Design and Evaluation of Fast Dissolving Films Containing Nizatidine

Abstract:

The present study deals with the formulation of fast dissolving films of nizatidine as a model drug which is used for the treatment of acid-reflux disorders, peptic ulcer disease, and active duodenal ulcer. Rapidly dissolving dosage forms have acquired great importance in pharmaceutical industry because of their unique properties. In the present research work various trails were carried out using maltodextrin and the concentration of excipients were optimized to prepare an ideal film for drug loading. Casting method was used for the preparation of films. The prepared films were evaluated for film thickness, folding endurance, disintegration time, dissolution time and for drug content. The in vitro dissolution studies were carried out in three media, distilled water, simulated gastric fluid ( pH 1.2 ) and simulated salivary fluid ( pH 6.8 ). The prepared films were found to be uniform, flexible, more than 90 % of the drug was found to be released from the film with in 4 min which is a desirable characteristic for fast absorption. FT IR and DSC studies were carried out to study drug excipient interactions. From these studies it is observed that there was no interaction between drug and excipients used and the drug is stable in the formulation. The in vivo disintegration time and taste evaluation studies were carried out in human volunteers after taking approval by the ethical committee, IPT, SPMVV(Sri padmavathi mahila Visva Vidyalayam). These results revealed that there was no bitter taste, no irritation and good mouth fell was observed. The in vivo disintegration time was in agreement with in vitro results. This confirms the successful formulation of nizatidine in the form of fast dissolving films.

Keywords : Fast dissolving Films, Nizatidine, Taste masking.