Ask-the-Expert: What does new clinical evidence mean for CBtru® and oral solid drug delivery?

Summary 

• New clinical data evaluating PK profile of CBtru® has now been published in CNS Drugs—a peer-reviewed journal—marking a significant step forward in improving the development of solid oral drug delivery for highly lipophilic molecules, like cannabidiol (CBD).
• The published findings reveal how CBtru® offers optimized bioavailability of CBD in oral solid dosage form, which was as good as the current gold-standard liquid oil-based medicine. Plus, it may offer a more reliable and consistent uptake, less dependent on food intake.
• In this article, dsm-firmenich's experts unpack what the data reveal-, why peer-reviewed publication matters for pharmaceutical developers, and what the findings mean for the future of drug development with highly lipophilic molecules.

When formulating highly lipophilic active pharmaceutical ingredients (APIs) with low and variable oral bioavailability, like cannabinoids or the anticancer drugs paclitaxel and docetaxel, developing solid oral dosage forms can be tricky, meaning these therapies are often limited to liquid-based formulations. However, as interest in these active ingredients grows, there is a rising need to prove—via sound clinical data—that these molecules can be delivered effectively in solid oral dosage forms too, like pills or tablets. To address this, dsm-firmenich took a deliberate, science-led approach to developing CBtru®, a novel drug delivery system designed to unlock the potential of highly lipophilic molecules.

To understand how the body interacts with CBtru® over time, from absorption through to distribution, metabolism, and excretion, a phase I randomized cross-over clinical study was conducted to evaluate its pharmacokinetic profile. The promising results are now published in peer-reviewed journal, CNS Drugs, which marks an important milestone—not just for CBtru®, but for the broader field of drug development with highly lipophilic molecules.¹ Why? Because by generating human pharmacokinetic data under clinically relevant conditions, we’ve not only validated CBtru® technology, but also provided the kind of evidence that can meaningfully support formulation decision-making and de-risk the drug development path from concept to patient-ready products.

To explore what the findings mean in practice, we spoke with two experts at dsm-firmenich: Zdravka Misic, Associate Innovation Director, Pharma, and Carlos Almasqué, Global Marketing Director for Pharma Excipients. Zdravka kicked off the discussion by talking about the clinical rationale behind the study and what the pharmacokinetic findings reveal about the future of solid oral drug delivery, and beyond:

1. What key question was the pharmacokinetic study designed to answer—and why was it important to explore it in a controlled clinical setting?

Zdravka: “The study set out to investigate the absorption and pharmacokinetic profile of cannabidiol (CBD) formulated with CBtru® in capsules, compared to Epidiolex®—the only market-approved CBD drug product, which is delivered as a liquid sesame oil-based formulation. Rather than relying on theoretical or in vitro assumptions, we wanted to generate human pharmacokinetic data to better understand how CBtru® performs under clinically relevant conditions. This is particularly important given that pharmacokinetic and safety data across different CBD formulations is limited. Conducting this study in a controlled clinical environment was essential because it allowed us to minimize variability from external factors and generate robust, reliable data that pharmaceutical developers can trust.”

2. What were the most important findings?

Zdravka: “As food intake is known to significantly influence the absorption of lipophilic compounds like CBD, the study was designed to evaluate the molecule’s absorption when formulated with CBtru® under both fed and fasted conditions. The data revealed that in both conditions, CBtru® was absorbed faster and more consistently than the oil-based reference product. In the fasted state specifically, individuals demonstrated higher levels of CBD metabolites in the plasma, suggesting greater overall bioavailability.

Together, these results illustrate how purposeful formulation design can influence pharmacokinetic profiles and reduce variability—particularly in relation to food effects, which has long been one of the central difficulties with lipophilic drug delivery. While the study was conducted using CBD, the findings highlight the potential for CBtru® to support delivery of other similar challenging molecules."

3. How can studies like this help reduce uncertainty for developers moving toward patient-ready dosage forms?

Zdravka: "One of the most significant hurdles in pharmaceutical development is the transition from early-stage formulation concepts to clinically viable products—and uncertainty at that stage can be a real barrier, particularly for compounds where absorption variability has implications for both efficacy and safety. Clinical pharmacokinetic studies help address this directly. By generating human data earlier in the process, we give developers a much clearer picture of how a formulation is likely to behave in practice.”

"In that sense, CBtru® serves as a case study in using clinical evidence to de-risk innovation. But more broadly, it reflects our commitment at dsm-firmenich to integrating clinical research into formulation development from the outset—going beyond theoretical performance to provide peer-reviewed evidence that supports confident drug development.”

Following Zdravka, Carlos Almasqué continued the conversation, highlighting the value of clinical trials and published findings in early-stage drug development—and what this means for pharmaceutical innovation more broadly.

4. Why is it important to invest in—and publish—clinical data for enabling technologies like CBtru®?

Carlos: "Technologies like CBtru® are not finished drug products, they are platforms that underpin the development of future therapies. That distinction matters, because it means developers need a high level of confidence in how they perform before committing to a development pathway. Publishing clinical data is central to building that certainty because it brings transparency and gives the wider scientific and pharmaceutical community the opportunity to evaluate the evidence independently. This includes areas where standardized, clinically validated approaches to oral solid delivery are still emerging, meaning making peer-reviewed data available and accessible isn't just good practice, it’s fundamental to enabling informed development decisions."

5. How does clinical pharmacokinetic data shape formulation choices and development strategies?

Carlos: “Pharmacokinetic data bridge the gap between what you design in the lab and how the drug formulation actually performs in patients. For developers evaluating different drug delivery approaches, that connection is fundamental. Understanding how variables like bioavailability, absorption consistency, and food effects play out in a clinical setting allows teams to make smarter decisions earlier, whether that's at the formulation selection stage or during later-stage optimization. Ultimately, it supports more efficient development pathways—reducing trial-and-error and offering developers a clearer route from the start – saving time and cost.”

6. How does dsm-firmenich’s science-led approach—particularly its investment in clinical trials—set it apart from other suppliers?

Carlos: “Scientific rigor isn’t an afterthought for us; it’s a core part of how we develop and validate our solutions. This approach allows us to move beyond theoretical benefits and provide evidence that is directly relevant to our customers’ needs and challenges. It also reflects something we feel strongly about—a genuine commitment to supporting patient-centric outcomes, not just supplying ingredients. 

“By combining deep formulation expertise with clinical validation, we're working to develop more reliable, effective oral dosage forms achievable—especially in areas where the therapeutic promise is real, but the development pathway can be complex. Ultimately, our goal is to be the type of partner that gives customers the scientific foundation they need to bring new therapies to market with confidence.”

From evidence to impact with dsm-firmenich

By investing in rigorous clinical data and making it available to the scientific community, we’re helping to close the gap between formulation science and patient-ready therapies—and contributing to a more science-led approach to the development of next generation solid oral medicines.