Plaster for the treatment of painful recurring mouth ulcers

Organisation: Position: Deadline Date: Location:
Mouthulcer

Credit: Sheffield University

A plaster which sticks to the inside of your mouth is revolutionising the treatment of painful recurring ulcers. Scientists from the University of Sheffield’s School of Clinical Dentistry, working in close collaboration with Dermtreat A/S from Copenhagen, have developed a unique patch using special polymers which are able to stick to moist surfaces.

The patch successfully administers steroids directly to oral ulcers or lesions whilst also creating a protective barrier around the affected area, accelerating the healing process.

The novel plaster is a breakthrough therapy for the treatment of mucosal conditions such as oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS), which are diseases that cause painful lesions and affect 1%-2% of the population.

Until now, ulcers and lesions inside the mouth have been treated using either creams or mouthwashes, which are used in the whole mouth rather than targeting the specific area, making them less effective. However, the biodegradable Rivelin® patch, has a long adhesion time and a high flexibility which conforms to the surface inside the mouth.

Dr Craig Murdoch, reader in oral bioscience, School of Clinical Dentistry and lead author of the research, said: “Chronic inflammatory conditions such as OLP and RAS, which cause erosive and painful oral lesions, have a considerable impact on quality of life.
“Current treatments consist of using steroids in the form of mouthwashes, creams or ointments, but these are often ineffective due to inadequate drug contact times with the lesion.

“The patch acts like a plaster inside your mouth, which means it is very effective at directly targeting the specific area as well as forming a protective barrier. “Patients who have trialled the patch found it to be very comfortable to wear and they were really pleased with the length of adhesion which makes it particularly effective and efficient.”

Jens Hansen, CEO at Dermtreat A/S, added: “Collaboration with the University of Sheffield has undoubtedly accelerated the translation of our intellectual property towards clinical use. Our company are very confident that we will soon gain regulatory approval for the first adhesive drug delivery technology to address pressing clinical needs in oral medicine.

“We look forward to continuing this collaboration, which will be increasingly directed at finding new clinical applications for muco-adhesive patches.”

Dermtreat A/S was recently awarded $17.7m from the venture capital firm Sofinnova. The funding will take the patches into phase two clinical trials, which will run at several sites in both the US and the UK – including at the Charles Clifford Dental Hospital in Sheffield. In addition, Dermtreat are funding further research at the Dental School to develop the next generation of patches that contain other useful drugs.

Abstract
Oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS) are chronic inflammatory conditions often characterised by erosive and/or painful oral lesions that have a considerable impact on quality of life. Current treatment often necessitates the use of steroids in the form of mouthwashes, creams or ointments, but these are often ineffective due to inadequate drug contact times with the lesion. Here we evaluate the performance of novel mucoadhesive patches for targeted drug delivery. Electrospun polymeric mucoadhesive patches were produced and characterised for their physical properties and cytotoxicity before evaluation of residence time and acceptability in a human feasibility study. Clobetasol-17-propionate incorporated into the patches was released in a sustained manner in both tissue-engineered oral mucosa and ex vivo porcine mucosa. Clobetasol-17 propionate-loaded patches were further evaluated for residence time and drug release in an in vivo animal model and demonstrated prolonged adhesion and drug release at therapeutic-relevant doses and time points. These data show that electrospun patches are adherent to mucosal tissue without causing tissue damage, and can be successfully loaded with and release clinically active drugs. These patches hold great promise for the treatment of oral conditions such as OLP and RAS, and potentially many other oral lesions.

Authors
HE Colley, Z Said, ME Santocildes-Romero, SR Baker, K D’Apice, J Hansen, L Siim Madsen, MH Thornhill, PV Hatton, C Murdoch

University of Sheffield material
Biomaterials abstract


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