Comparison of dissolution profile characteristics of 11 berberine hydrochloride tablet brands in different dissolution media

doi:10.5246/jcps.2020.02.008

Abstract

Abstract:

Berberine hydrochloride is commonly used to treat bacterial dysentery, gastroenteritis and other diseases. Many manufacturers are available on the market today, while the production process and formulation are quite different, which may directly affect the therapeutic effect of the drug. To this end, 11 different production producers of berberine hydrochloride tablets were collected according to the pharmacopeia berberine hydrochloride dissolution method (basket method). In addition, the dissolution process was carried out in four elution media with different pH, and the difference was similar (f₂). Factors were calculated to evaluate in vitro dissolution requirements, and in vitro dissolution of different manufacturers of berberine hydrochloride tablets was determined by high performance liquid chromatography (HPLC). The method was verified by linearity, precision, stability and robustness. Based on the f₂ value, there was a significant difference in the dissolution behavior of the formulations of most berberine hydrochloride tablet brands. This research provided the basis for further in-depth research in the later period. Although the drug specifications (0.1 g) were the same, the dissolution curve was different. This phenomenon may be attributed to the fact that the excipients and crystal form of the tablets affected the release and dissolution of the tablets in vitro.

Key words: Berberine hydrochloride, Tablet, Dissolution, HPLC analysis, Method validation, In vitro test

CLC Number:

R944

Supporting:

Fei Yu, Wenli Zhou, Jiayi Kan, Can Peng. Comparison of dissolution profile characteristics of 11 berberine hydrochloride tablet brands in different dissolution media[J]. Journal of Chinese Pharmaceutical Sciences, 2020, 29(2): 102-112.

References

[1] Jia, B.X.; Li, Y.Q.; Wang, D.C.; Duan, R. Study on the interaction of β-cyclodextrin and berberine hydrochloride and its analytical application. PLoS One. 2014, 9, e95498.

[2] Wen, A.L.; Peng, X.X.; Zhang, P.P.; Long, Y.F.; Gong, H.M.; Xie, Q.R.; Yue, M.; Chen, S. Spectrofluorometric determination of berberine using a novel Au nanocluster with large Stokes shift. Anal. Bioanal. Chem. 2018, 410, 6489-6495.

[3] Tan, W.; Li, Y.B.; Chen, M.W.; Wang, Y.T. Berberine hydrochloride: anticancer activity and nanoparticulate delivery system. Int. J. Nanomedicine. 2011, 6, 1773-1777.

[4] Zhu, T.Y.; Wang, Y.D.; Kong, H.W. Clinical study on Berberine Hydrochloride Tablets combined with mesalazine in treatment of distal ulcerative colitis. Drugs Clin. 2018, 33, 3183-3186.

[5] Guo, S.J.; Wang, Y.P.; Fu, S.J.; Zhang, Z.M.; Xu, Q.Q.; Determination of Berberine Hydrochloride Content in Qingwen Baidu Granule by HPLC. Anim. Husb. Feed Sci. 2014, 6, 27-30.

[6] Wang, D.; Xu, Q.L.; Zuo, D.; Xiong, H.L. Determination of berberine hydrochloride in Shihu yeguang pills by HPLC. Med. Plant. 2010, 1, 74-75, 78.

[7] Nie, L.R.; Song, H.; Yohannes, A.; Liang, S.W.; Yao, S. Extraction in cholinium-based magnetic ionic liquid aqueous two-phase system for the determination of berberine hydrochloride in Rhizoma coptidis. RSC Adv. 2018, 8, 25201-25209.

[8] Wagner, D.; Glube, N.; Berntsen, N.; Tremel, W.; Langguth, P. Different dissolution media lead to different crystal structures of talinolol with impact on its dissolution and solubility. Drug Dev. Ind. Pharm. 2003, 29, 891-902.

[9] Desai, D.; Wong, B.; Huang, Y.D.; Tang, D.; Hemenway, J.; Paruchuri, S.; Guo, H.; Hsieh, D.; Timmins, P. Influence of dissolution media pH and USP1 basket speed on erosion and disintegration characteristics of immediate release metformin hydrochloride tablets. Pharm. Dev. Technol. 2015, 20, 540-545.

[10] Kovačič, N.N.; Pišlar, M.; Ilić, I.; Mrhar, A.; Bogataj, M. Influence of the physiological variability of fasted gastric pH and tablet retention time on the variability of in vitro dissolution and simulated plasma profiles. Int. J. Pharm. 2014, 473, 552-559.

[11] Hoti, E.; Censi, R.; Ricciutelli, M.; Malaj, L.; Barboni, L.; Martelli, S.; Valleri, M.; Di Martino, P. Validation of an HPLC-MS method for rociverine tablet dissolution analysis. J. Pharm. Biomed. Anal. 2008, 47, 422-428.

[12] Ji, J.; He, X.; Yang, X.L.; Du, W.J.; Cui, C.L.; Wang, L.; Wang, X.; Zhang, C.F.; Guo, C.R. The in vitro/vivo evaluation of prepared gastric floating tablets of berberine hydrochloride. AAPS PharmSciTech. 2017, 18, 2149-2156.

[13] Paim, C.S.; Martins, M.T.; Malesuik, M.D.; Steppe, M. LC determination of entacapone in tablets: in vitro dissolution studies. J. Chromatogr. Sci. 2010, 48, 755-759.

[14] Huang, J.; Goolcharran, C.; Ghosh, K. A Quality by Design approach to investigate tablet dissolution shift upon accelerated stability by multivariate methods. Eur. J. Pharm. Biopharm. 2011, 78, 141-150.

[15] Box, K.J.; Comer, J.; Taylor, R.; Karki, S.; Ruiz, R.; Price, R.; Fotaki, N. Small-scale assays for studying dissolution of pharmaceutical cocrystals for oral administration. AAPS PharmSciTech. 2016, 17, 245-251.

[16] Rachid, O.; Rawas-Qalaji, M.; Simons, F.E.; Simons, K.J. Dissolution testing of sublingual tablets: a novel in vitro method. AAPS PharmSciTech. 2011, 12, 544-552.

[17] Kraemer, J.; Gajendran, J.; Guillot, A.; Schichtel, J.; Tuereli, A. Dissolution testing of orally disintegrating tablets. J. Pharm. Pharmacol. 2012, 64, 911-918.

[18] Ferrero, C.; Jiménez-Castellanos, M.R. In vitro release testing of matrices based on starch-methyl methacrylate copolymers: effect of tablet crushing force, dissolution medium pH and stirring rate. Int. J. Pharm. 2014, 461, 270-279.

[19] Maezawa, K.; Yajima, R.; Terajima, T.; Kizu, J.; Hori, S. Dissolution profile of 24 levofloxacin (100 mg) tablets. J. Infect. Chemother. 2013, 19, 996-998.

[20] Yuce, M.; Capan, Y. Development and validation of hplc analytical methods used-for determination of assay, content uniformity and dissolution of immediate release candesartan cilexetil 32 Mg tablets. Acta Pol. Pharm. 2017, 74, 357-367.

[21] Hussain, A.; Qureshi, F.; Abbas, N.; Arshad, M.S.; Ali, E. An evaluation of the binding strength of okra gum and the drug release characteristics of tablets prepared from it. Pharmaceutics. 2017, 9, E20.

[22] Simionato, L.D.; Petrone, L.; Baldut, M.; Bonafede, S.L.; Segall, A.I. Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina. Saudi Pharm. J. 2018, 26, 578-584.

[23] Gabbott, I.P.; Al Husban, F.; Reynolds, G.K. The combined effect of wet granulation process parameters and dried granule moisture content on tablet quality attributes. Eur. J. Pharm. Biopharm. 2016, 106, 70-78.

[24] Guo, H.; Zhang, Z.; Yao, Y.; Liu, J.L.; Chang, R.R.; Liu, Z.; Hao, H.Y.; Huang, T.H.; Wen, J.; Zhou, T.T. A new strategy for statistical analysis-based fingerprint establishment: Application to quality assessment of Semen sojae praeparatum. Food Chem. 2018, 258, 189-198.

[25] Kassahun, H.; Asres, K.; Ashenef, A. In vitro and in vivo quality evaluation of glibenclamide tablets marketed in Addis Ababa, Ethiopia. J. Pharm. (Cairo). 2018, 1-7.

[26] Grube, A.; Gerlitzki, C.; Brendel, M. Dissolution or disintegration - substitution of dissolution by disintegration testing for a fixed dose combination product. Drug Dev. Ind. Pharm. 2019, 45, 130-138.

[27] Nickerson, B.; Kong, A.; Gerst, P.; Kao, S.M. Correlation of dissolution and disintegration results for an immediate-release tablet. J. Pharm. Biomed. Anal. 2018, 150, 333-340.

[28] Stumpf, F.; Keck, C.M. Tablets made from paper. Int. J. Pharm. 2018, 548, 812-819.

[29] Mayock, S.P.; Saim, S.; Fleming, A.B. In vitro drug release after crushing: evaluation of xtampza® ER and other ER opioid formulations. Clin. Drug Investig. 2017, 37, 1117-1124.

[30] Franc, A.; Muselík, J.; Zeman, J.; Lukášová, I.; Kurhajec, S.; Bartoníčková, E.; Galvánková, L.; Mika, F.; Dominik, M.; Vetchý, D. The effect of amorphous and crystal sodium warfarin and its content uniformity on bioequivalence of tablets. Eur. J. Pharm. Sci. 2018, 125, 120-129.

[31] Braig, V.; Konnerth, C.; Peukert, W.; Lee, G. Enhanced dissolution of naproxen from pure-drug, crystalline nanoparticles: A case study formulated into spray-dried granules and compressed tablets. Int. J. Pharm. 2019, 554, 54-60.