| Summary: | 碩士 === 嘉南藥理科技大學 === 藥物科技研究所 === 97 === The active ingredient in an oral solid dosage form must dissolve in the GI fluid and then penetrate the GI mucosa into blood to reach the action site. Therefore, a disintegrant is commonly added in the fast release dosage forms to help the dissolution process. It is also used in controlled release and oral-disintegrating tablet dosage forms.
The official tests related with the function of a disintegrant are disintegration and dissolution tests. But the two tests sometimes cannot distinguish the efficiency of the various disintegrants and can only give limited information about the disintegration mechanism. Wetting and disintegration force tests were studied but not extensively. Especially the disintegration force test was measured by customer-made instrument. This study evaluates the disintegration force test using a texture analyzer.
Experimental conditions such as pretest speed, trigger force, filter paper, water temperature, compression pressure, and surrounding the lateral side of the tablet with impermeable adhesive tape were studied. Optimized conditions of pretest speed and trigger force for instrumental variables were obtained. Quantitative parameters such as maximum disintegrating force, disintegrating force generation rate slope, and the area under the curve were derived to characterize the disintegrating force versus time profiles. The change of these parameters corresponding to the change of experimental conditions was used to explain different disintegration behavior.
The results suggest that disintegration force test using a texture analyzer may be used as an alternative tool to study the function of a disintegrant.
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