Innovative drug delivery may facilitate MS treatment
Multiple sclerosis (MS) is an immune-driven neurological disorder that can have a major impact on a person’s quality of life. It affects around 3 million people worldwide, and incidences are increasing. “It has been called the disease with a thousand faces,” says N2B-patch project coordinator Carmen Gruber-Traub from the Fraunhofer Institute in Germany. “Patients can experience different symptoms, ranging from fatigue to mobility problems, and no case is the same.” It is also one of the most common incurable neurological disorders in young adults. Patients are typically diagnosed at a young age, when they are for example launching their careers or thinking about starting a family. Existing treatments include long-lasting infusions, taking daily tablets, or injections into the spinal cord. All are not ideal; patients have to either remember this every day or visit the hospital for several hours. Injections and infusions are also not the most efficient in targeting medication to the central nervous system, where it is needed.
Efficient drug delivery
The N2B-patch project brought together researchers, medical professionals and MS patients in order to deliver an efficient drug delivery system that might fit better into busy lives. “Patient involvement in the project has been very helpful,” notes Gruber-Traub. “They expected the treatment to above all be safe, to increase treatment efficiency and to have fewer side effects. They also wanted a treatment that might minimise the frequency of hospital visits.” The solution developed was a nose-to-brain patch that would ideally need to be applied about every 2 weeks. “Nose-to-brain delivery is effective because it is direct,” explains Gruber-Traub. “The upper chamber of the nose – the olfactory chamber – is separated from the brain by just a few layers of cells and a special bone.” Delivery via the olfactory chamber circumvents the blood-brain barrier, the body’s defence against foreign particles reaching the brain. Going directly through the olfactory chamber also avoids drugs entering the respiratory tract, which is again less efficient and can cause severe side effects. For this purpose, a patch just a few millimetres in size was developed. It contained active pharmaceutical ingredients encapsulated in a special formulation combining particles and hydrogel. Using a patented device, the viscous patch can be placed in the upper olfactory chamber, where medicine for treating MS is then released in a controlled manner. “A key result for me has been the acceptance and enthusiasm of MS patients,” says Gruber-Traub. “We were cautious about the invasiveness of the procedure, but they were very open about the possibility of this improving their quality of life.”
Pathways to market
The device cannot be self-administered, and thus, requires medical assistance. The project team is hopeful however that a regular patch could one day replace daily tablets and injections. “MS patients were keen for the device to be available as soon as possible,” adds Gruber-Traub. “Getting the product onto the market however will take a number of years.” The next steps on the path towards commercialisation, which include clinical trials, are currently being discussed with patent attorneys, researchers and pharmaceutical companies. The drug delivery system pioneered by the project holds potential not only for treating MS, but also for other brain disorders such as strokes and other neurodegenerative diseases. The particle-hydrogel-patch and application device could transport other active pharmaceutical ingredients, which might also benefit from being deployed directly to the olfactory chamber.
Keywords
N2B-patch, multiple sclerosis, neurological, olfactory, brain, medical, injections