Abstract:
OBJECTIVE To investigate the difference of generic drugs and the original drug by researching the polymorphs and dissolution.
METHODS Reference Raman spectra of the 2 crystal forms of cilnidipine were established; then the polymorphs of the cilnidipine tablets from different manufacturers were analyzed, and a dissolution method was established to distinguish the different samples.
RESULTS The polymorph of samples from manufacture A and manufacture B were polymorph α. The polymorph of samples from manufacture C and original drug were amorphous form. The dissolution method (0.5% SDS pH 6.8 phosphate buffer, 900 mL, 75 r·min
-1) was established and could distinguish the different samples.
CONCLUSION There exist certain differences between generic drugs and the original drug in terms of dissolution and the polymorphs.