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The drive for high-quality packaging has helped manufacturers focus on increasing consistency of performance in devices such as auto-injector and patch injection systems. In addition, there is an increased focus on providing drug delivery systems that are easy to use. A consistent quality of components can help to improve performance and ensure delivery in the home environment, while user-centric systems can help assist with compliance.
Systems that enable patients to control the rate of the dose, offer options for those with dexterity challenges and provide an easy-to-use option for home injection are ideal for home use. West’s SelfDose® injection system technology platform* is provided by West to the pharmaceutical partner to be combined with their specific drug product packaged in a 1mL long prefilled syringe. The system has been designed as a two-step operation where the patient simply removes the cap and presses the system against the skin to deliver a subcutaneous injection. Audible, visual and tactile end-of-dose indicators, as well as a passive safety system that covers the needle after injection, ease the drug delivery process for patients with dexterity challenges.
Patient-activated and controlled systems like the SelfDose system assist with compliance since the systems are not indicative of a syringe injection, which may be less frightening for the patient. Thus compliance may be easier and the therapy more successful for those with needle phobias. In addition, the patient can self-inject, which offers the possibility of alternative dose frequencies to help aid with comfort and preference. In addition, patient-activated and controlled systems do not rely on complicated mechanics (spring activation, etc.), which can help to shorten the development time needed to pair the device with a drug.
For more information about SelfDose, click here.
SelfDose™ is a trademark of West Pharmaceutical Services, Inc. or its subsidiaries, in the United States and other jurisdictions.
For injectable drug product package systems, seals are considered to be secondary package components. Though not in direct contact with drug products, they perform critical functions such as: Maintain an integral sterile seal by holding the stopper firmly in place, protect the injection site on the stopper and provide evidence of tampering (dependent on seal design).
In March technical experts from both West and SCHOTT joined together to share insight on the current trends and challenges of the injectable drug market. The two companies held technical seminars sharing their knowledge and expertise related to component and container selection, as well as the integration of primary packaging for filling from clinical to scale up. <br />
The plunger rod is a fundamental feature of a complete syringe drug delivery system. There are three key functional characteristics that all pharmaceutical manufacturers should consider when determining the appropriate plunger rod for a specific drug product and syringe system.
What does it mean to have package integrity for your container closure system? It means an absence of breaches that can lead to product loss or ingress. Container closure integrity testing should not be just a “one and done” study. It should be understood throughout the life cycle of the product.
Moisture-sensitive drug products are commonly lyophilized to enhance their shelf life and to prepare them for storage and transport. Maintaining a constant moisture level in a lyophilized drug product “cake” ensures product quality. Not only is proper selection of a container closure system (vial, stopper, seal) necessary, but sealing conditions are as well. This is achieved through demonstration of container closure integrity (CCI).
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