FORMULATION AND EVALUATION OF N-ACETYLCYSTEINE LOZENGES

Abstract

N-Acetylcysteine is used as a beneficial drug in the management of Asthma. The objective of the study is to enhance bioavailability of N-Acetylcysteine using modification in dosage form. N-Acetylcysteine is a mucolytic agent which has 10% bioavailability. The N-Acetylcysteine’s absolute bioavailability is very low as it undergoes an extensive hepatic metabolism in the gut wall and liver. To overcome this problem, lozenges of N-Acetylcysteine were prepared to avoid first pass metabolism by heating and congealing method to enhance bioavailability. The different natural polymers like xanthan gum, tragacanth and gelatin were used in the formulation. The lozenges were assessed by their physical characteristics, weight uniformity, thickness, diameter, hardness, friability, drug content, moisture levels, in vitro drug release, and stability. Total 09 batches were prepared, and from the results, Batch A6 was identified as the optimized formulation as it gives 99.45 % drug release in 75 mins. Stability study showed no significant changes. Present study suggested that lozenges of N-Acetylcysteine containing tragacanth polymer provided rapid drug release 99.54 % within a short period of time.