Abstract

FORMULATION AND DEVELOPMENT OF AMISULPRIDE TABLETS AND IT'S COMPARATIVE EVALUATION OF PHYSICAL AND CHEMICAL PARAMETERS BETWEEN ACCELERATED AND REAL TIME STABILITY

Vijay Kumar Panthi*

ABSTRACT

Amisulpride used for easing the symptoms of severe or sudden (acute) and ongoing or long term (chronic) schizophrenia, a sort of mental health condition which affects the way of thinking, feeling, or action. In this formulation frequent problem were high disintegration and low hardness. As per formulation elaborated in formulation chart it is mainly concluded that the both high disintegration and low hardness problem of amisulpride tablets can be counteracted by mainly MCCP 200, Crospovidone and polyvinylpyrrolidone k-30 but extra more amounts of MCCP 200 was appeared required. In addition, as per trials it is also justified that the dried Maize starch (without paste) was not appeared effective ingredients in formulation of amisulpride tablets. Although other surfactants were not used, the anionic surfactants i.e. Sodium Lauryl Sulphate is observed good ingredients in this formulation for obtaining the good dissolution from initial phase up to six month stability. Aerosil, crospovidone, kollidon VA 64 were other successful supportive ingredients for the formulation of amisulpride tablets. Although there is higher humidity and temperature in Accelerated stability than Real time, the hardness of tablet is very slightly increased in Accelerated as compared to Real time but rest of the parameters were observed equally stable. No gradual increment of any parameters in both stability, it further illustrated that there is no significant changes in any physical and chemical parameters in both accelerated and real time but disintegration time is increasing very slightly as per gradual basis which can be considered as a negligible impact.

Keywords: Amisulpride, Physical Parameters, Chemical Parameters, Accelerated stability, Real Time Stability.