APPLICATION OF SURFACE RESPONSE METHODOLOGY FOR SPRAY DRIED- FLUID BED PROCESSED TECHNOLOGY OF MOUTH DISSOLVING PLATFORM FOR SILDENAFIL CITRATE IN PULMONARY HYPERTENSION

摘要

Now day’s formulation research is breaking barriers of conventional methods. Today, active ingredients can be delivered with a level of convenience, performance and bioavailability never seen in the market place. Fast disintegrating or Mouth dissolving tablet (MDTs) is one such novel approach to increase consumer acceptance by virtue of rapid disintegration, self-administration without water or chewing. The objective of this research was to develop the mouth dissolving tablets platform for sildenafil citrate for pediatric patient in pulmonary hypertension . Mouth dissolving tablets platform was developed using mannitol, crosspovidone, low substituted hydroxypropyl cellulose and povidone. Sucralose and orange flavor are used as sweetener and taste masking agent respectively. Spray dried fluid bed processed technology was utilized to prepare granules. Direct compression technology was used to prepare tablets. Response Surface Methodology was utilized to establish relationships between identified independent variables and selected responses. The quality of mouth dissolving tablets was evaluated by evaluation of the in vitro release profiles, as well as friability, crushing and tensile strength, disintegration time, wetting time, in vitro dispersion time and the water absorption ratio of the tablets. All parameter was found satisfactory and tablets can deliver the required amount at onset time.