Acute Toxicity of Self Nano-emulsifying Formulation of Curcumin Analogue Gamavuton-0, A New Candidate for Rheumatoid Arthritis Treatment L Chabib 1,2,3 *, Z Ikawati 1 , R Martien 1 , H Ismail 1,4 1 Faculty of Pharmacy, Gadjah Mada University, Yogyakarta, 555281, Indonesia 2 Pharmacy Department, Islamic University of Indonesia, Yogyakarta 55584, Indonesia 3 Professional Pharmacy Education Program, Islamic University of Indonesia, Yogyakarta 55584, Indonesia 4 Curcumin Research Centre, Faculty of Pharmacy, UGM, Skip Utara Yogyakarta 555281, Indonesia Abstract : Gamavuton-0 (GVT-0), a newly developed compound synthesized by a carbonyl group and a methylene reduction of Curcumin, has been proven to have several anti arthritic activities. The compound has been further proven to have no short-term toxicity in rat in vivo. However, GVT-0 still burdens low water solubility therefore poorly absorbed in oral administration. Currently, a self-nano-emulsifying system has been developed to formulate GVT-0 into a more effective oral anti RA candidate using various oils and surfactants (SNE GVT-0). To study whether this formulation would not alter the safety of the compound in oral administration, an in vivo acute toxicity testing was conducted. A 14 day-study was performed by using four groups of wistar strain Rattus norvegicus, three rats per group, with 300 mg/kg BW GVT-0 as preliminary dose and 2000 mg/kg BW as oral treatment dose, along with naïve GVT-0 and solvent as controls. The protocols and toxic parameters were all conducted following OECD 423. The study showed that all the treatments on both 300 and 2000 mg/kg BW of SNE GVT-0 did not compromise rats’ body weight, and toxicity clinical behaviours were observed on the 2000 mg/kgBW of adminis tration, but there is no significance observed for 300 mg/kg BW administration. Microscopic observation under haematoxylin and eosin staining confirmed the clinical findings by showing degeneration and destruction for the most of organs on the 2000 mg/kg BW of administration. The results suggest SNE GVT-0 as in category four in OECD 423 globally harmonized classification system (GHS) with estimated LD50 cut-off as 2000 mg/kg BW. Keywords : Gamavuton-0, self nano-emulsifying system, acute toxicity. Introduction Rheumatoid arthritis (RA) is a chronic inflammation event located in joints, causing degeneration and deformity. Untreated arthritis condition might bring the disease into more advance and persistent inflammation 1,2 . However, available treatments for a chronic inflammatory disease like rheumatoid arthritis nowadays are still hampered by the following side effects such as gastritis and heart attack 3 . Thus, there is a significant demand on safe long term medication for the disease. International Journal of PharmTech Research, Vol.10, No.2, pp 83-88 (2017) http://dx.doi.org/10.20902/IJPTR.2017.10112 International Journal of PharmTech Research CODEN (USA): IJPRIF, ISSN: 0974-4304, ISSN(Online): 2455-9563 Vol.10, No.02, pp 83-88, 2017