24/7 BIOPHARMA - issue 1 / October 2024

LLS HEALTH

The world population is aging at an unprecedented rate. Between 2015 and 2050, it is estimated that the number of people aged 60 years and older will nearly double. [1] This trend has brought with it an increased number of patients suffering from chronic diseases, such as diabetes, gastrointestinal (GI) tract disorders, neurodegenerative and cardiovascular diseases. Indeed, from 2020 to 2050, it’s estimated that the number of adults over 50 in the US suffering from at least one chronic disease will increase by 99.5%. [2] These factors mean a growing proportion of patients are being prescribed complex drug regimens, which can entail a high number of tablets or tablets that are too large to comfortably swallow. Adverse side effects are another challenge, and one which can reduce compliance – meaning patients forego the treatments they need. In addition, patients are beginning to benefit from better access to information that empowers them to request more desirable treatment options. Doctors are also more likely to prescribe a medicine that is easier to take or that does not require many doses to help a chronic patient comply with the treatment plan.

So, what role can drug formulators play in easing pill burden and improving the lives of patients? One approach is the use of carefully chosen excipients to facilitate reformulations of vital medicines.

Opportunities for patient-centric innovation

Developing an effective medicine is the main priority for any formulator. However, in response to rising demand, patients are increasingly placed at the heart of new drug development projects. Encouraged by the FDA 505(b)(2) drug approval route – which streamlines a reformulated drug’s journey to market by allowing existing safety data to be used – innovative, more patient-friendly formulations are emerging. For example, topical nonsteroidal anti-inflammatory drug (NSAID) formulations have been developed that are believed to be just as effective as oral pills with the added benefit of causing fewer side effects. [3] Extended-release oral solid dosage formulations are another route to improved patient satisfaction and commercial differentiation. These are designed to release the drug in a controlled manner over a prolonged period of time, which can reduce the

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TWENTYFOURSEVENBIOPHARMA Issue 1 / October 2024