Translational medicine company Absorption Systems reported on Tuesday the receipt of patent from the Japanese Patent Office 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. The company's technology enables testing of drug absorption and formulation performance in a single step

The company added that 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.

Using the company's IDAS2, pharmaceutical scientists can evaluate two fundamental properties of a finished drug product (tablet, capsule, etc) simultaneously: the rate of dissolution 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. The ability of IDAS2 to capture the interconnectivity under experimental conditions resemble the intestinal environment, which has led to accurate predictions of the way drugs behave in vivo.

However, the US 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. But the BCS Class 2 and Class 4 APIs are not eligible for biowaivers and must be evaluated in vivo, concluded the company.