PARK, CALEB HYUNGMIN,朴 炯玟,朴 炯玟,KWON, YOENG JIN,权容珍,權容珍,LEE, SEUNG JUN,李承俊,李承俊,KIM, YONG IL,金用镒,金用鎰,PARK, JAE HYUN,朴宰贤,朴宰賢,WOO, JONG SOO,禹锺守,禹鍾守
申请号：
TW103122328
公开号：
TWI663990B
申请日:
2014.06.27
申请国别(地区):
TW
年份:
2019
代理人:
摘要：
The present invention relates to a chewable tablet comprising granules containing tadalafil or a pharmaceutically acceptable salt thereof as an active ingredient； 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.本發明係有關一種咀嚼錠，其包含：含有他達拉非或其藥學上可接受的鹽類作為活性成分之顆粒；藉由一種濕式製粒法製備之具有特定粒徑和密度之顆粒；選自由羥乙酸澱粉鈉、羧甲基纖維素鈣、澱粉、海藻酸及海藻酸鈉所組成的群組之至少一種崩散劑；及一種藥學上可接受的添加劑。如本發明之咀嚼錠展現極佳的溶解率；在口腔中引發的異物感極微；當在口腔中崩解時，由於口感和風味之改善，不會引起不愉悅的感受。同時，咀嚼錠不需喝水即可咀嚼，而提高吞嚥困難的病患之遵囑率。因此，本發明的調配物可增進PDE-5抑制劑的功效，因而適用於勃起功能障礙與肺動脈高血壓之治療。
