Journal of Pharmaceutical Sciences

Copyright © 2012 Wiley Periodicals Inc. and the American Pharmacists Association

Cover image for Journal of Pharmaceutical Sciences

Special Issue: Dedicated to Michael J. Pikal

September 2009

Volume 98, Issue 9

Pages 2869–3498

  1. Commentaries

    1. Top of page
    2. Commentaries
    3. Reviews
    4. Research Articles
    5. Note
    1. Professor Michael J. Pikal: Scientist, family man, educator, colleague and friend (pages 2869–2874)

      Steven Nail

      Article first published online: 4 JUN 2009 | DOI: 10.1002/jps.21804

    2. Current status of amorphous formulation and other special dosage forms as formulations for early clinical phases (pages 2875–2885)

      Kohsaku Kawakami

      Article first published online: 16 JUL 2009 | DOI: 10.1002/jps.21816

  2. Reviews

    1. Top of page
    2. Commentaries
    3. Reviews
    4. Research Articles
    5. Note
    1. Mechanisms of protein stabilization in the solid state (pages 2886–2908)

      Liuquan (Lucy) Chang and Michael J. Pikal

      Article first published online: 30 JUN 2009 | DOI: 10.1002/jps.21825

    2. Protein aggregation: Pathways, induction factors and analysis (pages 2909–2934)

      Hanns-Christian Mahler, Wolfgang Friess, Ulla Grauschopf and Sylvia Kiese

      Article first published online: 29 SEP 2008 | DOI: 10.1002/jps.21566

    3. Local mobility in amorphous pharmaceuticals—characterization and implications on stability (pages 2935–2953)

      Sisir Bhattacharya and Raj Suryanarayanan

      Article first published online: 4 JUN 2009 | DOI: 10.1002/jps.21728

  3. Research Articles

    1. Top of page
    2. Commentaries
    3. Reviews
    4. Research Articles
    5. Note

    1. Biotechnology

      Mixing properties of lyophilized protein systems: A spectroscopic and calorimetric study (pages 2954–2969)

      Derrick S. Katayama, John F. Carpenter, Kevin P. Menard, Mark Cornell Manning and Theodore W. Randolph

      Article first published online: 11 JUL 2008 | DOI: 10.1002/jps.21467

    2. Stability of a trivalent recombinant protein vaccine formulation against botulinum neurotoxin during storage in aqueous solution (pages 2970–2993)

      Christina Vessely, Tia Estey, Theodore W. Randolph, Ian Henderson, Julianne Cooper, Rajiv Nayar, LaToya Jones Braun and John F. Carpenter

      Article first published online: 4 AUG 2008 | DOI: 10.1002/jps.21498

    3. Evaluation of chemical degradation of a trivalent recombinant protein vaccine against botulinum neurotoxin by LysC peptide mapping and MALDI-TOF mass spectrometry (pages 2994–3012)

      Tia Estey, Christina Vessely, Theodore W. Randolph, Ian Henderson, LaToya Jones Braun, Rajiv Nayar and John F. Carpenter

      Article first published online: 9 SEP 2008 | DOI: 10.1002/jps.21543

    4. Elucidation of two major aggregation pathways in an IgG2 antibody (pages 3013–3030)

      Nicholas Van Buren, Douglas Rehder, Himanshu Gadgil, Masazumi Matsumura and Jaby Jacob

      Article first published online: 4 AUG 2008 | DOI: 10.1002/jps.21514

    5. Conformational implications of an inversed pH-dependent antibody aggregation (pages 3031–3042)

      Natalie Perico, Judith Purtell, Thomas M. Dillon and Margaret S. Ricci

      Article first published online: 19 SEP 2008 | DOI: 10.1002/jps.21539

    6. Liquid high concentration IgG1 antibody formulations by precipitation (pages 3043–3057)

      Susanne Matheus, Wolfgang Friess, Daniel Schwartz and Hanns-Christian Mahler

      Article first published online: 29 SEP 2008 | DOI: 10.1002/jps.21526

    7. Quantitation of protein particles in parenteral solutions using micro-flow imaging (pages 3058–3071)

      Chi-Ting Huang, Deepak Sharma, Peter Oma and Rajesh Krishnamurthy

      Article first published online: 20 OCT 2008 | DOI: 10.1002/jps.21575

    8. Freeze-dry microscopy of protein/sugar mixtures: Drying behavior, interpretation of collapse temperatures and a comparison to corresponding glass transition Data (pages 3072–3087)

      Eva Meister and Henning Gieseler

      Article first published online: 29 SEP 2008 | DOI: 10.1002/jps.21586

    9. Temperature scanning FTIR analysis of secondary structures of proteins embedded in amorphous sugar matrix (pages 3088–3098)

      Koreyoshi Imamura, Ken-ichi Ohyama, Toru Yokoyama, Yoshinobu Maruyama and Nakanishi Kazuhiro

      Article first published online: 13 NOV 2008 | DOI: 10.1002/jps.21568

    10. Adsorption and function of recombinant Factor VIII at the air–water interface in the presence of Tween 80 (pages 3099–3107)

      Omkar Joshi, Liping Chu, Joseph McGuire and D.Q. Wang

      Article first published online: 9 SEP 2008 | DOI: 10.1002/jps.21569

    11. Viscoelastic characterization of high concentration antibody formulations using quartz crystal microbalance with dissipation monitoring (pages 3108–3116)

      Ankit R. Patel, Bruce A. Kerwin and Sekhar R. Kanapuram

      Article first published online: 24 NOV 2008 | DOI: 10.1002/jps.21610

    12. Characterization of the photodegradation of a human IgG1 monoclonal antibody formulated as a high-concentration liquid dosage form (pages 3117–3130)

      Pei Qi, David B. Volkin, Hui Zhao, Michael L. Nedved, Robert Hughes, Ryan Bass, Sun C. Yi, Mark E. Panek, Dana Wang, Paul DalMonte and Michael D. Bond

      Article first published online: 13 NOV 2008 | DOI: 10.1002/jps.21617

    13. Impact of sucrose level on storage stability of proteins in freeze-dried solids: I. correlation of protein–sugar interaction with native structure preservation (pages 3131–3144)

      Bingquan Wang, Serguei Tchessalov, Nicholas W. Warne and Michael J. Pikal

      Article first published online: 9 DEC 2008 | DOI: 10.1002/jps.21621

    14. Impact of sucrose level on storage stability of proteins in freeze-dried solids: II. Correlation of aggregation rate with protein structure and molecular mobility (pages 3145–3166)

      Bingquan Wang, Serguei Tchessalov, Marcus T. Cicerone, Nicholas W. Warne and Michael J. Pikal

      Article first published online: 9 DEC 2008 | DOI: 10.1002/jps.21622

    15. Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution (pages 3167–3181)

      Renuka Thirumangalathu, Sampathkumar Krishnan, Margaret Speed Ricci, David N. Brems, Theodore W. Randolph and John F. Carpenter

      Article first published online: 9 APR 2009 | DOI: 10.1002/jps.21719

    16. Light-induced aggregation of type I soluble tumor necrosis factor receptor (pages 3182–3199)

      Shouvik Roy, Bruce D. Mason, Christian S. Schöneich, John F. Carpenter, Thomas C. Boone and Bruce A. Kerwin

      Article first published online: 21 APR 2009 | DOI: 10.1002/jps.21750

    17. Physical and biophysical effects of polysorbate 20 and 80 on darbepoetin alfa (pages 3200–3217)

      Songpon Deechongkit, Jie Wen, Linda O. Narhi, Yijia Jiang, Sungae S. Park, Justin Kim and Bruce A. Kerwin

      Article first published online: 22 APR 2009 | DOI: 10.1002/jps.21740

    18. Monoclonal antibody interactions with micro- and nanoparticles: Adsorption, aggregation, and accelerated stress studies (pages 3218–3238)

      Jared S. Bee, David Chiu, Suzanne Sawicki, Jennifer L. Stevenson, Koustuv Chatterjee, Erwin Freund, John F. Carpenter and Theodore W. Randolph

      Article first published online: 2 JUN 2009 | DOI: 10.1002/jps.21768

    19. Evidence of partial unfolding of proteins at the ice/freeze-concentrate interface by infrared microscopy (pages 3239–3246)

      J. Jeff Schwegman, John F. Carpenter and Steven L. Nail

      Article first published online: 18 JUN 2009 | DOI: 10.1002/jps.21843

    20. Immunogenicity of aggregates of recombinant human growth hormone in mouse models (pages 3247–3264)

      Amber Haynes Fradkin, John F. Carpenter and Theodore W. Randolph

      Article first published online: 30 JUN 2009 | DOI: 10.1002/jps.21834

    21. Analysis of insulin allostery in solution and solid state with FTIR (pages 3265–3277)

      Morten Jonas Maltesen, Simon Bjerregaard, Lars Hovgaard, Svend Havelund and Marco van de Weert

      Article first published online: 1 APR 2009 | DOI: 10.1002/jps.21736

    22. Effects of moisture content on the storage stability of dried lipoplex formulations (pages 3278–3289)

      Jinxiang Yu and Thomas J. Anchordoquy

      Article first published online: 30 JUN 2009 | DOI: 10.1002/jps.21846

    23. Precipitation of a monoclonal antibody by soluble tungsten (pages 3290–3301)

      Jared S. Bee, Stephanie A. Nelson, Erwin Freund, John F. Carpenter and Theodore W. Randolph

      Article first published online: 19 FEB 2009 | DOI: 10.1002/jps.21707

    24. Drug Discovery Interface

      Extreme sensitivity of botulinum neurotoxin domains towards mild agitation (pages 3302–3311)

      Stephen I. Toth, Leonard A. Smith and S. Ashraf Ahmed

      Article first published online: 18 FEB 2009 | DOI: 10.1002/jps.21676

    25. Pharmaceutics, Preformulation and Drug Delivery

      Reversibility and regioselectivity in thiol/disulfide interchange of tocinoic acid with glutathione in lyophilized solids (pages 3312–3318)

      Lei Zhang, Todd D. Williams and Elizabeth M. Topp

      Article first published online: 6 AUG 2008 | DOI: 10.1002/jps.21516

    26. Synergistic effects of surfactants and sugars on lipoplex stability during freeze-drying and rehydration (pages 3319–3328)

      Jinxiang Yu and Thomas J. Anchordoquy

      Article first published online: 9 SEP 2008 | DOI: 10.1002/jps.21564

    27. Evaluation of the viability of Lactobacillus spp. after the production of different solid dosage forms (pages 3329–3339)

      Mariya I. Brachkova, Aida Duarte and João F. Pinto

      Article first published online: 24 NOV 2008 | DOI: 10.1002/jps.21609

    28. Structural stability of hepatitis C virus envelope glycoprotein E1: Effect of pH and dissociative detergents (pages 3340–3357)

      Feng He, Sangeeta B. Joshi, Fons Bosman, Marijke Verhaeghe and C. Russell Middaugh

      Article first published online: 12 DEC 2008 | DOI: 10.1002/jps.21657

    29. Effect of the pH grade of silicates on chemical stability of coground amorphous quinapril hydrochloride and its stabilization using pH-modifiers (pages 3358–3372)

      Shumet A. Hailu and Robin H. Bogner

      Article first published online: 10 APR 2009 | DOI: 10.1002/jps.21767

    30. Novel methods for the assessment of miscibility of amorphous drug-polymer dispersions (pages 3373–3386)

      Igor Ivanisevic, Simon Bates and Ping Chen

      Article first published online: 12 MAR 2009 | DOI: 10.1002/jps.21717

    31. The effect of bulking agents on the chemical stability of acid-sensitive compounds in freeze-dried formulations: Sucrose inversion study (pages 3387–3396)

      Enxian Lu, Susan Ewing, Larry Gatlin, Raj Suryanarayanan and Evgenyi Shalaev

      Article first published online: 18 JUN 2009 | DOI: 10.1002/jps.21727

    32. Thermal analysis of frozen solutions: Multiple glass transitions in amorphous systems (pages 3397–3405)

      Gregory A. Sacha and Steven L. Nail

      Article first published online: 21 APR 2009 | DOI: 10.1002/jps.21737

    33. Non-invasive product temperature determination during primary drying using tunable diode laser absorption spectroscopy (pages 3406–3418)

      Stefan C. Schneid, Henning Gieseler, William J. Kessler and Michael J. Pikal

      Article first published online: 9 SEP 2008 | DOI: 10.1002/jps.21522

    34. The impact of protein concentration on mannitol and sodium chloride crystallinity and polymorphism upon lyophilization (pages 3419–3429)

      Daniel Dixon, Serguei Tchessalov, Anthony Barry and Nicholas Warne

      Article first published online: 9 SEP 2008 | DOI: 10.1002/jps.21537

    35. Pharmaceutical Technology

      In-line and real-time process monitoring of a freeze drying process using Raman and NIR spectroscopy as complementary process analytical technology (PAT) tools (pages 3430–3446)

      T.R.M. De Beer, P. Vercruysse, A. Burggraeve, T. Quinten, J. Ouyang, X. Zhang, C. Vervaet, J.P. Remon and W.R.G. Baeyens

      Article first published online: 7 JAN 2009 | DOI: 10.1002/jps.21633

    36. Gravimetric measurement of momentary drying rate of spray freeze-dried powders in vials (pages 3447–3455)

      Henning Gieseler and Geoffrey Lee

      Article first published online: 14 JUL 2009 | DOI: 10.1002/jps.21677

    37. Amorphous drug–PVP dispersions: Application of theoretical, thermal and spectroscopic analytical techniques to the study of a molecule with intermolecular bonds in both the crystalline and pure amorphous state (pages 3456–3468)

      Michael Tobyn, Jonathan Brown, Andrew B. Dennis, Michael Fakes, Qi Gao, John Gamble, Yaroslav Z. Khimyak, Gary McGeorge, Chhaya Patel, Wayne Sinclair, Peter Timmins and Shawn Yin

      Article first published online: 14 JUL 2009 | DOI: 10.1002/jps.21738

    38. Rapid freeze-drying cycle optimization using computer programs developed based on heat and mass transfer models and facilitated by tunable diode laser absorption spectroscopy (TDLAS) (pages 3469–3482)

      Wei Y. Kuu and Steven L. Nail

      Article first published online: 5 JUN 2009 | DOI: 10.1002/jps.21813

    39. Computational analysis of fluid dynamics in pharmaceutical freeze-drying (pages 3483–3494)

      Alina A. Alexeenko, Arnab Ganguly and Steven L. Nail

      Article first published online: 30 JUN 2009 | DOI: 10.1002/jps.21862

  4. Note

    1. Top of page
    2. Commentaries
    3. Reviews
    4. Research Articles
    5. Note
    1. Ice nucleation temperature influences recovery of activity of a model protein after freeze drying (pages 3495–3498)

      Teresa Cochran and Steven L. Nail

      Article first published online: 2 JUN 2009 | DOI: 10.1002/jps.21815

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