PHARMACIE GLOBALE INTERNATIONAL JOURNAL OF COMPREHENSIVE PHARMACY OPTIMIZATION OF SUPER DISINTEGRANTS AND SUBLIMING AGENT ON DISSOLUTION RATE OF ROSUVASTATIN ORODISPERSIBLE TABLETS BY USING A 3 2 FACTORIAL DESIGN

B Akbari, B Valaki, V Maradiya, A Akbari, Vidyasagar
2011 Pharmacie Globale (IJCP) 2011, 1 (09) Pharmacie Globale ® (IJCP)   unpublished
The aim of this work was to develop Rosuvastatin Orodispersible tablets by exploiting the solubilizing effect of hydroxy propyl β-cyclodextrin (HP-β-CD). Drug-CD complex systems, prepared bydifferent techniques, were characterized by differential scanningCalorimetry (DSC), X-ray diffractometry, and Fourier transforminfra-red (FT-IR) spectroscopy. The inclusion complex containing RST: HP-β-CD (1:1) was formulated into Orodispersible tablets using superdisintegrants like sodium starch glycolate
more » ... SG) and subliming agent such as camphor. Tablets containing RST-HP-β-CD inclusion complex were prepared by direct compression and evaluated for various post compression parameters like hardness, friability, weight variation, thickness, drug content and invitro dissolution. 3 2 factorial design was applied to systematically optimize the drug release profile. The proportion of subliming agent Camphor (X 1 ) and superdisintegrant sodium starch glycolate (X 2 ) were selected as independent variables. The % friability (Y 3 ), Disintegration time (Y 2 ) and drug release in 15 mins (Y 3 ) was selected as dependent variable. The optimization was carried out using intensive grid and ANOVA. The derived polynomial equations for Y 1 , Y 2 and Y 3 were verified by two check point formulations, which showed that factor X 1 and X 2 , significantly affects the studied dependent variables.The amount of superdisintegrants didn't show any significant effect on percentage friability, disintegration time and % release but data analysis showed that camphor alone had significant effect on friability.
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