Insulin pill The news that a new drug that can change the way diabetics are administered insulin has been doing the rounds. The new insulin pill – that is swallowed rather than injected — is touted to be the next big thing is diabetes care. A pill that promises to replace the painful insulin injections that diabetics have to regularly self-administer, is an invention that has all the industry biggies sit up and take notice. And what’s more it has been developed by an Indian scientist. In an attempt to understand more about the pill, we caught up with Sanyog Jain, the lead researcher of the study, and asked him about the pill, its possibility to revolutionise diabetes treatment and his journey towards this discovery. Here are excerpts from the exclusive interview.

How and why did you decide to take up this research?

My research interest is not only restricted to developing oral insulin pills. For more than one decade I have been actively involved in developing different types of nano-drug delivery systems for specific drugs. My aim is to identify the challenges in conventional drug dosage and come up with new delivery systems. We (my team and I) have developed several patented technologies like:

  • Targeted anticancer drug delivery (to enhance the anticancer efficacy and reduce its side effects and toxicity)
  • Oral vaccine delivery (currently except for oral polio vaccine, all other vaccines are administered through injections)
  • Enhanced oral delivery of drugs which are currently available as injections only (especially anticancer drugs like doxorubicin, antifungal drug like amohotericin B etc)
  • Topical drug delivery for treatment of skin related diseases like psoriasis and acne
  • Single formulations encapsulating anticancer drug and antioxidant (for their synergistic effect and to reduce the toxicity of the drugs),
  • Non-viral vectors, for site specific gene delivery

In the case of insulin, it is conventionally delivered via an injection. Although, lots of newer preparations, with improved efficacy and sophisticated semi-automatic devices that promise lesser pain have been developed. Poor patient compliance and hypoglycemia are the most noticeable drawbacks of conventional injections. Looking at the pain and suffering of the patients I decided to take up this research. (Read: How to use an insulin pen)

How long did it take for you to finally see some positive results?

I started work on the oral insulin delivery system four years back and we filed one Indian patent in 2011. We have also published our first research article on oral insulin delivery in year 2012, but the problem was that it used expensive materials, making the drug too expensive. We have only now found some promising results, that holds the possibility of an affordable oral insulin pill.

What challenges did you face while working towards this scientific breakthrough?

The major challenge in the case of delivering insulin through the oral route is to protect the insulin from degradation in the stomach or intestine. Insulin is a protein molecule which when swallowed is digested by proteolytic enzymes which are present in the stomach and are responsible for digestion. The second challenge we faced was the fact that insulin, being a high molecular weight protein, is unable to cross the intestinal membrane and be absorbed in the blood stream. (Read: Treatments for diabetes: Oral medications, insulin and other methods)

Therefore, we aimed to develop a formulation which offers protection to insulin from degradation and to facilitate its absorption into the blood. But developing a stable formulation was a challenge in itself, since preparation conditions involved the use of organic solvents, high speed centrifugation/ homogenization which may cause degradation of insulin etc. Further, the stability of the carrier system inside the harsh conditions of the stomach and its long term storage stability were also challenging tasks.

How will this medicine change the face of diabetes?

The problem of diabetes is becoming more severe everyday, and the unhealthy lifestyle people live these days is one of the major causes behind this alarming rise in numbers. India and China are considered to be diabetic capital of the world. Needless to mention that an oral pill will definitely overcome the limitations associated with current therapy. (Read: Diabetes – Symptoms, causes, diagnosis, treatment and complications)

How expensive will this medicine be? When will it be available in the Indian market?

Frankly speaking, the cost of any drug formulation is decided by the manufacturing company. There is huge margin in the actual production cost and the retail price. However, in my opinion the expected cost would be lesser or comparable with current formulations.

As for is availability in the market, it is very difficult to comment. So far, we have tested the safety and efficacy of the formulation in animal models only. The next step is to evaluate its efficacy on human subjects, which is beyond our current capability due to regulatory hurdles and financial constraints. This can be made possible if we have the backing of some pharmaceutical manufacturer, who can help us take this further to the stage of clinical trials. If everything goes well, then this drug can be sold commercially in the next three to five years.

What are the possible areas that this medicine could fail?

Till now we have got very conclusive results at every level. The only two percieveable problems are the industrial scalability and the conversion of our data into human data. (This is because we produced the drug on a small scale and tested it on diabetic rats. But how they will fare when produced on a large scale and their stability during clinical trials is yet unknown).As the present formulation is based on liposomes, and there is a well established technology for it, we hope the formulation will perform well in future too, without complications.

Can it cause any side effects in humans? 

The chances of side effects are almost nil as all the components of the pill are biocompatible and have been approved by FDA for human use.

Will this medication be as efficient in patients with gastric ulcers or conditions like acidity as well?

Yes, the formulation is expected to be effective equally in such patients as well. The possibility of such a problem is negligible because the nano-carriers (which are used to transport the insulin from the stomach into the blood) follow a particular path for absorption (through specialised cells that are present in the small intestine). Moreover, drugs that work on acidity and ulcers have a different site of action and the transportation of the nanoparticles carrying insulin is different. Therefore, the drugs to fight acidity and ulcers might not create any interference with the uptake and subsequent performance of the insulin pills. (Read: 10 home remedies for acidity that really work!)

Finally, this pill is being touted as the most significant breakthrough in the field of diabetes and its treatment. What are your thoughts on that? 

An oral pill of insulin will definitely be a breakthrough in the field of diabetes; it has the potential to revolutionise the very method of treatment. Diabetics will no longer have to suffer the pain of multiple injections and there will be at least a marginal drop in the number of people who forget to take their injections. Apart from all that, it will also reduce the chances of a diabetic suffering from insulin shock, coma and even death. 

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