European Patent Granted for Absorption Systems’ IDAS2™, a Uniquely Predictive Test System for Fundamental Drug Properties
Technology enables testing of drug absorption and formulation performance in a single step
EXTON, Pa., Oct. 2, 2018 /PRNewswire/ — Absorption Systems, a global leader in the science of translational medicine, announces that the European Patent Office has issued a Decision to Grant European Patent Number 3221696 on September 26, 2018. The patent, titled “System for the Concomitant Assessment of Drug Dissolution, Absorption and Permeation and Methods of Using the Same,” covers the In Vitro Dissolution Absorption System (IDAS2™), a groundbreaking, first-in-class technology. The patent covers the following jurisdictions: Denmark, France, Germany, Sweden, Switzerland, and the United Kingdom.
IDAS2™ is a unique test system that enables the simultaneous evaluation of drug dissolution and absorption in various dosage forms, including tablets, capsules, and pre-formulations. Demand for testing dissolution and absorption with IDAS2™ is high and continues to rise, due to its innovative design and its ability to predict in vivo pharmacokinetic product performance based on bench-top testing. Click here to view a video about IDAS2™.
Using IDAS2™, pharmaceutical scientists can rapidly evaluate two fundamental properties of a finished drug product (tablet, capsule, etc.) simultaneously:
- the rate of dissolution, which is determined by the formulation and/or the manufacturing process used to incorporate the active pharmaceutical ingredient (API) into a solid dosage form; and
- the rate of permeation of the dissolved drug substance across a human intestinal cell monolayer, which is an intrinsic property of the API.
IDAS2™ makes it possible to evaluate two fundamental drug properties, permeability and dissolution, at the same time. Historically, those properties have been measured independently, and usually under conditions that bear little resemblance to the in vivo situation. The ability of IDAS2™ to capture the interconnectivity between these processes, under experimental conditions that resemble the intestinal environment, has led to more accurate predictions of the way drugs behave in vivo.
The U.S. Food and Drug Administration’s implementation of the Biopharmaceutics Classification System (BCS), allowing biowaivers of in vivo bioequivalence (BE) studies for BCS Class 1 and BCS Class 3 APIs, has resulted in improved access to high-quality, affordable generic drugs. However, BCS Class 2 and Class 4 APIs are not eligible for biowaivers and must be evaluated in vivo; for drug substances in these classes, IDAS2™ could be particularly impactful in the development and/or selection of formulations with a higher probability of success in clinical BE studies. Thus, the availability of IDAS2™ for use in product development will have an immediate impact on development timelines and costs.
Dr. Ismael J. Hidalgo, Chief Scientist of Absorption Systems and co-inventor of the technology with Dr. Jibin Li, commented that “This latest milestone is the result of several years of hard work by our team of R&D scientists. We believe that IDAS2™ will help us achieve our goal of getting more effective and safer drugs to patients throughout the world sooner.”