Development of calcium-alginate gummies for drug delivery

PEREYRA, R.; TOSTO, M.; GONZALEZ VIDAL, N.

Rosario

Congreso; 7ma. Reunión Internacional de Ciencias Farmacéuticas (RICiFa); 2023

Universidad Nacional de Rosario

The difficulty in swallowing is a frequent problem when solid dosage forms, as conventional tablets and capsules, are administered to pediatric population or patients with dysphagia [1]. An interesting alternative to overcome these problems are non-conventional formulations like gummies. Gelatin is the most frequently used gelling agent to develop these products. However, a certain part of the population, for religious and ideological reasons or by their own choice (vegetarians or vegans), rejects the use of products of animal sources. This resulted in motivation to design formulations using materials from vegetable origin, including alginate (commercially extracted from marine algae). This natural gelling agent requires the presence of calcium ions to gel. To avoid premature gel formation, a sequestering agent must be incorporated [2]. Therefore, this work deals with the design, development, and characterization of nine formulations of sodium alginate gummies, using different sources of calcium and sequestering agents (see table). Deionized water was used for the preparation of the alginate solution. Moreover, glycerin and sorbitol (plasticizers), citric acid (acidulant) and sodium benzoate (preservative) were used. Gummies were produced by molding, followed by a drying phase (storage at 25 °C for 7-8 days). The obtained products were characterized in terms of weight, dimensions (height and upper and lower diameters, with the subsequent volume estimation), texture profile analysis (TPA), pH, and water activity (aw). The weight, height and the upper and lower diameters were around 3.0g, 9.8 mm, 14.0 mm and 19.8 mm respectively, with a calculated volume of 2,29 cm3. From TPA results, hardness (i.e., the force necessary to achieve deformation in the first compression cycle, which mimics the first bite of the chewing process), was around 12 N for dicalcium phosphate formulations. However, it was more variable for the formulations with calcium citrate (16, 12 and 10 N for F3, F6 and F9, respectively). The lowest hardness was obtained for the formulations with calcium carbonate (F1, F4 and F7), which presented values of around 10 N. Other results for texture parameters were cohesiveness (≈0.7), gumminess (≈8 N) and springiness (≈4), which were considered adequate for this type of product [3]. Considering water activity, results were in the range 0.38-0.42; and for pH, between 4.12-5.02. Both parameters were considered optimal, specially to prevent microbial growth. In conclusion, the developed gummies constitute a very promising platform to drug delivery, particularly for patients not-consumers of animal derivatives.REFERENCES: [1] Liu F et al. 2014. Drugs; 74(16):1871–1889.[2] Ortiz-Romero N et al. 2021. TecnoLógicas; 24 (52): e1962.[3] Gonzalez MA et al. 2023. Pharmaceutical development and technology; 28:143-151