Treatment of Evans’ Syndrome With Human Intravenous Immunoglobulin and Leflunomide in a Diabetic Dog
Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, 1352 Boyd Avenue, St. Paul, Minnesota 55108, USA.Journal of the American Animal Hospital Association (Impact Factor: 0.86). 05/2009; 45(3):147-50. DOI: 10.5326/0450147
An 11-year-old, spayed female miniature schnauzer with diabetes mellitus was presumptively diagnosed with Evans' syndrome (ES). Because of the potential adverse effects of immunosuppressive doses of glucocorticoids in a diabetic dog, a single infusion of human intravenous immunoglobulin and oral leflunomide were used as first-line immunomodulatory therapy, after informed owner consent was received. This treatment resulted in complete remission of the ES, and leflunomide was discontinued after 10 months of therapy. Over a 19-month follow-up, the dog did not relapse and has remained a well-regulated diabetic.
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ABSTRACT: Leflunomide, an immune modulatory prodrug that is rapidly converted to its active metabolite possibly in the gut wall, plasma and in the liver was microencapsulated by the solvent evaporation technique using a nonaqueous solution of polymethacrylate polymer to achieve its release from the microcapsules at a slower rate. At the optimal condition of process variables such as stirring speed, temperature of the medium, drug polymer ratio and ratio of light liquid paraffin and heavy liquid paraffin, maximum encapsulation efficiency was obtained. These microspheres were free-flowing in nature, discrete and uniform spherical in size, as evident by scanning electron microscopy. The in vitro release experiments were carried out in the simulated intestinal fluid (pH 7.2 phosphate buffer) using united States Pharmacopoeia (USP) XXII apparatus II. The data obtained from the dissolution profiles were compared using different kinetics models and the regression coefficients were compared.
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ABSTRACT: A sensitive reverse phase high performance liquid chromatography (HPLC) method has been developed and validated for the determination of Leflunomide related substances in solid oral formulation. Leflunomide and its related substance requires aqueous mobile phase for the elution and separation. The developed method was found specific, reproducible, and stability indicating. The Inertsil ODS-3, 150 × 3.0mm, 3μ column was used and mobile phase consisted of 5.0 ml of triethylamine in 650 ml of HPLC grade water (Buffer) and Acetonitrile to achieve good resolution and retention of the analyte and its impurities. The detector linearity was established from concentrations ranging from 0.04 μg/ml to 0.75μg/ml for Leflunomide and its impurities with a correlation coefficient of 0.999.The limit of detection (LOD) and limit quantification (LOQ) found to be in a range of 0.005 μg/ml and 0.015μg/ml for Leflunomide and related substances respectively. The molecule was found stable in all the stress conditions such as acid, base, oxidation, heat and photolysis. The method was proved to be robust with respect to changes in flow rate and pH. The proposed method is found to be sensitive, precise, rapid and reproducible.
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