Container Closure and Delivery Considerations for Intravitreal Drug Administration
| Autor: | Mohammed Shameem, Ashwin Parenky, Hunter H Chen, Kenneth S. Graham, Amardeep S Bhalla, Saurabh Wadhwa |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Drug
medicine.medical_specialty media_common.quotation_subject Pharmaceutical Science Pharmacy Review Article Aquatic Science 030226 pharmacology & pharmacy 03 medical and health sciences 0302 clinical medicine Endophthalmitis Drug Delivery Systems Ocular Drug Discovery medicine Needle Humans Dosing Adverse effect Intensive care medicine Ecology Evolution Behavior and Systematics Syringe Drug Packaging media_common Ecology business.industry Syringes Sterilization General Medicine medicine.disease Formulation Pharmaceutical Preparations Needles Container (abstract data type) New product development Intravitreal Injections 030221 ophthalmology & optometry business Agronomy and Crop Science |
| Zdroj: | AAPS PharmSciTech |
| ISSN: | 1530-9932 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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