Technology enables testing of drug absorption and formulation performance in a single step
EXTON, Pa., Jan. 25, 2017 /PRNewswire/ — Absorption Systems, a global leader in the science of translational medicine, announces that U.S. patent number 9,546,991 has been issued, covering its groundbreaking technology called In Vitro Dissolution Absorption System (IDAS2™). 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. Industry demand for IDAS2 is already high, thanks to its innovative design and integrated predictive ability.
All claims in the patent application were allowed. The first and primary claim is a device for assessing drug dissolution, absorption and permeation comprising a reservoir (for dissolution) in fluid contact with a permeability barrier composed of living human intestinal cells. For more details, click here to see the patent application on the U.S. Patent and Trademark Office website. 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 dissolution rate, which is determined by the formulation (excipients) and/or the manufacturing process used to incorporate the active pharmaceutical ingredient (API) into a solid dosage form; and
- the absorption rate of the dissolved drug substance across a human intestinal cell monolayer, which is an intrinsic property of the API.
In addition, IDAS2 allows for the assessment of various formulations at the same time.
The FDA’s position on bioequivalence, in particular the Biopharmaceutics Classification System (BCS), continues to evolve, and IDAS2 was designed with this in mind. Formulation is more important for some APIs (BCS class II and class IV) than others (BCS class I and III). Thus, the availability of IDAS2 for use in product development will have an immediate impact on development timelines and costs, and Absorption Systems’ understanding of the nuances of the BCS will further benefit the users of the technology.
Dr. Ismael J. Hidalgo, Chief Scientific Officer of Absorption Systems and co-inventor on the patent with Dr. Jibin Li, commented that, “It’s very rewarding to be awarded a patent for IDAS2, because it has taken several years to get to this point. This is the result of a lot of hard work by our R&D scientists. As always, our goal is to help get more effective and safer drugs to patients 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 to 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, PA, in San Diego, CA, and in Panama City, Panama, and serves customers throughout the world. For information on the company’s comprehensive contract services and applied research programs, please visit absorption.com.
Written By: Chris Bode, Absorption Systems