#124 Preparation and evaluation of Glibenclamide tablet using soyalecithin as a lubricant and as a solubility enhancer

Abstract

The literature review reveals that soyalecithin is used as a lubricant and increases poorly soluble drugs' solubility. The present investigation was undertaken to prepare a glibenclamide tablet using soyalecithin as a lubricant and a solubility enhancer. Microcrystalline cellulose is added as disintegrant-magnesium stearate, a lubricant. Pre and post-compression studies were compared. Glibenclamide is sulphonylurea which is used in the treatment of Type II Diabetes Mellitus. It has poor solubility (BCS class II). Soya lecithin is added to enhance solubility. Formulations were made by direct compression. The drug and excipients were mixed by geometric dilution method and passed through 100# mesh sieve. The mixture was compressed in an electrically driven rotary tablet punching machine (Cadmech mini-press) using 11/32 punch to obtain tablets. The weight of the tablet was maintained at 200±5 mg. The observed benefits of using soya lecithin as a direct compression vehicle resulted in faster and greater release of the drug, reduced excipient use, reduced cost and time of manufacture, and revealed the potential use of soy lecithin as a substitute of lubricant and solubility enhancer in directly compressed tablets of glibenclamide. The post-compression studies were conducted (for formulations F 1, F 2, F 3, F 4, F 5, and marketed product) and the results were tabulated and compared. All the formulations passed the weight variation test, friability test, and hardness test. The results of the disintegration test revealed that formulations F 1, F 2, F 3, and F 4 show fast disintegration compared to F5 and marketed products. Dissolution studies were carried out for 30 min. The results are shown and compared. It shows the formulations which contain soya lecithin release, i.e., above 90% of the drug within 30 min. The observed benefits of using soy lecithin as a direct compression vehicle resulted in faster and greater release of the drug, reduced excipient use, reduced cost and time of manufacture, and revealed the potential use of soy lecithin a substitute of lubricant and solubility enhancer in directly compressed tablets of glibenclamide.