Insights into tablet sticking: a quantitative case study with an ibuprofen and methocarbamol-based formulation.

OBJECTIVES AND METHODS: Tablet sticking is a continuous accumulation of pharmaceutical powder onto tooling surfaces during compression. Its occurrence greatly impacts tablet productivity, quality attributes, and tooling age. In a previous study, the authors proposed a multivariate data analysis approach to gain insights into tablet sticking directly on the industrial stage. The objective was to determine the combination of factors that could help distinguish between batches affected and unaffected by sticking. The present study aims to generalize this approach by extending it to quantitative predictions of punch sticking intensity. A total of 345 variables was gathered on 28 industrial batches of an ibuprofen and methocarbamol-based formulation.

RESULT AND CONCLUSION: Using PLS regression models, it was shown that the association of granulation duration and compression force allows to significantly explain ∼60% of sticking variations of studied formulation. In addition, unlike the classification models developed in the earlier work, the validation residues in the present study were found to be normally distributed (Shapiro-Wilks p value = 0.96) and independent from the target variable (R2 = 9.5%).