Kinetic Approach to Determine the Generation Rate of Available Surface Area during the Dissolution Process

概要

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The initial rate of increase (K_h) of available surface area (S(t)) of flufenamic acid (FFA) in tablets during the disintegration and deaggregation (dispersion) processes, as well as the rate of decrease (K_d) of S(t) during the subsequent dissolution process, was determined by using two approaches. One was based on the assumption that the increase and decrease are dependent in a first-order manner on S(t) generated at time t. The other was based on the assumption that the initial rate of increase of S(t) is independent of S(t), whereas the subsequent rate of decrease is dependent on the S(t) at time t. By using the S(t) equations developed from these two approaches, the ratio of the S(t) generated by time t to the total S(t) generated during the dissolution process (F(t)) could be expressed as a function of time, which included K_h and K_d as the constants. Furthermore, from the non-linear regression of F(t) data, which it is possible to obtain from a dissolutio study, to these F(t) functions, well-matching K_h and K_d values for the FFA (200 mg) tablets could be obtained. The influence of the level of disintegrant and the compression pressure on K_h and K_d, as well as the results of simulation of the S(t)-generation patterns of FFA (200 mg) tablets are also discussed.
公益社団法人日本薬学会の論文
1986-03-25