Design and In-Vitro Characterization of ORO Dispersible Tablets of Azithromycin

H. Padmalatha*
 HOD, Pharmaceutical analysis and QA, Gyana Jyothi College of Pharmacy, Boduppal, Hyderabad.

A B S T R A C T
The goal of this project is to formulate Oro-dispersible tablet of Azithromycin that is intended to disintegrate rapidly into the oral cavity and form a stabilized dispersion. A direct compression method was failed to formulate dispersible tablet of Azithromycin so wet granulation method was used. In all the formulations, water was used as a granulating agent. Avicel was used as diluents. Aspartame was used as a sweetening agent. Magnesium stearate and Aerosil were used as lubricant and glidant respectively. FT-IR studies were utilized to obtain the compatibility of the drug and excipients. In preliminary study different super disintegrants Croscarmellose sodium (CCS), Sodium starch glycolate (SSG) and Crospovidone (CPVP) were evaluated for physicochemical parameters of tablet. The simplex lattice design was utilized using amount of intra-granular concentration of super disintegrants, Sodium starch glycolate (A), Croscarmellose sodium (B) and Crospovidone (C) were selected as independent variable. The Hardness (R₁), Disintegration time (R₂), Friability (R₃) and Wetting time (R₄) were selected as dependent variables. A total of 11 formulations with 4 replicas was obtained and optimized. From response surface plot of disintegration time, wetting time, friability and hardness it was found that lower disintegration time of tablets could be obtained when C and B are kept at optimum level. Stability study of final batch showed no significant changes in tablet properties.
Keywords: Azithromycin; Oro-dispersible tablet; Optimization; Disintegration time; FT-IR; Simplex lattice; Wetting time.