Introduction <p>The objectives of evaluating the toxicological study of polysaccharide-based multiparticulate formulation should be explicitly the safety of oral drug deliver through clinical observations, biochemical tests, and histopathological analyses in animal models. The safety of oral drug delivery using biopolymer-based multi-particulate formulation was assessed by acute and sub-acute toxicity. The acute and sub-acute studies were conducted on male and female rats, following the OECD Guideline 423 &amp; 407 for the formulation based on polysaccharides as a biomaterial.</p> Methods <p>The white albino rats were split into four groups (I-IV), and the polysaccharide-based formulation was administered in different dosages of 50 mg/kg, 100 mg/kg, and 200 mg/kg of body weight, except for the control group (I), which did not receive any treatment. The rats were observed for sub-acute toxicities, while body weight, food intake, necropsy, haematology, biochemistry and histopathology were examined in animals.</p> Results <p>In the acute toxicity study, no toxic signs were observed during the study and no abnormalities were observed after oral administration. Sub-acute toxicity studies showed no death and no abnormalities in the rats treated with the multi-particulate formulation. A repeated-measures analysis of variance (ANOVA), which uses food intake, water intake, and body weight to evaluate the changes over time, was used. The statistical significance was determined by a P-value less than or equal to 0.05.The histopathology results of the vital organs did not show any abnormalities.</p> Conclusion <p>Study results confirmed that a polysaccharide-based multi-particulate formulation was not toxic and does not pose a significant safety risk. It is possible that oral delivery of drugs could be made safe and efficient by using such formulations.</p> Graphical Abstract <p></p>