PharmAust (ASX:PAA) says it has successfully identified a reformulation method that can be used to prepare monepantel for clinical trial.
According to the company, working in collaboration with BRI Pharmaceutical Research, it has shown that micronisation of monepantel successfully meets the company’s minimal requirements for dosing, taste masking and oral bioavailability.
"Micronisation refers to a milling technique that grinds monepantel into a fine powder that after further processing can then be packaged into capsules or tablets," said the company. "Depending on the size of the capsule or tablet, this approach can deliver over 10 times more drug than the current formulation."
It continued, "In terms of taste, studies in animals and humans have shown that dry powder monepantel is much more palatable than the liquid form of the drug. Further, micronised monepantel is amenable to a number of conventional taste-masking approaches that can further improve palatability."
PharmAust said BRI is currently optimising the micronisation method to identify the final formulation. Once established, the formulation will be scaled to produce sufficient drug for clinical trial, it said, adding it anticipates completing the reformulation optimisation phase with scaled production and toxicity studies to commence in dogs during the first half of calendar year 2018.