EPM speaks to Kirsty Gapp, 3M Drug Delivery Systems about the challenges and trends within the industry and why interest in microneedle technology is surging.
EPM: With many years’ experience in drug delivery, could you give an overview of available solutions and important factors that must be considered when designing an appropriate delivery system?
KG: When designing an appropriate delivery system, it is essential for each system to meet the needs of the patient. Solutions can include inhalation, transdermal and microneedle technologies, all of which have the same goal of delivering efficient, cost-effective and patient-centered solutions. As scientists and engineers begin drafting new designs for drug delivery methods, they are now starting with the patient at the ground level and working their way up. Previously, the patient’s input came later in the research and development process, but that is changing fast.
Changes in the marketplace must also be kept in mind when designing a delivery system. For instance, the rapid growth of the global biologics market is greatly influencing the approach to microneedles. In the last 10 years, pharmaceutical and biotech companies have been increasingly focused on the discovery and development of large biologic molecules. This is because of their ability to target previously hard-to-address diseases like cancer.
However, delivering larger molecules to a patient is much different than delivering smaller molecules. Most biologics cannot be given orally and are instead typically delivered via injection. Many patient groups aren’t used to injecting themselves using the standard needle and syringe, and microneedles offer great potential to bridge that gap.
EPM: How do you approach the different patient groups when looking at which delivery system would be best used for each product?
HTMS
3M's Hollow Microstructured Transdermal System in comprised of small needles designed to be less intimidating to patients.
KG: Individual patient groups often face their own sets of unique challenges. We work hard to help them overcome those challenges by creating a delivery system that is as user-friendly as possible and that they can have confidence in, and ultimately trust. That is key to ensuring adherence and long-term success. Our approach is really focused on functionality.
Within the elderly population, for example, swallowing tablets – often in large numbers - can be difficult, as these patients often take multiple drugs daily. Transdermal drug delivery can provide a solution as they work to deliver a drug over time, often over several days. Because they comfortably adhere to the patient’s skin, they can improve compliance – and because they can allow the treatment to be continuously delivered over several days, they can eliminate the need to remember, and track, individual doses throughout the course of the day.
Transdermal patches can also make it easier for the caregivers of patients battling elderly diseases such as Alzheimer’s disease to ensure compliance, because they can see if the patch is present. Additionally, with some patches, caregivers/family members can even write date and time information on the backing for increasingly accurate compliance monitoring.
Another example would be designing delivery devices for patients with limited dexterity, where the design of an easy-to-use application system for delivery of biologic therapies is important. Hollow microneedle devices can help make administration easier.
EPM: Could you provide a rundown of some of the common pitfalls that may be encountered when companies try to decide on which delivery system to use for a drug?
KG: One pitfall we often see is an attempt to alter a delivery method after a drug is already far along in the development process. It is impossible to overstate the importance of understanding the best route for the specific drug as early on as possible. At 3M, we work together with our partners to help identify the best delivery route in the early stages of development.
Microneedle technology is experiencing a surge in interest of late, how exactly can this technology benefit the manufacturer and patient and are there any difficulties with implementing this technology?
New technologies can take time to get off the ground and through the regulatory process for the first time. They also often require new manufacturing processes to be developed and scaled up for commercial supply, which can’t be underestimated. However, with the growth of drugs such as therapeutic vaccines, the benefits of intradermal delivery, which can be achieved using microneedle technology, are becoming clearer and garnering a greater willingness for drug developers to move to evaluate this type of technology. Intradermal delivery is challenging to achieve using a traditional needle and syringe. It requires specially trained practitioners and even then, the delivery can be inconsistent. In addition to this, many therapeutic vaccines require higher volumes to be delivered. Intradermal delivery using a needle and syringe is generally restricted to 0.1 ml of volumes.
For other biologic therapies, coated microneedles offer a distinct difference for patients unaccustomed to frequent injections or patients who are needle phobic. As for manufacturers, coated microneedles have the potential to reduce challenges posed by cold chain logistics. If you consider systems in which the drug is coated on the microneedle patch, these systems can be potentially stable at room temperature.
EPM: How important are delivery systems in terms of patient adherence?
KG: To help ensure patient adherence, it is extremely important to have a delivery system that addresses the needs of the patient. A 2008 research report showed that up to 94% of patients make mistakes when using their inhalers, and these were the dry powder inhalers that were intended to be easier to use (1). Additionally, up to 60% of patients don’t adhere to their medication. When patients forget to dose themselves or inadvertently use their inhalation devices incorrectly, it doesn’t matter how great the drug is – it will be less effective.
For patients faced with regular injections, both needle fatigue and mobility issues can impact compliance. For instance, if a patient must go to a clinic for an injection, but can’t drive, patient adherence will be greatly impacted. Microneedles have the potential to improve adherence because they can be self-administered in the comfort of a patient’s home.
EPM: In your opinion, how do you see drug delivery systems evolving over the next decade? (Are there any important industry trends to keep an eye on etc.
KG: I think the patient-centered approach will continue to grow and be adopted by the industry as a whole. Today, patient empowerment is at the center of the conversation surrounding healthcare and drug delivery technology. I am encouraged by the fact that this mindset is becoming mainstream, because I believe it will result in vastly improved patient care. Empowering patients to take control of their own health, through the use of data and other insights, is a critical piece of the healthcare puzzle that has been missing for way too long. When we can help patients have the information they need to use their medication correctly and use it according to their protocol, it will improve the picture overall for stakeholders – patients, providers and payers.
References
1: Lavorini et al., 2008. Respir. Med. 102(4):593-604