Preclinical Safety, toxicology studies of Wamup gel- A novel Formulation with L-Arginine on Wistar Rats

U. Venkatesh1*, Sri Rama Radha1, P. Suresh1, G. Sravan Reddy2
1St John’s College of Pharmacy, Yemmiganur, Kurnool, Andhra Pradesh
2Hi-Q Herbals, Kothapet, Hyderabad, Telangana

A B S T R A C T
WAMUP is an aqueous based gel formulation containing 5% L-Arginine for topical application for both males & females. L-arginine in WANUP GEL releases nitric oxide (NO) through nitric oxide synthase enzyme (NOS). nitric oxide which reduces blood vessels Stiffness, increases blood flow and improves blood vessel function. Larginine also used for erectile dysfunction by enhancing the action of Nitric Oxide, which relaxes muscle surrounding blood vessels supplying to the penis. The present study was performed to asses the systemic toxic effects of WAMUP GEL, L-arginine administered sub cutaneously to male and female Wistar Rats.  All the animals were conditioned, randomized and divided in three groups (5 Females and 5 Males). Two groups of animals (TG-I and TG-II) were administered with 150mg/ml and 300mg/ml dose of L-Arginine respectively and another Group of 5 male and 5 female were kept as control (Group II-Control) and treated with vehicle solution. Animals were observed for a period 14 days after the administration. Parameters evaluated including clinical signs of toxicity, body weight and food consumption. Blood samples were collected on day14 for hematology and clinical chemistry analysis. Animals were necropsied and vital organs were weighed and subjected to histopathological examination. The cytotoxicity test, intracutaneous irritation test, and skin sensitization test was also performed by the test substance and evaluated.
Keywords: Wamupgel with L-Arginie,Nitric oxide(NO), Hemotology, Wamug gel cytotoxicity, Histopathology.