Formulation, Characterization and Optimization of Mouth Dissolving Tablets of Diacerein: Β-Cyclodextrin Solid Dispersion
Diacerein is a poorly water soluble drug and bioavailability from its crystalline form is very low. The purpose of the present investigation was to increase the solubility and dissolution rate of Diacerein by preparing a solid dispersion with β- cyclodextrin (β-CD) using Kneading method. The dissolution profiles of developed formulations in acetate buffer pH 4.5 containing 0.45% SLS were studied. The prepared complexes were characterized by Fourier transform infra red spectroscopy (FTIR), differential scanning calorimetry (DSC) and powder X-ray diffractometry (PXRD). For the preparation of Diacerein mouth dissolving tablets, a 1:2 (Diacerein: β-CD, Batch DK3) solid dispersion was used with LHPC and croscarmellose sodium as a superdisintegrant. A 32 full-factorial design was employed to study the effect of independent variables, the amounts of L-HPC (X1) and croscarmellose sodium (X2) on dependent variables disintegration time and percentage friability. FTIR, DSC and PXRD data indicate that Diacerein was in the amorphous form, which explains the faster dissolution rate of the drug from its solid dispersions. Concerning the optimization study, multiple regression analysis reveals that an optimum concentration of croscarmellose sodium and a higher percentage of L-HPC are required for obtaining rapidly mouth dissolving tablets. Accelerated stability studies of mouth dissolving tablets carried out as per ICH guidelines revealed that the tablets were stable
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).