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Research of Casein Solid Self-emulsifying Drug Delivery Systems (SEDDS) for Improving Oral Bioavailability

Author: TaoBo
Tutor: YangXiangLiang
School: Huazhong University of Science and Technology
Course: Biochemistry and Molecular Biology
Keywords: Simvastatin Casein Solid self-emulsifying drug delivery systems High Performance Liquid Chromatography LC-MS Pharmacokinetics
CLC: R96
Type: Master's thesis
Year: 2011
Downloads: 44
Quote: 0
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Abstract


Casein is a natural surfactant, and can replace the ordinary surface active agent, to reduce the irritation and toxicity of conventional surface active agents of the gastrointestinal tract. The solid self-emulsifying formulation than the liquid emulsion is stable, easy to carry, can increase the solubility of the drug, enhance the bioavailability of insoluble drugs. Simvastatin can effectively control cholesterol levels and prevention of cardiovascular disease. Simvastatin poor water solubility, oral bioavailability of less than 5%. This article using casein as a surface active agent, and screening a suitable oil phase and the successful preparation stability, re-insoluble casein solid self-emulsifying formulation is very good. Completed research work are: (1) the establishment of a liquid detection method that can simultaneously detect simvastatin and simvastatin acid, simvastatin and simvastatin acid peak area and concentration of 0.3 to 50 μg · mL -1 good linear relationship within the range of solution stability, high precision, can meet the needs of the preparation process of detection. (2) self-emulsifying formulation of the oil of the solid phase, the concentration of the casein solution, pH, water-soluble carrier, the drying process a filter. Selected the capryol 90 and maisine 35 -1 ratio of 1:1 mixture of oil phase to prepare the emulsion, casein concentration of 50 mg · mL of -1 , the pH value The spray drying method, is 6.0, the first with a Microfluidizer prepared liquid microemulsion, and then a liquid emulsion having a solid powder. The prepared solid emulsion stability, good multiplexing insoluble. (3) effects of simvastatin casein solid self-emulsifying preparations in vitro release behavior. The in vitro dissolution method emulsions in artificial intestinal fluid release tablets have been significantly improved the intestinal sac eversion experimental water-soluble carrier is not conducive to the absorption of the drug in the emulsion. (4) the establishment of simvastatin and simvastatin acid plasma samples simvastatin and simvastatin acid liquid chromatography detection method can simultaneously detect 0.1 ng · mL -1 -1 50 ng · mL -1 The linear range of a good relationship. Recoveries between 70-80% simvastatin, simvastatin acid recoveries in the range of 65-75%, simvastatin and simvastatin acid high school low concentration the intra-day coefficients of variation are less than 10% were good stability, tightness the measuring method found Biosamples requirements. (5) to study the pharmacokinetic behavior of the different formulations of simvastatin. Rats oral gavage, the plasma concentration detected at different time points rats. To simvastatin tablets as a reference preparation, simvastatin bulk drug bioavailability lowest; bioavailability compared with tablets of the added water-soluble carrier hydroxyethyl starch casein emulsion little difference; without water soluble highest relative bioavailability of casein emulsion carrier, simvastatin reached 184.08%, 284.53% simvastatin acid, casein promotes self-emulsifying drug simvastatin absorption in the body, improve the bioavailability of simvastatin degrees.

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