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Design, Formulation and Evaluation of Pravastatin Fast Dissolving Tablets.

机译:普伐他汀速溶片的设计,配制和评价。

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Objective: The main objective of present research investigation is to formulate the Pravastatin Fast Dissolving tablets. Pravastatin, a newer antihyperlipidemic agent, belongs BCS class-III agent and used to treat hypercholesterolemia and to reduce the risk of Cardiovascular disease. Methods: The Fast Dissolving tablets of Pravastatin were prepared employing various 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%,t90% were selected as dependent variables. Results and Discussion: 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 (F1) containing combination of 8% Crospovidone and 8% Croscarmellose, is the most similar formulation (similarity factor f2= 89.724, dissimilarity factor f1= 1.307 & No significant difference, t= 0.0465) to marketed product (PRAVACHOL-40). Conclusion: 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= 1.875).
机译:目的:本研究的主要目的是配制普伐他汀速溶片。普伐他汀是一种新型的抗高血脂药,属于BCS III类药物,用于治疗高胆固醇血症和降低心血管疾病的风险。方法:采用32因子设计,采用直接压片技术,以不同组合的不同浓度的Crospovidone和Croscarmellose钠作为超级崩解剂,制备Pravastatin速溶片。选择Crospovidone和Croscarmellose钠的浓度作为自变量,分别为X1和X2,而将润湿时间,崩解时间,t50%,t90%作为因变量。结果与讨论:共设计了9种配方,并对硬度,脆性,厚度,含量,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)。开发了润湿时间,崩解时间,t50%,t90%的多项式方程式。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,与市售产品(F1)组合的8%(交联维酮和8%交联羧甲基纤维素)是最相似的制剂(相似因子f2 = 89.724,相异因子f1 = 1.307&无显着性差异,t = 0.0465) PRAVACHOL-40)。结论:选定的配方(F5)遵循一阶,Higuchi动力学,药物释放机理为非菲克扩散Super Case-II转运(n = 1.875)。

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