固體劑型的藥品，所含的活性成分必須先溶離在胃腸道體液，然後穿透過胃腸道黏膜藉由血流運輸，到達作用部位發揮藥效。因為崩散劑有助於溶離的發生，故常見於快速釋放的劑型，亦廣泛的應用在控制釋放及口腔快速崩散錠的處方當中。崩散劑的規範在藥典中就只有崩散試驗及溶離試驗，但崩散試驗及溶離試驗有時也不能比較出不同崩散劑之效能，無法表明崩散劑的機轉，所能提供的資訊往往有限。本實驗嘗試採用濕潤試驗與膨脹力試驗，探討錠劑濕潤時間及膨脹力量對崩散行為之影響。
在崩散力的研究中，採用商用的質地分析儀來測量觀察，探討的參數包括了探頭的前進速度（pretest speed），啟動值（trigger force），濾紙種類，水溫，打錠壓力及錠劑側邊膠帶框之影響，並找出關於儀器最佳化的參數，如探頭的前進速度與啟動值。崩散力與時間作圖可得到定量化的參數如最大崩散力，產生崩散力速率之斜率以及曲線下面積，隨著實驗控制變因不同而造成的參數變化可用來解釋崩散行為之差異。根據崩散力試驗結果顯示，在研究崩散劑之功能上，質地分析儀可作為替代工具的選項。 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.
