Inorganic Chemistry Department, Center for Engineering and Chemical Researches, F Street, # 115 be/Ave 5th and Calzada, Havana 10400, Cuba. eutimiocu@yahoo.com
Abstract:
The purpose of this paper was to develop a statistical methodology to optimize tablet manufacturing considering drug chemical
and physical properties applying a crossed experimental design. The assessed model drug was dried ferrous sulphate and the
variables were the hardness and the relative proportions of three excipients, binder, filler and disintegrant. Granule properties
were modeled as a function of excipient proportions and tablet parameters were defined by the excipient proportion and hardness.
The desirability function was applied to achieve optimal values for excipient proportions and hardness. In conclusion, crossed
experimental design using hardness as the only process variable is an efficient strategy to quickly determine the optimal
design process for tablet manufacturing. This method can be applied for any tablet manufacturing method.