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Oral toxicity of Miglyol 812(®) in the Göttingen(®) minipig
G Le Bars1, S Dion1, B Gauthier1
1Preclinical Development, Galderma R&D, Biot, France.
Abstract:
Miglyol 812(®), a mixture of medium-chain triglycerides, has been identified as an oral vehicle that could improve the solubility and possibly the bioavailability of orally administered drugs during the non-clinical safety assessment. The toxicity of Miglyol was assessed in Göttingen(®) minipigs upon daily oral administration (gavage) for six weeks, at dosing-volumes of 0.5 and 2 mL/kg/day, compared to controls receiving 0.5% CarboxyMethylCellulose/0.1% Tween(®) 80 in water at 2 mL/kg/day. The control vehicle did not induce any findings. Miglyol at 0.5 and 2 mL/kg/day induced transient tremors, abnormal color of feces and increase in triglycerides. Miglyol at 2 ml/kg/day also induced reduced motor activity, decreased food intake, respiratory signs (2/6 animals) and increased total and LDL-cholesterol. At necropsy, the lung of 3/6 animals treated at 2 mL/kg/day presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation. This finding is probably due to aspiration pneumonia in relation to the administration method and the high viscosity of Miglyol. Overall, the oral administration of pure Miglyol 812(®) for six weeks up to 2 mL/kg was less tolerated than that of the control vehicle. Miglyol as vehicle for sub-chronic oral toxicity studies in minipigs should be used with a limited dosing-volume.
Insights
Medium-chain triglycerides (Miglyol 812®) showed transient tremors and increased triglycerides in minipigs. Higher doses caused more severe effects, including lung inflammation, suggesting limited dosing volumes for toxicity studies.
Area of Science:
- Pharmacology
- Toxicology
- Drug Development
Background:
- Miglyol 812®, a medium-chain triglyceride mixture, is explored as an oral vehicle to enhance drug solubility and bioavailability.
- Non-clinical safety assessments require understanding the toxicity profiles of such excipients.
Purpose of the Study:
- To evaluate the toxicity of Miglyol 812® in Göttingen® minipigs following six weeks of daily oral administration.
- To compare the effects of Miglyol 812® at different dosing volumes against a standard control vehicle.
Main Methods:
- Daily oral gavage administration of Miglyol 812® at 0.5 and 2 mL/kg/day for six weeks in minipigs.
- Control group received 0.5% CarboxyMethylCellulose/0.1% Tween® 80 in water at 2 mL/kg/day.
- Clinical observations, blood chemistry, and necropsy findings were assessed.
Main Results:
- Miglyol 812® induced transient tremors, abnormal feces, and elevated triglycerides at both doses.
- The 2 mL/kg/day dose additionally caused reduced motor activity, decreased food intake, respiratory signs, and increased cholesterol.
- Lung pathology consistent with aspiration pneumonia was observed in 50% of animals at the highest dose.
Conclusions:
- Miglyol 812® at 2 mL/kg/day was less tolerated than the control vehicle, with observed adverse effects including potential aspiration pneumonia.
- The use of Miglyol 812® as a vehicle in sub-chronic oral toxicity studies in minipigs warrants careful consideration of limited dosing volumes.
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