In-vitro models reduce ‘risk and cost’ for topically-delivered generics
MedPharm, a developer of drug delivery formulations and technologies, designed in-vitro models allowing drug makers to prove bioequivalence of generic drugs without needing to take their products through human trials.
Jeremy Drummond, senior VP of business development for MedPharm, told us that the technology answers a significant market need, since the use of such models was encouraged by regulatory guidelines established during the past year, driving the consequent demand from generic companies looking to develop topical drug products.
“Generic companies are appreciating that using these models reduces both the risk and cost of development,” the executive noted, and explained that expensive and risky clinical trials for such drugs have created a ‘major barrier’ to generic entry.
Instead, MedPharm’s in-vitro models are based on human tissue and have the potential to provide a convenient solution, according to Drummond, with results directly relatable to clinical outcomes and provide answers to specific research questions.
Direct route to the brain
MedPharm’s executive noted that the range of uses for in-vitro models can be expanded to include drugs administered through the nasal cavity, with intranasal delivery currently getting ‘increased attention’ due to the prevalence of neurodegenerative diseases in aging populations.
“The direct route to the brain avoids first-pass metabolism and potentially avoids issues associated with the blood-brain barrier,” Drummond said.
As a consequence, in-vitro tools that “can reliably model the penetration of drugs through viable human nasal epithelia” are of growing interest, according to the executive.
Furthermore, such models can provide pharmacodynamic, as well as pharmacokinetic readouts for cannabinoid derivatives, which, according to Drummond, form another ‘major trend’ of the industry, due to the ‘explosion’ of interest in the potential indications.
“With the increased deregulation, investors want quick screens to point them towards the best target indication for this diverse range of products,” he said.
