The effect of recompression and concentration of polyvinylpyrrolidone (PVP) K-30 on the quality of paracetamol tablets

Abstract

Quality control during production is a critical process that ensures the quality of the tablets until they reach the consumer. In the pharmaceutical industry, reworking is possible, including tablet recompression. Nevertheless, the recompression process may have affected the potential of PVP K-30 as a binder to reunite the particles of tablet ingredients. However, the difference in PVP K-30 concentration might result in differences in granule and tablet characteristics. This study aims to determine whether there is an effect of recompression and the difference in PVP K-30 on the quality of paracetamol tablets. The effect of recompression and the difference in PVP K-30 was seen based on whether there is a significant difference in the physical properties of the mixture of tablet ingredients (mixture’s flow rate and compressibility) and the tablets (compactibility, tablet hardness, friability, and disintegration time) from the formula with a concentration of 2% w/w and 4% w/w PVP K-30 after experiencing 2 times of recompression. Paracetamol tablets were made by the wet granulation method through the stages of granulation, lubrication, physical properties testing of the mixture, tablet compression, physical properties testing of tablets, crushing, and recompression. Data analysis was performed statistically using the Shapiro-Wilk normality test, followed by a two-way analysis of variance (ANOVA), or Kruskal-Wallis test, and post-hoc Mann-Whitney test. The results showed there was an effect of recompression and different concentrations of PVP K-30 on the potential of PVP K-30 as a binder, as seen from the significant differences in the physical properties of the mixture and tablets in each test group.