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Formulation development and optimization of nimesulide tablets by central composit design and effect of surfactants on dissolution studies

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Author(s): Muhammad Hanif1, Muhammad Harris Shoaib1*, Rabia Ismail Yousaf1, Iyad Naeem Muhammad1, Ahmad Khan1, Tariq Ali2 and Shahnila Sattar3

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 7;
Start page: 2447;
Date: 2011;
Original page

Keywords: Central composite design | direct compression method | Sodium lauryl sulphate | Polysorbate 80 | cetrimide | Response surface methodology.

ABSTRACT
This study consists of two parts, application of Central composite rotatable design (CCRD) and surfactant effect on dissolution of Nimesulide tablets. CCRD was used to analyze the effect of independent variables, croscarmellose sodium, magnesium strearate and avicel PH102 on dependent variables, disintegration time and friability. The ranges of variables used in the design were croscarmellose sodium (0.5-3 %), magnesium strearate (1-5 %) and Avicel PH 102 (45-95 %). Overall seventeen formulations were prepared which were designed from rotatable central composite model in such a way that fourteen formulations were on the axial points and three formulations were on central points of the quadratic shape. Concentration of croscarmellose sodium and magnesium stearate hadthe direct effect on disintegration time and friability respectively while combination of both showed the direct effect on disintegration and inverse effect on friability at higher concentration. Combination of Avicel pH 102 and magnesium stearate had the inverse effect on disintegration time and friability, while magnesium strearate and croscarmellose sodium in combination decreased the friability and disintegration time. Three best formulations were chosen byconsidering the least amount of excipients, bulk density, tap density, angle of repose, disintegration time, weight variation, friability and assay having the minimum, middle and maximum ranges of all the excipients with fixed concentration of Nimesulide. Drug release of selected formulations were further investigated by model independent approach (similarity and differential factor i.e. f2 and f1 were applied), Model dependent approach (First order release,Hixson Crowell and Weibull model). Similarity values between marketed brand, Nimaran and three formulations revealed that F7 showed the greatest similarity percentage (58-65%) and lowest differential percentages (5-30%), while first order release rate and Weibull showed the best results and the highest R2(0.9534- 0.9956) values ā€œSā€ shape respectively of the F7 curve at different pH i.e. 1.2, 4.5, 6.8 and 7.4. Nimesulide, Class II drug, had low solubility and highpermeability; its solubility was evaluated by using three different types of surfactants i.e. Sodium lauryl sulphate (SLS), Polysorbate ester (Tween-80) and cetrimide (CTAB) having the same concentration of i.e. 1%. Among them 1 % SLS had shown the best solubility as compare to other two surfactants due to formation of large number of micelle. Response surface methodology by using the Design expert was applied to express the effect of in dependent variables on dependent variable and also graphical representation of predicted and actual values.
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