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Formulation Development and Evaluation of Moxifloxacin.HCL Fast Dissolving Tablets

机译:莫西沙星.HCL速溶片的处方开发与评价

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The main objective of present research investigation is to formulate the Moxifloxacin.HCl Fast Dissolving tablets. Moxifloxacin.HCl, a synthetic fluoroquinolone antibacterial agent, and used to treatacute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis. The Fast Dissolving tablets of Moxifloxacin.HCl were prepared employing different concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Superdisintegrants by Direct Compression technique using 32 factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1 and X2 respectively whereas, wetting time, Disintegration time, t50%, and t90% were selected as dependent variables. Totally nine formulations were designed and are evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, In-vitro drug release. From the Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines the formulation (F5) containing combination of 7.5% Crospovidone and 7.5% Croscarmellose, is the most similar formulation (similarity factor f2=68.88, dissimilarity factor f1= 3.35& No significant difference, t= 0.00354) to marketed product (AVELOX-400). The selected formulation (F5) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non-Fickian Diffusion Super Case-II Transport (n= 1.902).
机译:本研究的主要目的是配制莫西沙星.HCl速溶片。莫西沙星盐酸盐,一种合成的氟喹诺酮类抗菌剂,用于治疗急性细菌性鼻窦炎,慢性支气管炎的急性细菌急性发作。采用3 2 析因设计,采用直接压片法,以不同浓度的交联聚维酮和交联羧甲纤维素钠作为超级崩解剂,制备了莫西沙星.HCl速溶片。选择Crospovidone和Croscarmellose钠的浓度作为自变量,分别为X1和X2,而选择润湿时间,崩解时间,t 50%和t 90%作为自变量。因变量。总共设计了九种配方,并对硬度,脆性,厚度,含量,测定时间,润湿时间,崩解时间,体外药物释放进行了评估。从结果得出的结论是,发现所有制剂均符合药典限制,并且所有制剂的体外溶出度均适用于不同的动力学模型,其统计参数如截距(a),斜率(b)和回归计算系数(r)。建立了润湿时间,崩解时间,t 50%,t 90%的多项式方程。通过设计2个检查点公式(C1,C2)验证了开发的多项式方程的有效性。根据SUPAC指南,与市场上出售的产品(F5)组成的最相似的配方(相似系数f2 = 68.88,相似系数f1 = 3.35&无显着性差异,t = 0.00354)包含7.5%交联维酮和7.5%交联羧甲基纤维素的组合。 AVELOX-400)。选定的制剂(F5)遵循一阶,Higuchi动力学,药物释放机理为非菲克扩散超级病例II运输(n = 1.902)。

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