Translation of an innovative microgel technology for improving swallowing in the elderly
Lead Research Organisation:
University of Leeds
Department Name: School of Food Science and Nutrition
Abstract
Dry mouth, due to a reduction/absence of salivary flow/lubricity, affects at least 10 million people in the UK, predominantly elders. Largely driven by age-related chronic/neurogenerative diseases and polypharmacy, oral dryness significantly increases the risk of dental caries, periodontal diseases, candidiasis, oral ulceration, and dysphagia - all of which adversely impact the nutritional status and quality of life of elderly people. Numerous salivary replacers are commercially available, but none offers long-lasting relief due to their poor lubrication properties, thus forcing sufferers to use mouth spray repeatedly all day long to be able to eat. Subsequent malnutrition, which affects 1.3 million over-65s, results in a £7.3 billion annual loss.
We have recently patented an innovative, highly lubricating saliva substitute for dry mouth sufferers, which offers 95% more effective lubrication and a 50% longer relief period than both currently marketed saliva-replacing products and the naturally lubricating human saliva. Our technology forms a viscous fluid film that moistens/lubricates the mouth (lubricity-improving hydration thanks to the water-encapsulating biopolymeric hydrogel) and stays adsorbed onto the human tongue/palate following ingestion (long-lasting hydration thanks to the efficiently adsorbing proteinaceous microgel). Besides technical development, we have demonstrated up-scaling feasibility and regulatory compliance.
Our novel lubricant will overcome the bottleneck of the sub-optimal performance of marketed aqueous lubricants, and will surely contribute to addressing the long-standing swallowing issues faced by elders. This award will allow conducting further proof-of-principle work, including manufacturing a safety compliant medical device, assessing its cost, and building a robust business case.
We have recently patented an innovative, highly lubricating saliva substitute for dry mouth sufferers, which offers 95% more effective lubrication and a 50% longer relief period than both currently marketed saliva-replacing products and the naturally lubricating human saliva. Our technology forms a viscous fluid film that moistens/lubricates the mouth (lubricity-improving hydration thanks to the water-encapsulating biopolymeric hydrogel) and stays adsorbed onto the human tongue/palate following ingestion (long-lasting hydration thanks to the efficiently adsorbing proteinaceous microgel). Besides technical development, we have demonstrated up-scaling feasibility and regulatory compliance.
Our novel lubricant will overcome the bottleneck of the sub-optimal performance of marketed aqueous lubricants, and will surely contribute to addressing the long-standing swallowing issues faced by elders. This award will allow conducting further proof-of-principle work, including manufacturing a safety compliant medical device, assessing its cost, and building a robust business case.
Organisations
Publications
Pabois O
(2023)
Benchmarking of a microgel-reinforced hydrogel-based aqueous lubricant against commercial saliva substitutes
in Scientific Reports
| Description | We filed a patent application in May 2020 (GB priority and PCT patent application), which covers the core technology and its application as a saliva substitute. In November 2022, we have reached national phase entry. In addition, in August 2022, we filed an additional patent application on the application of our technology as a fat replacer, therefore contributing to building a strong IP fortress. We worked with a commercial expert, who helped us assess the market opportunity size for dry mouth therapeutics, the competitive landscape, and the potential of our solution. The dry mouth therapeutics market has been estimated to reach $1billion in 2030, with the US being the top country of interest, and the business expert has positioned our solution at around $10million. We worked with a regulatory expert, who helped us define the regulatory route/requirements. Our technology was identified to be a Class I Medical Device and a list of safety/stability testing to be validated following manufacturing has also been determined. We are currently looking for a medical device-specialised manufacturing partner for the development of a prototype in different packaging formats at a large/production scale (at least 100 kgs). We are currently working on developing a range of packaging formats: we have a gel, which we are converting into a sprayable liquid. We demonstrated that dilution of the gel is one potential option. We are currently investigating the addition of another polymer as another solution. We are exploring the application of our technology as a fat replacer. We have obtained preliminary results demonstrating its high performance as such, using a sensory trial with 100 participants. We are currently looking to optimise our technology formulation for such an application, and to develop different low-fat food products. |
| Exploitation Route | We are currently developing a saliva substitute at large scale, which could be either licensed to commercial partners or directly sold to patients suffering from dry mouth. We are also looking to develop a fat replacer, which could be of considerable interest as a food ingredient for the food industry. |
| Sectors | Agriculture, Food and Drink,Pharmaceuticals and Medical Biotechnology |
| Description | Results from this award will contribute to improving the nutritional status and overall quality of life of patients suffering from either dry mouth (predominantly elders) (saliva substitute) or obesity (fat replacer), in addition to reducing economic burdens associated with these diseases. |