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Journal of Pharmaceutical Sciences

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  1. Opalescence in monoclonal antibody solutions and its correlation with intermolecular interactions in dilute and concentrated solutions.

    Journal of Pharmaceutical Sciences 104(4):1263 (2015) PMID 25556561

    Opalescence indicates physical instability of a formulation because of the presence of aggregates or liquid-liquid phase separation in solution and has been reported for monoclonal antibody (mAb) formulations. Increased solution opalescence can be attributed to attractive protein-protein interaction...
  2. Particle shedding from peristaltic pump tubing in biopharmaceutical drug product manufacturing.

    Journal of Pharmaceutical Sciences 104(4):1440 (2015) PMID 25605257

    In a typical manufacturing setup for biopharmaceutical drug products, the fill and dosing pump is placed after the final sterile filtration unit in order to ensure adequate dispensing accuracy and avoid backpressure peaks. Given the sensitivity of protein molecules, peristaltic pumps are often prefe...
  3. Achieving continuous manufacturing for final dosage formation: challenges and how to meet them. May 20-21, 2014 continuous manufacturing sym...

    Journal of Pharmaceutical Sciences 104(3):792 (2015) PMID 25501530

    We describe the key issues and possibilities for continuous final dosage formation, otherwise known as downstream processing or drug product manufacturing. A distinction is made between heterogeneous processing and homogeneous processing, the latter of which is expected to add more value to continuo...
  4. Association efficiency of three ionic forms of oxytetracycline to cationic and anionic oil-in-water nanoemulsions analyzed by diafiltration.

    Journal of Pharmaceutical Sciences 104(3):1141 (2015) PMID 25557590

    The association efficiency of oxytetracycline (OTC) to pharmaceutical available, ionic oil-in-water nanoemulsions is studied. Theoretical mathematical developments allowed us to differentiate by diafiltration (DF) between thermodynamically and kinetically controlled binding of the drug to the nanoem...
  5. Systematic screening of different surface modifiers for the production of physically stable nanosuspensions.

    Journal of Pharmaceutical Sciences 104(3):1128 (2015) PMID 25630623

    The role of a surface modifier is important in the formation of stable nanosuspensions. In this study, a simple and systematic screening method for selecting optimum surface modifiers was performed by utilizing a low-energy wet ball milling method. Nine surface modifiers from different classes with...
  6. Mutation choice to eliminate buried free cysteines in protein therapeutics.

    Journal of Pharmaceutical Sciences 104(2):566 (2015) PMID 25312595

    We report a comprehensive structure and stability study of Ala, Ser, Thr, and Val mutations at each of the three buried free-Cys positions (Cys16, Cys83, and Cys117) in fibroblast growth factor-1. Mutation was almost universally destabilizing, indicating a general optimization for the wild-type Cys,...
  7. Lengthening of cardiac repolarization in isolated guinea pigs hearts by sequential or concomitant administration of two IKr blockers.

    Journal of Pharmaceutical Sciences 100(6):2469 (2011) PMID 21491454

    Block of I(Kr) is of major concern in drug safety. The objective of this study was to assess prolongation of cardiac repolarization during the combined use of two I(Kr) blockers when administered concomitantly or sequentially. (1) When isolated hearts from male guinea pigs were perfused concomitantly...
  8. Expect the unexpected-screen your screens

    Journal of Pharmaceutical Sciences 100(5):1996 (2011) PMID 21154629

  9. Response to ldquocommercial aluminum hydroxidesrdquo

    Journal of Pharmaceutical Sciences 74(8):903 (2006)

  10. Progress in pharmaceutical research critical reports on applied chemistry, vol. 4. Edited by K. R. H. Wooldridge. Blackwell Scientific Publi...

    Journal of Pharmaceutical Sciences 74(5):593 (2006)