Literature DB >> 26852837

Technology, Applications, and Process Challenges of Dual Chamber Systems.

Tobias Werk1, Imke S Ludwig2, Joerg Luemkemann2, Hanns-Christian Mahler2, Joerg Huwyler3, Mathias Hafner4.   

Abstract

Dual-chamber systems provide an option as a drug and device combination product, when home care and emergency lyophilized products are intended. Nevertheless, until today, there are only a few products on the market, due to the challenges and limitations in manufacturability, product formulation, and product stability in a dual-chamber configuration, as well as economic considerations. This review serves to describe currently available dual-chamber systems and to discuss factors to be considered for appropriate selection and establishing fill-finish processes.
Copyright © 2016. Published by Elsevier Inc.

Keywords:  aseptic processing; biologics; biopharmaceutical; dual-chamber cartridge; dual-chamber syringe; dual-chamber systems; fixed dose combination; freeze-drying; home care; small volume parenterals

Mesh:

Substances:

Year:  2016        PMID: 26852837     DOI: 10.1016/j.xphs.2015.11.025

Source DB:  PubMed          Journal:  J Pharm Sci        ISSN: 0022-3549            Impact factor:   3.534


  5 in total

1.  Opportunities in an Evolving Pharmaceutical Development Landscape: Product Differentiation of Biopharmaceutical Drug Products.

Authors:  Andrea Allmendinger
Journal:  Pharm Res       Date:  2021-04-26       Impact factor: 4.200

2.  Study Protocol for Two-Steps Parallel Randomized Controlled Trial: Pre-Clinical Usability Tests for a New Double-Chamber Syringe.

Authors:  Pedro Parreira; Liliana B Sousa; Inês A Marques; Paulo Santos-Costa; Sara Cortez; Filipa Carneiro; Arménio Cruz; Anabela Salgueiro-Oliveira
Journal:  Int J Environ Res Public Health       Date:  2020-11-12       Impact factor: 3.390

3.  Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification.

Authors:  Feroz Jameel; Alina Alexeenko; Akhilesh Bhambhani; Gregory Sacha; Tong Zhu; Serguei Tchessalov; Puneet Sharma; Ehab Moussa; Lavanya Iyer; Sumit Luthra; Jayasree Srinivasan; Ted Tharp; Joseph Azzarella; Petr Kazarin; Mehfouz Jalal
Journal:  AAPS PharmSciTech       Date:  2021-11-08       Impact factor: 3.246

4.  Dual-chamber injection device for measles-rubella vaccine: The potential impact of introducing varying sizes of the devices in 3 countries.

Authors:  Patrick T Wedlock; Elizabeth A Mitgang; Sheryl S Siegmund; Jay DePasse; Jennifer Bakal; Jim Leonard; Joel Welling; Shawn T Brown; Bruce Y Lee
Journal:  Vaccine       Date:  2018-08-23       Impact factor: 3.641

5.  Brief Report on Double-Chamber Syringes Patents and Implications for Infusion Therapy Safety and Efficiency.

Authors:  Liliana B Sousa; Paulo Santos-Costa; Inês A Marques; Arménio Cruz; Anabela Salgueiro-Oliveira; Pedro Parreira
Journal:  Int J Environ Res Public Health       Date:  2020-11-06       Impact factor: 3.390

  5 in total

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