Quotient Sciences said an artificial intelligence algorithm used to select modified-release tablet compositions and doses reached a preset pharmacokinetic target within three dosing periods in an interim clinical study involving healthy participants.
The Nottingham, England-based contract research, development and manufacturing organization said the study is assessing whether an algorithm trained initially on laboratory dissolution data can learn how changes in tablet composition affect pharmacokinetics in people.
Modified-release formulations are designed to release a medicine over time. Their development can require repeated laboratory formulation work and clinical testing to achieve a planned pharmacokinetic profile.
The algorithm was initially trained using in vitro drug-release data. After each dosing period, researchers retrained it using tablet dissolution results and pharmacokinetic data collected from the study participants. It then selected the composition and dose for the next prototype within parameters established by Quotient.
The company said it imposed limits on the algorithm’s selections, including a dose cap for the first prototype. A safety committee reviewed and approved each composition before manufacturing and dosing.
The clinical study used a generic medicine selected because it has an established safety record and extensive published data. Quotient said the drug is being used to evaluate the technology and is not intended for product development.
The work follows laboratory screening in which the same algorithm mapped the formulation design space after evaluating one-third fewer formulations than conventional methods, according to the company. That result led Quotient to test whether the model could also learn the relationship between formulation composition and pharmacokinetics in humans.
Dosing is continuing, and Quotient said it expects to report full results after the trial is completed toward the end of 2026.
The company said the technology will be incorporated into its Translational Pharmaceutics platform, which combines drug-product development, manufacturing and clinical testing.