Characterization of humidity-dependent changes in crystal properties of a new HMG-CoA reductase inhibitor in support of its dosage form development

摘要: Abstract Humidity-dependent changes in the crystal properties of disodium salt a new HMG-CoA reductase inhibitor (SQ-33600) were characterized using combination gravimetric, thermal, and spectral techniques. The drug substance was found to exhibit rapid moisture sorption and/or desorption, depending on environmental conditions. Three crystalline solid hydrates one liquid phase identified, each having definite stability over range humidity. turned amorphous upon wet granulation, reconverted exposure 33–75% relative To avoid physical instability dosage forms due changes, manufacturing by dry processing below 52% humidity recommended. dissolution from observed be independent form active.