Integrated Devices for Reconstituting Injectables
|出版商||Greystone Research Associates||商品編碼||356827|
The inherent instability of biological drugs is a limitation that has a direct impact on the drug delivery sector. Therapeutic proteins must either be stored under special conditions or formulated to retain their efficacy from the time of manufacture until they are dispensed. Liquid protein drugs require refrigeration until dispensed. Alternatively, proteins can be formulated as powders (lyophilization) and must be reconstituted prior to injection. Historically, this was accomplished by including a disposable syringe and diluent vial for manual reconstitution. As the number of drugs developed for self-administration has grown, devices that integrate a reconstitution step with the injection step have gained traction. As biological drugs continue to grow in terms of therapeutics and total prescriptions, the impact of specialty devices will increase.
A longer life span is expected to translate to a growing number of patients diagnosed with chronic conditions. To counteract the financial and medical infrastructure implications of this trend, pressure from the public sector and managed care organizations will place a premium on therapeutic self-administration, an expectation that is creating an increased interest in routes of administration that are patient-friendly and cost-effective. Pharma company decision makers have come to the realization that for many products, success no longer only depends on the medication itself but also on achieving a consumer-compatible form of packaging and application.
‘Currently only a small number of lyophilized drugs are supplied in integrated reconstitution devices - most lyophilized drugs for injection are typically sold in vials packaged with a diluent syringe - but this number is expanding with the growing number of branded injectables that cannot be stored as liquids at room temperature. The simplicity and patient acceptance of integrated reconstitution devices is becoming an accepted method for differentiating injectables in an increasingly competitive market.’