STERIS and W.L. GORE collaborated on a case study testing the compatibility of a new prefilled syringe plunger design with VHP terminal sterilization. VHP chamber conditions require deep vacuum pulsing, which may represent challenges to prefilled syringe container integrity. The growing industry trend toward VHP sterilization is driven by the FDA search for alternative sterilization methods to EO and the recent publication of a VHP specific process standard. The purpose of the study is to test and report compatibility of the new 0.5 mL GORE IMPROJECT plunger, a silicone free syringe solution for ophthalmic application, with VHP sterilization. Various challenges have been reported when using conventional, siliconized, prefilled syringe systems for intravitreal injections such as subvisible particles, inflammation, silicone floaters, and intraocular pressure increases. The GORE plunger eliminates the need for silicone oil as a lubricant on the plunger and barrel, while meeting strict container closure and terminal sterilization requirements of ophthalmic applications. This case study presents successful results of deep vacuum VHP terminal sterilization process compatibility with the GORE plunger design and material composition. Test results include primary container integrity, stopper off-gassing/ingress, and visual inspection. Principles of VHP vacuum sterilization process, test cycle configuration, and its main parameters are presented.

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Comparative pharmacokinetics (PK) studies have efficiently served as the bridge between autoinjectors and prefilled syringes given the underlying principles that comparable exposure could translate to comparable efficacy and safety. This article discusses approaches used to address uncertainties associated with the observation of noncomparable PK leading to the successful introduction of new autoinjector devices for monoclonal antibody and Fc-fusion protein products. Information from seven case examples suggests a knowledge gap that warrants attention in autoinjector development.

Errors in injectable preparations with high-risk drugs can be fatal. This study aimed to identify the factors influencing the accuracy of high-risk injectable drug concentrations in appliances used for intensive care unit preparation practices. Norepinephrine (NE) was chosen as an example of a high-risk medication drug. The concentration (0.2 and 0.5 mg/mL), the diluent (sodium chloride 0.9% and 5% dextrose), and the container type (prefilled- and empty-infusion bag and syringe) were tested as potential variability factors. An ultraviolet spectrophotometric method was used for NE dosage. 108 NE solutions were prepared by five individuals (pharmacists or laboratory technicians) with clinical experience as well as experience in the aseptic preparation of solutions. The container type was found to be the only factor influencing the accuracy of NE concentration. NE solutions in syringes proved to be the most accurate while preparations in prefilled bags tended to underdose NE.

OBJECTIVE: Proton pump inhibitors are potent suppressors of gastric acid secretion, and are commonly prescribed in palliative medicine. Despite multiple relevant indications in patients at the end-of-life, their use is often precluded as oral and intravenous administration is frequently inappropriate or not possible. Limited anecdotal evidence suggests proton pump inhibitors may be administered subcutaneously. Our objective was to investigate the tolerability and effectiveness of the administration of esomeprazole as a continuous subcutaneous infusion over 24 h via a syringe driver.
METHODS: Case series (n = 7) design assessing sequential patients admitted to a specialist inpatient centre for palliative care, who required parenteral proton pump inhibitor therapy.
CONCLUSIONS: Four patients reported complete resolution of dyspeptic and reflux symptoms post commencement of esomeprazole. Two patients developed upper gastrointestinal bleeding, which via observation of vomitus and stools, resolved with the initiation of esomeprazole. A single patient, deemed high risk of gastrointestinal bleeding, was commenced on esomeprazole and no bleeding events occurred.
CONCLUSIONS: Esomeprazole when administered via a syringe driver over 24 h appears well tolerated and effective for the symptomatic management of dyspepsia and treatment of gastrointestinal bleeding. Overall, this series adds to the limited evidence base for using subcutaneous proton pump inhibitors in the palliative demographic.

CHOICES was an open-label, randomized, comparative effectiveness trial of office-based extended-release naltrexone versus treatment as usual in people with untreated opioid use disorder and HIV. This study explored facilitators to recruitment in Miami, a successful recruiting site in the national trial. The mixed-methods study included quantitative surveys of randomized participants, medical record abstraction, and qualitative interviews with study staff. Miami recruited 47 (40.5%) of 116 randomized participants in the six-site national trial. In-depth interviews of study staff (n = 6) revealed that Miami had a recruitment approach consisting of street level outreach and a close relationship with the local syringe services program (SSP). Partnership with a local SSP provided access to people living with HIV who inject drugs in Miami. SSPs\' fundamental trust within the community of people who inject drugs can be leveraged in studies aiming to improve health outcomes in this underserved and high-priority population.

The current study was undertaken to evaluate clinical-grade disposable syringes of various brands based on the identification of an extraneous impurity leaching out from the rubber gasket of the syringe during sample preparation for liquid chromatography method development. The syringes were evaluated using aqueous and organic solvents and their mixtures to understand susceptibility towards extractables. It was observed that the extraction propensity of different brands of syringes was varying in terms of number and levels of extractables. A total of eight extractables (including the extraneous impurity observed during method development) were identified from the syringe gaskets with the help of liquid chromatography coupled with high-resolution mass spectrometry (LC-HRMS), nuclear magnetic resonance (NMR) and/or infrared (IR) spectroscopy. To the best of authors\' knowledge, four out of eight proposed extractables are not reported in the literature. A tentative pathway for the formation of the extractables was also proposed.

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This case report details how occupational therapy treatment in an outpatient setting successfully guided the parents of a child with autism spectrum disorder and a history of prematurity from restrained syringe feedings to the acceptance of spoon feedings. Occupational therapy practitioners are qualified, needed and available to assess and treat feeding disorders in children with autism spectrum disorder and a history of prematurity. Family-centered practice must be utilized for successful outcomes in an outpatient service delivery model.

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