The SIMulation of Gastric Activity Tool (SimGAT) project is funded by the PR CAMPANIA FESR 2021-2027 – Axis I – Specific Objective 1.1 – Action 1.1.3 – Public Notice CAMPANIA STARTUP 2023 – CUP B68I23005720007. Its objective is the industrialization of patent EP4284346, owned by the proposing company Enhanced Systems & Technologies (EST) S.R.L.
The patented device replicates, within a simulator of the human or animal gastrointestinal tract, any pH history, including physiological ones. This device will significantly enhance the reliability of testing enteric pharmaceutical and nutraceutical forms, designed to protect active ingredients from gastric environments.
The tool to be industrialized and marketed is a stand-alone device useful in dissolution and release tests of oral pharmaceutical tablets. Specifically, the device, using two dosing pumps to regulate acidic and/or basic solutions, can modify and control the pH of a buffer solution to simulate the characteristic curve occurring in the gastric antrum when food is ingested.
The device reaches its full potential when paired with conventional dissolution systems, where dissolution and release tests must be conducted according to the official pharmacopeia guidelines. Furthermore, being capable of simulating various pH curves, the device serves as an excellent assistant for both unconventional tests and conventional tests, which often require rapid pH changes during the transition from gastric to intestinal simulation.
The device has been validated both in combination with a classic USP II dissolution apparatus and in stand-alone mode. Additionally, a non-conventional dissolution system was designed and developed, accounting for the real physiology of the human stomach, simulating peristalsis in terms of both the strength and frequency of contractions occurring during digestion. In this system, the pH control tool was implemented. Validation results demonstrated significant differences in dissolution and release profiles of orally administered pharmaceutical preparations when tested under conditions more closely resembling real physiological conditions compared to conventional dissolution systems. This validates the device’s utility for testing pharmaceutical forms, particularly enteric ones.
The final project device will be user-friendly and accessible to companies after a training period.
Total project cost: € 261,353.49
Granted funding: € 182,947.44
