“The number of novel compounds going into the market is decreasing as well as trends changing from highly soluble to less soluble drugs”. This was the opening statement made by Dr. David Harris, a fellow at Merck as well as a formulation scientist with over 20 years experience in the development of new chemical entities.
These trends he said have led to the need for a highly collaborative process in Oral development programs which in turn has created a laundry of opportunities for young graduating scientists within industry. Opportunities in areas such as per formulation analysis, pre clinical compound assessments, discovery, API development just to mention but a few are available to young scientists.
Dr. Harris followed these statements with a presentation on oral development Programs and what they entail.
He talked about key elements of these programs which are classified around the physical and chemical properties of the oral compound to be developed.
Amongst such properties, he mentioned the importance of stability testing, degradation mechanism studies, accelerated stability studies as well as extreme conditions stability testing which is important for drugs that will go through shipping excursions. Dissolution tests more so, bio relevant dissolution studies and clinical bio comparison are all studies that need to be undertaken in developing oral formulations.
From the above Dr. Harris clearly showed that a priori of prediction of bio performance of a drug is needed before the product is marketed. He however made it clear that most products do not make it to market as success in these studies has presented a challenge to many pharmaceutical companies thus only a few drugs actually manage to hit the market and stay in market.
Dr. Harris further went onto talking about various solid dispersion formulations and hot melt extruded solid dispersion’s giving some knowledge on why such formulations are preferred for development.
He also talked about the optimization of blend flow with respect to composition and processing of the formulation (the API and its attributes). From this he gave a comparison of spray dried and hot melt extrusion preparations in relation to their compression properties and costs of production. He stressed the importance of establishing robustness to variations of API and excipient attributes. Optimization, he added is a very important exercise to undertake in this respect.
Dr. Harris concluded his discussion by presenting a number of case studies undertaken in the oral development program.
We thank this brilliant scientist for making time to come and speak with us.