The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes

Tobias Werk; Imke S. Ludwig; Hanns-Christian Mahler; Joerg Luemkemann; Joerg Huwyler; Mathias Hafner

doi:10.5731/pdajpst.2015.006387

Research ArticleResearch

The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes

Tobias Werk, Imke S. Ludwig, Hanns-Christian Mahler, Joerg Luemkemann, Joerg Huwyler and Mathias Hafner

PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 508-522; DOI: https://doi.org/10.5731/pdajpst.2015.006387

Tobias Werk

1Pharmaceutical Technology, University of Basel, Basel, Switzerland;

2Pharmaceutical Development & Supplies, F. Hoffmann-La Roche Ltd., Basel, Switzerland;

3Institute for Medical Technology, Heidelberg University and Mannheim University of Applied Sciences, Mannheim, Germany; and

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: tobias.werk@roche.com

Imke S. Ludwig

2Pharmaceutical Development & Supplies, F. Hoffmann-La Roche Ltd., Basel, Switzerland;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Hanns-Christian Mahler

4current address: Lonza AG, Drug Product Services, Basel, Switzerland

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Joerg Luemkemann

2Pharmaceutical Development & Supplies, F. Hoffmann-La Roche Ltd., Basel, Switzerland;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Joerg Huwyler

1Pharmaceutical Technology, University of Basel, Basel, Switzerland;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Mathias Hafner

3Institute for Medical Technology, Heidelberg University and Mannheim University of Applied Sciences, Mannheim, Germany; and

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Article
Figures & Data
References
Info & Metrics
PDF

Article Information

vol. 70 no. 6 508-522

DOI

https://doi.org/10.5731/pdajpst.2015.006387

PubMed

27974591

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online December 13, 2016.

Article Versions

previous version (June 20, 2016 - 13:19).
You are viewing the most recent version of this article.

Author Information

Tobias Werk1,2,3,*,
Imke S. Ludwig2,
Hanns-Christian Mahler4,
Joerg Luemkemann2,
Joerg Huwyler1 and
Mathias Hafner3

¹Pharmaceutical Technology, University of Basel, Basel, Switzerland;
²Pharmaceutical Development & Supplies, F. Hoffmann-La Roche Ltd., Basel, Switzerland;
³Institute for Medical Technology, Heidelberg University and Mannheim University of Applied Sciences, Mannheim, Germany; and
⁴current address: Lonza AG, Drug Product Services, Basel, Switzerland

↵* Corresponding Author: F. Hoffmann-La Roche Ltd., Pharmaceutical Development & Supplies (PTDE-P), Bldg 64/443, Grenzacherstrasse 124, CH-4070 Basel, Switzerland. Telephone: +41 61 688 5417; e-mail: tobias.werk{at}roche.com

View Full Text

Cited By...

8 Citations
Google Scholar

This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

Mechanisms by which crystalline mannitol improves the reconstitution time of high concentration lyophilized protein formulations

Shreya S. Kulkarni, Raj Suryanarayanan, Joseph V. Rinella, Robin H. Bogner

European Journal of Pharmaceutics and Biopharmaceutics 2018 131
Toward a Point-of-Need Bioluminescence-Based Immunoassay Utilizing a Complete Shelf-Stable Reagent

Mary P. Hall, Virginia A. Kincaid, Emily A. Jost, Thomas P. Smith, Robin Hurst, Stuart K. Forsyth, Connor Fitzgerald, Valerie T. Ressler, Kris Zimmermann, Dan Lazar, Monika G. Wood, Keith V. Wood, Thomas A. Kirkland, Lance P. Encell, Thomas Machleidt, Melanie L. Dart

Analytical Chemistry 2021 93 12
Key factors governing the reconstitution time of high concentration lyophilized protein formulations

Shreya S. Kulkarni, Sajal M. Patel, Raj Suryanarayanan, Joseph V. Rinella, Robin H. Bogner

European Journal of Pharmaceutics and Biopharmaceutics 2021 165
Opportunities in an Evolving Pharmaceutical Development Landscape: Product Differentiation of Biopharmaceutical Drug Products

Andrea Allmendinger

Pharmaceutical Research 2021 38 5
Prefilled dual chamber devices (DCDs) – Promising high-quality and convenient drug delivery system

Rahul G. Ingle, Wei-Jie Fang

International Journal of Pharmaceutics 2021 597
Multiple approaches to reduce reconstitution time of lyophilized drug products with high protein concentration

Xiaozhang Zhang, Ningning Zhou, Chunsheng Yang, Zhaowei Jin, Jeremy Guo

Antibody Therapeutics 2024 7 1
Principles and Practices of Lyophilization in Product Development and Manufacturing

Andrea Allmendinger, Christina Häuser, Lokesh Kumar, Ilona Vollrath

2023 59
Standardization of the Reconstitution Procedure of Protein Lyophilizates as a Key Parameter to Control Product Stability

Kerstin Traub-Hoffmann, Britta Furtmann, Lars Laber, Sarah Helm, Claus Geiger, Till Bussemer

Journal of Pharmaceutical Sciences 2020 109 1

PreviousNext

In This Issue

PDA Journal of Pharmaceutical Science and Technology

Vol. 70, Issue 6

November/December 2016

Table of Contents
Index by Author

Download PDF

Article Alerts

User Name *

Password *

Email *

Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Your Email *

Your Name *

Send To *

Enter multiple addresses on separate lines or separate them with commas.

You are going to email the following The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes

Message Subject (Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology

Message Body (Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.

Your Personal Message

CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Math question * 6 + 11 =

Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

Citation Tools

The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes

Tobias Werk, Imke S. Ludwig, Hanns-Christian Mahler, Joerg Luemkemann, Joerg Huwyler, Mathias Hafner

PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 508-522; DOI: 10.5731/pdajpst.2015.006387

Citation Manager Formats

BibTeX
Bookends
EasyBib
EndNote (tagged)
EndNote 8 (xml)
Medlars
Mendeley
Papers
RefWorks Tagged
Ref Manager
RIS
Zotero

The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes

Tobias Werk, Imke S. Ludwig, Hanns-Christian Mahler, Joerg Luemkemann, Joerg Huwyler, Mathias Hafner

PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 508-522; DOI: 10.5731/pdajpst.2015.006387

Share This Article:

Tweet Widget
Facebook Like
Google Plus One

Jump to section

Article
Figures & Data
References
Info & Metrics
PDF

No related articles found.

PubMed
Google Scholar

Cited By...

No citing articles found.

Google Scholar

Main menu

User menu

Search

The Effect of Formulation, Process, and Method Variables on the Reconstitution Time in Dual Chamber Syringes

Article Information

Article Versions

Author Information

Cited By...

In This Issue

Citation Manager Formats

Related Articles

Cited By...

More in this TOC Section

Similar Articles

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.