Application of Simplex and Statistical Analysis for Correction of Pitting in Aqueous Film Coated Tablets

Abstract

Pitting or pin hole formation is a tablet defect that is commonly observed in aqueous film coated tablets containing highly moisture-sensitive materials. It is generally believed that pitting is due to dissolution of soluble particles on the tablet surface when the tablet is overwetted during the coating process. An experiment was conducted to study the effects of spray rate and pan speed, the two important factors contributing to this condition. The data thus obtained were analyzed by using the simplex search procedure and the appropriate statistical methods. The levels of the two factors that minimized pitting were achieved as a result of the analysis.