Innovative gel aid for administering tablets to stroke and other dysphagic patients

Lead Research Organisation: University of East Anglia
Department Name: Chemistry

Abstract

We propose to develop a gel, within which tablets can be inserted, which makes swallowing easier and safer for patients with swallowing difficulties. Current approaches to helping patients with swallowing difficulties to take their tablets involve mixing crushed, dispersed or whole tablets in foodstuffs such as jam and yoghurt. Tampering with tablets not designed to be crushed or dispersed can have undesirable consequences. Similarly mixing with foodstuffs may affect drug absorption or leave carers open to accusations of administering medicines without the patient s consent (covert administration).
We have developed a clear gel to be placed around tablets and therefore make them easier to swallow. Our gel consists of products which are both safe for human use and are known not to interact with tablet ingredients or coatings. The gel is designed to become more slippy on contact with saliva which means that tablets can be swallowed without water. This is particularly useful in patients who cannot safely swallow solids and liquids at the same time. We believe that with 2 years additional funding we will be able to both finalise the composition of the gel by the potential addition of stabilising agents, preservatives and possible flavourings (which can increase saliva production) and perform small patient trials to demonstrate that in healthy volunteers there is no effect on drug absorption and that the gel is acceptable to patients who are likely to utilise it.

Technical Summary

At least 110,000 people suffer a stroke each year in the UK, with an NHS cost of #2.8 billion. More than half of such patients experience swallowing difficulties which may render oral medication administration extremely difficult and unpleasant. This has also led to the dangerous practice of tablet crushing which may seriously compromise the absorption process, particularly for controlled release medications, as well as increasing risks associated with fragment aspiration and nasogastric tube blockage. We have invented a gel system into which the tablet may be inserted immediately prior to administration to aid the swallowing process. The gel is inexpensive, composed of safe components and is simple to manufacture reproducibly; our market research has established that such an intervention is desired by patients, carer groups and clinicians. A small scale trial has been performed. We request support for further developmental and early evaluation studies so as to bring the prototype to the stage of full clinical trials. We also argue that in the slightly longer term the invention may be generally applicable to patients with swallowing difficulties, particularly the elderly, and hence may prove to be an invaluable device for a significant patient population.

Publications

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Title Swallowing Aid 
Description A novel semi-solid gel based swallowing aid for use as a delivery vehicle to assist tablet administration in patients with swallowing difficulties. 
IP Reference WO2009098520 
Protection Patent granted
Year Protection Granted 2013
Licensed No
Impact None to date.
 
Title Swallowing aid 
Description The product comprises a gel-based swallowing aid whereby a tablet is inserted prior to swallowing. While a prototype (and associated IP application) was in place prior to the MRC (DPFS) award, we have considerably refined the formulation in the course of the project. We are in the p[rocess of commencing a clinical study to establish bioequivalence and are writing the protocols for a patient study. 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2012
Development Status Under active development/distribution
Impact As the product is in the process of being protected we have not felt it appropriate to disseminate findings without a Non Disclosure Agreement being put in place, hence we have not been in a position to promote or gauge impact to the wider community. However we are very encouraged by the interest shown by companies in the concept.