Abstract
AbstractA convenient and reproducible dissolution method for soft and hard gelatin capsules containing testosterone undecanoate in oleic acid is described. The method uses a flowthrough dissolution cell and a dissolution medium the composition of which was optimized for both its capacity to dissolve the gelatin capsule wall completely and to give homogeneous filtrates of drug and oily excipient for convenient analysis of the collected fractions.The discriminating power of the dissolution method for oily formulations of testosterone undecanoate was tested with three batches of the commercial formulation AndriolR, and with two experimental formulations. The three batches of AndriolR, soft gelatin capsules containing testosterone undecanoate in pure oleic acid, displayed biphasic dissolution patterns while dissolutions were always complete within 45 minutes. Dissolution of testosterone undecanoate from the experimental capsule formulation containing oleic acid and beeswax took about 3 hours to complete, wher...
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