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Preparation of Compound Niacin Simvastatin Tablets and Studies on Quality Control

Author: GaoXiuRui
Tutor: ZuoHengChang
School: Shandong University
Course: Pharmaceutical Engineering
Keywords: compound niacin simvastatin tablets preparation in vitro release quality control
CLC: TQ466.2
Type: Master's thesis
Year: 2009
Downloads: 81
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Niacin, a water-soluble vitamin B, is one of the first used to lipid-lowering drugs, especially used to lower blood lipid, which has a very strong increase in high-density lipoprotein (HDL), although lower low-density lipoprotein (LDL) role is weak. It has the significant effect on lowering lipid in spite of side effects which were significantly reduced when its dose form is extended-release preparations. Simvastatin, an HMG-CoA reductase inhibitors, is a current first-line lipid-lowering drug, on the contrary, which has significant LDL lowering effect, but weak effect on increasing HDL. Niacin and simvastatin were combined, which had some advantages, such as enhancing their reducing effect on hyperlipidemia and decreasing the frequency of drug use, while alleviating hypercholesterolemia effect than just taking drug alone more efficient. Niacin and simvastatin will be made once a day fixed-dosage preparation, in which extended-release layer containing niacin and immediate-release layer containing simvastatin.The optimal ratio of niacin and other excipients in extended release layer were determined by orthogonal design method on the basis of relevant literature and pre-test experiments, the domestic marketed niacin extended-release tablets BENYUE (?) as reference, in vitro release as index. The immediate-release layer containing simvastatin were determined by experiment, the dissolution rate at 45min as indicator. After established the formula of each layer, three lots of samples were prepared.The standard curve of niacin was plotted by ultraviolet spectrophotometry, and content assay of niacin in compound preparation assay was set up by studying on analysis method such as precision, test analysis of stability, test recovery test.The dissolution rate of niacin in experiment formulation and reference BENYUE? was compared in three different dissolution medium, including water, 0.1 mol·L-1 hydrochloric acid and pH6.8 and phosphate buffer. The release of niacin at different rotate rate (50rpm, 75rpm, 100rpm) and by different method (paddle method, basket method) also was compared and were measured in three lots of experiment formulation. In order to explaine the release of niacin, the regression equation and correlation coefficient of three experiment formulation and reference were obtained by simulating Higuchi equation. In accordance with similarity factor f2 stated by FDA in US,f2 of three lots of experiment formulation was calculated.The standard curve of simvastatin was plotted by high-performance liquid chromatography (HPLC), and content assay of simvastatin in compound preparation was set up by studying on analysis method such as precision test, analysis of stability, recovery test. Due to content of simvastatin less than 5% in preparation, content uniformity of simvastatin of three lots were determined.The above results show that (1) the concentration of niacin from 2.51μg·mL-1 to25.10μg·mL-1 and simvastatin from4.62μg·mL-1 to27.72μg·mL-1 have good linear relationship, in which recoveries of niacin and simvastatin were 99.89% (n=9 , RSD 0.57%) and 100.1% (n=9, RSD 0.29%) respectively. Content uniformity of simvastatin is also in line with the requirements set up. The analysis method of compound preparation to determine niacin and simvastatin was effective, feasible and applicable.(2) The release of niacin in compound preparation is in line with extended release preparation slowly releasing within 24h. At 3, 9 and 16h three sample points, cumulative release of niacin meets requirement of 10% - 30%, 40% - 60% and more than 75% respectively. Release of simvastatin at 45min also meets requirement of more than 80%, which illuminate that process of compound preparation is feasible and quality is reliable.

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CLC: > Industrial Technology > Chemical Industry > Pharmaceutical chemical industry > Vitamin manufacturing > Vitamin B
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