SYNTHESIS AND CHARACTERIZATION OF STARCH MALONATE: DEVELOPMENT OF FAST DISSOLVING TABLETS OF ACECLOFENAC BY 23 FACTORIAL DESIGNS

Objective: The aim of the research work is to develop a new superdisintegrant (starch malonate) which can help in enhancing the solubility and drug dissolution of poorly soluble drugs. Hence, starch malonate (new superdisintegrant) was prepared and has been evaluated for its superdisintegrant property by incorporating it into fast dissolving tablets of Aceclofenac. Methods: Superdisintegrant was developed by using esterification reaction. Prepared starch malonate was then subjected for different characterization tests (solubility, pH, melting point, swelling index, FTIR, DSC studies. 23 factorial design method was used to formulate fast dissolving tablets of aceclofenac employing starch malonate. Two known superdisintegrants croscarmellose sodium and crospovidone have been used along with starch malonate in combinations to develop fast dissolving tablets. Prepared tablets were then subjected to different tests for tablets like hardness, friability, disintegration time, dissolution studies. A stability study was performed to determine the stability of the formulation. Design expert study was conducted to know the interaction between different superdisintegrants and to select best optimized formulation in among all formulations. Results: Starch malonate prepared was found to be fine, free flowing slightly crystalline powder, insoluble in aqueous and organic solvents. Tablets of all formulations were of excellent quality concerning drug content (100±5%), hardness (3.8-4.2 kg/cm2), and friability (less than 0.15%). In all formulations, formulation F2 found to be optimized formulation with least disintegration time 38 S, less wetting time 17±0.08 s and enhanced percent dissolved rate in 5 min i.e., 99.84% as compared to other formulations. Conclusion: From this it was concluded that starch malonate can be used as a novel superdisintegrant to enhance the drug dissolution of poorly soluble drugs. Optimized formulation F2 showed enhanced drug dissolution at 5% concentration as compared to other formulation and showed least disintegration time and enhanced drug dissolution as compared to other formulations and pure drug