CoreRx

Thursday April 28, 2022 at 11am ET | 10am CT | 8am PT In this new video series, Drug Digest, the Pharmaceutical Technology editors examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements. Join the editors as they speak with experts from Regulatory Compliance Associates (RCA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), and others.

Drug development timelines are shortened by the corporate and clinical strategies of biotech and pharmaceutical companies to achieve proof-of-concept or to rapidly get to the market. For new drug entities entering clinical trials, selecting the right drug product depends on many factors, including the corporate and clinical strategy, and the physiochemical properties of the drug substance. This episode will consider time and cost for developing and compounding or manufacturing the different types of oral drug products dosed in early clinical trials.

Cationic Adsorbent Gel Raft formulation for use in proton pump inhibited stomach.   Concept proven with fiberoptic UV probes eliminating the need for HPLC analysis. 

The bioavailability of insoluble compounds remains one of the biggest challenges to drug delivery. While there are strategies that can be applied at lower dosage levels, it is particularly difficult to formulate for improved bioavailability at high dosage levels. Improving bioavailability can be crucial to creating a dosage form that is easy to use and meets requirements for patient compliance. CoreRx tackles bioavailability challenges for molecules by leveraging our membrane flux in vitro technology. Today, we will discuss how using this technology enabled CoreRx to discern which factors were most important for bioavailability of a model Class IV compound, and led to development of a formulation with ~70% increase in bioavailability.

Bioavailability of insoluble compounds is one of the biggest challenges to drug delivery. Improving bioavailability is crucial to creating dosage forms that are easy to use and meet demands for patient compliance.