OSD
Looking to the future of oral solid dose development and manufacturing
With the oral solid dose (OSD) market expected to continue to grow rapidly, rising from an estimated $493 billion in 2017 to $926 billion in 20271, a surge in demand for development and manufacturing support is expected. As the biopharma industry witnesses technological improvements and advancing drug modalities, it is important to consider how these changes will manifest - from discovery to commercial manufacture.
Prepare for increasingly complex APIs
One area of the OSD market in particular expected to expand is the development and manufacturing of highly potent active pharmaceutical ingredients (HPAPIs). The production of HPAPIs like corticosteroids or controlled substances is often challenging because they pose environmental and health and safety issues and are often poorly soluble. The bioavailability challenges posed by poorly soluble drugs like many HPAPIs will necessitate specialist technology and excipients to improve solubility and ensure a therapeutically effective formulation - As no two APIs are alike, there is no “one-size-fits-all” approach to overcome them. Developers should instead rely on upholding principles of Quality by Design (QbD) and Design of Experiments (DoE) to ensure an effective approach to improving solubility. When working with HPAPIs, this should be implemented in parallel with measures to secure the safety of operators that ensure regulatory compliance.
Consider other potential administration routes
As parenteral products such as vaccines can sometimes be developed, approved, and commercialised faster than most OSDs, they can be an attractive alternative administration route. This is particularly true for HPAPIs as parenteral products do not see the same bioavailability issues as OSDs and consequently necessitate fewer steps to finish a drug product, resulting in potential cost benefits2.
Although parenteral products will likely see a similar surge in demand, OSDs will likely remain a favoured format due to a preferable patient experience. The benefits of OSDs therefore often outweigh the potential cost advantages of using parenteral formulations3.
Embrace modified release and pellet technologies
As opposed to seeking alternative administration routes, developers will likely become more reliant on OSD technologies providing improved capabilities. Modified release (MR) formulation development and manufacturing demand is rising, offering a possible reduced dosage frequency and enhancing patient centricity.
When manufacturing MR products, capsules can offer additional benefits, allowing the use of pellet technologies to achieve specific controlled-release profiles. Pellets can be used to:
- Improve MR product diversity by offering different strengths of the same therapeutic without separate production lines
- Allow relatively simple adjustment of the strength and release profile of an OSD
- Enable straightforward combination of different APIs to produce new fixed-dose combination products when required
As pellets offer a flexible approach to enhancing drug innovation, it can be expected that the biopharma industry will increasingly lean on those offering this technology in the future.
Key lessons
Looking on the horizon, the demand for OSD products can be expected to rise along with innovative formulation approaches like MR and pellet technologies. As a result, it is important to consider seeking support from contract development and manufacturing organisations (CDMOs) with experience and expertise to overcome potential challenges surrounding complex API production like Recipharm.
To learn more about why solid dose pharmaceuticals are going to remain strong, click the button below to read the World Pharma Today Roundtable Interview.
References
- https://www.futuremarketinsights.com/reports/oral-solid-dosage-pharmaceuticalformulation-market
- Ball P. The lightning-fast quest for COVID vaccines - and what it means for other diseases. Nature. 2021;589(7840):16-18.
- Helliwell M, Taylor D. Solid oral dosage forms. Prof Nurse. 1993;8(5):313-317.