Role of Formulation Parameters on Intravitreal Dosing Accuracy Using 1 mL Hypodermic Syringes

Weinmann, Christian; Sediq, Ahmad S.; Vogt, M.; Mahler, Hanns‐Christian; Joerg, Susanne; Rodríguez, Sergio; Mathaes, Roman; Jere, Dhananjay

doi:10.1007/s11095-020-02880-2

Cited by 3 publications

(3 citation statements)

References 18 publications

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“…This is supported by another experimental study that evaluated six brands of 1-mL syringes and demonstrated that presence of surfactants or high protein concentration can lead to aeration, which negatively affects the dose accuracy and precision of the output volume. 13 Our results also showed that the "downward" technique was less accurate than the commonly used "upward" technique. Although mean output volumes were very similar (57.76 6 7.00 mL and 55.89 6 5.70 mL, respectively), the absolute and mean absolute percentage error differences achieved statistical significance.…”

Section: Discussionmentioning

confidence: 56%

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Syringe Design and Filling Technique Affect Accuracy of Anti–vascular Endothelial Growth Factor Intravitreal Injections

Krauthammer¹,

Harel

Moisseiev

2023

Retina

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Section: Discussionmentioning

confidence: 56%

Section: Discussionmentioning

confidence: 99%

Syringe Design and Filling Technique Affect Accuracy of Anti–vascular Endothelial Growth Factor Intravitreal Injections

Krauthammer¹,

Harel

Moisseiev

2023

Retina

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“…Solutions with viscosity in the range of 1-80 cP were evaluated when delivering dose volumes in the range of 0.03-0.1mLusing various commercially available 1-mL disposable plastic syringes. Dose errors as high as 40% were observed for high-viscosity solutions (45 cP) depending on the type of syringe used (39).…”

Section: Accuracy and Repeatability Of Delivered Volumementioning

confidence: 99%

Container Closure and Delivery Considerations for Intravitreal Drug Administration

et al. 2021

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Intravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal specialists, IVT administration is associated with unique challenges related to drug product, device and the procedure, which may result in adverse events. Container closure configuration plays a crucial role in maintaining product stability, safety, and efficacy for the intended shelf-life. Careful design of primary container configuration is also important to accurately deliver small volumes (10-100 μL). Over- or under-dosing may lead to undesired adverse events or lack of efficacy resulting in unpredictable and variable clinical responses. IVT drug products have been traditionally presented in glass vials. However, pre-filled syringes offer a more convenient administration option by reducing the number of steps required for dose preparation there by potentially reducing the time demand on the healthcare providers. In addition to primary container selection, product development studies should focus on, among other things, primary container component characterization, material compatibility with the formulation, formulation stability, fill volume determination, extractables/leachables, and terminal sterilization. Ancillary components such as disposable syringes and needles must be carefully selected, and a detailed administration procedure that includes dosing instructions is required to ensure successful administration of the product. Despite significant efforts in improving the drug product and administration procedures, ocular safety concerns such as endophthalmitis, increased intraocular pressure, and presence of silicone floaters have been reported. A systematic review of available literature on container closure and devices for IVT administration can help guide successful product development.

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Ophthalmic wild olive (ACEBUCHE) oil nanoemulsions exert oculoprotective effects against oxidative stress induced by arterial hypertension

Santana-Garrido,

Durán-Lobato,

Mate

et al. 2024

International Journal of Pharmaceutics

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Role of Formulation Parameters on Intravitreal Dosing Accuracy Using 1 mL Hypodermic Syringes

Cited by 3 publications

References 18 publications

Syringe Design and Filling Technique Affect Accuracy of Anti–vascular Endothelial Growth Factor Intravitreal Injections

Syringe Design and Filling Technique Affect Accuracy of Anti–vascular Endothelial Growth Factor Intravitreal Injections

Container Closure and Delivery Considerations for Intravitreal Drug Administration

Ophthalmic wild olive (ACEBUCHE) oil nanoemulsions exert oculoprotective effects against oxidative stress induced by arterial hypertension

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