Development and clinical evaluation of a palatable calcium acetate gummy formulation for patients undergoing...

Phosphate binder therapy is essential for managing hyperphosphatemia in patients undergoing hemodialysis. However, nonadherence remains a common challenge. Gummy formulations are considered patient-friendly because they do not require water and are easily chewed. In this study, we developed a calcium acetate gummy formulation (CA-G) and evaluated its pharmaceutical properties and palatability in both healthy volunteers and patients undergoing hemodialysis. CA-G (3.5 g per formulation) was prepared using a gelatin-based matrix containing calcium acetate (CA; 250 mg) and organoleptic masking agents (flavors and sweeteners). The formulation was evaluated for drug content, dissolution behavior, water activity, penetration distance, and phosphate-binding efficacy. Four flavored CA-Gs (yuzu, Darjeeling tea, lemon, and apple) were prepared. In a gustatory sensation test, 24 healthy volunteers evaluated palatability using a 100-mm visual analog scale (VAS). In addition, palatability was assessed by nine patients undergoing hemodialysis using a 5-point scale, and changes in serum phosphate levels were explored. CA content was 102.8% of the intended amount; maximum dissolution rate was 97.6%; water activity was 0.732; and penetration distance was 13.1 mm. Incorporation of CA into the gummy matrix did not compromise maximum phosphate-binding efficacy. Flavored CA-Gs showed significantly higher palatability VAS scores than the non-flavored formulation in healthy volunteers, with at least 75% of patients rating them acceptable. Serum phosphate levels decreased after CA-G supplementation. These findings suggest that palatable and flavor-varied CA-G may represent a patient-friendly dosage-form option for patients undergoing hemodialysis.