title: Vented spikes improve delivery from intravenous bags with no air headspace.
abstract: Flexible plastic bags are the container of choice for most intravenous (i.v.) infusions. Under certain circumstances, however, the air-liquid interface present in these i.v. bags can lead to physical instability of protein biopharmaceuticals, resulting in product aggregation. In principle, the air headspace present in the bags can be removed to increase drug stability, but experiments described here show that this can result in incomplete draining of solution from the bag using gravity delivery, or generation of negative pressure in the bag when an infusion pump is used. It is expected that these issues could lead to incomplete delivery of medication to patients or pump-related problems, respectively. However, here it is shown that contrary to the standard pharmacy practice of using nonvented spikes with i.v. bags, the use of vented spikes with i.v. bags that lack air headspace allows complete delivery of the dose solution without impacting the physical stability of a protein-based drug.
authors.affiliation: Early Stage Pharmaceutical Development, Genentech, Inc, San Francisco, California.
authors.forename: William J
authors.initials: WJ
authors.lastname: Galush
authors.affiliation: Early Stage Pharmaceutical Development, Genentech, Inc, San Francisco, California.
authors.forename: Travis A
authors.initials: TA
authors.lastname: Horst
mesh_terms: D004349:Drug Packaging / Q000379:methods; D004355:Drug Stability; D006801:Humans; D007262:Infusions, Intravenous / Q000379:methods*; D019999:Pharmaceutical Solutions / Q000008:administration & dosage*; D012996:Solutions
chemical_list: D019999:Pharmaceutical Solutions; D012996:Solutions
keywords: biotechnology; injectables; monoclonal antibody; physical stability; protein delivery; protein formulation