Find a Diamond in the Rough: Utilizing Formulation to Maximize Your Pharmaceutical Product's Potential

by Robert Buckheit III

February 24, 2016

The design and selection of lead compounds is not always as straightforward as we would like it to be. In a perfect world, one would identify a lead compound based on efficacy against an organism in an appropriate model of the disease caused by the organism. This compound would potently eliminate the infectious organism or cancer cell, have limited off-target effects and toxicity and breeze through clinical trials to FDA approval to improve patients' lives. However, counterintuitively, the most potent compound is not always the best one to proceed with IND-enabling studies. Often, the most efficacious compound has a fatal flaw: its pharmaceutical properties do not allow it to be effectively formulated and delivered into the body. Perhaps the compound crashes out of solution when injected, maybe it is completely eliminated by first pass metabolism, and maybe you did not anticipate the importance of pharmaceutical characterization and formulation design early in the lead development process. Bottom line, you have a highly active drug, with no way for it to actually get to the site of disease in the body, and like so many other promising compounds, failure in advanced development and clinical trials results. Perhaps your best drug may actually be the one that wasn't ranked the highest during your preclinical efficacy evaluations, and you don’t even know it…and maybe you overlooked a blockbuster drug, that diamond hiding in the rough.

ImQuest BioSciences developed the ImQuestSUCCESS platform to analyze the efficacy, toxicity and pharmaceutical properties of a potential new drug candidate early in the lead development process. Each criterion is evaluated comprehensively to ensure that the best potential clinical product is chosen for continued development and investment. Our PharmaSENS platform focuses on the incorporation of pharmaceutical product characterization (pre-formulation) and formulation design early in the development process, with a goal of minimizing downstream lead compound failures and maximizing success. ImQuest BioSciences offers expert formulation services, with the capability to develop standard oral, intravenous, and topical cream or gel formulations for your compound of choice. We specialize in novel and custom formulations, such as transdermal patches, quick-dissolving films, melting or dissolving suppositories, intravaginal rings, and nanoparticle-based delivery systems. We have recently reported a novel dual chamber vaginal/rectal microbicide gel (DuoGel) which dramatically improves the utility of microbicidal products targeting sexually transmitted organisms. We have the tools and critical expertise to identify, optimize and customize the best delivery system for your pharmaceutical product.

For more information on the ImQuest SUCCESS platform and our PharmaSENS program please Contact Us.

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