The objective of this work was to study the coating process of nifedipine extended release pellets using Opadry and Opadry II, in a\nfluid bed coater with aWurster insert.The coating process was studied using a complete experimental design of two factors at two\nlevels for each polymer.The variables studied were the inlet air temperature and the coating suspension flow rate. The agglomerate\nfraction and coating efficiency were the analyzed response variables. The air temperature was the variable that most influenced\nthe coating efficiency for both polymers. In addition, a study of the dissolution profiles of coated and uncoated pellets using 0.5%\nsodium lauryl sulfate in simulated gastric fluid without enzymes (pH 1.2) was conducted. The results showed a prolonged release\nprofile for the coated and uncoated pellets that was very similar to the standards established by the U.S. Pharmacopoeia. The drug\ncontent and the release profiles were not significantly affected by storage at 40�°C and 75%relative humidity.However, when exposed\nto direct sunlight and fluorescent light (light from fluorescent bulbs), the coated pellets lost only 5% of the drug content, while the\nuncoated ones lost more than 35%; furthermore, the dissolution profile of the uncoated pellets was faster.
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