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Abstract

STUDIES ON FORMULATION OF DOXAZOSIN MESYLATE TABLETS USING CROSCARAMELLOSE SODIUM AND SODIUM DODECYL SULFATE - OPTIMIZATION BY 22 FACTORIAL DESIGN

CH. Saibabu*, Dr. K. Thejomoorthy and Rakesh Kumar Jat

ABSTRACT

Doxazosin Mesilate, a widely prescribed anti hypertensive drug belongs to class II under BCS classification and exhibit low and variable oral bioavailability due to its poor aqueous solubility. It needs enhancement in the dissolution rate in its formulation development to derive its maximum therapeutic efficacy. In the present study croscarmellose sodium (superdisintegrant) and Sodium dodecyl sulfate (Anionic surfactant) were tried to enhance the dissolution rate of Doxazosin Mesilate in its tablet formulation development. The objective of the study is to optimize Doxazosin Mesilate tablet formulation by 22 factorial design to achieve NLT 85% dissolution in 15 minutes. For optimization of Doxazosin Mesilate tablets as per 22 factorial design the croscarmellose sodium (superdisintegrant) and Sodium dodecyl sulfate (Anionic surfactant) are considered as the two factors. The four levels of the factor A (croscarmellose sodium) are ratio of drug: croscarmellose sodium and the four levels of the factor B (Sodium dodecyl sulfate). Four Doxazosin Mesilate tablet formulations employing selected combinations of the two factors i.e. croscarmellose sodium (superdisintegrant) and Sodium dodecyl sulfate (Anionic surfactant) as per 22 factorial design were formulated. The tablets were prepared by direct compression method and were evaluated. The physical parameters of the Doxazosin Mesilate tablets evaluated and hardness of the tablets was in the range 89-117 N. Weight loss in the friability test was less than 0.02% in all the cases. Doxazosin Mesilate content of the tablets prepared was within 100±3%. Much variations were observed in the disintegration and dissolution characteristics of the Doxazosin Mesilate tablets prepared. The disintegration times were in the range 2 min 22 sec to 4 min 28 sec. Dissolution rate of Doxazosin Mesilate tablets prepared was studied in 0.01N HCl. Dissolution of Doxazosin Mesilate from all the tablets prepared followed first order kinetics with coefficient of determination (R2) values above 0.985. The first order dissolution rate constant (K1) values were estimated from the slope of the first order linear plots. Much variations were observed in the dissolution rate (K1) and DE30 values of the tablets prepared due to formulation variables. ANOVA of K1 values indicated that the individual and combined effects of the two factors, croscarmellose sodium and Sodium dodecyl sulphate except S010 (Combined effect of croscarmellose sodium and Sodium dodecyl sulphate) in influencing the dissolution rate of Doxazosin Mesilate tablets are highly significant (P < 0.01). Doxazosin Mesilate tablet formulations S006 and S010 gave very rapid dissolution of Doxazosin Mesilate than others. These tablets (S006 and S010) gave above 90% dissolution in 15min. Higher levels of croscarmellose sodium and lower levels of sodium dodecyl sulphate gave low dissolution of Doxazosin Mesilate tablets. The increasing order of dissolution rate (K1) observed with various formulations was S002 > S004 > S006 > S010. The optimized Diltiaazem tablet formulation gave 91% dissolution in 15 min fulfilling the target dissolution set. Hence optimization by 22 factorial design could be used to formulate Doxazosin Mesilate tablets with the desired dissolution i.e., NLT 85% in 15 min.

Keywords: Optimization, Doxazosin Mesilate tablets, Factorial design, Croscarmellose sodium, Sodium dodecyl sulphate.


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