Considering Bio/Pharma Reformulation Strategies

ABSTRACT

[...]of the significant cost of development, companies seek to recoup finances through data exclusivity and patent protection of intellectual property, such as the drug product's formulation. Bio/pharma companies reformulate existing therapies for a whole host of reasons, such as treating underserved or neglected disease areas, improving patient adherence (particularly for target patient groups, such as paediatrics), reducing the potential of drug abuse, and providing alternative options in crisis situations-as has been apparent during the COVID-19 pandemic. Pentamidine is an anti-infective agent that can be used to treat an earlier stage of the disease;however, it is unable to penetrate the blood-brain barrier sufficiently to treat the secondary stage of HAT. [...]it was hypothesized that a combined pentamidine-Pluronic formulation may be a suitable approach to provide patients with a single therapeutic option for treatment of all stages of HAT. [...]it was concluded that the pharmacokinetic data attained supports the use of safety and tolerability data from the conventional risperidone formulation for further testing of VAL401 (4).