OSD
Oral solid dosage (OSD) forms have long dominated the pharmaceutical market for decades due to the patient convenience benefits of their ease of administration, as well as additional shelf-life advantages.
Growth in this segment is set to continue, with innovations taking place behind the scenes of many pharmaceutical companies to help enhance the patient experience and open up OSD solutions to drugs that cannot traditionally be taken via the GI tract.
The key trends facing the OSD market include:
- The rise of fixed-dose combination products to optimise patient centricity
- Changing patient demands
- Continual growth of biopharma
- Small-batch manufacturing to support orphan drug production
While exciting, the development and manufacture of effective OSD formulations pose challenges for drug developers that must be overcome. These include:
Formulation development challenges
Whether developing new formulations or reformulating existing active pharmaceutical ingredients (APIs), drug developers must ensure that their final OSD solution meets the needs of its API to deliver optimal therapeutic performance.
Depending on the OSD in development, there is a range of formulation challenges that may occur. These include ensuring the stability of the active once it enters into a patient's gastrointestinal tract, as well as optimising absorption into the body, (particularly for larger biologic molecules).
If working with fixed-dose formulations that use multiple APIs, drug developers must determine how they interact with each other during oral solid dosage development, and how this might impact the final formulation of their OSD.
Capacity issues
When working to deliver an OSD at speed and scale, it can be difficult to build the optimal capacity required in a cost-effective and reliable way.
For pharma companies working with OSDs for rare or orphan diseases that require small batch sizes, it can be challenging to develop the required infrastructure to produce these lower volumes in a cost-effective way, which may in turn impact the commercial viability of their OSD project.
In our latest article with IPI Magazine, Philippe Gorria, Recipharm’s Senior Director Formulation Development and Sales, and Dr. Uwe Hanenberg, Head of Product Development, dive deeper into these trends and challenges facing the OSD space and how pharma companies can overcome them.