| Literature DB >> 26852837 |
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.Keywords: aseptic processing; biologics; biopharmaceutical; dual-chamber cartridge; dual-chamber syringe; dual-chamber systems; fixed dose combination; freeze-drying; home care; small volume parenterals
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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