Putting contract dose manufacturing trends under the spotlight
New drug discoveries, innovative delivery technologies, as well as the evolving needs of patients and healthcare providers (HCPs) over the last year have driven transformation across the sector. Contract dose manufacturers, including small-molecule and biologic outsourcing partners have had to respond rapidly in order to continue to meet customers’ rapidly shifting needs.
Here, Deirdre Whelan, Director PfizerCentreOne Operations, explores the key trends affecting the pharmaceutical sector, and explores how outsourcing partners are supporting companies in keeping up to speed in the future.
OSD’s patient benefits being harnessed
Increasingly, drug developers are favoring the development of critical medicines in oral solid dose (OSD) forms, due to patient and payer benefits compared with parenteral. While we are seeing growth in demand for biologics outsourcing partners to provide capacity to process and finish large-molecule parenteral medicines, it is unlikely to overtake demand for OSD contract development and manufacturing services.
Thanks to innovations in combinatorial chemistry and changing drug development trends (such as an increased focus on cancer treatments), we are seeing the introduction of complex, highly potent active pharmaceutical ingredients (HPAPIs) with poorly soluble chemistries. These potent molecules require sophisticated formulation and manufacturing solutions to enhance bioavailability and dose control when administered orally, impacting pharma companies, as well as their small-molecule outsourcing partners.1
It can be complex and expensive to develop poorly soluble drugs for oral administration. Parenteral drugs like vaccines can often be developed, approved and brought to market faster than OSD products because there are fewer steps to finishing a liquid drug product.2
The chemistry for oral solids can be more complex, with labor-intensive processes to prepare batches. Depending on the specific API chemistry, manufacturing a finished OSD form may require more steps and longer lead times to create a validatable compliant commercial scale process.
Nevertheless, patients continue to prefer their medication in tablet and capsule forms, meaning the benefits of OSD outweigh the costs.3 With this in mind, we can expect more and more drug developers to explore OSD for their products over the coming years.
Patient centricity challenges spur further OSD innovation
Patient needs continue to be at the forefront of pharmaceutical development. For a growing number of drug developers, simply opting for traditional OSD is not enough from a patient centricity perspective. They are demanding innovative OSD solutions and new ways to further improve the efficacy and patient centricity of their oral solid drug products.
Contract dose manufacturing organizations are working hard in this area, supporting drug developers in addressing a range of patient-centred issues, from problematic side effects, to reducing dose frequency and the size of the individual dose, all to optimize patient adherence.
To achieve these goals over the coming years, we can expect drug developers to turn to their outsourcing partners for support in harnessing advanced dose form manufacturing techniques.
Examples of these include multiple-unit pellet-system (MUPS) and amorphous solid dispersions (ASDs). These technologies have the potential to achieve the effective delivery of problematic actives through the GI tract, minimizing adverse side effects that can cause patients discomfort, all while reducing the number of doses needed.
Another OSD technology that can support in achieving developers’ patient centricity goals in the future is the osmotic pump tablet. Featuring a semi-permeable membrane coating, the tablet is breached in one location by a laser-drilled port. On administration, water permeates through the membrane, dissolving excipients in the core and thus raising the internal pressure. The raised pressure in the core causes the contents to be forced through the laser-drilled port at a constant rate.
Expert OSD development support needed to achieve patient centricity goals
HCPs and patients are clear that if a jab can be avoided, it should. Despite the potential for more risk and higher development costs, the extra expense of OSD is worth it because it serves both patient and payer interests best.4 It is no surprise, then, that we are seeing not just the adoption of OSD over other less patient-centric delivery routes, but the choice of more advanced OSD technologies to further enhance the patient experience.
Whether your project is biologic or small-molecule, by working with an experienced contract dose manufacturing partner, like Pfizer CentreOne, you can be sure that you have the expert support you need to deliver an OSD product that is effective and truly meets the needs of your patients.
- Kanikkannan N (2018). Technologies to Improve the Solubility, Dissolution and Bioavailability of Poorly Soluble Drugs. J Anal Pharm Res 7(1): 00198.