Lankan scientists win international award:

The puff that prevents asthma

by Zahrah Imtiaz

On an average, today, one in five Sri Lankans suffer from asthma. The patient gets spasms of attacks in the bronchi of the lungs, causing difficulty in breathing. For some, asthmatic attacks are random and would go away with time, but for others it can be a lifelong battle.

Manoj Hettiarachchi and Nalin Kannangara with the Silver Medals

Inhalers, tablets and nebulizers plague the lives of many an asthmatic, with no way out. However, two Sri Lankan scientists Manoj Hettiarachchi and Nalin Kannangara have come up with a method of drug delivery which will help asthmatics faster and for longer periods.

"It is a horrible sight to see and so very common. Some of my own family members suffer from asthma. In a way, it has been quite a personal endeavour for me", said Hettiarachchi, as he sat next to his partner, Kannangara. They are the first Lankans to be awarded a 'process patent' in medicine in Sri Lanka.

Hettiarachhi and Kannangara have worked for the pharmaceutical company Emerchemie NB Ceylon Ltd since 2002 and 2003, respectively. Their common interests in research brought them together to work on how best to improve the manufacturing process for an asthma drug so that its delivery into the lungs is optimized.

It has been a good year for the duo, their process patent for a therapeutic in the treatment of asthma (specifically Chronic Obstruction Pulmonary Disease (COPD)) won the Presidential Award in February; and in April they won the Silver Medal at the Inventions Convention held in Geneva, where they represented Sri Lanka.

"We were influenced by our mother company Emerchemie which was already into marketing respiratory medicines in the country. And over the years we have noticed the increase in the medications, the value of the medicine and the number of patients affected by asthma", explained Hettiarachchi.

In addition, as Sri Lanka faces an ageing population, the number of older patients suffering from asthma will increase.

"The elasticity of the lung parenchyma becomes less as you age and the person has to make a greater effort to (inspire) breathe. Thus, a patient suffering from COPD or asthma, has to take more drugs as he grows older. All these problems meant we need a process where the drugs would be delivered efficiently into the lungs," said Hettiarachchi.

To overcome these problems, Hettiarachchi and Kannangara have been working tirelessly for the last seven years to design a process which would be both safe, effective and affordable.

"Asthmatic drugs mostly target the lungs because the disease is such that you need a quick response," said Hettiarachhi.

"The best way to have localized and fast action is to use oral inhalation where an inhaler device is used to inhale the drug directly into the lungs. It has less side effects compared to the tablets", Kannangara said.

The inhaler

There are two forms of oral inhalation drugs; aerosols and dry power inhalation (DPI). The latter being cheaper the two scientists decided that DPI would be the most cost effective drug for Sri Lankans.

Their patent involves finding the best way to deliver the active ingredient in the asthmatic drug into every part of the lung.

The end product is a capsule carrying six micro grams of the active ingredient in powder form. The capsule is inserted into an inhaler device and sent directly into the lungs.

The challenge however was to carry this minute amount of drug into the lungs without it being wasted on the way. The solution was to use a 'carrier molecule' which would take the drug right into the lung and leave it there without interrupting its pathway, explained Kannangara.

"It is like a passenger travelling on a bus, and reaching the destination, leaves the bus and moves on, without taking the bus with him", he said.

The best carrier molecule for the job was inhalation grade lactose. The lactose however, has to be mixed with the active ingredient and pre mixed in very specific proportions to work and the ratio of carrier molecule to active ingredient won them the patent.

"The velocity at which the drug is delivered is also important, thus the inhaler device which the patient uses also matters. While we are working on two inhaler devices, our lab tests have shown that almost all devices currently in use are acceptable, though in varying degrees of effectiveness,", said Hettiarachchi.

Commercializing the concept

Many inventions fall on the wayside when it comes to commercialization and as all inventors, Hettiarachchi and Kannangara had to struggle to find the level of investment they needed to set up their factory and laboratory.

"When we tested our results in vitro, we got impressive results but we needed a fairly large capital investment to start such precision manufacturing", said Hettiarachchi.

In 2012 they found the capital to go big and established a company called 'Emergence Life' to manufacture under. They started supplying to private companies at first and soon expanded to state hospitals through the Health Ministry.

"With our process, we have managed a lower cost of production than the imported drugs thus enabling us to compete effectively", said Kannangara.

"There is a common feeling that local products cannot compete with imported items. But in our part of the world, if we are to produce the cheapest drug with the best quality, we need to find ways to improve our manufacturing process, not cut costs and find short cuts", Hettiarachchi said.

Kannangara explained they followed the Good Manufacturing Practices (GMP) guidelines prescribed by the WHO to adhere to quality and safety standards,

"Our products have also been tested by an independent laboratory of international repute to certify that they are safe. Our drugs act directly on the lungs, so we have to make sure they are of the best standards. We cannot afford to take risks in safety when dealing with drugs", said Kannangara.

Given their company's ties to international pharmaceutical companies, Hettiarachchi said they were always exposed to the international culture of research. They were supported by the company to take risks and persist with the project.

"We have been very lucky in that aspect. We didn't have the necessary capital, so it was great that Emerchemie agreed to invest. Most inventors and innovators fail because they have no financial backing to turn their inventions into reality", said Hettiarachchi.

He observed that greater research in pharmaceuticals was the need of the hour as the country lost millions in foreign exchange every year through the import of drugs.

They also noted that the inventors commission of Sri Lanka helped them with their application process to win the award.

Hettiarachhi, the business minded of the two said the next stage of the project was to further consolidate their process and improve on it to produce more.

"We want the people to get to know our equipment, the processes and design standard operating procedures. There have been times when we have thrown away millions worth of goods because it did not meet standards. We are not looking for short term commercial success but long term benefits", he said.

They plan to introduce more niche products in the respiratory field and expand their product portfolio in the next three years.

Producing precision drugs in a tropical environment however, has not proven to be easy. Their laboratories have been designed under strict climate controls but increasing humidity due to climate change would pose greater challenges for storage and production.

Both Hettiarachchi and Kannangara are science graduates from the Universities of Colombo and Sri Jaywardenapura respectively, and have hired local science graduates to work with them.

"We have around 15-20 science graduates now but it is hard to keep them and find more", said Kannangara.

According to the National Academy of Sciences 80 percent of all special degree science graduates leave for the UK and USA within the first year of graduation.

Hence, scaling up of production would depend on the availability of qualified people in the industry.

Advice to inventors

Being pioneers in the field of process patents, they advise young inventors and innovators to persist and find something the people would need.

"Never give up. Research is difficult, especially in the scientific field. Very few products in the pharmaceutical industry reach commercial success. When you do your research identify a niche and go against the tide. Many asked us to do a simple filling job and get the premix made in a foreign country, I hope we have proven them wrong", said Hettiarachchi.

"The inventor should identify a product which will be of value to the end user, then, the product will definitely succeed. Otherwise, there's no market and no demand. Also, it has to be cost effective and of good quality", said Kannangara.