EXTON, Pa., Sept. 4, 2018 /PRNewswire/ -- Absorption Systems, a global leader in the science of translational medicine, announces that the Japanese Patent Office has issued a Decision to Grant a patent covering the In Vitro Dissolution Absorption System (IDAS2™), a groundbreaking, first-in-class technology. 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.
The primary claim in the patent application is a device for assessing drug dissolution, absorption and permeation, comprising a reservoir (for dissolution) with fluid bathing a permeability barrier composed of living human intestinal cells. 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.
Although, historically, permeability and dissolution have been measured independently, and usually under conditions that bear little resemblance to the in vivo situation, IDAS2 makes it possible to evaluate these two fundamental drug properties at the same time. 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 FDA'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 good-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 be extremely valuable in the pursuit of our goal of helping to get more effective and safer drugs to patients throughout the world sooner."
About Absorption Systems
Absorption Systems uses GxP-compatible biological services and testing platforms to assist pharmaceutical, biotechnology and medical device companies in identifying and overcoming absorption, distribution, metabolism, excretion, and toxicity (ADMET) barriers in the development of drugs, biologics, and medical devices. The company's mission is to develop innovative GxP biology research tools, and provide exemplary service, to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies® platform, a suite of human cell-based test systems for drug transporter characterization, exemplifies Absorption Systems' commitment to innovation and excellence in GxP biology. Absorption Systems has facilities near Philadelphia and Boston, as well as in San Diego and Panama, and serves customers throughout the world. For information on the company's comprehensive contract services and applied research programs, please visit absorption.com.
CONTACT: Chris Bode, [email protected]
SOURCE Absorption Systems