經由口服的固體劑型，其藥效取決於劑型中活性成分的溶離與穿透口腔黏膜而進入血液中，經由血液的循環將藥物送至作用部位。溶離速率為藥物進入血液循環的速率決定步驟，有許多方法可用以增進溶離速率，包括處方中所使用的崩散劑，為一個常見且方便的方法。因此，崩散劑長久以來被用於增進固體劑型中活性成分的溶離。研究中所選用的澱粉是一個傳統的天然崩散劑，屬於天然來源。人們長久以來一直在尋找新的崩散劑。現今仍然有許多物質被研究作為新的崩散劑。
本研究的目的為尋找新的天然來原材料做為崩散劑，而這些新的崩散劑在錠劑處方中僅需加入少量即可增進錠劑的崩散與溶離。本研究以氫氯苯嗪 (Hydrochlorothiazide) 為模式藥物，為一個水難溶性藥物，因此其溶離速率往往取決於崩散劑的效果。並以磷酸二鈣 (Di-Tab®，Dicalcium phosphate dihydrate) 為不可溶性賦形劑，以直接打壓錠製備藥錠。所製備藥錠於pH 1.2 鹽酸緩衝液中進行崩散試驗與溶離試驗(USP 30)。
所有篩選得到的具良好崩散效果之物質則進一步以吸水及膨脹試驗探討其促進崩散劑之機轉。 Fast dissolving dosage forms are drug delivery systems that dissolve or disintegrate in the patient’s mouth in less than a minute without the need for water. The objective of this study was to find some new materials as disintegrants. These new disintegrants improve tablet disintegration and dissolution when added in small amounts to tablet formulations.
The efficiency of new disintegrants in promoting tablet disintegration and dissolution can overtake starch, was used as a disintegrant in orally tablets. The dissolution rate of the model drug, hydrochlorothiazide, was found highly dependent on both tablet disintegration efficiency and the solubility of base material(s) in the testing medium.
In the end, we showed the effect of new disintegrants in promoting tablet disintegration and dissolution in pH1.2 HCl buffer.
