包含他达拉非或其药学上可接受之盐类的咀嚼锭调配物;CHEWABLE TABLET FORMULATION COMPRISING TADALAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF

摘要

本发明系有关一种咀嚼锭，其包含：含有他达拉非或其药学上可接受的盐类作为活性成分之颗粒；藉由一种湿式制粒法制备之具有特定粒径和密度之颗粒；选自由羟乙酸淀粉钠、羧甲基纤维素钙、淀粉、海藻酸及海藻酸钠所组成的群组之至少一种崩散剂；及一种药学上可接受的添加剂。如本发明之咀嚼锭展现极佳的溶解率；在口腔中引发的异物感极微；当在口腔中崩解时，由于口感和风味之改善，不会引起不愉悦的感受。同时，咀嚼锭不需喝水即可咀嚼，而提高吞咽困难的病患之遵嘱率。因此，本发明的调配物可增进PDE-5抑制剂的功效，因而适用于勃起功能障碍与肺动脉高血压之治疗。; granules having a specific particle size and density prepared by a wet granulation; at least one disintegrant selected from the group consisting of sodium starch glycolate, carboxymethyl cellulose calcium, starch, alginic acid, and sodium alginate; and a pharmaceutically acceptable additive. The chewable tablet according to the present invention exhibits excellent dissolution rate, causes little foreign body sensation in the oral cavity, and does not cause unpleasant feelings when disintegrated in the oral cavity due to improved taste and flavor. Also, the chewable tablet can be chewed without water to improve compliance rate of patients who do not have difficulty in swallowing. Therefore, the inventive formulation can improve efficacy of PDE-5 inhibitors, and thus can be useful in the treatment of ED and pulmonary arterial hypertension.