Reducing the Risk of Contamination of Sterile Parenteral Products via Ready-to-Use Closure Components

Curry, Wayne; Conway, Samuel; Goodfield, Clara; Miller, Kenneth S.; Mueller, Ronald L.; Polini, Eugene

doi:10.1208/s12249-010-9531-8

Cited by 10 publications

(8 citation statements)

References 1 publication

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“…Due to their close contact, several elastomeric matrix ingredients may migrate into the pharmaceutical product. This process is governed by the chemical affinity and diffusion characteristics of the pharmaceutical product and the chosen packaging material, under the storage, transportation, and handling conditions [ 24 ]. mRNA-1273 and BNT162b2 use chlorobutyl and synthetic bromobutyl rubber stoppers, respectively, while AD26.COV2.S uses chlorobutyl with a fluoropolymer-coated surface.…”

Section: Discussionmentioning

confidence: 99%

Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data

et al. 2023

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This study aimed at producing an updated assessment of the incidence of anaphylaxis associated with COVID-19 vaccines based on pharmacovigilance data. Anaphylactic reaction and anaphylactic shock data post-COVID-19-vaccination reported from week 52, 2020 to week 1 or week 2, 2023 were collected from the VAERS and EudraVigilance databases, respectively, and analyzed comparatively. Incidence rates were calculated using the corresponding administered vaccine doses as denominators for all licensed vaccines and both platform types (mRNA or vectored). The latest data from the present analysis showed lower anaphylaxis incidence associated with COVID-19 vaccination compared to previous estimates from week 52, 2020 to week 39, 2021 (anaphylactic reaction: 8.96 (95% CI 8.80–9.11)/million doses overall (EEA: 14.19 (95% CI 13.92–14.47)/million/US: 3.17 (95% CI 3.03–3.31)/million); anaphylactic shock: 1.46 (95% CI 1.39–1.52)/million doses overall (EEA: 2.47 (95% CI 2.36–2.58)/million/US: 0.33 (95% CI 0.29–0.38)/million)). Incidence rates varied by vaccine and were higher as captured in EudraVigilance compared to the VAERS and for vectored compared to mRNA vaccines. Most reported cases had a favorable outcome. The extremely rare fatalities (overall rates across continents 0.04 (95% CI 0.03–0.06)/million doses for anaphylactic reaction and 0.02 (95% CI 0.01–0.03)/million vaccine doses for anaphylactic shock) were also associated with vector-rather than mRNA-based vaccines. The diminished incidence of anaphylaxis post-vaccination with COVID-19 vaccines offers assurance about their safety, as does the continuous potential adverse events monitoring through specialized pharmacovigilance databases.

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Section: Discussionmentioning

confidence: 99%

Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data

et al. 2023

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“…Curry et al . ( 31 ) reviewed how materials from elastomeric closures, including butyl rubber stoppers, can contaminate specimens with these container closures. Metals such as calcium, aluminum, magnesium, and zinc are used to manufacture rubber stoppers; it is essential that these metals are not extracted upon contact with blood ( 32 ); specially formulated rubber stoppers have been made to limit divalent cation leaching ( 33 ).…”

Section: Blood Collection Tubesmentioning

confidence: 99%

Interferences from blood collection tube components on clinical chemistry assays

2014

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Improper design or use of blood collection devices can adversely affect the accuracy of laboratory test results. Vascular access devices, such as catheters and needles, exert shear forces during blood flow, which creates a predisposition to cell lysis. Components from blood collection tubes, such as stoppers, lubricants, surfactants, and separator gels, can leach into specimens and/or adsorb analytes from a specimen; special tube additives may also alter analyte stability. Because of these interactions with blood specimens, blood collection devices are a potential source of pre-analytical error in laboratory testing. Accurate laboratory testing requires an understanding of the complex interactions between collection devices and blood specimens. Manufacturers, vendors, and clinical laboratorians must consider the pre-analytical challenges in laboratory testing. Although other authors have described the effects of endogenous substances on clinical assay results, the effects/impact of blood collection tube additives and components have not been well systematically described or explained. This review aims to identify and describe blood collection tube additives and their components and the strategies used to minimize their effects on clinical chemistry assays.

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“…Furthermore, lyophilized products may be too expensive for developing countries. Reconstitution also poses a risk of contamination [ 30 ]. The volume and mass of freeze-dried products, including both vials used for lyophilized powder and its reconstitution liquid, are typically up to twice the size of those used for liquid formulations, resulting in more extensive packaging material, larger storage area, and higher transportation costs [ 29 ].…”

Section: Introductionmentioning

confidence: 99%

Designing Formulation Strategies for Enhanced Stability of Therapeutic Peptides in Aqueous Solutions: A Review

et al. 2023

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Over the past few decades, there has been a tremendous increase in the utilization of therapeutic peptides. Therapeutic peptides are usually administered via the parenteral route, requiring an aqueous formulation. Unfortunately, peptides are often unstable in aqueous solutions, affecting stability and bioactivity. Although a stable and dry formulation for reconstitution might be designed, from a pharmaco-economic and practical convenience point of view, a peptide formulation in an aqueous liquid form is preferred. Designing formulation strategies that optimize peptide stability may improve bioavailability and increase therapeutic efficacy. This literature review provides an overview of various degradation pathways and formulation strategies to stabilize therapeutic peptides in aqueous solutions. First, we introduce the major peptide stability issues in liquid formulations and the degradation mechanisms. Then, we present a variety of known strategies to inhibit or slow down peptide degradation. Overall, the most practical approaches to peptide stabilization are pH optimization and selecting the appropriate type of buffer. Other practical strategies to reduce peptide degradation rates in solution are the application of co-solvency, air exclusion, viscosity enhancement, PEGylation, and using polyol excipients.

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Reducing the Risk of Contamination of Sterile Parenteral Products via Ready-to-Use Closure Components

Cited by 10 publications

References 1 publication

Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data

Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data

Interferences from blood collection tube components on clinical chemistry assays

Designing Formulation Strategies for Enhanced Stability of Therapeutic Peptides in Aqueous Solutions: A Review

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