The Delivery Systems division of West Pharmaceutical Services, works with clients to manufacturer and assemble pen delivery devices, often used for at-home injection.

In many therapeutic areas, devices and home delivery systems are becoming essential. Growth in injectable therapies has been driven by increased incidence of long-term diseases such as diabetes and auto-immune diseases (including multiple sclerosis and rheumatoid arthritis). Many of these treatments require regular injections, often performed by the patient or caregiver in the home setting. As new home therapies are developed, devices and delivery systems such as auto-injectors must evolve to meet patient needs. It is important that manufacturers fully understand and incorporate these needs when developing a new system.

Experience with and knowledge of these needs, in addition to human factors testing during early and late-stage development, can create a unique delivery system that is at once simple, compliant, and safe for use in any situation, and that differentiates the drug product in a crowded market.

The trend toward home health care

Administering injectable drugs in the home is difficult. Patients needed to measure dosages, store medications and supplies, and were often at risk for needle-stick injuries. Pen injectors and multidose cartridges were created for those who had frequent needs; however, these systems were limited to specific therapies such as diabetes and growth hormones, which often require weighed dosages or dose titration. Designed for frequent injections and for those who required variable dose capabilities, pen injectors were not ideal for chronic users of fixed-dose medications. Auto-injectors were recognized as a convenient method for delivering drug products, especially for patients who may have dexterity or needle phobia issues.

Daikyo Crystal Zenith syringes, made from a novel cyclic olefin polymer, can help reduce the risks associated with glass.

Today, many sophisticated delivery systems incorporate new technology to aid in patient compliance and safety, although most are still based around conventional glass syringes designed primarily for manual injection. However, as new drugs reach the market, including those with high viscosity or that need to be administered in high-volume, administration challenges have arisen. Costly recalls due to glass syringe breakage or slow or incomplete delivery of a drug in an auto-injector system have occurred, and in recent years, needle-stick safety legislation has pushed manufacturers to develop safer systems for use in every health care setting.

Biopharmaceutical and pharmaceutical companies, with the help of delivery systems companies such as West, are adapting to stay competitive with new materials for prefillable syringes, including break-resistant cyclic olefin polymers, such as Daikyo Crystal Zenith polymer, and unique designs that allow for easier and safer injection. These Daikyo Crystal Zenith systems are not only manufactured from a novel plastic material that reduces the risks of breakage, but the dimensional tolerances, quality standards, and freedom from materials such as silicone oil, tungsten, or adhesives ensure that the systems provide the combined benefits of a plastic with the features necessary to contain a sensitive biopharmaceutical.

Growth in devices and systems

When creating a delivery system, the pharmaceutical company must consider patient needs in conjunction with functionality. Human factors testing helps to develop a deeper view of the emotional needs and desires of the intended user, and it provides perspective on features and visual cues. Human factors testing also can help the manufacturer understand the nuances between where a device is used (clinic, doctor’s office or patient’s home) and who is using it (doctor, patient or care giver).

Such an analysis begins with patient interviews to determine issues with current systems and needs for future designs. Often, simple factors are important. These include the size of the device, how easy it is to hold and where the button will be placed. Visual, audible, and tactile features also may help end users comply with drug delivery instructions.

After this initial interview, prototypes are created and should be tested by end-users. This stage should include mock self injection by potential in-home users of a device. All considerations should be noted and prototypes redesigned to ensure that the basic form and feel of the delivery system is acceptable to the patient. Later testing, which may include more formal training through written Instructions for Use or verbal instruction, will help to fine-tune the system and ensure that it works as intended.

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