Effects of Intravenous Administration of Travenol 10% Lipid Emulsion to Miniature Swine for 28 Consecutive Days

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Abstract
The potential toxicity of Travenol 10% lipid emulsion was studied using miniature swine. Physiological (0.9%) saline, USP, was used as the control, and Intralipid 10% fat emulsion as the reference article. The emulsions were administered intravenously at dosages of 40 milliliters (approximately 4 grams of lipid) and 60 milliliters (approximately 6 grams of lipid) per kilogram of body weight per day to eight animals (four males and four females) in each treatment group on each of 28 consecutive days. The saline was administered to eight animals at 60 milliliters per kilogram per day. On day 29, one half of the male and female animals in each group were necropsied. The remaining pigs were observed and necropsied on either day 56 or 57. Toxicity was assessed on the basis of animal survival; changes in body weight, urinalyses, and hematological, and serum biochemical analyses; ophthalmological examination; gross pathology; and histopathology.The results obtained for the Travenol emulsion correlated well with those for the Intralipid emulsion. The emulsions were well tolerated, and they did not produce any major clinical signs of toxicity. All Travenol emulsion‐treated animals survived. In addition to demonstrating the similarity of Travenol and Intralipid emulsions, the results of this study indicate that the Travenol emulsion demonstrated an adequate margin of safety for prolonged administration. Travenol emulsion was well tolerated by miniature swine infused at about one and one‐half (40 milliliters per kilogram per day) and two (60 milliliters per kilogram per day) times the proposed clinical dose, and at three and two times the anticipated clinical rate, respectively.

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