Vehiculization of amiodarone in vegan gummies

PEREYRA, R.; GONZALEZ VIDAL, N.

Rosario

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

Universidad Nacional de Rosario

In recent years, ecological, ethical, religious, and health considerations, as well as dietary restrictions, have increased the demand for plant-based products, including in the pharmaceutical field [1]. In addition, there is great interest for the development of easy-to-use dosage forms, in which a chewable delivery system is considered a practical alternative for patients suffering dysphagia and/or pediatric population [2]. Therefore, this work deals with the design, development, and characterization of amiodarone vegan gummies, based on low-methoxyl pectin, a vegetable-based gelling agent. Amiodarone is an antiarrhythmic agent, particularly applied for pediatric treatment of congenital heart diseases, at a dose of 100 mg per chewable unit. Pectin was hydrated in a phosphate-sodium citrate buffer solution to prepare the gummies, in association with glycerin and sorbitol (plasticizers), vanilla essence (flavoring), sodium benzoate (preservative), and calcium chloride (source of calcium; essential for gelification). Eight formulations were obtained by application of a 23 experimental design and molding, with a subsequent drying phase carried out in a stove at 25 °C (Figure 1). Gummies were characterized in terms of weight, syneresis (loss of liquid from the gel), dimensions (height and upper and lower diameters, with the following volume estimation), texture profile analysis (TPA), pH, water activity (aw), disintegration time, in vitro dissolution and uniformity of amiodarone content. The latter three determinations were performed using a 0.5% sodium lauryl sulfate solution, and spectrophotometric quantification. The weight was around 4.0 g and the average syneresis was 23 %. The average height and upper and lower diameters were 10.7 mm, 14.9 mm and 20.9 mm respectively; with an associated volume of around 2.7 cm3. Hardness, the force necessary to achieve deformation of the gummies, was quite variable for different formulations (45.6 for F1 and 15.4 N for F8; but all values in regular range), with a consequent variable gumminess. Cohesiveness and springiness were around 0.3 and 3.3 mm respectively. Water activity result was round 0.3, and pH was 3.8. The disintegration time was 16 min, the mean amiodarone content was 81.7%, and considering in vitro dissolution, more than 80 % of amiodarone was dissolved after 120 min. In conclusion, the obtained results could be considered satisfactory for chewable systems [3], so that pectin-based gummies offer a good vehicle for amiodarone administration.REFERENCES[1] Alcorta A et al. 2021. Foods; 10(2):293.[2] Baydin T et al. 2022. Applied food research; 2:100225.[3] Gonzalez MA et al. 2023. Pharmaceutical Development and Technology; 28:143-151.