ACUTE TOXICITY STUDIES OF METHACRYLIC ACID BASED COMPOSITE HYDROGEL OF SALVIA SPINOSA SEED MUCILAGE: A POTENTIAL NON-TOXIC CANDIDATE FOR DRUG DELIVERY

Safety evaluation of a newly designed polymeric drug delivery system (DDS), with/without the addition of active pharmaceutical ingredients (APIs), is now mandatory for their regulatory approval for human use. Hence, Salvia spinosa seed mucilage/hydrogel (SSH) was treated with methacrylic acid (MAA) to synthesize a composite hydrogel (SSH-co-MAA). Acute oral and acute dermal toxicity studies of the SSH-co-MAA for API delivery were ascertained following OECD guidelines 420 and 402, respectively. Moreover, an ocular toxicity study was also performed and analyzed through Draize scale. Animals of two species, rodent (rat) and non-rodent (rabbit), were divided into four groups. Group A of both rats and rabbits was assigned as control and remained untreated. Meanwhile, groups B, C, and D were labelled as treated groups and received a single dose of SSH-co-MAA, i.e., 0.05, 0.3 and 2 g/kg body weight of the animal. During 14 days after the treatment, animal monitoring was done for behavioral changes, food and water intake, adverse effects, and mortality. All animals remained alive, with no statistically significant abnormality. Hematological and biochemical parameters of control and treated animals were analyzed after the completion of 14 days and found in harmonization. The vital organs of animal models were removed to determine absolute organ weights. Histopathology of the vital organs of animal models revealed normal cellular architecture, without any lesions. SSH-co-MAA was also free from dermal and ocular toxicity. The overall results of acute oral and dermal toxicity studies prove that SSH-co-MAA is safe, especially after oral administration. Hence, SSH-co-MAA can be used as a non-toxic excipient for drug delivery systems.