A Welcome Change: The Benefits of Reformulation

"Due to the high costs of drug development, as well as the high rate of clinical failures, it's vital that pharmaceutical companies evaluate formulation opportunities for every approved or late-stage clinical product to determine how its commercial lifecycle can be optimized," explains Paul Spencer, head of Pharmaceutical Polymers and Services, Evonik Health Care. "To minimize regulatory risk and accelerate speed to market, it is common for pharma companies to seek initial approval for products with a simple lead formulation followed by the introduction of superior formulations that can expand the patient population or enhance safety and efficacy." "Enhancing the bioavailability can reduce the dose and remove the food label requirement that calls for patients to strictly take the product with or without food, which can improve patient safety," explains Mudie. According to Spencer, ocular drug delivery is currently experiencing intense focus in terms of reformulation.