Granulation Surface Area as Basis for Magnesium Stearate Concentration in Tablet Formulations

AbstractTablets provide drug delivery in a convenient and uncomplicated manner. Despite this apparent simplicity, they must comply with a formidable number of physico-chemical compendial requirements defined by specifications and test methods. What these specifications indirectly control is that each dosage form or each lot of dosage form my vary but the variance is held within stated limits.This communication focuses on the weight variation of formulation ingredients that my be allowed in general and for magnesium stearate in particular and to define a relationship between the lubricant level and granulation surface area of a calcium phosphate matrix to obtain optimal tablet properties.