The Dissolution Test and the Content Uniformity Test are necessary to secure safety, efficiency and quality control. These tests were performed to compare their efficiencies among preparations with same active ingredient and its amount. Those were used as a method in measuring bioavailability of each product.
The materials were four famotidine tablets which were made in four different manufacturers (A, B, C and D). The results were as follows. 1) The Dissolution Test was performed for an hour using Paddle method, in the solution of pH 4.5 and artificial gastric juice. D_(30) min(Dissolution rates for 30 minutes) of A, C and D products were more than 75%, but the one of B product was much less. 2) In the Content Uniformity Test, all the contents of products(A, B, C and D) were more than 90%.
As a result, although the contents of all products were the same, the dissolution rates of B product was not equivalent to A, C and D products.
In conclusion, the dissolution rate is one of major factors which can affect the bioavailability of products. It is recommended that the Dissolution Test be disseminated as a method in comparing the bioavailability of each product.
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