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- W2783189307 abstract "In this study Eplerenone pellets are prepared using powder layering technique and coated using Fluid bed processor for the strength of 50% to achieve the final tablet formulation of 70mg dose. Eleven formulations of sustained release pellets are prepared by using different cellulosic polymers varying in their concentration (10%, 7.5% & 5%). Ethyl cellulose at 5% level gave the dissolution profile meeting the requirement. Further Surelease/ Aqua coat at 7.5% concentration gave the dissolution profile matching to the specification with the release at lower side of the specification. At 5% level both Surelease and Aqua coat ARC gave acceptable dissolution profile matching to the specification. Since concomitant consumption of alcoholic beverages along with the products might be expected to have the potential to induce dose dumping. Due to concerns of dose dumping from this drug product when taken with alcohol, we have studied additional dissolution testing using various concentrations of ethanol in the dissolution medium for the batches which showed match in the dissolution profile. Based on the study it is further concluded that the pellets prepared using Aqua coat ARC at 7.5% concentration (Trial 10) was more identical and not showed any significant effect in the presence of alcohol. Further the final formulation trail 10 compressed in to tablets for 70mg dose and from the study it is concluded that the concentration of 10mg Lubritab found to be meeting in all respect. The prepared formulation studied for stability and the results were found to be satisfactory after one month accelerated condition (40oC/ 75% RH)." @default.
- W2783189307 created "2018-01-26" @default.
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- W2783189307 date "2013-10-01" @default.
- W2783189307 modified "2023-09-27" @default.
- W2783189307 title "A Study of Effect of Different Cellulosic Polymers on Sustained Release Dosage form Eplerenone as Model Drug" @default.
- W2783189307 hasPublicationYear "2013" @default.
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