(W1230-08-53) Surelease^® Encapsulated Caffeine for Gummies

Purpose: In recent years, there has been a notable increase in the popularity of gummies as an innovative dosage form for dietary supplements¹. This trend may be attributed to younger consumers and those seeking a more enjoyable sensory experience, as well as individuals with dysphagia, for whom traditional formats like tablets or capsules are less desirable^{2, 3}. However, the unpleasant tastes of certain active ingredients can impact the sensory experience of gummy dosage forms⁴. One model active ingredient that has gained traction in gummies is caffeine, primarily used for its stimulating effects, with some brands promoting it as alternative to coffee and others targeting it for focus enhancement and as a pre-workout stimulant⁵. Unfortunately, caffeine is often very bitter, leading to an undesirable sensory experience. In this study, we investigated the use of Surelease^®, Ethylcellulose Dispersion Type B NF, for encapsulating caffeine as a means of taste-masking the active ingredient while ensuring that the encapsulation maintained its integrity during the pectin-based gummy cooking process to ultimately enable a more pleasant experience by the consumer. Additionally, gummies with wax-encapsulated and non-encapsulated caffeine were compared against the gummies with Surelease^® encapsulated caffeine.

Methods: Caffeine anhydrous fine powder (Aarti Pharmalabs) was selected for processing. Due to the active ingredient’s very fine particle size and irregular morphology, the material was very challenging to process efficiently within the fluid bed technology⁶. Because of this, a flow aid was first pre-blended with the caffeine at 5% to enhance the flowability and fluidization while preventing re-caking of the active. The caffeine pre-blend was then granulated with a clear Opadry^® coating at 12% weight gain and 10.5% w/w solids in a VFC-Lab 3 Flo-Coater system (Vector Corp) using a 4-liter top-spray bowl and was afterward encapsulated with Surelease^® E-7-19040 to 65% weight gain. The Surelease^® encapsulated caffeine samples were tested for microscopy imaging and particle size analysis (Malvern Mastersizer 3000). The encapsulated caffeine samples were also used to manufacture lab-scale pectin-based gummies (Melt-to-Make™)⁷ using typical pectin-based cooking techniques targeting 40mg per gummy. The gummies were pigmented with Opatint^® liquid dispersion containing a natural brown colorant which was added at 0.5% of the recipe. Additionally, gummies using non-encapsulated and commercially available wax encapsulated caffeine were manufactured similarly as above. The gummies were subsequently tested for content uniformity and dissolution in purified water (900 mL, apparatus 2, 50 rpm) through four hours to understand its release characteristics.

Results: After granulating with the clear Opadry^® coating, the caffeine was able to be fluidized more efficiently during the encapsulation process with Surelease^®. The granulation and encapsulation methods appear to have modified the particle morphology, leading to more uniform sized encapsulated particles, as shown on the microscopy images in Figure 1. Also, particle size analysis of the caffeine after processing showed good control and progression of the size distribution of the particles through final encapsulation, which is also shown in Figure 1. Lab-scale pectin-based gummies prepared with the Surelease^® encapsulated caffeine appeared visually discreet and uniform within the gummies, as shown in Figure 2 A). and B)., but the non-encapsulated and wax-encapsulated caffeinated gummies appeared discolored with an opaque appearance, as shown in Figure 2 B) . and C). Pectin-based gummies containing Surelease^® encapsulated caffeine, as well as non-encapsulated and wax encapsulated caffeinated gummies, were found to have good content uniformity with low RSD per mg/g, as shown in Figure 3. Additionally, gummies dissolution tested in purified water indicated that samples with 65% WG of Surelease^® encapsulated caffeine provided effective protection of the caffeine, resulting in slight delay in release, as compared to the gummies with non-encapsulated and wax encapsulated caffeine which both exhibited significantly faster release suggesting reduced barrier protection of the caffeine. It was also noted that the Surelease^® encapsulated caffeinated gummies resulted with 83% release of active within 45 minutes indicating an immediate-release profile, as shown in Figure 3.

Conclusion: Fine particle caffeine was encapsulated with Surelease^®, Ethylcellulose (Aqueous) Dispersion Type B NF, via top-spray fluidization process resulting in small and acceptable particle size distribution. The encapsulated caffeine was able to be incorporated into pectin-based gummies and provide discretet and uniform particle dispersal. Surelease^® encapsulation was shown to effectively protect the active ingredient during the gummy cooking process as compared to non-encapsulated and wax encapsulated caffeine differentiated by a slight delay in release with the Surelease^® encapsulated caffeine as compared to the non-encapsulated and wax encapsulated gummies, which both appeared similarly discolored and resulted in notably similar, faster release rates in dissolution, suggesting reduced barrier protection of the caffeine as compared to the Surelease^® encapsulated caffeinated gummies. In conclusion, the findings of this study demonstrated Surelease^® as an effective encapsulating agent for caffeine for gummy applications, providing and maintaining a protective barrier as compared to alternatives such as wax-encapsulated options.

References: 1. Grand View Research. “Gummy Market Size, Share & Trends Analysis Report By Product (Vitamins, Minerals, Dietary Fibers), By Ingredient (Gelatin, Plant-Based Gelatin Substitutes), By End-use (Adults, Kids), By Distribution Channel, By Region, And Segment Forecasts, 2024 - 2030”. Web site: Gummy Market Size, Share & Growth Analysis Report, 2030. Accessed May-28, 2025.
2. Strauss M. Nutritional Outlook. “A gaggle of gummies”. Web site: https://www.nutritionaloutlook.com/view/a-gaggle-of-gummies?. Accessed May-28, 2025.
3. Influx Healthtech LTD. “Influx Launches Gummy Format: A Sweet Solution for Health and Wellness”. Web site: https://influxhealthtech.com/influx-launches-gummy-format-a-sweet-solution-for-health-and-wellness/. Accessed May-28, 2025.
4. National Library of Medicine. “Taste Perception of Nutrients Found in Nutritional Supplements: A Review”. Web site: https://pmc.ncbi.nlm.nih.gov/articles/PMC6770818/. Accessed May-28, 2025.
5. Grand View Research. “Caffeine Gummies Market Size, Share & Trends Analysis Report By Application (Energy Booster, Workout Gummies, Focus & Alertness, Flavor Enhancement), By Distribution Channel (Pharmacies, Specialty Stores), By Region, And Segment Forecasts, 2024 - 2030”. Web site: https://www.grandviewresearch.com/industry-analysis/caffeine-gummies-market-report. Accessed May-28, 2025.
6. Gedart D. “Types of Gas Fluidization”. Powder Technology. 1973;7(5) p: 285-292.
7. Trademark Reference: Melt-to-Make™ is a trademark of Melt-to-Make™, which does not sponsor, authorize, or endorse this document.

Figure 1. Microscopy and Particle Size of Granulated and Encapsulated Caffeine Particles

Figure 2: Gummies with A). and B). Surelease® Encapsulated Caffeine, C). Non-Encapsulated Caffeine, D). Wax-Based Encapsulated Caffeine

Figure 3. Content Uniformity and Dissolution