From left: Emergen Managing Director Dr. Janaka Weeratunge, Emergen Chairman Manoj Hettiarachchi, Emerchemie NB Chairman Nimal Dias Jayasinha, Emergen Chief Scientific Officer Nalin Kannangara and Emerchemie NB Director Marketing M. Prathaban
In what can be hailed as a national achievement, two Sri Lankan scientists, Manoj Hettiarachchi and Nalin Kannangara of Sri Lankan pharmaceutical company Emergen Life Sciences, were recently honoured with a Silver Award at the 44th International Exhibition of Inventions held in Geneva for their innovation of a process of manufacturing of Budenoside+Foremtrol dry powder inhalation medicines.
The two scientists, who are alumni of Sri Lankan universities, have also been honoured with a Sri Lankan Presidential Award in February 2016 for this unique innovation.
The significance of this breakthrough is that unlike the imported medications that are costly, the patent process innovated by the Sri Lankan scientists provides low-cost, easily accessible medications for asthma and its more aggressive form, Chronic Obstructive Pulmonary Disease (COPD).
Hettiarachchi and Kannangara were proud to head a team consisting of young scientists from Sri Lankan universities, in a state-of-the-art high-tech manufacturing complex equipped with a versatile range of pharmaceutical testing and production equipment.
“We are proud of the fact that this is a truly Sri Lankan achievement,” they both said.
Commenting on the thinking behind the innovation, Emergen Life Sciences Chairman Manoj Hettiarachchi said, “We identified a noticeable trend in the increase of asthma COPD and also understood that the country depended on costly imported medications for treatment. Our researchers were able to identify respiratory care medication as a fundamental area of research and were focused on improving the currently available pharmaceutical formulations.”
Emergen Life Sciences Managing Director Dr. J. Weeratunge added that asthma is classified as one of the biggest non-communicable diseases that cost the private sector and the state a considerable amount of money in importing treatment.
Medications prescribed for such diseases are among some of the most expensive pharmaceutical preparations in the country.
Manoj Hettiarachchi said that the trends in the treatment of asthma and COPD also impacted the research as powder inhalation are more expensive than metered dose inhalers (MDIs/aerosols); the need for the public to be able to buy an effective medication at an affordable cost was primary in their minds.
“In dry power inhalation (DPI) treatment, the active ingredient is routed through the respiratory pathway to the site of action i.e. the lungs to exert the desired therapeutic effect. An inactive carrier molecule facilitates the passage of the active drug and an inhalation device aids the process. The inhalation device and the powder inhalation mix inside the capsule constitute the drug delivery system. The inhaler device and the capsule have to work hand in glove for optimum therapeutic benefit. “
Commenting on the scientific thinking behind their prize-winning innovation, Emergen Life Sciences Chief Scientific Officer and co-winner of coveted prize Nalin Kannangara said that the unique factor in their research was with regard to the preparation of a novel carrier particle of a suitable particle size in an inhalation powder mix intended for the pulmonary route of administration.
“As the first aspect, the innovation targeted a novel carrier, consisting of a crystalline substance in powder form within the particle size range of 50-100 µm that have smooth surfaces. Researchers identified a grade of lactose mimicking the ideal surface properties for this purpose. In the second aspect, the invention focused on a method to mix the active drug with an aerodynamic diameter of 1-5 µm with the carrier particles,” he said.
Explaining the manufacturing process, he added that during the manufacturing process, the active drug was mixed with the carrier, in this case a special grade of lactose, and was filled into a hard gelatin capsule. The mixing process was fine tuned and validated to obtain the optimum homogeneity. The capsule was loaded into an inhaler designed by the researchers with enhanced aerodynamic properties to deliver the active ingredient to the lungs even at a low inspiratory flow of a patient.
The capsule contains a single dose and the inhaler is a monodose inhaler as it can only be loaded with one capsule. He stressed that despite the identical formulation of Budenoside+ Foremetrol being available from different manufacturers, the formulation process adopted by Emergen Life Sciences is different and unique, which was the reason for it to be recognized for a Special Award both locally and internationally.
In conclusion, Hettiarachchi said that the research led to the setting up of a fully GMP compliant manufacturing facility in Kelaniya while commercial production commenced in 2012. Both the state and the private healthcare sectors have acknowledged the formulation for its high quality and effectiveness, he confirmed.
“The manufacturing facility has the capability of manufacturing the entire spectrum of dry powder inhalation preparations that are prescribed in Sri Lanka and is proud to rank as the first and the only such manufacturing unit that supplies two formulations of dry powder inhalation preparations to the healthcare sector in Sri Lanka.”