Solubility continues to be a critical challenge in drug formulation. How is Lubrizol addressing this issue through its excipient technologies?

Lubrizol's novel excipients, ApisolexTM and ApinovexTM polymers, solve formulation challenges by improving the solubility of brick-dust APIs. The polyamino acid-based Apisolex polymer increases solubility of hydrophobic APIs by up to 50,000-fold, while Apinovex polymer is a high molecular weight polyacrylic acid that enables homogenous amorphous dispersion, with as much as 80% drug loading.

One of Lubrizol’s excipients was recently featured in a formulation that has entered clinical trials. Can you share more details about this development and the role your excipient played?

An Apisolex™ polymer-enabled drug formulation is currently in Phase 1 clinical trials. In addition to this study, Apisolex polymer is being evaluated in multiple programs across the globe, enabling delivery of hard-to-formulate APIs from various therapeutic classes and by multiple routes.

Improving bioavailability is essential for the success of many new drug candidates. What innovations is Lubrizol currently working on to enhance oral bioavailability, particularly for poorly soluble APIs?

Between 40-70% of marketed drugs and up to 90% of all new chemical entities (NCEs) registered suffer from poor water solubility. This can have significant negative consequences for the bioavailability of the active pharmaceutical ingredient (API), with a potential impact on therapeutic effects. Apisolex polymer allows amorphous solid dispersion, a growing technology that enhances the solubility and stability of APIs.  

From a regulatory standpoint, how is Lubrizol ensuring its excipients meet the evolving expectations of both global and APAC-focused drug developers?

Lubrizol is an active member of the International Pharmaceutical Excipients Council (IPEC-Americas) which is part of a global federation (IPEC Federation). Members of IPEC include excipient manufacturers, distributors, and finished drug manufacturers. As members of IPEC, we are able to track global regulatory expectations and emerging regulatory trends.

What are some of the key trends you're observing in the pharmaceutical excipients market, especially with regard to emerging modalities such as biologics, peptides, or mRNA?

Emerging modalities are evaluated with the goal of developing new target therapies, like oncology and immunotherapy. Because of their properties that enable improved solubility and bioavailability, Lubrizol’s excipients are a key component of the development of therapies targeted to these modalities.

You’re participating in several key industry events this year including CRS, DDF North America, and CPHI Frankfurt. What will Lubrizol be showcasing, and what kinds of partnerships or conversations are you hoping to spark?

Lubrizol is proud to highlight its award-winning excipients, ApisolexTM and ApinovexTM polymers as the key to easier formulation of therapies that provide sought-after benefits for today's patients. Both ApisolexTM and ApinovexTM polymers have been honored in industry events that recognize their innovative technologies, as well as support the formulation of challenging APIs in products that provide superior efficacy and patient compliance. As well, the progression to clinical trials of a medicinal product formulated with Apisolex polymer excipient demonstrates its ability to provide differentiated solutions to solubility and bioavailability challenges in parenteral formulations. Lubrizol continues to invest in expanding the reach of its excipients across global markets and nurturing relationships with drug product manufacturers that are facing insoluble API challenges.

Looking ahead, what excipient or formulation innovations do you believe will be game-changers for the pharma industry over the next 3 to 5 years?

Today, consumers are taking a highly personalized approach to medicine and increasingly want therapies that solve their often-unmet needs.Meanwhile, pharmaceutical manufacturers are feeling growing pressure to provide safe, effective solutions to meet these needs. In the United States in particular, regulatory approval is often a moving target, with the result sometimes being at odds with market demands to bring compliant solutions to market quickly. In addition, formulators in other regions are often up against regulatory challenges unique to their specific markets.

In the face of these challenges, excipients are critical in enabling rapid development of highly personalized therapies. Clinically validated excipients are known entities that allow screening and platforming simulations of interchangeable APIs. This factor alone can help support a variety of ever-evolving solutions to patients’ greatest needs for their health.