Abstract

Crystal morphology or habit modification can have profound influence on the pharmaceutical and biopharmaceutical properties of active pharmaceutical ingredients. The effect of crystallization medium on nisoldipine (NSL) crystal habit was studied, wherein modified habits were observed in solvent system, methanol, and solvent antisolvent system of acetonitrile–IPA. Modified crystal habits of NSL were in correlation with the simulated habits in terms of their shape and aspect ratio. The comparative dissolution rate of the recrystallized NSL habits was in the order of NSL-M (NSL recrystallized with methanol) > NSL-AI (NSL recrystallized with acetonitrile and IPA) > NSL (plain NSL). A statistically significant (p < 0.05) enhancement in the dissolution rate of NSL-M was observed on comparison with NSL. NSL-M also exhibited a significantly higher Cmax than NSL in an oral bioavailability study. The study of specific surface area values of important facets of NSL-M revealed a notable enhancement of the crystal fac...

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