(T1530-02-10) Evaluation of Stability of Ion Exchange Resin Based Carrageenan Gummies

Purpose: It is becoming more and more important for consumers to find formulations that are high quality, safe and vegan products. For people who are not keen on animal-based products, carrageenan gummies provide an excellent alternative. An issue with gummy formulations is long-term stability, so the present study was focused on this issue. In our previous research in 2019, we’ve successfully demonstrated the taste masking efficacy of ion exchange resin by incorporating the resin into vegan carrageenan gummies containing Dextromethorphan. In the new study in 2023, stability of the gummy formulations was evaluated. They were stored at ambient conditions for 36 months to evaluate the taste masking efficacy of the formulation after this period.

Methods: Previously prepared gummy formulations were stored in plastic airtight containers at ambient conditions. To demonstrate the stability of these gummies, the taste masking efficacy was evaluated using novel patented flow-through buccal dissolution test, which simulates the buccal environment. Simulated Saliva solution at pH 6.2 was used as the dissolution media. Controls were also run using Dextromethorphan standard and free resinate (drug-resin complex). Fractions were collected at set time intervals over a period of 20mins and analyzed on HPLC. The concentration of drug in the simulated saliva is used as a proxy for taste, thus giving % taste masking efficacy data calculated by the difference in concentration of pure drug (Cmax) vs drug release from resin.

Results: Integrity of gummy formulations was good although formulations #1(control, no Dex or resin) & #2(Dex only gummy) both exhibited mild stickiness (ref Image#1). Using Cmax as the proxy for taste, the control, with Cmax of 2129.47mg/L, was high representing Cmax of pure drug in simulated saliva. Drug release from the formulation #3 (gummy with resinate) was not only extremely low showing 97% taste masking efficacy in simulated saliva but also the results were similar to previous study. Interestingly, not only did formulation #4 (In-situ gummy) showed an increase in taste masking efficacy when compared to the previous study, but also, formulation #3 and #4 showed better integrity over all over the 36month period (ref Table#1).

Conclusion: Carrageenan gummies made with ion exchange resin was stable and remained intact. Formulations without ion exchange resins (#1 and #2) over a 36month period, exhibited stickiness. The gummies made with resinate (formulation #3) continued to provide excellent taste masking efficiency of 97% with results similar to previous study in 2019. In-situ gummy formulation (formulation #4) showed improved taste masking, showing that the drug continued to load onto the resin during the storage period. No unknown/degradant peaks were observed in the chromatograms showing that the API remained stable in the resinate without degradation. The study demonstrated that ion exchange resins can be successfully used in gummies to address both taste masking and stability challenges.

Acknowledgements: Hughes, Lyn, Buccal Dissolution of Active Substances. US Patent No. 2008/US7,470,545,B2, Dec 30th 2008.

Picture of gummy formulations in 2023

Comparison of results of taste masking efficacy from 2019 and 2023

Chart showing taste masking efficacy of gummy formulations from 2019 and 2023