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Navigating the Changing Oral Solid Dose Landscape

Oral solid dose (OSD) forms have accounted for the lion’s share of the pharmaceutical market for decades, thanks to their easy administration leading to patient convenience benefits, not to mention their shelflife advantages. As a mature market, it has an unfair reputation for stasis. Much of the innovation spotlight has been on other dosage forms as they have evolved to enhance their own useability, or as they have risen to prominence as a means of enabling the delivery of new therapies, such as biologics.

Despite this, the segment is not standing still. There is considerable innovation going on behind the scenes to provide an ever improved patient experience and to open the oral delivery route to an ever-expanding array of treatments and molecules, including those not traditionally able to be administered via the GI route.

So, what does the future hold for OSD forms? What challenges face pharmaceutical companies as they try to harness the patient experience benefits of OSD in the future?

Philippe Gorria, Senior Director of Formulation Development and Sales, and Dr. Uwe Hanenberg, Head of Product Development at Recipharm, explore the trends shaping the OSD space, discuss the development pitfalls facing the developers of new OSD products, and how to overcome them.

OSD Trends Under the Spotlight

A number of trends are shaping the OSD space at the moment and look set to transform the segment over the coming years. These include:

• The Rise of Fixed-dose Combination products to Optimise Patient Centricity – this has been a trend for several years now, and there is no sign it will be diminishing in importance in the foreseeable future. These formulations allow multiple active pharmaceutical ingredients (APIs) to be combined in a single dosage form, such as a tablet or capsule. They harness modified release technologies to stagger or delay the release of each API into the bloodstream to minimise side effects or maximise the duration of therapeutic action. As a result, it is possible to reduce the number of doses a patient has to take each day, enhancing convenience and boosting patient adherence.

• Changing Patient Demands – by 2030, 1 in 6 people in the world will be aged 60 years or over.1 As global populations continue to age, patient demands are evolving, requiring OSD drug developers to respond. Older patients present administration challenges, from poor dexterity to issues swallowing. As such, OSD products need to adapt to ensure they continue to meet patient needs – tablets need to be smaller and easier to swallow for example, and packaging needs to be easier for elderly patients to open. Alternatives to tablets and capsules are being explored by drug developers to meet these needs, such as easy-open stick packs containing powdered drug products, designed either to be dissolved in water or swallowed dry. The older cohort isn’t the only demographic OSD drug developers need to consider. Younger patients also have unique administration needs to support adherence. For instance, bitter-tasting medicine can be particularly unpleasant for young patients to take – drug developers increasingly need to consider the flavour of their child-centric drug products to optimise patient adherence.