3D Raman mapping as an analytical tool for investigating the coatings of coated drug particles

The properties of dry-coated paracetamol particles(fast-dissolving model drug)with carnauba wax particles as the coating agent(dissolution retardant)were investigated.Raman mapping technique was used to non-destructively examine the thickness and homogeneity of coated particles.The results showed that the wax existed in two forms on the surface of the paracetamol particles,forming a porous coating layer:i)whole wax particles on the surface of paracetamol and glued together with other wax surface particles,and ii)deformed wax particles spread on the surface.Regardless of the final particle size fraction(between 100 and 800 mm),the coating thickness had high variability,with average thickness of 5.9±4.2 mm.The ability of carnauba wax to decrease the dissolution rate of paracetamol was confirmed by dissolution of powder and tablet formulations.The dissolution was slower for larger coated particles.Tableting further reduced the dissolution rate,clearly indicating the impact of subsequent formulation processes on the final quality of the product.

Sample Size Determination and Statistical Hypothesis Testing for Core Centration in Press Coated Tablets

A novel statistical approach to evaluate the manufacturing quality of press coated tablets in terms of the centering of their core is presented. We also provide a formula to determine the necessary sample size. This approach is applied to real data.