Design, optimization and evaluation of aceclofenac fast dissolving tablets employing starch glutarate: A new superdisintegrant

Abstract

In solid dosage forms, fast dissolving tablets has proven the best way for ease of administration for the pediatrics and geriatric patients. The current study involves in the evaluation of starch glutarate as a superdintegrant in the formulation of fast dissolving tablets of poorly soluble drugs employing 23factorial design. Starch glutarate was synthesized by esterification process. The synthesized starch glutarate was subjected to physical and micromeritic evaluation. To establish as starch glutarate as a superdisintegrant, fast dissolving tablet of aceclofenac was prepared employing starch glutarate in different proportions in each case by direct compression method employing 23 factorial design. All fast dissolving tablets prepared were evaluated for drug content, hardness, friability, disintegration time and other dissolution characteristics like percent dissolved in 5 min (PD5), Dissolution efficiency in 5 min (DE5%) and first order rate constant (K1). The starch glutarate prepared was found to be fine, free flowing amorphous powder. Starch glutarate exhibited good swelling in water. Fourier transform infrared spectra (FTIR) and Differential scanning calorimetry (DSC) study indicated the absence of interaction between aceclofenac and starch glutarate. All the fast dissolving tablets formulated employing starch glutarate were of good quality with regard to drug content (100±5%), hardness (3.6–4 kg/sq. cm), and friability (0.12-0.15%). The optimized formulation F8 has the least disintegration time i.e., 30±0.02s. The in vitro wetting time was less (i.e., 90s) in optimized formulation F8. The cumulative drug dissolved in the optimized formulation F8 was found to be 99.15±0.56% in 15 min. Starch glutarate was found to be a superdisintegrant which enhanced the dissolution efficiency when combined with crospovidone, croscarmellose sodium, with the aceclofenac and hence it could be used in the formulation of fast dissolving tablets to provide immediate release of the contained drug within 15 minutes.
 Keywords: Fast dissolving, Superdisintegrant, Starch glutarate, Dissolution efficiency.