FORMULATION AND EVALUATION OF FLUVASTATIN SODIUM
BILAYERED OSMOTIC TABLETS

LATHA KUKATI1*, ARCHANA CH1, NASEEB BASHA SHAIK1, SUBRAHMANYAM PVS2
1G. Pulla Reddy College of Pharmacy, Hyderabad, Andhra Pradesh, India
2Hetero Labs limited, Hyderabad, Andhra Pradesh, India
*corresponding author: lathakukatil@gmail.com
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Abstract:
The aim of this study was to design bi-layered osmotic tablets of fluvastatin sodium using osmogens in the upper layer and in
the lower layer, PEO (polyethylene oxide) - Coagulants. The tablets were prepared by wet granulation method and evaluated
for hardness, friability, drug content, and weight variation. All the parameters were found within the compendial limits.
Osmogens (mannitol:lactose) in the upper layer were taken in different ratios of 1:1, 1:2 and 1:3. From the dissolution
studies, 1:3 was considered as optimum for further studies. In the push layer, the osmogen (NaCl) was varied in
concentrations of 50, 75 and 100 mg. To the best batch of the above (i.e. 75 mg NaCl), PEO-N-80 was added in different
proportions. The resultant tablet was coated with cellulose acetate. A tablet weight gain of 7%, and an orifice size of 0.8 mm
was set as optimum for all the batches. The formulations were subjected to different kinetic models and the regression
coefficient was 0.995 indicating a zero order release and the “n” value was 0.902, indicating an anomalous transport
mechanism. F1 and F2 values were 5 and 80 respectively indicating similarity to that of the innovator drug (Lescol® XL 80
mg, Novartis GMBH). The optimized batch was kept for accelerated stability study under ZONE III according to
the International Conference on Harmonisation (ICH) guidelines and the formulation was found to be stable.






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