There is a growing interest in transdermal drug delivery, driven by the need for product differentiation and the increasing importance of patient preference and compliance in a crowded pharmaceutical marketplace. Given demographic trends impacting the healthcare industry, pharmaceutical companies that invest in patient-friendly delivery systems now will be well positioned to meet both current and future demands for innovative patient-centric treatments.
One relatively recent transdermal product introduction that 3M was part of exemplifies how this method of treatment has gained popularity because of its unique suitability for the target therapeutic application and its patient-friendly characteristics. The success of transdermal delivery can be seen with SANCUSO (granisetron transdermal system), marketed by ProStrakan*. Granisetron is indicated to treat chemotherapy-induced nausea and vomiting, and has been available in a tablet and an IV injectable form for a number of years. From the patient’s perspective, both these delivery methods pose challenges. An IV injection requires a hospital or infusion center visit, causing the patient inconvenience and potential administration costs. An oral dosage form is not an effective dosage form when delivering an antiemetic. Transdermal delivery was a clear choice for an alternative delivery system as patient preference – and ease of use was top of the list for ProStrakan when developing the product.
*SANCUSO is a registered trademark of ProStrakan Group Inc.
Transdermal delivery systems offer many patient-friendly features, as patches can be administered painlessly and provide clear visual evidence that a dose has been given. Transdermal delivery can also offer efficacy benefits, as the method can avoid first pass metabolism and helps maintain a steady blood level of medication, as opposed to the peak-and-trough effect seen with many pills.
Depending on the drug’s characteristics, transdermal technology has the potential to deliver a drug with a release profile of up to seven days, further easing the demands placed on patients and caregivers. Another patient and caregiver-friendly feature of a transdermal patch is the ability to verify compliance. It is far simpler to confirm that a dose has been given if one can visually see the patch on their skin. In nursing home settings, for instance, it is not uncommon for caregivers to write with a marker on the patch itself to indicate the time and date the patch was applied.
Obviously, not all drug formulations can utilize transdermal delivery. The classic candidate for traditional transdermal delivery is a small, lipophilic molecule that can diffuse through the stratum corneum and pass into the systemic circulation. The stratum corneum is made up of dense, hydrophilic structures surrounded by an intercellular lipid matrix, so hydrophilic structures are typically not good candidates.
Pharma will always start with a tablet; however, when pharmaceutical companies truly examine the usage scenarios for a product and consider how to best match a delivery system with the patient profile, the solution is not always a pill. It can be a daunting realization for companies that have little to no experience with alternative delivery systems.
Once the transdermal route has been established as the optimal drug-delivery method, the next task is to create a well thought out product profile, which includes considerations such as the desired duration of wear, patch size, and desired delivery rate.
Considering transdermal drug delivery can be a challenge for pharmaceutical companies, especially when they tend to focus most product development activities on the oral route. By working with a partner with expertise in the development and manufacturing of transdermal treatments, companies can increase the speed to market for their products and reduce the number of challenges along the way. When considering an outsourcing partner, it is important to carefully examine the potential partner’s past track record of quality, as well as its experience with navigating regulatory hurdles in the countries targeted for marketing of the product.
In 2015, 3M’s Hollow Microstructured Transdermal System (hMTS) became available for clinical trials. This microneedle technology can reproducibly deliver up to 2ml of liquid formulation intradermally with no needles to dispose of and patients can administer themselves. With the ability to provide reproducible intradermal delivery of biologics over a range of viscosities and volumes, hollow microneedle technology presents a compelling delivery route for pharmaceutical companies to explore. In addition, 3M’s Solid Microstructured Transdermal System (sMTS) continues to be available for clinical trials following formulation development for doses <300 mcg.
As payers around the world continue to focus on cost reduction alongside improvements in health outcomes, stakeholders need to be open to the possibilities afforded by new digital technologies. Though on the surface more expensive, connected devices allow the payer and clinician to track usage and, in some cases, disease state, allowing real-time condition-management. Information can then be used by healthcare professionals to manage their patients better and make healthcare more efficacious and economical over the long run needs to be considered when making these decisions. New technologies to drive patient compliance and adherence will be the future of drug delivery.
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