Pointed Debate: Expert Views on Injectables - Pharmaceutical Technology

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PharmTech Europe

Pointed Debate: Expert Views on Injectables
We bring industry experts together to discuss the importance of self-administration and what injection technologies are best suited to this cause.

Pharmaceutical Technology Europe
Volume 24, Issue 2

Q: Which technologies (autoinjector, prefilled syringes etc.) are most suited for self-administration and why?

Kaufman: As patients are not medically trained, empowering them to feel comfortable enough to properly inject themselves requires a device that can make them feel safe both mentally and physically. To address this, devices with special features and technologies, such as the auto injector, are often designed so the patient never sees the needle and may finish administering the drug within a relatively short period of time. While reactions to physical pain may vary for each patient, the mental pain connected to visually seeing a needle inject can largely be reduced, especially when the patient also has control over when to initiate the injection. As a result, auto injectors are becoming a commonly accepted drug delivery technology for self-administrated injectable therapies.

However, it is very important to note that each patient needs to be properly trained on how to use such devices and they must be provided with very clear instructions for use. The use of picture-oriented instructions and video has been a good step towards addressing this issue. Another potential drawback related to self-administration technology is the cost associated with developing a drug delivery device and the actual cost of each device. At this time, it is much easier for larger biopharmaceutical companies, which have the necessary financial resources, to initiate these programmes. Additionally, the market value of the drug must be able to justify the cost of the device.

Novara: The most suitable technology depends on many factors:
  • Technical specifications. A high volume or highly viscous biologic, which may be infused in a hospital setting, may require a patch injector/patch pump to deliver the medicine in the home setting. It is also important that careful consideration is given to the delivery of drugs that have a unique viscosity or volume that needs to be delivered.
  • Competitive dynamics. Pharma and biotech companies are increasingly looking to their device as a source of differentiation.
  • Patient factors. Certain patients will have certain needs and preferences given their condition and how mature that market is with devices.
  • Frequency of administration. Whether a drug is injected on a daily basis, versus a weekly or monthly basis, is also an important factor (along with the cost factor).

All these considerations are crucial factors in selecting the right technology. For device manufacturers, it's important to have expertise across a range of delivery platforms and technologies in order to meet the above needs for customers.

Potter: Auto-injectors and pen-injectors have been designed for self-administration. These technologies are widely used, work very well and are far easier to use and more convenient for patients than a standard needle and syringe. However, they still use a needle, which brings about issues related to needle reuse, needle disposal and needle phobia. In addition, many drugs that have to be injected are not very stable in a liquid formulation. Some biologics are stored in a powdered form to provide better stability, but they need reconstituted prior to injection, which adds to costs and treatment complexity. Liquid jet injectors avoid the issues with needles, but still incorporate a liquid formulation. They are also very expensive and have not achieved significant market traction.

None of the technologies mentioned really provide a simple way to inject a controlledrelease formulation. Typically, a controlledrelease formulation comprises polymer microspheres in a solution, but because of the issues of needle clogging these expensive products are normally injected by specially trained healthcare professionals. Other injection technologies, such as solid dose injectors and microneedle patches, are in development, but they are not yet ready for routine patient use.

Sadowski: The key to considering self-administration technologies is to focus on the patient. Our company, for example, is not committed to any particular injection technology type. Companies should design the technical solution that best fits the circumstances in a given therapeutic application. In particular, it's important to consider the patient's needs and limitations in the target disease condition, and then to look at how best to apply technology to make the patients' self-injection experience most acceptable and successful.


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