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Subacute Oral Toxicity Study of New Formulation of Bacopa monnieri in Rats
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Brahmi (Bacopa Monnieri: BM) is widely used for its memory enhancing properties. The problem with commercially available BM formulations is that, its dose and duration of therapy is high, which indicates; that the permeability of its active components (bacosides) into the brain is meagre and its high doses cause gastric irritation. Hence we hypothesized and prepared a new formulation of BM extract (BME) which can have improved bioavailability so its dose can be low, frequency and duration of therapy is less, to have better tolerability and efficacy. We found that the new lipophylic formulation (20% phosphatidylcholine) of BM had better penetration into the brain due to the increased lipid solubility and had better pharmacokinetic profile than previously marketed formulations. We evaluated subacute toxicity of new formulation of BME and there was no morbidity&mortality, effects on body weight, food consumption, organ weight, urine analysis, hematology, histopathology&serum biochemical parameters. The biochemical parameters like Glucose, Blood Urea, Calcium, SGOT, and SGPT, Creatinine, Cholesterol, Total Bilirubin, Direct Bilirubin and Total Protein doses not shown any significant changes as compared to standard and control group of animals. We can conclude that new formulation of bacopa with 20% phosphotydylcholine is better and safe for oral administration.
Keywords
Bacopa, Phosphatidylcholine, Subacute Toxicity Study.
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