Formulation and Evaluation of Oro-Dispersible Tablets of an Antihypertensive Drug Using Superdisintegrants

The purpose of present investigation was to develop fast dissolving tablets of an oral antihypertensive drug Ramipril. Solid dispersion of Ramipril with PEG-6000 was prepared by solvent evaporation technique and orodispersible tablets were prepared by direct compression technique. Sodium starch glycolate, Crosspovidone and Crosscarmellose sodium were used as superdisintegrants and Camphor as subliming agent. The prepared tablets were exposed to vacuum drying to produce highly porous tablets. The blends were evaluated for pre-compressive parameters and the prepared tablets were analyzed for post-compressive parameters such as; weight variation, hardness, and friability, drug content, wetting time, disintegration time, invitro dissolution studies, short term accelerated stability study and drugexcipient compatibility studies.

All formulation showed weight variation and drug content within the acceptable limits. The results revealed that sublimation of camphor from the tablets resulted in highly porous tablets with dispersion time less than 30 seconds and rapid in-vitro dissolution. The optimized formulation (F6) showed desired disintegration time and good release profile with maximum drug being released at different time intervals.

It was concluded that oro-dispersible tablets of Ramipril with improved drug dissolution can be prepared by solid dispersions of the drug with PEG-6000 and a combination of superdisintegrants was proved more optimized compare to single superdisintegrant. Camphor can be used to produce highly porous tablets for the ease of quicker disintegration and dissolution. The present work helped in understanding the effect of formulation variables especially combination of superdisintegrants on the drug release profile, potentials for rapid dispersion, quicker absorption, improved bioavailability, effective therapy and improved patient compliance.