorial Synthesis. J. Chem. Inf. Comput. Sci. 2000; 40: 482–494
   PubMedGoogle Scholar
• Ihlenfeldt W.D., Gasteiger J. Computer Assisted Planning of Organic Synthesis: The Second Generation of Programs. Angew. Chem., Int. Ed. Engl. 1996; 34(23/24)2613–2633
   Web of Science ®Google Scholar
• Judson P.N., Lea H. Accessing Knowledge About Chemical Synthesis by Computer. Chim. Oggi 1996; 14(9)21–24
   Google Scholar
• , Available at http://www.epa.gov/oppt/exposure/docs/episuited/.htm<DLForm.htm>.
   Google Scholar
• Vogue P. Syracuse Research Corporation's Environmental Fate Data Bases. J. Chem. Inf. Comput. Sci. 1996; 36(3)615
   Google Scholar
• Jorgensen W.L., Laird E.R., Gushurst A.J., Fleischer J.M., Gothe S.A., Helson H.E., Pederes G.D., Sinclair S. cameo: A Program for the Logical Prediction of Products of Organic Reactions. Pure Appl. Chem. 1990; 62: 1921–1932
   Web of Science ®Google Scholar
• Walling C. Some Properties of Radical Reactions in Synthesis. Tetrahedron 1985; 41(19)3887–3900
   Google Scholar
• Howard J.A. Homogeneous Liquid Phase Autoxidations. Free Radic. 1973; 2: 3–62
   Google Scholar
• Maillard B., Ingold K.U., Scaiano J.C. Rate Constants for the Reactions of Free Radicals with Oxygen in Solution. J. Am. Chem. Soc. 1983; 105: 5095–5099
   Web of Science ®Google Scholar
• Von Sonntag C., Schuchmann H.-P. Z.B. AlfassiPeroxyl Radicals in Aqueous Solutions. Peroxyl Radicals, . John Wiley and Sons, New York 1997; 173–234
   Google Scholar
• , Porter, N. Personal communication.
   Google Scholar
• Ingold K.U. Peroxy Radicals. Acc. Chem. Res. 1969; 2(1)1–9
   Web of Science ®Google Scholar
• Russell G.A. Deuterium-Isotope Effects in the Autoxidation of Aralkyl Hydrocarbons. Mechanisms of the Interaction of Peroxy Radicals. J. Am. Chem. Soc. 1957; 79: 3871–3877
   Web of Science ®Google Scholar
• Cabelli D.E. The Reactions of HO2/O2− Radicals in Aqueous Solution. Peroxyl Radicals. Wiley, Chichester 1997; 407–437
   Google Scholar
• Rigo A., Scarpa M. Generation of Superoxide in the Autoxidation of Ascorbate and Glutathione. Oxygen Radicals in Chemistry and Biology. Walter de Gruyter and Co., Berlin 1984; 171–176
   Google Scholar
• Hartauer K.J., Arbuthnot G.N., Baetschi S.W., Johnson R.A., Luke W.D., Pearson N.G., Rickard E.C., Tingle C.A., Tsang P.K.S., Wiens R.E. Influence of Peroxide Impurities in Povidone and Crospovidone on the Stability of Raloxifene Hydrochloride in Tablets: Identification and Control of an Oxidative Degradation Product. Pharm. Dev. Technol. 2000; 5: 303–310
   PubMed Web of Science ®Google Scholar
• Buhler V. Kollidone. 2nd Ed., BASF Aktiengesellschaft, LudwigshafenGermany 1993
   Google Scholar
• , Union Carbide Customer Support Information.
   Google Scholar
• Dubost D.C., Kaufman M.J., Zimmerman J.A., Bogusky M.J., Coddington A.B., Pitzenberger S.M. Characterization of a Solid State Reaction Product from a Lyophilized Formulation of a Cyclic Heptapeptide. A Novel Example of an Excipient-Induced Oxidation. Pharm. Res. 1996; 13(12)1811–1814
   PubMed Web of Science ®Google Scholar
• Hancock B.C., Zografi G. Characteristics and Significance of the Amorphous State in Pharmaceutical Systems. J. Pharm. Sci. 1997; 86(1)1–12
   PubMed Web of Science ®Google Scholar
• Miller D.M., Buettner G.R., Aust S.D. Transition Metals as Catalysts for “Autoxidation” Reactions. Free Radic. Biol. Med. 1990; 8(1)95–108
   PubMed Web of Science ®Google Scholar
• Koppenol W.H. C.A. Rice-Evans, R.H. BurdonFree Radical Damage and Its Control. New Comprehensive Biochemistry, . Elsevier, Amsterdam 1994; 3–24
   Google Scholar
• Buettner G.R., Jurkiewicz B.A. Catalytic Metals, Ascorbate and Free Radicals: A Combination to Avoid. Radiat. Res. 1996; 145(5)532–541
   PubMed Web of Science ®Google Scholar
• Taqui Khan M.M., Matell A.E. 1974; vol 1: 143–149
   Google Scholar
• MacFaul P.A., Wayner D.D.M., Ingold K.U. Acc. Chem. Res. 1998; 31(4)159–162
   Google Scholar
• Roth H.J. Photochemistry and Pharmaceuticals. Farm Glas. 1968; 24(8–9)349–359
   Google Scholar
• Szwarc M., Streitwieser A., Mowery P.C. Ions and Ion Pairs in Organic Reactions. John Wiley and Sons, New York 1974; Vol. 2, Chapter 2
   Google Scholar
• Lowry T.H., Richardson K.S. Mechanism and Theory in Organic Chemistry. 3rd Ed., Harper and Row, New York 1987; 177–180
   Google Scholar
• Lowry T.H., Richardson K.S. Mechanism and Theory in Organic Chemistry. 3rd Ed., Harper and Row, New York 1987; 297–298
   Google Scholar
• R.C. WeastHandbook of Chemistry and Physics, . 52nd Ed., The Chemical Rubber Co., Ohio 1971
   Google Scholar
• Streitweiser A., Jr, Heathcock C.H. Introduction to Organic Chemistry. 2nd Ed., Macmillan Publishing Co., New York 1981; 938
   Google Scholar
• A.H. KibbeHandbook of Pharmaceutical Excipients, . 3rd Ed., American Pharmaceutical Association, Washington, DC 2000
   Google Scholar
• Byrn S.R., Pfeiffer R.R., Stowell J.G. Solid-State Chemistry of Drugs. 2nd Ed., SSCI, West Lafayette 1999
   Google Scholar
• Crowley P.J. Excipients as Stabilizers. Pharm. Sci. Technol. Today 1999; 2: 237–243
   PubMedGoogle Scholar
• Bennett J.E., Root K.D.J. Free Radicals in the Solid State. Electron Spin Reson. 1972; 1: 118–155
   Google Scholar
• , Garcia-Garibay, M. Personal communication.
   Google Scholar
• Duddu S.P., Weller K. Importance of Glass Transition Temperature in Accelerated Stability Testing of Amorphous Solids: Case Study Using a Lyophilized Aspirin Formulation. J. Pharm. Sci. 1996; 85: 345–347
   PubMed Web of Science ®Google Scholar
• Akers M.J. Preformulation Screening of Antioxidant Efficiency in Parenteral Solutions. J. Parenter. Drug Assoc. 1979; 33(6)346–356
   PubMedGoogle Scholar
• Parasrampuria J., Li L., Dudleston A., Zhang H. The Impact of an Autoclave Cycle on the Chemical Stability of Parenteral Products. J. Parenter. Sci. Technol. 1993; 47(4)177–179
   PubMedGoogle Scholar
• Akers J., Agalloco J. Sterility and Sterility Assurance PDA. J. Pharm. Sci. Technol. 1997; 51(2)27–77
   Google Scholar
• Duncan M.R., Wang P.L., Moldenhauer J.E. Determining the Capability of a Drug Product to Be Terminally Sterilized: A Case Study Involving a Heat-Sensitive, Oxygen Sensitive Drug Product. Pharm. Dev. Technol. 1998; 3(4)527–534
   PubMedGoogle Scholar
• Jacobs G.P. A Review of the Effects of Gamma Radiation on Pharmaceutical Materials. J. Biomater. Appl. 1995; 10(7)59–83
   PubMedGoogle Scholar
• Reid B.R. Gamma Processing Technology: An Alternative Technology for Terminal Sterilization of Parenterals. J. Pharm. Sci. Technol. 1995; 49(2)83–88
   Google Scholar
• Jacobs G.P. Gamma Radiation Sterilization. Encyclopedia of Pharmaceutical Technology. Marcel Dekker, Inc., New York 1992; 305–328
   Google Scholar
• Gopal N.G.S. Radiation Sterilization of Pharmaceuticals and Polymers. Radiat. Phys. Chem. 1978; 12: 35–50
   Web of Science ®Google Scholar
• Pandula E., Farkas E. Elimination of Gamma-Induced Radiation in Aqueous Pharmaceutical Preparations. Acta Pharm. Hung. 1969; 40: 165–169
   Google Scholar
• am Ende M.T., Peppas N.A. FTIR Spectroscopic Investigation and Modeling of Solute/Polymer Interactions in the Hydrated State. J. Biomater. Sci. Polym. Edn. 1999; 10: 1289–1302
   PubMed Web of Science ®Google Scholar
• Donbrow M. Stability of the Polyoxyethylene Chain. Surfactant Sci. Ser. 1987; 23(Nonionic Surfactants)1011–1073
   Google Scholar
• Cleland J.L., Powell M.F., Shire S.J. The Development of Stable Protein Formulations: A Close Look at Protein Aggregation, Deamidation, and Oxidation. Crit. Rev. Ther. Drug Carrier Sys. 1993; 10: 307–377
   PubMed Web of Science ®Google Scholar
• , Lai, M.C.; Topp, E.M. Solid-State Chemical Stability of Proteins and Peptides. J. Pharm. Sci. 1999, 88, 489–500.
   Google Scholar
• E.J. McNallyProtein Formulation and Delivery, . Marcel Dekker, Inc., New York 2000; 111–200
   Google Scholar
• Halliwell B., Gutteridge M.C. Role of Free Radicals and Catalytic Metal Ions in Human Disease: An Overview. Methods in Enzymology: Free Radicals and Metal Ions in Human Disease. Academic Press, New York 1990; Vol. 186: 1–85
   Google Scholar
• Means G.E., Feeney R.E. Chemical Modification of Proteins. Holden-Day, Inc., San Francisco 1971; 1–254
   Google Scholar
• Foote C.S. Mechanisms of Photosensitized Oxidation. Science 1968; 162(3857)963–970
   PubMedGoogle Scholar
• Matheson I.B.C., Lee J. Chemical Reaction Rates of Amino Acids with Singlet Oxygen. Photochem. Photobiol. 1979; 29(5)879–881
   Google Scholar
• Sluyterman L.A.Æ. Photooxidation, Sensitized by Proflavine, of a Number of Protein Constituents. Biochim. Biophys. Acta 1962; 60: 557–561
   PubMedGoogle Scholar
• Spikes J.D., Straight R. Sensitized Photochemical Processes in Biological Systems. Ann. Rev. Phys. Chem. 1967; 18: 409–436
   Web of Science ®Google Scholar
• Pikal M.J., Dellerman K., Roy M.L. Formulation and Stability of Freeze-Dried Proteins: Effects of Moisture and Oxygen on the Stability of Freeze-Dried Formulations of Human Growth Hormone. Dev. Biol. Stand. 1992; 74: 21–38
   PubMedGoogle Scholar
• McDermott M., Chiesa R., Roberts J.E., Dillon J. Photooxidation of Specific Residues in α-Crystallin Polypetides. Biochemistry 1991; 30(35)8653–8660
   PubMedGoogle Scholar
• Rietveld A.W.M., Ferreira S.T. Kinetics and Energetics of Subunit Dissociation/Unfolding of TIM: The Importance of Oligomerization for Conformational Persistence and Chemical Stability of Proteins. Biochemistry 1998; 37(3)933–937
   PubMedGoogle Scholar
• Xie M., Schowen R.L. Secondary Structure and Protein Deamidation. J. Pharm. Sci. 1999; 88(1)8–13
   PubMed Web of Science ®Google Scholar
• Farber J.M., Levine R.L. Sequence of Peptide Susceptible to Mixed Function Oxidation. Probable Cation Binding Site in Glutamine Synthetase. J. Biol. Chem. 1986; 261(10)4574–4578
   PubMedGoogle Scholar
• Hovorka S.W., Hong J., Cleland J.L., Schoeneich C. Metal-Catalyzed Oxidation of Human Growth Hormone: Modulation by Solvent-Induced Changes of Protein Conformations. J. Pharm. Sci. 2001; 90(1)58–69
   PubMedGoogle Scholar
• Stadtman E.R. Oxidation of Free Amino Acids and Amino Acid Residues in Proteins by Radiolysis and by Metal-Catalyzed Reactions. Ann. Rev. Biochem. 1993; 62: 797–821
   PubMed Web of Science ®Google Scholar
• Sanches R., Melo W.L.B., Columbo M.F. Effects of Hydration in the Oxygenation and Autoxidation of Carbonmonoxyhemoglobin Powder. Biochim. Biophys. Acta 1996; 874(1)19–22
   Google Scholar
• Karel M. R.B. DuckworthFree Radicals in Low Moisture Systems. Water Relations in Foods, Proceedings of International Symposium, . Academic Press, New York 1975; 435–453
   Google Scholar
• Smith J., Zhang Y., Niven R. Toward Development of a Non-viral Gene Therapeutic. Adv. Drug Deliv. Rev. 1997; 26(2,3)135–150
   PubMedGoogle Scholar
• Wolff J.A. Naked DNA Gene Transfer in Mammalian Cells. The Development of Human Gene Therapy. 1999; 279–307
   Google Scholar
• Evans R.K., Xu Z., Bohannon K.E., Wang B., Bruner M.W., Volkin D.B. Evaluation of Degradation Pathways for Plasmid DNA in Pharmaceutical Formulations via Accelerated Stability Studies. J. Pharm. Sci. 2000; 89(1)76–87
   PubMed Web of Science ®Google Scholar
• Anchordoquy T.J., Koe G.S. Physical Stability of Nonviral Plasmid-Based Therapeutics. J. Pharm. Sci. 2000; 89(3)289–296
   PubMed Web of Science ®Google Scholar
• Adami R.C., Collard W.T., Gupta S.A., Kwok K.Y., Bonadio J., Rice K.G. Stability of Peptide-Condensed Plasmid DNA Formulations. J. Pharm. Sci. 1998; 87(6)678–683
   PubMed Web of Science ®Google Scholar
• Lindahl T. Instability and Decay of the Primary Structure of DNA. Nature (Lond.) 1993; 362(6422)709–715
   PubMed Web of Science ®Google Scholar
• Aust A.E., Eveleigh J.F. Mechanisms of DNA Oxidation. Soc. Exp. Biol. Med. 1999; 222(3)246–251
   PubMedGoogle Scholar
• Núñez M.E., Hall D.B., Barton J.K. Long-Range Oxidative Damage to DNA: Effects of Distance and Sequence. Chem. Biol. 1999; 6(2)85–97
   PubMedGoogle Scholar
• Steenken S., Javanovic S.V. How Easily Oxidizable Is DNA? One-Electron Reductive Potentials of Adenosine and Guanosine Radicals in Aqueous Solution. J. Am. Chem. Soc. 1997; 119: 617–618
   Web of Science ®Google Scholar
• Viswanathan A., Doestsch P.W. Effects of Nonbulky DNA Base Damages on Escherichia coli RNA Polymerase-Mediated Elongation and Promoter Clearance. J. Biol. Chem. 1998; 273(33)21276–21281
   PubMed Web of Science ®Google Scholar
• Araki K., Silva C.A., Toma H.E., Catalani L.H., Medeiros M.H., Mascio P.D. Zinc Tetraruthenated Porphyrin Binding and Photoinduced Oxidation of Calf Thymus DNA. J. Inorg. Biochem. 2000; 78(4)269–273
   PubMedGoogle Scholar
• Middaugh C.R., Evans R.K., Montgomery D.L., Casimiro D.R. Analysis of Plasmid DNA from a Pharmaceutical Perspective. J. Pharm. Sci. 1998; 87(2)130–146
   PubMed Web of Science ®Google Scholar
• Thompson J.A. A Review of High-Performance Liquid Chromatography in Nucleic Acids Research III. Isolation, Purification and Analysis of Supercoiled Plasmid DNA. Biochromatography 1986; 1(2)68–71, (see also pp 74–80)
   Google Scholar
• de Carmejane O., Schwinefus J.J., Morris M.D. Plasmid Topoisomer Separation by Capillary Gel Electrophoresis. Proc. SPIE-Int. Soc. Opt. Eng. 1999; 3602(Advances in Fluorescence Sensing Technology IV)346–354
   Google Scholar
• Billany M.R., Khatib K., Gordon M., Sugden J.K. Alcohols and Ethanolamines as Hydroxyl Radical Scavengers. Int. J. Pharm. 1996; 137: 143–147
   Web of Science ®Google Scholar
• Gordon A.J., Ford R.A. The Chemists' Companion. John Wiley and Sons, New York 1972
   Google Scholar
• Wolff S.P. Ferrous Ion Oxidation in Presence of Ferric Ion Indicator Xylenol Orange for Measurement of Hydroperoxides. Methods Enzymol. 1994; 233: 182–189
   Web of Science ®Google Scholar
• Bruton G.W., Ingold K.U. Autoxidation of Biological Molecules. Antioxidant Activity of Vitamin E and Related Chain-Breaking Phenolic Antioxidants In Vitro. J. Am. Chem. Soc. 1981; 103(21)6472–6477
   Google Scholar
• Doba T., Burton G.W., Ingold K.U. EPR Spectra of Some α-Tocopherol Model Compounds. Polar and Conformational Effect and Their Relation to Antioxidant Activities. J. Am. Chem. Soc. 1983; 105(21)6505–6506
   Google Scholar
• Burton G.W., Doba T., Gabe E., Hughes L., Lee F.L., Prasad L., Ingold K.U. Autoxidation of Biological Molecules. Maximizing the Antioxidant Activity of Phenols. J. Am. Chem. Soc. 1985; 107(24)7053–7065
   Google Scholar
• Porter N.A. Mechanisms for the Autoxidation of Polyunsaturated Lipids. Acc. Chem. Res. 1986; 19(9)262–268
   Google Scholar
• Akers M.J. Antioxidants in Pharmaceutical Products. J. Parenter. Sci. Technol. 1982; 36(5)222–228
   PubMedGoogle Scholar
• Buettner G.R. Spin Trapping: ESR Parameters of Spin Adducts. Free Radic. Biol. Med. 1987; 3(4)259–303
   PubMed Web of Science ®Google Scholar
• Walling C. Fenton's Reagent Revisited. Acc. Chem. Res. 1975; 8(4)125–131
   Web of Science ®Google Scholar
• Rush J.D., Koppenol W.H. Oxidative Intermediates in the Reaction of Ferrous EDTA with Hydrogen Peroxide. Reactions with Organic Molecules and Ferrocytochrome c. J. Biol. Chem. 1986; 261: 6730–6733
   PubMed Web of Science ®Google Scholar
• Klaui H. Tocopherol, Carotene and Ascorbyl Palmitate. Int. Flavors Food Addit. 1976; 7: 165–171
   Google Scholar
• Acarturk F. The Effect of Cyclodextrines on the Physical and Chemical Stability of Drugs. Effect on Solid State Stability. FABAD Farm. Bilimler Derg. 1993; 18(2)77–85
   Google Scholar
• Lutz B., Volker M. Cyclodextrins—Molecular Capsules with Useful Cavities. Prax. Nuturwiss. Chem. 1990; 39: 10–17
   Google Scholar
• Duchene D., Debrueres B., Vaution C. Improvement of Drug Stability by Cyclodextrin Inclusion Complexation. S.T.P. Pharma 1985; 1: 37–43
   Google Scholar
• , Eastman Chemical Company product information on bottle polymer materials.
   Google Scholar
• Wang Y., Easteal A.J., Chen X.D. Ethylene and Oxygen Permeability Through Polyethylene Packaging Films. Packag. Technol. Sci. 1998; 11: 169–178
   Google Scholar
• Forcinio H. Choosing a Blister Material. Pharm. Technol. 2000; May: 26–30
   Google Scholar
• Taborsky C.J., Foster M.G., Lockhart H., Polgar B. Permeation of Unit-Dose Blister Market Containers Under USP and ICH Conditions. Pharm. Technol. 2000; August: 38–42
   Google Scholar
• Pilchik R. Pharmaceutical Blister Packaging, Part 1, Rationale and Materials. Pharm. Technol. 2000; November: 68–77
   Google Scholar
• Pavanetto F., Gento I., Conti B., Modena T., Montanori L. Investigation on the Contribution of Raw Materials and of the Primary Container on Aluminum, Cadmium and Lead Contamination of Large-Volume Parenteral Solutions. Int. J. Pharm. 1989; 54(2)143–148
   Google Scholar
• Avis K.E., Levchuk J.W. A.R. GennaroRemington: Science and Practice of Pharmacy, . 19th Ed., Mack Publishing Co., Easton, PA 1995; Vol. 2: 1531
   Google Scholar
• Sanga S.V. Review of Glass Types Available for Packaging Parenteral Solutions. J. Parenter. Drug Assoc. 1979; 33(2)61–67
   PubMedGoogle Scholar
• Roseman T.J., Brown J.A., Scothorn W.W. Glass for Parenteral Products: A Surface View Using the Scanning Electron Microscope. J. Pharm. Sci. 1976; 65(1)22–29
   PubMedGoogle Scholar
• Bontempo J.A. Considerations for Elastomeric Closures for Parenteral Biopharmaceutical Drugs. Drugs Pharm. Sci. 1997; 85(Development of Biopharmaceutical Parenteral Dosage Forms)223–240
   Google Scholar
• Airaudo C.B., Gayte-Sorbier A., Memburg R., Laurent P. Leaching of Antioxidants and Vulcanization Accelerators from Rubber Closures into Drug Preparations. J. Biomater. Sci. Polym. Ed. 1990; 1(4)231–241
   PubMedGoogle Scholar
• Danielson J.W., Oxborrow G.S., Placencia A.M. Quantitative Determination of Chemicals Leached from Rubber Stoppers into Parenteral Solutions. J. Parenter. Sci. Technol. 1984; 38(3)90–93
   PubMedGoogle Scholar
• Danielson J.N., Oxborrow G.S., Placencia A.M. Chemical Leaching of Rubber Stoppers into Parenteral Solutions. J. Parenter. Sci. Technol. 1983; 37(3)89–92
   PubMedGoogle Scholar
• , Physicians' Desk Reference (Online). Medical Economics Co.: Montvale, NJ, 2000.
   Google Scholar