Design of Experiments for the Establishment of the Dissolution Test Conditions of Rupatadine Fumarate 10 mg tablets
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.
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.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).