Design, development and characterization of Ganoderma lucidum gummies

PEREYRA, R.; GONZALEZ VIDAL, N.

Rosario

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

Universidad Nacional de Rosario

Ganoderma lucidum is a medicinal mushroom, with prebiotic activity. Besides, it presents other pharmacological benefits such as anti-inflammatory, immunosuppressive, hypocholesterolemic, hypotensive, antioxidant as well as antitumoral activity. Therefore, it has been widely used as an alternative or adjuvant to chemotherapy treatment, in order to control the side effects or limit cancer expansion [1]. In recent times, the need for a product to deliver this probiotic has been observed, with emphasis on a dosage form that can be administered to people with generalized weakness and swallowing difficulties, as occurs with oncological patients. In this sense, gummies represent very promising pharmaceutical forms, considering other advantages such as low cost of production, simple storage and transportation logistics, and no sophisticated equipment required for the manufacturing process. Therefore, this work deals with the design, development, and characterization of Ganoderma lucidum gummies. Gelatin (gelling agent), glycerin and sorbitol (plasticizers), citric acid (acidulant), sodium benzoate (preservative), vanilla essence (flavoring) and G. lucidum extract were used for gummies design. The gummies were produced by molding, with a subsequent drying phase, carried out in a vacuum oven at 25 °C, until a constant weight was reached. The obtained gummies had an initial weight of around 4.6 g/unit and after the drying phase, a weight loss of 26% was registered. The gummies were evaluated in terms of dimensions (height and upper and lower diameters, with the subsequent volume estimation), pH, water activity (aw), and disintegration time (using a 0.5% sodium lauryl sulfate aqueous solution at 37.0 ± 0.5 °C). Besides, texture profile analysis (TPA) was assessed in terms of hardness (force necessary to achieve deformation at first compression), springiness (elastic recovery that occurs when the compressive force is removed), cohesiveness (strength of the internal bonds in the sample), and gumminess (energy required to disintegrate a semi-solid product until it is ready for swallowing); with results of 22.2 N, 4.5 mm, 0.8 N, and 18.5 N, respectively. The obtained gummies showed a mean final volume of 2,26 cm3 and a pH value of 4.6. The latter result can be considered acceptable, since the strength of the gel is affected by pH values lower than 4, low pH values are beneficial to avoid microbial growth and to ensure the preservative activity of sodium benzoate. Water activity (indicator of available water, capable to interact with other components of the formulation or for microbial growth promotion) value was 0.38, which ensure the stability and an adequate lifecycle of the product. Finally, the disintegration time was 16 min, an adequate value for semisolid formulations. In conclusion, all obtained results were considered suitable for this type of product [2], and consequently, the developed gummies have substantial potential to deliver G. lucidum extract. References: [1] Pascale C et al. 2022. European Journal of Natural Sciences and Medicine; 5 (1):39-47.[2] Gonzalez MA et al. 2023. Pharmaceutical development and technology; 28:143-151.