title: Safety assessment of a solid lipid curcumin particle preparation: acute and subchronic toxicity studies.
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.
authors.affiliation: Pre-Clinical Department, Cadila Pharmaceuticals Ltd., Dholka 387 810, India.
authors.forename: Paresh
authors.initials: P
authors.lastname: Dadhaniya
authors.forename: Chintan
authors.initials: C
authors.lastname: Patel
authors.forename: Jayesh
authors.initials: J
authors.lastname: Muchhara
authors.forename: Nilesh
authors.initials: N
authors.lastname: Bhadja
authors.forename: Neeta
authors.initials: N
authors.lastname: Mathuria
authors.forename: Kapil
authors.initials: K
authors.lastname: Vachhani
authors.forename: Madhu G
authors.initials: MG
authors.lastname: Soni
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001682:Biological Availability; D001835:Body Weight / Q000187:drug effects; D030024:Curcuma / Q000737:chemistry; D003474:Curcumin / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006403:Hematologic Tests; D007928:Lethal Dose 50; D008055:Lipids / Q000737:chemistry; D008297:Male; D051379:Mice; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D010936:Plant Extracts / Q000633:toxicity*; D051381:Rats; D017208:Rats, Wistar; D023382:Toxicity Tests, Acute / Q000379:methods*; D036401:Toxicity Tests, Chronic / Q000379:methods*; D016482:Urinalysis; D015430:Weight Gain / Q000187:drug effects
chemical_list: D008055:Lipids; D010936:Plant Extracts; D003474:Curcumin