Safety assessment of a solid lipid curcumin particle preparation: Acute and subchronic toxicity studies |
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Authors: | Paresh DadhaniyaChintan Patel Jayesh MuchharaNilesh Bhadja Neeta MathuriaKapil Vachhani Madhu G. Soni |
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Affiliation: | a Pre-Clinical Department, Cadila Pharmaceuticals Ltd., 1389 Trasad Road, Dholka 387 810, India b Soni and Associates Inc., 973 37th Place, Vero Beach, FL 32960, USA |
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Abstract: | Curcumin, a polyphenol, is obtained from turmeric, the ground rhizomes of Curcuma longa L. Extensive research over the past half century has revealed several health benefits of curcumin. The objective of the present study was to investigate potential adverse effects, if any, of a novel solid lipid curcumin particle (SLCP) preparation in rats following acute and subchronic administration. The oral LD50 of the preparation in rats as well as in mice was found to be greater than 2000 mg/kg body weight (bw). In the subchronic toxicity study, Wistar rats (10/sex/group) were administered via oral gavage 0 (control), 180, 360, and 720 mg/kg bw/day of SLCP preparation for 90 days. Administration of the curcumin preparation did not result in any toxicologically significant treatment-related changes in clinical (including behavioral) observations, ophthalmic examinations, body weights, body weight gains, feed consumption, and organ weights. No adverse effects of the curcumin preparation were noted on the hematology, serum chemistry parameters, and urinalysis. Terminal necropsy did not reveal any treatment-related gross or histopathology findings. Based on the results of this study, the No Observed-Adverse-Effect Level (NOAEL) for this standardized novel curcumin preparation was determined as 720 mg/kg bw/day, the highest dose tested. |
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Keywords: | ALP, alkaline phosphatase ALT, alanine aminotransferase AST, aspartate aminotransferase FDA, food and drug administration ICH, international conference on harmonization NOAEL, no-observed-adverse-effect level OECD, organization for economic co-operation and development SLCP, solid lipid curcumin particle |
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