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

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 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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vol. 72 no. 1 50-61

DOI

https://doi.org/10.5731/pdajpst.2017.008169

PubMed

29030531

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online January 30, 2018.

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previous version (October 12, 2017 - 19:14).
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Author Information

Galen H. Shi2,
Ganapathy Gopalrathnam1,
Sharon L. Shinkle1,
Xia Dong4,
Jeffrey D. Hofer3,
Eric C. Jensen2 and
Natarajan Rajagopalan1,*

¹Bioproduct Pharma Design, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN;
²Delivery Device and Connected Solutions, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN;
³Statistics - Discovery and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN; and
⁴Biotechnolgy Research (Bio TDR), Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN

↵*Corresponding Author: Telephone: 317-276-4023; e-mail: rajagopalan.natarajan{at}lilly.com

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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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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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