Design of Experiments for the Establishment of the Dissolution Test Conditions of Rupatadine Fumarate 10 mg tablets
Abstract
Design of Experiments (DoE) is a statistical model that aims to determine if the factors under study affect the response, and if so, it determines the conditions under which this variable of interest can be optimized. In terms of pharmaceutical technology, independent variables are usually factors of the formulation, while dependent variables are properties of the product or parameters that indicate the performance of the process. Precisely, the dissolution test is a tool of interest for the developers of medicines since it allows them to evaluate the performance of a formulation designed in a solid pharmaceutical form, such as tablets. The present investigation used the design of experiments to establish and optimize the conditions of the dissolution test of a 10 mg Rupatadine fumarate tablets formulation, resulting in the use of HCl 0,1 N (pH 1) dissolution medium and a rotation speed of 100 rpm for the apparatus II USP, which allow the analysis of the product in a reproducible and reliable way.
Keywords: Analysis of variances, Design of experiments, Dissolution test, Factorial design, Rupatadine Fumarate, Tablets, Test conditions.
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References
2. Djuris J, Ibric S, Djuric Z. Quality by Design in pharmaceutical developments. Computer-aided applications in pharamceutical technology. 1st ed. Belgrado: Woodhead Publishing Limited; 2013. p. 1-16.
3. Yu L, Amidon G, Khan M, Hoag S, Poli J, Woodcock J. Understanding Pharmaceutical Quality by Design. AAPS Journal. 2014; 16(4):771-783.
4. U.S. FDA/CDER, Guidance for Industry, “Dissolution testing of immediate release solid oral dosage forms”, 1997.
5. Farmacopea de los Estados Unidos (USP). Disolución (711). USP 39 - NF 34. Maryland: Convención de la Farmacopea de los Estados Unidos; 2016. p. 579-590.
6. Zhang H, Yu L, “Dissolution Testing for Solid Oral Drug Products: Theoretical Considerations”, American Pharmaceutical Review, September/October 200;, 7(5):26-31.
7. Wang Q, Fotaki N, Mao Y, “Biorelevant Dissolution: Methodology and Application in Drug Development”, Dissolution Technologies, August 2009, 6-12.
8. Uriach, J. & Compañía S.A. 8-cloro-11-(1-((5-metil-3- piridil)metil)-4-piperidiliden)6,11-dihidro-5H-benzo- (5,6)cicloheptal(1,2-b)piridina, fumarato. España; ES 2 087 818, 2017.
9. Zhuhai Jin Hong Pharmaceutical. One kind of fumaric rupatadine compounds, their synthesis and pharmaceutical compositions thereof. China; CN103804357 B, 2016.
10. Shangguan Qing. Rupatadine fumarate compound as well as synthesis method and pharmaceutical composition thereof. China; CN103804357 A, 2014
11. Dalmora S, Nogueira D, Zanini G. Development and Validation of a Dissolution Test with Reversed-Phase Liquid Chromatography Analysis for Rupatadine in Tablet Dosage Forms. Quim Nova. 2010; 33(5):1150-1154.
12. Azeem S, Sharma S. Design & Evaluation of Immediate Release Tablet of Rupatadine Fumarate. International Journal Of Pharma Professional’s Research. 2012; 3(4):660-668.
13. Gutiérrez Pulido H, Vara Salazar R. Análisis y diseño de experimentos. México: McGraw-Hill; 2008.
14. Pukelsheim F. Optimal design of experiments. 2nd ed. Philadelphia: Society for Industrial and Applied Mathematics; 2006.
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