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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System

Galen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan Rajagopalan
PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169
Galen H. Shi
2Delivery Device and Connected Solutions, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN;
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Ganapathy Gopalrathnam
1Bioproduct Pharma Design, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN;
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Sharon L. Shinkle
1Bioproduct Pharma Design, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN;
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Xia Dong
4Biotechnolgy Research (Bio TDR), Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN
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Jeffrey D. Hofer
3Statistics - Discovery and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN; and
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Eric C. Jensen
2Delivery Device and Connected Solutions, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN;
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Natarajan Rajagopalan
1Bioproduct Pharma Design, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN;
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  • For correspondence: rajagopalan.natarajan@lilly.com
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PDA Journal of Pharmaceutical Science and Technology: 72 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 1
January/February 2018
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Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System
Galen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen, Natarajan Rajagopalan
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 50-61; DOI: 10.5731/pdajpst.2017.008169

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Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System
Galen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen, Natarajan Rajagopalan
PDA Journal of Pharmaceutical Science and Technology Jan 2018, 72 (1) 50-61; DOI: 10.5731/pdajpst.2017.008169
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  • A Predictive Modeling Approach to Support the Overfill Volume Definition of Liquid-in-Vial Drug Products
  • Physicochemical Excipient-Container Interactions in Prefilled Syringes and Their Impact on Syringe Functionality
  • Risk Mitigation of Drug Shortages--A New Concept for Vials Designed to Improve Fill and Finish Performance
  • Drug Formulation Impact on Prefilled Syringe Functionality and Autoinjector Performance
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  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
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Keywords

  • Formulation development
  • Buffer
  • Semi-finished
  • prefilled syringe
  • functionality
  • Break loose force
  • Glide force
  • Schlieren imaging
  • Contact angle
  • Monoclonal antibodies
  • Silicone oil
  • Inductively coupled plasma emission spectroscopy
  • Thin film interference reflectometry

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