A rising number of active pharmaceutical ingredients (APIs) are classed as “highly potent”. They are being increasingly harnessed by pharma companies developing oral solid dose (OSD) treatments to treat a variety of chronic conditions. For instance, they are being explored as potential new cancer therapies and as treatments designed to block the immunological response to prevent organ rejection following transplants. They even have the potential to provide enhanced contraception capabilities, as well as to manage a range of other disease states and chronic conditions, such as heart disease. Mario Di Carmine, Pfizer CentreOne Lead at the Pfizer manufacturing site at Ascoli, Italy, explores the challenges facing pharmaceutical companies when using highly potent active ingredients (HPAPIs) for the first time.

Extract:

‘Understanding the Challenges of Highly Potent Actives‘

A rising number of active pharmaceutical ingredients (APIs) are classed at “highly potent”.

They are being increasingly harnessed by pharma companies developing oral solid dose (OSD) treatments to treat a variety of chronic conditions. For instance, they are being explored as potential new cancer therapies, and as treatments designed to block immunological response to prevent organ rejection following transplants. They even have the potential to provide enhanced contraception capabilities, as well as to manage a range of other disease states and chronic conditions, such as heart disease.

The popularity of HPAPIs is due precisely to their high potency. They elicit a more targeted pharmacological effect at a lower concentration than standard APIs, which results in smaller dosage requirements.

For OSD products in particular, this key benefit can significantly enhance the patient experience in a number of ways:

• Allows for smaller pills – a significant advantage when creating medication for patients who may have difficulty swallowing
• Allows for less frequent dosing – enhances convenience for patients as they don’t have to interrupt their routine as often to administer.

HPAPIs don’t just have benefits for patients, they offer advantages for drug developers as well. In many cases, such ingredients are being explored for their potential to treat the currently unmet needs of patients with serious, life-threatening conditions. As a result, for many drug applications, HPAPIs can receive fast-track designation or accelerated approval from regulatory bodies, significantly speeding up time-to-market.

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