Abstract:
Recent developments in technology have presented viable dosage alternatives for patients who may have difficulties in swallowing tablets or capsules. Conventional tablets and capsules administered with water may be inconvenient or impractical for other patients. In such conditions there is a requirement of fast disintegrating/dissolving tablets (FDT) which can be administered without water. In the present study an attempt to formulate fast dissolving tablets containing Nizatidine-Eudragit E100 complex using direct compression method. The main objective is prepare the Nizatidine complexes with Eudragit E100 to mask the bitter taste of the drug and to prepare fast dissolving tablets containing these complexes to improve patient compliance. The complexes were prepared by solvent evaporation method and spray drying method and were characterized by IR, SEM and DSC to check for chemical integrity, crystallinity and stability. FDTs were prepared by direct compression method using various superdisintegrants like crospovidone(CRP), croscarmellose sodium(CSS) and soypolysaccharide (SYP) in varying range (6-15%). The formulated tablets were evaluated for thickness, hardness, friability, weight variation, wetting time, drug content uniformity, disintegration time and In-vitro dissolution study. It was concluded that CRP was beneficial in decreasing disintegration time of tablets. Solvent Evaporation technique was found to be more suitable and cost effective than spray drying to prepare solid dispersions of Nizatidine in small scale.

Keywords: Eudragit E 100, Nizatidine, Fast Disintegrating/Dissolving Tablets, Crospovidone, Croscarmellose Sodium, Soypolysaccharide.