*Corresponding author
Seed-based polymers are gaining attention in pharmaceutical formulations due to their biodegradable and biocompatible nature. The present study evaluates the acute toxicity profile of three different seed-based polymers in Wistar rats. Single oral doses (2000 mg/kg) were administered as per OECD guideline 423. The study recorded mortality, body weight changes, behavioral alterations, and biochemical parameters to assess any potential toxic effects. No mortality or significant behavioral changes were observed, confirming the safety of these polymers. Histopathological examination revealed no signs of toxicity, reinforcing their biocompatibility. The findings suggest the potential safe use of these polymers in drug delivery applications and highlight the need for further studies on their long-term safety.
The study involved extracting, purifying, and characterizing three different seed-based polymers before use in a study. The animals were healthy female Wistar rats, housed in polypropylene cages under controlled conditions. The study adhered to OECD 423 guidelines and followed a 14-day acute toxicity study. Animals were closely monitored for signs of toxicity, mortality, and behavioural changes. Blood samples were collected at the end of the observation period, and biochemical and hematological analysis were performed. Histopathological examination of the liver, kidney, and heart tissues revealed structural alterations, inflammation, necrosis, and other histological changes indicative of toxicity. The study adhered to ethical guidelines for animal research.
The study aimed to investigate the safety of seed-based polymers in treating rats with various conditions. Throughout the 14-day observation period, no mortality was reported in any of the experimental groups, and no abnormal clinical signs such as tremors, convulsions, respiratory distress, or abnormal gait were observed. The absence of these symptoms suggests that the tested seed-based polymers exhibit a high degree of safety at the administered dose.
Rats were observed for clinical signs prior to dosing, immediately after dosing, continuously for the first 30 minutes, after 4 hours, 12 hours, and daily thereafter for 14 days for morbidity and mortality. The rats were observed for changes in skin and fur, eyes, respiratory, behaviour pattern, convulsions, lethargy, sleep, and coma. Individual body weights of the rats were determined shortly before the drug administration and after 7 days and 14 days. After 14 days, the rats were euthanized with an overdose of urethane and sacrificed for gross anatomical and histopathological examinations of the liver, kidneys, and heart.
The study found that the seed-based polymers exhibited a high degree of safety at the administered dose. The effects of the seed-based polymers on body weight, lipid profile, liver function parameters, renal function markers, and hematology parameters were also examined. The results suggest that the seed-based polymers exhibit a high degree of safety at the administered dose.
The study concludes that the tested seed-based polymers are safe at the administered dose, supporting their potential use as pharmaceutical excipients.
Seed-based polymers, Acute toxicity, Wistar rats, OECD 423 guideline, Drug delivery, Histopathology
