OSD
Across the oral solid dose (OSD) market, significant developments are impacting both prescription drugs and over-the-counter (OTC) medications.
Facing heightened demand for more patient-centric drug products, pharmaceutical companies must explore new formulations that improve ease of administration and help maintain a competitive market share.
But what are the most pressing trends and challenges across the OSD space, and how can companies innovate to ensure their products reach the patients who need them most?
Enhancing the patient experience
Patients now expect more than just the efficacy of their medication; they demand an overall positive treatment experience. Factors such as texture, shape and taste are being optimised to improve patient adherence to medication regimens. This is particularly important for more vulnerable patient populations, such as children and the elderly.
Formulating OSDs with more palatable flavours and sweeteners can mask the naturally bitter taste of their APIs, making them more appealing to children, in line with paediatric guidelines. Similarly, the geriatric population often faces swallowing difficulties such as dysphagia, making it challenging to take OSD medications. With appropriate excipients, smaller, easier-to-swallow pills can be formulated to ensure comfortable administration for older patients.
Streamlining decision-making for physicians
General practitioners must consider a medication’s convenience and its impact on patient adherence. Therefore, ease of administration becomes a central focus during the design and development of both OTC and prescription medications. By designing convenient and user-friendly OSD formulations, pharmaceutical companies can support healthcare professionals in making treatment decisions that align with patient preferences.
The emergence of OSD biologics
Recent advancements in OSD technology are enabling the oral administration of biologics, reducing the need for parenteral administration and encouraging patients to comfortably self-administer treatments.
However, the formulation of OSD biologics faces challenges due to their hypersensitivity to environmental conditions and their large molecular size. Overcoming these challenges requires the development of novel formulations, production processes and solutions for absorption issues. Selecting the optimal excipients is key to making oral delivery a viable alternative to injections for biopharmaceutical treatments.
Facing the upcoming “patent cliff”
As numerous originator drug products approach the end of their patents, the market will see a surge in generic alternatives. To maintain a competitive edge, pharmaceutical companies must explore alternative administration options, such as OSD. By adapting dosage forms to meet patient-centric objectives, companies can differentiate themselves in the market. The selection of optimal excipients plays a crucial role in making these new OSD formulations viable.
In a recent piece for EPM Magazine, Dr Uwe Hanenberg, Head of Product Development, Oral Solid Dose at Recipharm and Dr Maria Lundin-Johnson, Head of Formulation Development, dives deeper into these trends and challenges. He discusses how the use of new excipient solutions can help pharmaceutical companies in their mission to further the advancement of their life-changing medicines.