Addressing the self-injection challenges of lyophilized drug products

Main image: Duoject’s PenPrep EVO reconstitution device using a standard cartridge diluent and lyo vial.

The self-injection market continues to expand at a rapid pace due to the prevalence of chronic diseases, advancing drug delivery innovations and new product development with the intention of moving treatment from the clinical to the home environment. This growing demand is driven by the significant requirement to improve patient experience, including convenience and adherence, and the need to reduce the burden on healthcare systems. 

As an increasing number of complex drugs, such as peptides and biologics, are being developed for chronic conditions (many in a lyophilized form due to product stability), patients are faced with challenges associated with drug reconstitution and administration challenges including multiple step processes, and needlestick accidents. Whilst the offering for self-injection devices for liquid-stable drugs are commercially well-developed, few options exist for injectable lyophilized drugs. 

Duoject Medical Systems, a division of Novocol Pharma (a leading cartridge and combination products fill-finish CDMO), develops novel medical devices that enhance the safety, convenience and compliance of injectable therapies, with a focus on patient-centric care.  Our technologies and custom development services help reduce dosing errors and improve patient experience by emphasizing ease of use and minimizing discomfort associated with injections, allowing patients to manage their conditions at home and reducing the need for frequent hospital visits. In response to the patient needs and challenges for lyophilized drug self-injection, Duoject has developed solutions including the PenPrep EVO and Raven devices. 

The commercially marketed PenPrep EVO device, a cartridge-based reconstitution system, addresses administration challenges (including multiple steps and needlestick injuries) for lyophilized drug products that are typically supplied in a standard glass vial and allows for the patient to self-administer the admixture using commercially available cartridge-based pen injector devices.

The Raven device, is a new development program which includes a preassembled all-in-one reconstitution and injection device designed for seamless home care use. This innovative device integrates both a diluent cartridge and lyo drug vial into a single, compact unit, enabling the reconstitution of the medication with a few simple steps prior to self-administration using a standard pen needle for convenience.  Raven is a single-use, preassembled, and sterile device, which eliminates the need for patients to manually handle multiple components, simplifying the preparation process and reducing the risk of contamination and dosing errors. This new design addresses a significant challenge in the pharmaceutical industry: ensuring accurate and safe administration of reconstituted drugs in a home care setting. Traditional methods of drug reconstitution and injection often require multiple steps and a high level of precision, which can be daunting for patients, especially those with limited medical training. By simplifying the reconstitution and injection process into a single, user-friendly device, Duoject’s Raven device enhances patient adherence to treatment regimens, leading to better health outcomes. It empowers patients to confidently manage their own care, reducing the need for frequent healthcare visits and thereby lowering overall healthcare costs. Moreover, the device's safety features, such as hidden transfer needle and locking mechanism preventing reuse, as well as consistent dosing improve the overall safety profile of injectable medications, addressing concerns of contamination and dosing inaccuracies. This innovation represents a significant step forward in making complex lyophilized injectable therapies more accessible and manageable for patients worldwide.

About us: Since 1985, Duoject Medical Systems has provided design and development services for medical devices, drug delivery devices, and drug reconstitution systems, supporting clients at every stage of the product lifecycle. In addition to being a design and engineering partner for medical devices, Duoject supports its client’s missions at every step of the development process, including through regulatory affairs, manufacturing and project management support. Every project the company works on creates a strong IP background to ensure clients’ commercial success for many years to come. Duoject is a division of Novocol Pharma, a proud member of the Septodont Group of companines. Novocol is a well-established sterile injectable contract development and manufacturing organization (CDMO) specializing in aseptic cartridge fill-finish and combination product assembly.