(M1530-10-68) Assessing the In Vitro Performance of Solid Dosage Forms Over-Encapsulated with the ID-Cap System for Improved Compliance

Purpose: The ID-Cap™ System is a novel approach for monitoring and tracking oral medication adherence in clinical studies. We have investigated the in vitro performance of solid dosage forms over-encapsulated with the ID-Cap™ System, with a focus on Tagrisso® (osimertinib mesylate). The research aims to investigate whether the over-encapsulation process affects the dissolution profile and overall performance of the original drug product. We tested the hypothesis that the ID-Cap™ System does not compromise the dissolution behavior of the over-encapsulated dosage form, ensuring its effectiveness and therapeutic outcomes while improving patient compliance in clinical settings.

Methods: In vitro dissolution experiments were conducted in simulated gastric (0.1 N Hydrochloric acid) and Fasted State Simulated Intestinal Fluid (FaSSIF) condition. The experiment used original tablet and over encapsulated tablets with ID-Cap™ System. A liquid chromatography method was developed using osimertinib and nilotinib as internal standard, and the samples were quantified using LC-diode array detector. The two-dissolution profile results were compared using f2 statistics, as per current regulatory FDA and ICH guidelines.

Results: The dissolution profile of the drug indicates a comparable release profile, with a 5-minute time lag observed when using the tablet in ID-Cap System encapsulated form. The f2 statistic used to assess the similarity of two dissolution profiles, with a value of 56.14 in gastric pH media (0.1 N Hydrochloric acid) and 51.51 in simulated intestinal media (FaSSIF). The results obtained show that the f2 values are greater than 50 indicating similarity between the two dissolution profiles of original and over encapsulated tablet. The ID-Cap™ System consisted of an ingestible microsensor that is embedded in an oral dosage form and, once activated by stomach or intestinal fluid it communicates through digital messages to an external wearable device to confirm ingestion, which was also recorded during the study.

Conclusion: Osimertinib is a BCS class III drug, and it showed a very rapid in vitro dissolution profile under defined conditions. The investigation on the use of ID-Cap system also gave similar dissolution profile when compared via f2 statistics. Hence, the over-encapsulation with novel ID-Cap System does not affect the performance of the original drug product, beyond a slight delay in dissolution start and the time to achieve 85% of the dose dissolved in the media.

References: 1.MedSurgPI LLC, 3700 Lark Farm Road, Franklinton, NC 27525, USA & Klein, G. L. The Case for Digital Pill Use in Clinical Trials. Clin. Trials Pract. – Open J. 4, 16–21 (2021).
2.Flores, G. P. et al. Performance, Reliability, Usability, and Safety of the ID-Cap System for Ingestion Event Monitoring in Healthy Volunteers: A Pilot Study. Innov. Clin. Neurosci. 13, 12–19 (2016)

Acknowledgements: This work was supported by an award grant from the EtectRX.
Experiment was monitored and performed at University of Florida.

% Release of original osimertinib tablet in 0.1 N HCl and FaSSIF media

% Release of over-encapsulated osimertinib tablet in 0.1 N HCl and FaSSIF media