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Optimized furosemide taste masked orally disintegrating tablets

机译:优化的速尿掩味口腔崩解片

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Optimized orally disintegrating tablets (ODTs) containing furosemide (FUR) were prepared by direct compression method. Two factors, three levels (3^2) full factorial design was used to optimize the effect of taste masking agent (Eudragit E100; X1) and superdisintegarant; croscarmellose sodium (CCS; X2) on tablet properties. A composite was prepared by mixing ethanolic solution of FUR and Eudragit E100 with mannitol prior to mixing with other tablet ingredients. The prepared ODTs were characterized for their FUR content, hardness, friability and wetting time. The optimized ODT formulation (F1) was evaluated in term of palatability parameters and the in vivo disintegration. The manufactured ODTs were complying with the pharmacopeia guidelines regarding hardness, friability, weight variation and content. Eudragit E100 had a very slightly enhancing effect on tablets disintegration. However, the effects of both Eudragit E100 (X1) and CCS (X2) on ODTs disintegration time (Y1) were insignificant (p0.05). Moreover, X1 exhibited antagonistic effect on the dissolution after 5 and 30min (D5 and D30, respectively), but only its effect on D30 is significant (p=0.0004). Furthermore, the optimized ODTs formula showed good to acceptable taste in term of palatability, and in vivo disintegration time of this formula was about 10s.
机译:通过直接压片法制备了含有速尿(FUR)的优化口腔崩解片(ODT)。使用两个因素,三个级别(3 ^ 2)的全因子设计来优化掩味剂(Eudragit E100; X1)和超级歧化剂的效果。交联羧甲基纤维素钠(CCS; X2)对片剂的影响。通过将FUR和Eudragit E100的乙醇溶液与甘露醇混合,然后再与其他片剂成分混合来制备复合材料。所制备的ODT以其FUR含量,硬度,脆性和润湿时间为特征。根据适口性参数和体内崩解评估了优化的ODT配方(F1)。所生产的ODT符合药典关于硬度,易碎性,重量变化和含量的规定。 Eudragit E100对片剂崩解具有非常轻微的增强作用。然而,Eudragit E100(X1)和CCS(X2)对ODTs崩解时间(Y1)的影响均不显着(p> 0.05)。此外,X1对5分钟和30分钟后的溶出具有拮抗作用(分别为D5和D30),但仅对D30的影响显着(p = 0.0004)。此外,就口感而言,优化的ODTs配方显示出良好至可接受的味道,并且该配方的体内崩解时间为约10s。

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