Scientists Manoj Hettiarachchi and Nalin Kannangara, co-creators of a patented process for the manufacture of Dry Powder Inhalation medications to relieve Asthma and COPD (Chronic Obstructive Pulmonary Disease), were recently awarded a Silver medal at the Geneva International Patent Exhibition and competition having previously earned a Presidential Award at the Presidential Awards 2016 organised by the Sri Lanka Inventors Commission.
Manoj Hettiarachchi, an alumnus of the Colombo University, currently functions as the Deputy Chairman of Emerchemie NB (Ceylon) Limited and Chairman of Emergen Life Sciences (Private) Limited. Nalin Kannangara, having read for his BSc. Special Degree in Human Biology at the Sri Jayewardenepura University, operates as the Chief Scientific Officer of Emergen Life Sciences.
Due to the prevalence of Asthma in Sri Lanka with the incidence of the disease as high as 15%-20%, their innovation is praiseworthy, particularly taking into account the medications being made available to patients at reasonable prices.
“Whilst being heedful of the sizable number of patients afflicted by Asthma, we considered this difficult manufacturing process a challenge. Besides, we were mindful of our duty by the country as products of local schools and universities. We were also concerned of the aging population in the country and the possibility of the number of COPD patients increasing. We wanted to improve the manufacture process of these medications to curtail the production cost and compete with imported formulations,” said Manoj Hettiarachchi.
Excerpts of the exclusive interview the duo had with the Dailymirror :
QTell us about your invention. What type of inhaler formulation is it?
It should be aptly described as an ‘Innovation’ as opposed to an ‘Invention’ as this involves manufacturing of Dry Powder Inhalation formulations. Considering the different therapies involved in tackling Asthma, COPD inhalation products are widely used over oral preparations due to quick onset of action of the drugs which are directly inhaled in to the lungs. Oral preparations (medications) take time to get absorbed in to the targeted organs, and another disadvantage is that higher doses have to be taken in to compensate losses during their passage before reaching the intended organs. In the case of Asthma, inhalation preparations are far quicker in reaching the site of affliction, and the medications are given in micro quantities with fewer side-effects.
Regarding the two common inhalation dosage forms namely MDIs (Metered Dose Inhalers/Aerosols) and DPIs (Dry Powder Inhalers), we chose DPIs. They are more affordable in contrast to Aerosols. DPI depends on the inspiratory flow of the patients, and in asthma patients, we can observe that their breathing is compromised. However, due to our improved process of manufacture, we have managed to increase lung deposition of the intended formulations for better efficacy. The process was developed over a period of 5-6 years, and upon noticing an improvement whilst testing these preparations using world renowned analytical equipment in our laboratory, we decided to commercialize the products. It was in fact a big challenge and luckily Emerchemie NB (Ceylon) Limited came to our rescue, deciding to fund the project. In 2012, we set up our manufacturing facility in Kelaniya and in the beginning of 2013 obtained the GMP (Good Manufacturing Practices) licence to manufacture. Our products conform to International Pharmacopeia whilst our facility is subjected to regular inspections of the National Medicines Regulatory Authority.
We have also improved on an inhaler device with a patent that is pending. An aspect which is unique to our device is that the capsule rotates around a vertical axis making resistance and frictional forces minimal. This indeed facilitates asthma patients as they can get optimum results even with a low inspiratory flow, which we believe could help elderly patients as well as the youth.
QHow does this process work?
During an asthma attack, a patient’s breathing is compromised and in order to obtain quick relief, the intended formulations should reach the lungs right away. The capsule contains only microgram quantities of formulation. The capsule is perforated and the formulation enters the mouth cavity through inhalation. The formulation contains a carrier particle that does not relieve you of Asthma or COPD, and an active ingredient that acts on the ailment reducing its effects. The inert carrier particles have to go through the mouth cavity and ideally should not reach the lungs. The best situation is when the carrier particle detaches itself from the active ingredient and being removed with the exhaled breath. The active ingredient should flow into the lungs while the carrier particles should either hit the walls of the nasopharynx, or get evicted. The challenge any drug formulator or a researcher engaged in drug delivery has to face is the maximization of the active drug entering the targeted organ whilst getting detached from the carrier.
We have optimized the manufacturing process in order to deliver utmost benefit.
The ideal situation would be to see every carrier particles being evicted with all the active particles being absorbed. This is quite a difficult task to achieve, but you can maximize it to a great extent.
QCan children use it?
Powder inhalation preparations are best suited for older children and adults rather than small children (below 10 years), because of the difficulty they encounter coordinating their breath with the mechanics of the inhaler device.
QIs it cheaper than other inhaler formulations from multi-national companies?
Yes. The formulations are reasonably priced considering the capital infused and the processes involved. DPI is far more affordable than aerosol formulations and DPIs remain the most viable and predominant mode of therapy. A large amount of foreign exchange goes out of the country to import these preparations. Therefore, locally manufactured pharmaceuticals such as ours could reduce the outflow of much needed foreign exchange. It should also be noted that Asthma medication are within the top 20 highest selling pharmaceutical drugs in Sri Lanka.
The first batches of our formulations were sold in the private market, and we delivered the message of quality through the products and in return received overwhelming responses. We then got the opportunity to supply to the local government and the formulations are given free to Asthma patients who frequent national hospitals. This was further bolstered by a buy-back agreement. We are one of the leading Asthma medication suppliers to the government sector.
QCan the device produce micro-aerosols which reach the smallest airways?
We have to conform to pharmacopeia standards. So these particles are made in to micron sizes so that they would reach the deeper tissues. This is part of the challenge in manufacturing these formulations. You have a carrier particle and active ingredients in micron sizes to mix and obtain a homogenous mix, and ensure that all capsules contain virtually the same amount of micron quantities of active ingredients with an allowable deviation of say 5-10%.
QYou would have had prototypes that would have failed before and as the saying goes ‘Failure is the key to success.’ Do you believe in this when it comes to your invention?
There were many hurdles along the way from choosing the right kind of machinery including blenders. It certainly was a Herculean task. The process demands that you have a unique kind of a mixture. There were many concerns with the filling mechanism because we had to also maintain the variation of weight according to what pharmacopeia standards stipulate. You have monotherapy and combined therapy in Asthma. Some years ago, we only had monotherapy. The reliever and preventer medication were given separately. With the advent of time, the reliever and preventer were fused into one capsule. The inhaler device also has to be compatible.
QWhat are your plans with regard to your invention also considering the patent?
We hope to expand our product portfolio covering other maladies related to the respiratory system. For instance, Rhinitis, ACOS and COPD so forth. ACOS (Asthma COPD Overlap Syndrome) is a fringe form of Asthma which has not developed into full blown COPD. When you look at drugs for ACOS, we need to go further into what we have already spoken about. Our plan is to introduce them. We also wish to have a broader, more widespread Asthma and anti-Rhinitis medication. At present, we are the only company in Sri Lanka that manufactures a particular form of powder inhalation preparations called Muscarinic Receptor Antagonist (MRA). We are the only local establishment with the entire range of Dry Powder Inhalation as well.