Drug Reconstitution and Mixing

It is estimated that around a third of newly approved novel drugs and vaccines, including biologics, are initially marketed in a lyophilized (dry drug) format for reconstitution at the point of delivery. The molecular complexity of some biologics can mean they are unsuitable for use in a liquid stable form. Lyophilization can also provide the fastest route to market for some injectable therapies, with conversion to a liquid form possible at some later stage during the lifecycle management of the product. In addition, many pharmaceutical companies are developing combination therapies that may comprise two or more liquid, lyophilized or powder filled molecules.

For all such injectable therapies, the traditional process for reconstitution and mixing can involve a dozen or more steps of use and multiple pieces of inventory. This complexity can make lyophilized or combination drug therapies largely unsuitable for patient self-injection without extensive prior education by a clinician. Typically, injectable drugs requiring reconstitution are therefore administered in healthcare facilities, resulting in increased healthcare costs and inconvenience to patients requiring treatment for chronic diseases such as multiple sclerosis, rheumatoid arthritis and hemophilia. Where reconstitution and mixing does occur outside of healthcare facilities, the injectable therapy is often supplied in a kit including vials, syringes, needles and instruction booklets.

Pharmaceutical companies are increasingly seeking to utilize dual or multi-chamber prefilled syringes that contain each liquid, lyophilized or powder filled molecule in a separate container. Traditional dual-chamber systems can require the user to hold the device at a specific orientation and break sterility before reconstitution…forcing immediate injection. Needlestick prevention features are also not integrated within such traditional dual-chamber systems. Unilife is the first and only known Company to have developed a range of dual-chamber syringes enabling ventless, orientation free of any combination of liquid, powder filled or lyophilized therapies. As with Unifill syringes, this proprietary dual-chamber technology requires minimal steps of use making them ideal for patient self-injection, and also feature automatic, user controlled needle retraction.