Study of Factors Affecting the Dissolution of Piroxicam Capsule

賦形劑對膠囊溶離度之影響

許淑纓(Shu-Ying Hsu) ； 許清萍(Ching-Ping Hsu) ； 徐廷光(Ting-Guang Shyu) ； 簡俊生(Chun-Sheng Chien) ； 張柏林(Ber-Lin Chang)

《藥物食品檢驗局調查研究年報》 9號 (1991/09) Pp. 445-451

https://doi.org/10.6946/ASRNL.199109.0445

摘要

本報告係以數種自行調配之piroxicam膠囊處方作體外溶離度試驗，以探討硬脂酸鎂之添加量及其混合時間，及添加不同量之硫酸月桂酯鈉對膠囊溶離度之影響。
經實驗結果顯示，添加硬脂酸鎂對piroxicam膠囊有顯著之影響，硬脂酸鎂添加量達5%以上時，藥物粉末會形成黏滯性糰塊，導致溶離度降低；界面活性劑硫酸月桂酯鈉能減少以上糰塊之形成，因而消除硬脂酸鎂對piroxicam膠囊溶離度所造成之不利影響，並增加piroxicam之溶離度；但若添加達3.12%時，則因形成難溶之複合物，反致溶離度降低。又當piroxicam粉粒變細時，表面積增加，溶解度也跟著增加，在本實驗中亦經證實。因此，賦形劑對膠囊溶離度確有很大之影響，審慎評估和適切選擇將有助於溶離度之提升，以增加療效。

並列摘要

The result of in-vitro dissolution test of several experimental piroxicam capsule formulation is presented. It is shown that excipients have certain degree of effect on the dissolution of piroxicam capsule. The dissolution rate can be reduced, when the capsule contains magnesium stearate more than 5%; this may be due to the lamination and subsequent adhesion to the dry agglomerate. The mixing time of magnesium stearate didn't exhibit significantly effect on the test. It was also found that 0.75% and 1.56% of sodium lauryl sulfate can increase the dissolution of piroxicam capsule which contains magnesium stearate. Heigher concentration of sodium lauryl sulfate (3.12%) can decrease the dissolution. However sodium lauryl sulfate is not recommended for the oral formulations and looking for the edible nonionic surfactant would be expected.

並列關鍵字

Dissolution ； Piroxicam capsule ； Excipients