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Comparative evaluation of the physical parameters of uncoated tablets of Amlodipine Besylate with different types of primary packaging materials
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The objective of this study was to compare the physical parameters of uncoated tablets of Amlodipine Besylate in strip, blister and alu-alu type of primary packages under prescribed storage conditions recommended by the manufacturer, and finally to conclude the efficient primary package. The strip, blister and alu-alu packaging of antihypertensive drug Amlodipine Besylate 5mg of the same formulation type (uncoated tablets) were randomly collected from the pharmacy outlets. These tablets were subjected for various physical parameters testing like description (appearance), hardness, weight variation, friability and disintegration time. After performing Quality Control tests and comparing the results obtained, it was observed that the physical stability of the tablet has been retained very well and results were comparable in all three types of primary packages, i.e., strip, blister and alu-alu packaging. Based on supporting data we can conclude that if the formulation is stable enough, packing in aluminum strip or blister type of primary packaging shall take care of the product with respect to physical stability. Thus packing in alu - alu can be avoided which calls for additional product cost. This circumvents unnecessary cost burden on the patients and consumers. However it is better to use specifically alu-alu type of package for a sensitive product since it provides greater protection from the environmental conditions under the prescribed storage conditions recommended by the manufacturer.
Keywords
Amlodipine Besylate, Alu-alu, Blister, Strip, Primary Packaging
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