In recent years, an influx of innovative molecules has entered the development pipeline with potential to treat serious conditions such as cancer, epilepsy, diabetes and many more. However, these molecules also pose formulation development challenges due to absorption and bioavailability issues.

In this article, Kieran Coffey, Technical Services Lead at Pfizer CentreOne, discusses the challenges associated with developing these molecules into viable and effective treatments and how the right development partner is critical for the success of any solubility enhancement project.

The solubility challenge

Around 90% of molecules currently in the discovery pipeline are poorly water soluble[1]. This significantly increases the risk of low bioavailability which, if not addressed, may result in suboptimal drug delivery, ineffective drug efficacy, and adverse side effects for patients.

The bioavailability challenge of these new molecules can have major repercussions for drug development timelines, delaying the timely delivery of life-saving medicines into the hands of patients.

To address these bioavailability issues, having the right development support is key. Working with a trusted contract development and manufacturing organization (CDMO) can help deliver this high standard of guidance.

Overcoming obstacles

Collaboration between pharma companies and their partners is crucial to optimize drug formulation and manufacturing processes to mitigate against solubility issues and reduce downstream risk.

Trusted CDMOs can offer extensive experience in development and tech transfers that enable them to bring customers’ products to market quickly and effectively.

At Pfizer CentreOne, we have years of experience advancing clients’ drug development. Leveraging Pfizer’s scientific and development expertise gives us the unique ability to build a robust project team of experts from a wide talent pool, ensuring customers always have the right expertise for every stage of their project.

Benefiting from the latest technologies

CDMOs partners can also offer the latest innovative technologies for drug development that can be difficult for pharma companies to access in-house. Such technologies help overcome many solubility enhancement issues and may mean the difference between a project progressing or not.

At Pfizer CentreOne, we harness a range of innovative drug development technologies, including osmotic pump technologies and low dose active coating for oral solids development, which can play a major role in the successful development of poorly soluble molecules. We also offer proprietary analytical technology that can further support the identification of enabling solutions for bioavailability challenges.

Comprehensive project support

As a CDMO partner we do more than just assist in solubility enhancement. We focus on providing expert guidance and support throughout the drug development process so our customers feel assured along the way.

Our core offerings in development services include: formulation, manufacturing, analytical testing, validation, method development, as well as clinical manufacturing. Find out more information here.

Regulatory strategies are also central to our drug development programs and we facilitate early engagement with regulators and offer customized submission support for countries around the world.

The secret to successful drug development

As more new molecules enter the drug development pipeline, solubility challenges and other formulation issues will become more acute, making it even more important to have comprehensive support from an expert and trusted CDMO.

With extensive experience of successfully developing new products, Pfizer CentreOne has unique insight into the challenges of bringing a product to market and is ideally placed to tackle the complexities that accompany the process.

Working with us, you can be confident of a collaborative approach to overcoming solubility issues.

To find out how we can work with you on your drug development project, contact us today.