Borosilicate type I glass is the standard glass used for pharmaceutical primary packaging, but its supply has been stressed and constrained in recent years due to the movement in Asia to higher-quality glass packaging. Due to the need for billions of doses of COVID-19 vaccines, the situation has worsened during the pandemic. Challenges are expected to continue for the foreseeable future, with demand for not only borosilicate type I glass and tubular vials but plugs, stoppers, and various consumables needed to produce finished and packaged sterile injectable drug products.[93]
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Given the supply issues with pharma-grade glass, interest is rising in the use of plastic for the delivery of sterile injectables. Improvements in molding technology, including blow/fill/seal (BFS) solutions, are accelerating this trend.
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Volumes for subcutaneous injection have typically ranged from 1 to 2 mL, with up to 3 mL possible more recently. There is a need, however, for the delivery of larger volumes (see above). Approaches include increasing the concentration to reduce the volume or enabling the delivery of larger volumes through device–design advances and/or modification of the subcutaneous space.[100]
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Wearable injection devices, also referred to as on-body delivery systems (OBDS) or patch pumps, have the potential to enable delivery of high volumes or higher concentrations of sterile injectable drugs while minimizing patient discomfort. They can serve as a market differentiator for drug manufacturers, a cost-saving treatment approach for payers and providers, and a means of maximizing convenience for patients.[102]
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As part of the trend toward increased patient centricity, many of today’s devices for the self-administration of sterile injectable drugs include digital technology.[33] Sensors help patients position and use devices correctly. Smart devices allow for app-based tracking of usage, dosage, and adherence and/or send data to cloud-based systems for further analysis. These systems allow for ongoing patient–physician interactions. In addition, the data can, for instance, be used to create future therapies customized for specific patients.
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