Development and Evaluation of a Caffeine Capsule as an Over-the-counter Alertness Aid Using Coffea arabica Beans.

Abstract

Background: Sri Lanka lacks standalone caffeine options despite some gyms offering caffeinated supplements and a few imported products. This study addresses this gap by creating a locally made caffeine capsule using readily available Coffea arabica beans. Objectives: To formulate an over-the-counter alertness aid in Sri Lanka, utilizing locally sourced beans and dichloromethane extraction, and to assess in vitro efficacy using quality parameters of the formulated capsules; weight variation, disintegration, dissolution with a focus on enhancing accessibility compared to imported caffeine supplements

Methods: The study assessed the optimal solvent for caffeine extraction based on yield percentage, employing thirty minutes of ultrasound-assisted maceration in sodium carbonate infused distilled water followed by liquid-liquid extraction. The crude caffeine obtained was recrystallized using absolute ethanol. Empty hard gelatine capsules were filled with the prepared caffeine formulation (extracted caffeine and lactose). The resulting capsules with 200 mg of caffeine in each, were evaluated for weight variation, disintegration, and dissolution characteristics. Results: Dichloromethane was chosen as the optimal solvent over ethyl acetate based on the liquid-liquid extraction. Recrystallized caffeine was much whiter than yellowish crude. Formulated capsules carried an average content weight of 619 mg with all capsules falling within the acceptable pharmacopeial weight deviation range of 7.5. They disintegrated readily within 3 minutes and fully dissolved giving average absorbance of 1.025 similar to that of imported ‘Caffeine 200’ capsules (1.074) at 273 nm.

Conclusions: This study successfully formulated caffeine capsules that meet quality control standards for weight variation, disintegration, and dissolution. Comprehensive safety assessment, including residual solvents, microbial contamination, and clinical trials, is required before marketing. Locally-produced caffeine capsules can fill the market gap, offering a more accessible and cheaper alternative, potentially influencing alertness aid purchasing behaviour.