Solid Dispersion of Acetosal Using Polyvinyl Pyrrolidone (PVP) K-30 in Tablets with Direct Compressing Method

Khuswatun Khasanah, Desy Nawangsari, I. Y. Kusuma
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Abstract

Acetosal is classified in the Biopharmaceutical Classification System (BCS) class II (low solubility, high permeability). Low solubility causes a decreased dissolution rate. Polyvinyl pyrrolidone (PVP) K-30 is an inert carrier easily soluble in water and can influence the solubility of a drug substance. Efforts to increase the solubility of acetosal make a solid dispersion system. This study aims to determine the effect of the solid dispersion system of acetosal: PVP K-30 on dissolution rate, the ratio of the solid dispersion with the best dissolution rate, and the physical properties of acetosal tablets formed in the dispersion system. Solid dispersions using the dissolving method with variations in the concentration of acetosal: PVP K-30 1:1, 1:3, and 1:5. The results of the dissolution test of acetosal in solid dispersion powder, i.e., PVP Formula 1:5, which has the highest dissolution percentage compared to formula 1:1 and 1:3 with the concentration this formula was 140.96 mg, dissolution percentage was 28.19±0,63% in 30 minutes. Statistical results by ANOVA test show a significant difference of 0.044 (p<0.05). The physical properties of tablets with a dispersion system show higher addition of PVP K-30. This result is related to slower disintegration time and lower friability.
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聚乙烯吡咯烷酮(PVP) K-30在片剂中的固体分散
乙糖被归入生物制药分类系统(BCS) II类(低溶解度,高渗透性)。溶解度低导致溶解速率降低。聚乙烯吡咯烷酮(PVP) K-30是一种易溶于水的惰性载体,能影响原料药的溶解度。努力提高乙缩醛的溶解度,使之成为固体分散体系。本研究旨在确定丙酮醛:PVP K-30固体分散体系对溶出速率的影响,最佳溶出速率的固体分散体系的比例,以及在分散体系中形成的丙酮醛片剂的物理性质。固体分散体采用溶解法与乙糖浓度的变化:PVP K-30 1:1, 1:3和1:5。对丙酮醇在PVP配方1:5的固体分散粉中的溶出度进行了测试,结果表明,该配方的溶出率最高,其浓度为140.96 mg, 30 min溶出率为28.19±0.63%。方差分析的统计结果显示,差异有统计学意义(p<0.05)。分散体系下片剂的物理性能显示PVP K-30的添加量较高。该结果与较慢的崩解时间和较低的脆性有关。
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