Title:Spray-Dried Microspheres of Roxithromycin for Formulating into Dispersible Tablets Using Central Composite Design
Volume: 3
Issue: 2
Author(s): Deepak Kaushik and Harish Dureja
Affiliation:
Keywords:
Central composite design, Eudragit® EPO, roxithromycin, spray drying, taste masking, microspheres, dispersible
tablets.
Abstract: The present investigation aims at development of spray-dried microspheres
for formulation of roxithromycin dispersible tablets. The spray drying
process was optimized using a central composite design to study the effect of two
critical variables - amount of polymer Eudargit EPO® (X1) and inlet temperature
(X2) on entrapment efficiency of drug and percentage cumulative drug release (%
CDR). The maximum entrapment efficiency and % CDR was found at high values
of inlet temperature and high level of polymer concentration. A drug entrapment
efficiency of about 58.48 % (w/w), loading capacity of 64.22% (w/w), 94.26%
CDR and particle size of 615 nm were achieved for the optimized batch RMS-3 of
roxithromycin microspheres. ANOVA was applied to entrapment effeciency and
% CDR to study the fitting and the significance of the model. The model estimated using present
study has utility as response surface for cumulative percent of drug release from microspheres. The
spray dried optimized microspheres were further formulated into dispersible tablets using direct
compression method. The prepared tablets were evaluated for different parameters and the results obtained
were found to be within the pharmacopoeial limits. The developed dispersible tablets showed
better taste profile when compared with the marketed formulation and were found to be stable.
