Formulation and Development Studies on Enhancement of Dissolution Rate of BCS Class II Antidiabetic Drug

The main purpose of this research work was to improve the dissolution rate of poorly soluble drug i.e., Gliclazide by formulating complexation with Cyclodextrins in 1:1, 1:2 and 1:3 ratios. These Complexation with HP-β-CD and SBE-β-CD were prepared by solvent evaporation method and this prepared complex was subjected for Phase solubility studies, which is characterized by XRD and FT-IR studies. XRD studies revealed that the crystal nature of drug has been transformed to amorphous after preparing complexation. FT-IR studies reported no interactions. Best formulation (Gliclazide, SBE-β-CD complex in 1:2 ratio) was selected based on Phase solubility studies and Gliclazide tablets was developed with polymers Hydroxy propyl methylcellulose K-100M, Hydroxypropylcellulose-EXF. Tablets were subjected to various pre-formulation and post formulation studies. The evaluation of tablet batches i.e., Hardness, Friability, drug content and invitro drug release studies have been studied after the evaluation of all batches, F16 batch shows best release for 12 hours. These optimized formulation was compared against marketed product. Further can be concluded that dissolution rate of Gliclazide could be enhanced by tablets containing complex of SBE-β-CD.

Author(s):

Sunitha R, Venugopal K and Satyanarayana SV

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