Kinetics And Stability Studies Of Formulated Micro/Nano Suspension Of Metronidazole

I. OrduJ, A. Chukwu
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引用次数: 2

Abstract

Kinetic models describe the overall release of drugs from dosage form because qualitative and quantitative changes do occur in a formulation. These changes may alter drug release and in vivo performance hence the application of methods that facilitates product development and thereby reducing the necessity of bio studies, this leads to the adoption of in vitro drug dissolution analysis that involves the use of dialysis membrane and adopting a diffusion method. Stability studies revealed that the formulated nano/micro suspension was more stable at refrigerated condition (4 O C) showing no significant change in particle size distribution, %EE and release characteristics after 3months of study. The in vitro drug release analysis shows drug release from the various formulations (S, Y and W) to follow zero order release kinetics and this was confirmed after determination of line of best fit and from the correlation coefficients values obtained following the consideration of various kinetic models such as: first order, zero order, Korsmeyer- Peppas and Higuchi models. The stability studies and shelf life determinations of the formulations show formulation S, having a shelf life of 4.598 months, while that of formulation Y and W,   are 4.808 months and 3.085 months respectively. These values could be related to the size of the particles formed using the various polymers which might influence their film forming and protective ability over the particles. The protective ability of tragacanth when used alone seem not to be sustained over a long period of time and this reduced stability effect could lead to short shelf life as a result of the tendency of Ostwald ripening and agglomeration of particles after a short period of storage but when compared to the formulation involving C.olitorious gum used alone or that consisting of C.olitorious and Tragacanth, stability was sustained signifying better protective ability of the polymer.
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甲硝唑微纳混悬液的动力学及稳定性研究
动力学模型描述了药物从剂型的整体释放,因为在配方中确实发生了定性和定量的变化。这些变化可能会改变药物释放和体内性能,因此应用有助于产品开发的方法,从而减少生物研究的必要性,这导致采用涉及使用透析膜和采用扩散方法的体外药物溶出度分析。稳定性研究表明,配制的纳米/微悬浮液在冷藏条件下(4℃)更稳定,研究3个月后,粒径分布、EE百分比和释放特性无显著变化。体外释药分析表明,各剂型(S、Y、W)的释药均服从零级释药动力学,通过确定最佳拟合线和考虑一阶、零阶、Korsmeyer- Peppas、Higuchi等动力学模型得到的相关系数值,证实了这一点。稳定性研究和保质期测定表明,S型制剂的保质期为4.598个月,Y型和W型的保质期分别为4.808个月和3.085个月。这些值可能与使用各种聚合物形成的颗粒的大小有关,这可能会影响它们的成膜和对颗粒的保护能力。单独使用时,黄芪胶的保护能力似乎不能持续很长一段时间,这种稳定性的降低可能导致保质期短,因为在短时间的储存后,颗粒有奥斯特瓦尔德成熟和团聚的趋势,但与单独使用的黄芪胶或由黄芪胶和黄芪胶组成的配方相比,稳定性得到了维持,表明聚合物的保护能力更好。
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