Use of Statistical Experimental Design in Laboratory Scale Formulation Optimisation and Progression to Plant Scale

AbstractThe objective of these studies was to optimise the formulation of a dry powder blend to be filled into hard gelatin capsules and progress the product to plant production. The blend was to contain two active compounds (500mg active A and lOmg active B). Preliminary work had limited the independent formulation variables to levels of filling aid, glidant and lubricant. The effects and interactions of the independent variables were assessed using an augmented factorial experimental design demanding the examination of 31 formulations at small scale (less than 3kg). Critical dependent variables identified were blend homogeneity and flow, capsule weight variation and active dissolution rate.The study plan was to assess blend flow and active dissolution using formulations manufactured at laboratory scale (less than 3kg), select the optimum formulation, confirm the data and determine blend homogeneity at development scale (upto 30kg) and progress to pilot plant production (250kg).Statistical software was e...