Harnessing the Potential of Nanotechnology to Aid in the Delivery of Poorly Soluble Compounds

Ameet Ambarkhane, Principal Scientist at Novartis, joins Pharma IQ to discuss harnessing the potential of nanotechnology to aid in the delivery of poorly soluble compounds and bottlenecks in early drug development. 

Pharma IQ: Could you just give the audience a little bit of insight into your current role, please?

A Ambarkhane: Well, my role is based on working with research guys, so we look at compounds really early on, when they have been first dosed in animal studies, and then really taking them further to the first clinical trials and also the toxicity studies.  So, my role is around profiling these compounds and also getting the formulation ready for performing these in vivo studies.

Pharma IQ: Why is solving solubility problems one of the leading challenges in drug development at the moment?

A Ambarkhane: I think it’s really early on.  When the compound is initially profiled, there is less amount compound available, less knowledge available around the compound properties.  There is no understanding how it will behave in different species etc.  So, lack of understanding of compound properties and then coupled with different species, how they respond to the compounds.  I think these two things combined is, I think, a real challenge for the industry at the moment.

Pharma IQ: What measures are you seeing companies, including your own, taking to expediate the time to market for poorly soluble drug compounds?

A Ambarkhane: First of all, we are looking for something which is soluble.  Clearly that’s our objective.  If it’s not, then we have to go to enabling technologies.  That always takes it on a longer path but if that’s the way we have to go, then that’s the way it is.

Pharma IQ: How are companies harnessing the potential of nanotechnology to aid in the delivery of poorly soluble compounds?

A Ambarkhane: Nanoscience, by reducing the size it increases the surface area.  The idea is to get faster dissolution so when the particle passes through the GI tract, it’s got a faster dissolution rate and it’s got better chance to be available. 

Pharma IQ: Some people think that this a very promising but risky approach.  Why is that?

A Ambarkhane: I agree, it’s promising and risky.  It’s risky because there are a lot of stability issues with this technology and it’s quite challenging to make this formulation in different batches with the same quality.  So, that’s the challenge.  Then it’s to have stability issues with respect to its physical stability predominantly.  It tends to change/increase particle size, also there are some risks of inducing disorder or amorphous character in the particles, which poses a challenge for the technology itself.

Pharma IQ: Where are you seeing the real bottlenecks in using these enabling technologies in preclinical formulations?

A Ambarkhane: The bottlenecks are around, as I said before; less amount of compound is available initially and there is a lack of understanding how the compound itself will behave in different species.

Pharma IQ: How have you seen the pharmaceutical industry that you work in change in the last few years and what are your predictions for the industry as a whole in the next five years?

A Ambarkhane: More and more poorly water-soluble compounds will come, posing a challenge for the formulation scientist.  That’s my prediction about the next ten years.  So, if you’re in drug delivery, I think it’s going to be a challenging and exciting time.

Pharma IQ: What are you looking forward to about the 8th Annual Improving Solubility event?

A Ambarkhane: I’m looking forward to share some of my experience gathered during the working year and then also looking to network with other colleagues, other people from industry having a similar background and having similar problems.

Interview conducted by Andrea Charles.

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