Abstract
FORMULATION AND IN-VITRO CHARCTERIZATION OF PITAVASTATIN ORODISPERABLE TABLETS

Vasavi Jeekuru, Mayuri Konda, Sree Giri Prasad Beri and Krishna Mohan Chinnala*

ABSTRACT

Objective: The aim of the present study was to develop and evaluate orodispersible tablets of Pitavastatin by direct compression method. Material and methods: Sodium starch glycolate (SCG), Crosscarmellose sodium and Cross-povidone were used as disintegrates to achieve the desired disintegration time required for orodispersible tablets. To mask the bitter taste of drug, aspartame was added. Lactose was used as sugar based multifunctional diluents. PEG-6000, Plasidone S-650 is solubility enhancer for active ingredient in different concentrations. The prepared tablets were evaluated for their physical (hardness, friability, weight variation), and functional (disintegration time) properties and for the drug content. The excipients were used in various concentrations in order to optimize the desired properties. SCG and Crosscarmellose sodium and Cross-povidone, used. Results and Discussion: From the data obtained, it is observed from the formulation containing Sodium starch glycolate 15mg in Formulation F8, shows Disintegration time in 30 seconds and the Percentage drug release is of 99.20 % at the end of 30min which satisfied all the tablet evaluation parameters for dispersible tablet. Conclusion: Hence, looking at all the satisfactory parameters F8 batch is selected as the optimized batch. Hardness and friability values were also optimized in the formulations to produce tablets of acceptable physical stability and mechanical strength. Weight variation and drug content of all formulations fully complied with the official specifications. The release profile of the optimized formula F8 fitted best to Korsemeyer-Peppas model with R2 value of 0.999.

Keywords: Pitavastatin, orodispersible tablets, super disintegrants, Sodium starch glycolate (SCG), Crosscarmellose sodium and Cross-povidone.


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