FDF and Excipients’ characterisation as a tool for product development and regulatory support

Speaking on the topic ‘FDF and Excipients’ Characterisation as a Tool for Product Development and Regulatory Support’, Pradeep Behera, Managing Director, ThetaBeta Analgorithms introduced his organisation as a start-up which is focussed on service offering, and is planning to venture in product development for drugs and medical devices.

He started his presentation by talking about why characterisation is important: it helps to know your product and the excipient better- how they will behave and what is going to impact the output characteristics. “In totality, you need to understand the characteristics of all the components. It is important to know not just their output characteristics, but also their input characteristics,” he said. Furthermore, characterisation also helps as a QbD tool.

Talking about the kind of output we can get from characterisation, Behera said that it can help us find out the right grades and combinations for generics, what components are suitable for the formulation, Q1 and Q2 as alternative for clinical studies and bio-waivers, and using a component for target output and succeeding in achieving it.

He then discussed the tools which can be used for characterisation, but later added, “Though tools are important, the process and mechanism of study is very critical. You could have multiple instrumentation tools for identifying or quantifying a component but the sample matric statement will have to be very specific to do proper characterisation.”

Examining case studies as examples of characterisation, he talked about carbomers. “We characterise carbomers as an FDF, irrespective of the level at which it is used. Categorically, each grade of Carbopol can be identified and quantified in a FDF,” he said. He then similarly cited the examples of Glyceryl and Sucrose Stearates, MCC, etc.

Ending his presentation, Behera talked about the milestones that ThetaBeta Analgorithms has achieved and its expansion plans.