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Year : 2023  |  Volume : 8  |  Issue : 3  |  Page : 293-308

Safety assessment of Libirite capsule (a polyherbal formulation) in experimental animals (Sprague Dawley rats and Swiss albino mice)

1 Department of Toxicology, Bibwewadi, Pune, ToxIndia, India
2 Medical Services Department, Ari Healthcare Pvt. Ltd., Pune, Maharashtra, India

Correspondence Address:
Dr. Sanjay U Nipanikar
Ari Healthcare Pvt. Ltd., Office at No., 107, 1st Floor, S.No.1, World Trade Center, Tower one, Opp. EON SEZ, Kharadi, Pune 411014, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jdras.jdras_122_22

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BACKGROUND: Libirite capsule (LC) is a polyherbal formulation, developed to treat erectile dysfunction and loss of libido. Present study aimed to perform the acute oral toxicity studies of LC in Swiss Albino mice and Sprague Dawley rats, and repeated dose subchronic 90-day toxicity study were performed to assess the safety of LC. METHODS: LC was orally administered at 2000 mg/kg to the animals as per Organization for Economic Cooperation and Development (OECD)-423 guidelines. In a repeated dose oral toxicity study, LC was administered through oral gavage in a dose of 250, 500, and 1000 mg/kg for 90 days and compared with control groups as per OECD-408 guidelines. Posttreatment changes in food consumption, body weight, and biochemical, hematological, and laboratory parameters were observed. RESULTS: LC did not produce any adverse or mortality events in animals during acute studies. In a 90-day toxicity study, rats exhibited no toxicity symptoms or death. No significant changes were found in hematological and biochemical parameters. No significant alteration was seen in organ and body weight. Microscopic findings were incidental and identical for control and treated animals at 1000 mg/kg. LC did not produce any histopathological changes in target organs. No change in the recovery group was observed when compared with the control group animals, which indicated a complete reversal. CONCLUSIONS: Median lethal dose50 of LC was observed to be more than 2000 mg/kg. No observed adverse effect level of LC was considered 1000 mg/kg.

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