OSD
Developers and manufacturers of oral solid dose (OSD) drug products face significant challenges and opportunities as they enter 2023.
The OSD space is a mature market - the dosage form's reputation as convenient and easy to use means that it has always been an ideal option for pharma companies when developing new products.
However, the rise of alternative delivery routes, such as inhalation, which offer similar patient convenience and usability, means that OSD drug developers are facing a market that is more competitive than ever before.
To stay ahead of the competition and retain market share, players must adapt their OSD formulations to meet ever-evolving patient needs.
The expanded use of a new generation of excipients in OSD drug forms is helping developers harness their potential to bring vital characteristics to their drug formulations. These can not only help OSD to meet the ever-evolving needs of patients, but can even allow the dosage form to be harnessed for a wider array of treatments than ever before.
Combined with the right formulation development support, these excipients can help OSD pharmaceutical companies keep up with market trends and continue to retain their competitive advantage in the market.
As we enter 2023, how can pharmaceutical companies effectively harness the benefits of these excipients to stay competitive while optimising their product performance?
The main areas where we can expect to see excipient-enabled innovation in the new year include:
Formulation evolution to further improve patient experience
Patient experience is a crucial element of a successful drug product, and is a competitive area of focus for many pharmaceutical companies specialising in OSD formulations.
The shape, size and even taste of an OSD drug product can all impact its ease of administration. For example, in older patient populations conditions such as dysphagia may cause swallowing issues, and paediatric patients may be adverse to unpleasant tasting pills. Failure to get these steps right and the patient can struggle to take the medication, with negative consequences for patient adherence to treatment regimens.
Many innovative new excipients can help developers address these patient experience challenges, allowing them to formulate smaller tablets or better tasting pills that are easier to administer.
In 2023, we can expect pharma companies to focus their efforts on addressing these issues, identifying and harnessing the right new excipients to formulate more patient-centric OSD treatments for specific patient populations.
More focus on making OSD biologics possible
Traditionally, biologics have had to be delivered parenterally, due to the sensitivity of the active. However, advancements in excipients in recent years have made the prospect of OSD biologics increasingly viable. New tablet coatings, for example, can help protect the biological active ingredient from degradation in the GI tract.
This innovation has the potential to make a wide range of biopharma treatments available for oral self-administration by patients, removing the requirement for regular in-clinic visits to have an injection.
Enhanced focus on small-batch manufacturing and 3D printing
Many OSD treatments for rare and orphan diseases are often developed for niche patient populations, or personalised for use by a single individual. As such, they don’t require the scale of traditional manufacturing processes, and are instead developed in small batch sizes.
However, small-batch manufacturing can be expensive compared with large-volume production. It can be hard to justify investment in a dedicated production line that is only going to be used to manufacture a small number of doses.
3D printing is one option that can provide a cost-effective route to manufacturing treatments destined for a small number of patients.
This technology is highly flexible and can be used to manufacture a wide range of different treatments in small batches with minimal changeover downtime - meaning a single investment can be used for multiple projects.
Moreover, 3D printing allows companies to manufacture individual tablets with complex internal structures to achieve precision controlled release profiles.
Such equipment has the potential to bring many benefits to drug developers and manufacturers including greater cost-effectiveness, flexibility, speed and precision of bringing new drugs to market.
Read more on this topic as Uwe Hanenberg, Head of Product Development, Oral Solid Dose, and Maria Lundin-Johnson, Head of Formulation Development, explore the latest trends shaping the OSD market and the obstacles they pose for the industry in 2023.