Ranolazine, an approved antianginal drug, provides remarkable differences in solubility profile at different pH conditions. Due to its higher solubility characteristics at low pH, it rapidly absorbs from stomach, produces undesirable plasma drug concentration and clears from the body. This necessitates formulating a delayed release dosage form that provides desired drug release profile. The enteric coated pellets were prepared by fluid bed coater using pH dependent and independent polymer. All the process parameters were perfectly optimized and the process runs smoothly throughout the time course. The prepared pellets were evaluated for percentage yield, particle size distribution, surface morphology and dissolution study to confirm adequate enteric coating. This novel method achieved pellets, with percentage yield of 97.21%, free from agglomeration and fine particle development. It is concluded that this novel in house process can help provide an alternative approach to formulate enteric coated ranolazine pellets and the process can also be used by the pharmaceutical industries for enteric coating of other drugs.
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2022: 6.012
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