A closed-loop transdermal patch – a game changer in diabetes research
A patent has been granted to researchers from JSS Academy of Higher Education and Research, Mauritius, JSS College of Pharmacy, Ooty, India and Indian Institute of Technology, Bombay for the innovation “A Process for Fabrication of the Transdermal Dissolving Microneedle Patch for the Controlled Release of Insulin” on 30th November 2023 (Patent no. 475507, Patent office, Government of India).
According to the WHO, around 180 million people globally are affected by diabetes and that number is estimated to reach over 350 million by the year 2030. The last NCD survey conducted in 2021 shows around 20% of the overall population in Mauritius suffer from diabetes. The prevalence of uncontrolled diabetes is a real concern as it increases the risk of severe health complications such as heart disease, renal impairment, eyes problems and damaged arteries.
Diabetes: a metabolic disorder
Diabetes, which causes uncontrollable increases in blood glucose levels, is globally one of the most prevalent chronic diseases. It is a metabolic disorder that either causes permanent lack of insulin production from the pancreas (Type1 diabetes) or a condition where the cells fail to respond to insulin due to dysfunction (Type 2 diabetes) which later elevates blood glucose levels. Insulin is a hormone which is synthesised and secreted from the pancreas to meditate the metabolic reaction involving glucose.
In the absence of insulin, the cellular system cannot accurately convert carbohydrates such as sugars, starches, or other foods into energy which is used by the body. These factors in due course result in many complications, such as cardiovascular disease, chronic renal failure, retinal damage, nerve damage, and microvascular damage.
In the human body, insulin and glucagon are counter regulatory hormones that play a vital role in regulating blood glucose levels. Either excess or shortage of glucose in the blood is known as a metabolic disorder.
The problem associated with current therapy
In the case of diabetic patients, medications like oral drugs and insulin injections are taken which give rise tomultiple complications where delivery by parenteral route administers the
drug into the bloodstream. Some common problems associated with injectable insulin therapy are:
– Subcutaneous insulin injection is painful and leads to lipohypertrophy in patients.
– Injectable insulin taken with other anti-diabetic drugs increases risk of side effects.
– The traditional care for diabetic people often requires monitoring of blood glucose and insulin injections to maintain normal glycemia.
– Injectable insulin leads to poor patient compliance as it is causes pain and irritation.
JSS’s innovation – microneedle patch
Prof Dr Ashish Wadhwani, Principal Investigator of the project and Head Faculty of Health Sciences, Dean School of Pharmacy, JSS Academy of Higher Education and Research, Mauritius, assisted by Dr Baishali Jana, Senior Research Fellow, conducted research to mitigate the limitations of injectable insulin therapy, and they have developed a microneedle-mediated drug delivery system that may enable patients to painlessly self-administer therapeutic micro and macromolecule drugs.
The microneedles (MNs) have been described as a novel method of delivering effectively pharmacologically potent molecules to the deeper layers of the skin in a minimally invasive manner; it is also pain-free, bio-safe, patient-friendly, and self-applicable system. An alternate approach is insulin delivery via transdermal delivery system, which could provide insulin continuously using a system likely to be well accepted by patients.
The goal of the research was to design, fabricate and test arrays of dissolving microneedles for minimally invasive and continuous delivery of insulin in-vivo. Insulin is a hydrophilic protein drug that was found to be compatible with gelatin and sodium carboxymethyl cellulose thus making the two materials suitable for this study. The dissolving microneedle made up of the above material is widely being explored in many medical applications such as tissue engineering and drug delivery. Dissolving microneedle patches were fabricated mainly composed of a combination of carboxymethyl cellulose and gelatin.
Gelatin produces a tough and strong needle material suitable for penetration and, on the other hand, carboxymethyl cellulose is considered to be an excellent material as a dissolving factor and encapsulating drug and this composite has proved to be safe in drug formulation and release with no side effects.
This study demonstrated that the proposed microneedle system featured this unique design allowing more convenient and efficient self-administration of drug insulin into the skin.
Prof Wadhwani says this breakthrough invention is a significant step forward in the development of non-invasive insulin delivery methods. The transdermal microneedle patch offers a pain-free and convenient alternative to traditional insulin injections. The dissolving, polymeric microneedle patches were fabricated with a very simple process to maintain the protein drug ability, localize the drug in the needle and minimize the drug loss. The degradation of the polymeric compound takes place only after insertion of these dissolving microneedle patches into the skin thereby releasing drug in rapid and sustain manner.
He adds that compared with subcutaneous injections, dissolving microneedle patches are fully biocompatible and generate no biohazardous sharp waste making them an ideal candidate and this will certainly be a game changer in the field of diabetes research. The dissolving microneedle patch mainly offers a potentially fast and inexpensive pharmaceutical development model by using drug already proven safe and effective. It can also influence product stability and delivery to the intended site of action. “Ultimately there is remarkable increase in efficiency, with no side effects, long duration action, and slow reduction in blood glucose level and maintained at a significantly reduced level. The discussion is ongoing with pharmaceutical and biomedical companies and hopefully, the product will be in the market soon,” he adds.
Prof Dr Ashish Wadhwani
Head Faculty of Health Sciences & Dean School of Pharmacy,
JSS Academy of Higher Education and Research
Dr Baishali Jana
Senior Research Fellow
Mauritius Times ePaper Friday 8 December 2023
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