Methods of Evaluation of Release of Carbon Dioxide from Effervescent Suppositories

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Two different test methods were studied for the evaluation of release profiles of carbon dioxide, CO_2,from effervescent suppositories. Three lots of commercial suppositories containing sodium bicarbonate and anhydrous sodium dihydrogen phosphate were used. The volume of CO_2 released from these suppositories in normal saline with or without polysorbate 80 as a medium was measured with a gas burette.In the measurement performed using the apparatus without stirring, method 1,only 60% of CO_2 was released from the suppositories in the medium without polysorbate 80. In this measurement, a native release profile was detected because the medium was not stirred. In the case with stirring, however, method 2,100% was released from those suppositories in the medium containing 1% polysorbate 80 with comparatively low standard deviations.These findings indicate that method 1 is most beneficial for a test comparing the effects of various factors such as additives and melting points on the release profiles of CO_2 from the effervescent suppositories. However, this method is not practical for quality control of formulations because of the incomplete release of CO_2; method 2,in contrast, is useful because of its complete release and low standard deviations.These results suggest that methods 1 and 2 for release tests of CO_2 are most applicable to the early and late formulation studies of effervescent suppositories, respectively.
社団法人日本薬学会の論文
1993-02-15

Methods of Evaluation of Release of Carbon Dioxide from Effervescent Suppositories

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