Study on the evaluation and formulation of zolpidem tartrate

Abstract

Traditional solid dose forms have a number of drawbacks, including difficulties in swallowing as patients get older, a delayed commencement of action, and issues with physiological factors such as the length of time it takes for the stomach to empty. A tablet that dissolves in the mouth is a relatively recent development in the field of drug delivery. The use of zolpidem in the treatment of insomnia for a relatively short period of time is preferred. The purpose of this study is to improve the bioavailability of zolpidem tartrate and get around the effect of the first transit through the body by formulating and evaluating mouth-dissolving tablets of the drug. The tablet containing Zolpidem was made by employing the directed compression method, with croscarmellose sodium and sodium starch glycolate serving as the super disintegrants, and mannitol, microcrystalline cellulose, and dicalcium phosphate serving as the diluents. The effects of several super disintegrants and diluents on disintegration and dissolving time were optimized, and the formula was completed on the basis of these characteristics. The FTIR investigation revealed that the medication and the excipients were compatible with one another. According to the results of the pre-compression investigation, the bulk powder possesses outstanding flow qualities and falls within a range of pharmacopoeia standards that is considered acceptable. The findings of the post-compression evaluation of the parameters match the criterion that was anticipated. From all of the different formulations, the one that had the highest amounts of sodium starch glycolate (35 mg), mannitol (20 mg), and microcrystalline cellulose yielded the greatest results for the In vitro drug release profile (60 mg). These tablets have a hardness that is lower than 4 kg/cm2, a disintegration period that is only 24 seconds long, and they release 97.71 percent of their pharmacological content within 30 minutes.