Design, Optimization and Evaluation of Orally Disintegrating Tablet of Antiemetic Drug
Shaikh RG, Sharma AR, Patel KN, Patel BA, Patel PA
This work describes Design, Optimization & Evaluation of Orally Disintegrating Tablet (ODT) of Antiemetic Ondansetron HCl. The bitter taste of the drug was masked by Kyron T 114, a weak cation exchange resins with the method of ion exchange resin complexation, Which was prepared by the batch technique and resin ratio & pH was optimized to successfully formulate the resinate into ODT and it was confirmed by FTIR and DSC study. In preliminary trials selection of superdisintegrants (i.e., crosspovidone XL 10, cross carmellose sodium and sodium starch glycolate) and selection of diluent (i.e. mannitol SD 200, Avicel pH 102 Avicel pH 112, Starch and pregelatinized starch) were made. The cohesive force of mannitol increase wetting time and disintegration time so drug release was delayed. 32 factorial design was applied in which superdisintegrant and diluent ratio were taken as independent factor and disintegration time and wetting time were taken as response. The prepared tablets were evaluated for weight variation, hardness, friability, disintegration time, content uniformity, and % drug release. Dissolution studies were performed in 0.1 N HCl. The optimized batch was compared with the marketed formulation and charged for stability study. Results from an evaluation by a panel of ten human volunteers demonstrated that the orally disintegrating tablets prepared by Kyron T 114 improved the taste significantly. In 32 full factorial design, Quadratic model was suggested and contour and 3D Graph was generated. By using Overlay plot batch was optimized. ODT prepared with 9.92 % crosspovidone XL 10 and 27.32:44.46 Mannitol: Avicel pH 112 ratio decrease DT and Wetting time i.e. 13 and 19 second respectively, produced tablet with desired properties and showed satisfactory drug release profile.
Orally disintegrating tablets, Ondansetron HCl, Taste masking, Kyron T 114, Drug Resin Complex, Superdisintegrants, 32 full factorial Design.
Cite This Article
Shaikh RG, Sharma AR, Patel KN, Patel BA, Patel PA, Design, Optimization and Evaluation of Orally Disintegrating Tablet of Antiemetic Drug, International Journal for Pharmaceutical Research Scholars, 2012, 1(2), 281-295.