Formulation Design of Novel Fast Disintegrating Tablets of Prochlorperazine Maleate

In the present work, fast disintegrating tablets of prochlorperazine maleate were prepared with a view to enhance patient compliance by direct compression method. Three superdisintegrants i.e., crospovidone, croscarmellose sodium and sodium starch glycolate in different ratios with MCC (Avicel, PH-102) along with directly compressible mannitol (Pearlitol SD 200) to enhance mouth feel. The prepared batches of tablets were evaluated for hardness, friability, drug content uniformity, wetting time, water absorption ratio and in vitro dispersion time. Based on in vitro dispersion time (approximately 11 s), three formulations were tested for the in vitro drug release pattern (in pH 6.8 phosphate buffer), short-term stability (at 40o/75% RH for 3 m) and drug-excipient interaction (IR spectroscopy). Among the three promising formulations, the formulation prepared by using 8% w/w of crospovidone and 60% w/w of microcrystalline cellulose emerged as the overall best formulation (t50% 4.4 min), based on the in vitro drug release characteristics compared to conventional commercial tablet formulation (t50% 16.4 min). Short-term stability studies on the formulations indicated that there are no significant changes in drug content and in vitro dispersion time (p<0.5).