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http://dx.doi.org/10.5762/KAIS.2021.22.3.323

Development of a novel combination tablet containing silodosin and solifenacin succinate for the treatment of urination disorder  

Choi, Hyung-Joo (Department of Pharmaceutical Engineering, Gyeongnam National University of Science and Technology)
Lee, Jeong-Gyun (Department of Pharmaceutical Engineering, Gyeongnam National University of Science and Technology)
Kim, Kyeong Soo (Department of Pharmaceutical Engineering, Gyeongnam National University of Science and Technology)
Publication Information
Journal of the Korea Academia-Industrial cooperation Society / v.22, no.3, 2021 , pp. 323-332 More about this Journal
Abstract
This study was undertaken to develop a new combination tablet containing silodosin and solifenacin succinate for treating urination disorders, for which a simultaneous analytical method of silodosin and solifenacin succinate was established. The aqueous solubility of silodosin and solifenacin succinate was determined to be higher than 1 mg/ml in various buffers, and dissolution of the silodosin and solifenacin succinate commercial products was accomplished within 30 minutes. The drug-excipients compatibility test was subsequently evaluated using differential scanning calorimetry. Excipients without compatibility were selected, and various combination formulations were prepared applying the wet granulation method. Of these, the formulation comprising silodosin, solifenacin succinate, lactose hydrate, MCC PH101, sodium lauryl sulfate (SLS), Povidone K30, crospovidone and magnesium stearate, having a weight ratio of 8/10/56/112/2/6/6/2, respectively, showed equivalence comparative to the dissolution achieved with the commercial products of silodosin (Thrupas tab) and solifenacin succinate (Vesicare tab). Thus, we propose that compared to the currently available commercial products, this novel combination tablet containing silodosin and solifenacin succinate is an effective alternative for the treatment of urination disorders.
Keywords
Silodosin; Solifenacin succinate; Combination tablet; Formulation development; Dissolution test;
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1 A. S. Salinas-Sanchez, I. Hernandez-Millan, J. G. Lorenzo-Romero, M. Segura-Martin, C. Fernandez-Olano et al., "Quality of lifeof patients on the waiting list for benign prostatic hyperplasia surgery", Quality of Life Research, Vol.10, pp.543-553, 2001. DOI: https://doi.org/10.1023/A:1013004602682   DOI
2 M. Yoshida, J. Kudoh, Y. Homma, K. Kawabe. "Safety and efficacy of silodosin for the treatment of benign prostatic hyperplasia", Clinical Intervention in Aging, Vol.6, pp.161-172, 2011. DOI: https://doi.org/10.2147/CIA.S13803   DOI
3 S. J. Oh, "Review of the Anticholinergics for the Treatment of Overactive Bladder: 2009 Update", International Neurourology Journal, Vol.13, pp.7-22, 2009. DOI: https://doi.org/10.5213/jkcs.2009.13.1.7   DOI
4 K. Lee, M. Choo, D. Kim, J. Kim, H. Kim et al., "Combination treatment with propiverine hydrochloride plus doxazosin controlled release gastrointestinal therapeutic system formulation for overactive bladder and coexisting benign prostatic obstruction: A prosptective, randomized, controlled multicenter study", The Journal of Urology, Vol.174, pp.1334-1338, 2005. DOI:　https://doi.org/10.1097/01.ju.0000173630.94559.fd   DOI
5 C. Cheong, J. C. Barner, K. A. Lawson, M. T. Johnsrud, "Patient Adherence and Reimbursement Amount for Antidiabetic Fixed-Dose Combination Products Compared with Dual Therapy Among Texas Medicaid Recipients", Clinical Therapeutics. Vol.30, pp.1893-1907, 2008. DOI: https://doi.org/10.1016/j.clinthera.2008.10.003   DOI
6 J. H. Cho, J. C. Kim, H. S. Kim, D. S. Kim, K. S. Kim et al., "Novel dabigatran etexilate hemisuccinate-loaded polycp: Physicochemical characterization and in vivo evaluation in beagle dogs", International Journal of Pharmaceutics, Vol.525, pp.60-70, 2017. DOI: http://dx.doi.org/10.1016/j.ijpharm.2017.04.028   DOI
7 H. Moon, A. Yousaf, K. Cho, C. Yong, J. Kim et al., "Evaluation of stability and simultaneous determination of fimasartan and amlodipine by a HPLC method in combination tablets", Asian Journal of Pharmaceutical Sciences, Vol.9, pp.123-128, 2014. DOI: https://doi.org/10.1016/j.ajps.2014.04.002   DOI
8 J. Kim, K. Kim, D. Kim, S. Jin, D. Kim et al., "Effect of HM30181 mesylatesalt-loaded microcapsules on the oral absorption of paclitaxel as a novel P-glycoprotein inhibitor", International Journal of Pharmaceutics, Vol.506, pp.93-103, 2016. DOI: https://doi.org/10.1016/j.ijpharm.2016.04.034   DOI
9 Y. Sohn, A. Lee, "Compatibility Study Using Differential Scanning Calorimetry", Journal of Pharmaceutical Investigation, Vol.29, pp.117-126, 1999.
10 P. Abrams, C. Chapple, S. Khoury, C. Roehrborn, J. Rosette et al., "Evaluation and treatment of lower urinary tract symptoms in older men", The Journal of Urology, Vol.181, pp.1779-1787, 2009. DOI: https://doi.org/10.1016/j.juro.2008.11.127   DOI
11 C. Kim, S. Lee, K. Kim, "Development of a novel dapagliflozin orally disintegrating tablets", Yakhak Hoeji, Vol.64, pp.334-342, 2020. DOI: https://doi.org/10.17480/psk.2020.64.4.334   DOI
12 L. Martinez, E. Uribarri, A. Laguna, "Characterization and Compatibility Studies between Policosanol, a New Hypocholesterolemic Drug, and Tablet Excipients Using Differential Scanning Calorimetry (DSC)", Archiv der Pharmazie, Vol.332, pp.439-441, 1999. DOI: https://doi.org/10.1002/(SICI)1521-4184(199912)332:12<439::AID-ARDP439>3.0.CO;2-5   DOI
13 M. Kim, "Compatibility Study of Excipients for Pravastatin Tablet", Journal of Life Science, Vol.28, pp.472-477, 2018. DOI: https://doi.org/10.5352/JLS.2018.28.4.472   DOI
14 P. Tian, F. Yang, L. P. Yu, M. M. Lin, W. Lin et al., "Applications of excipients in ther field of 3D printed pharmaceuticals:,. Drug Development and Industrial Pharmacy, Veol.45, pp.905-913, 2019. DOI: https://doi.org/10.1080/03639045.2019.1576723   DOI
15 K. Cho, Y. Choi, J. Kang, H. Choi, C. Y. J. Park et al., "Development of a novel combination table containing trimebutine maleate and mosaprid citrate for the treatment of functional dyspepsia", International Journal of Pharmaceutics, Vol.400, pp.145-152, 2010. DOI: https://doi.org/10.1016/j.ijpharm.2010.08.047   DOI
16 H. T. Lim, P. Balakrishnan, D. Oh, K. Joe, Y. Kim et al., "Development of novel sibutramine base-loaded solid dispersion with gelatin and HPMC: Physicochemical characterization and pharmacokenetics in beagle dogs", International Journal of Pharmaceutics, Vol.397, pp.225-230, 2010. DOI: https://doi.org/10.1016/j.ijpharm.2010.07.013   DOI