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Abstract
Current parenteral administration of drugs suffers from several drawbacks including the requirement of healthcare personnel to administer the drug, the risk of needle stick injuries that may result in the transmission of blood borne pathogens, and patient discomfort. Prefilled devices have emerged as powerful tools to improve parenteral administration of drugs. There are a number of clinical conditions including treatment of endocrine diseases, neurological disorders, autoimmune diseases and emergency medicine where prefilled devices have made major improvements to patient care. Prefilled devices have become an important set of tools for the medical practitioner due to their ease of use and safety, cost effectiveness and patient convenience. This review provides a comprehensive summary of existing prefilled devices, their current clinical uses and corresponding regulatory processes.
Financial & competing interests disclosure
The authors would like to thank V Manjulov for his contribution for illustrations (Figures 2, 4, 6, 7, 8, 10, 11 and 12). This research work was supported by the US Army Research Office via the Institute for Soldier Nanotechnologies (ISN) at MIT (contract: W911NF-07-D-0004). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Key issues
Prefilled devices are drug delivery devices for parenteral administration (subcutaneous, intramuscular, intravenous and intraosseous routes) that integrate the delivery mechanism with the therapeutic drug.
Prefilled devices can come in the form of: prefilled syringes (syringes with drug already loaded), autoinjectors (for self-administration with a manual or automatic inject) and dual chamber (allows for additional reconstitution of lyophilized or powder drug).
Prefilled device designs have to take into account: accuracy, sterility, safety, waste minimization, materials interactions, logistical concerns, ergonomics and usability and affordability.
Prefilled devices are increasingly being adopted due to their increasingly safe and easy utilization by patients, portability, accuracy of dose and quick delivery, which lead to increased patient compliance.
Currently, prefilled devices are implemented in clinical therapies for: diabetes, infertility, human growth hormone deficiency, migraine, epilepsy, multiple sclerosis, pain management, rheumatoid arthritis, anaphylaxis and emergency intravascular access.
US FDA regulatory considerations for prefilled devices include: manufacturing and non-clinical/premarket testing, clinical trials, whether the device is a combination product including a drug packaged in the device, patient education and human factors.
Most prefilled devices filled with drugs will be considered ‘combination products’ and subject to additional manufacturing (good manufacturing practices) and quality standards.
Devices can be classified by the FDA as any of three classes: class I (low risk), class II requiring 510k premarket notification and class III (high risk) requiring a premarket approval application.
Among trends in prefilled device designs, some of the most notable include: capabilities for dose adjustment (e.g., dials), exploration of new materials for drug cartridge, adoption of electronic systems to monitor prefilled device deployment and obscuring of the needle.