Development of Film Coated Atrovastatin Calcium Tablet Using OPADRY-OY

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Journal Title, Volume, Page: 
International Journal of Drug Delivery Vol 4, 229-235
Year of Publication: 
Shehdeh Jodeh
Department of Chemistry, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Chemistry, An-Najah National University, Nablus, Palestine
Abdelnaser Zaid
Pharmacy Department
Abualhasan Murad
Department of Pharmacy
Preferred Abstract (Original): 

The aim of this study was to develop and evaluate the stability of film coated Atorvastatin Calcium (AtC) tablets using Opadry-OY-B-28920. AtC uncoated tablets were developed and manufactured through the Wet Granulation process. Opadry-OY-B-28920 white aqueous coating dispersion was used as film coating material. The film coated tablets were completely disintegrated within 10 minutes in water media, it was also completely dissolved (more than 85% of the drug was released) within 30 minutes in pH 6.8 buffer solutions. The film coated tablets were studied under both long term and accelerated stability study and the results showed no significant variation in physical characteristics, color, hardness, no obvious defects or signs of peeling or chipping. These results reflect that the film coated system Opadry-OY-B-28920 can be successfully used in order to produce AtC film coated tablet that is protected from environmental conditions such as light and humidity.These findings suggest that aqueous film coating with Opadry-OY-B-28920 system is an easy and economical approach for preparing stable film coated AtC tablet of immediate release.