Improved pH-dependent drug release and oral exposure of telmisartan, a poorly soluble drug through the formation of drug-aminoclay complex

International Journal of Pharmaceutics

Volumn 471, Issue 1-2, 2014, Pages 258-263

  Yang, Liang ^a   Shao, Yating ^a   Han, Hyo Kyung ^a  

^a Dongguk University   (South Korea)

Author keywords

3 Aminopropyl functionalized magnesium phyllosilicate; Aminoclay; Dissolution; Oral exposure; Telmisartan

Indexed keywords

AMINOCLAY; SILICATE; TELMISARTAN; UNCLASSIFIED DRUG; BENZIMIDAZOLE DERIVATIVE; BENZOIC ACID DERIVATIVE; DRUG CARRIER; GAMMA-AMINOPROPYLTRIETHOXYSILANE; MAGNESIUM CHLORIDE; SILANE DERIVATIVE;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; DRUG STRUCTURE; DRUG SYNTHESIS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INFRARED SPECTROSCOPY; MALE; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; PH; PRECIPITATION; PRIORITY JOURNAL; RAT; STATIC ELECTRICITY; TRANSMISSION ELECTRON MICROSCOPY; X RAY DIFFRACTION; ANIMAL; BLOOD; CHEMISTRY; MEDICINAL CHEMISTRY; ORAL DRUG ADMINISTRATION; SOLUBILITY; SPRAGUE DAWLEY RAT; TISSUE DISTRIBUTION;

ADMINISTRATION, ORAL; ANIMALS; BENZIMIDAZOLES; BENZOATES; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CARRIERS; DRUG LIBERATION; HYDROGEN-ION CONCENTRATION; MAGNESIUM CHLORIDE; MALE; RATS, SPRAGUE-DAWLEY; SILANES; SOLUBILITY; SPECTROSCOPY, FOURIER TRANSFORM INFRARED; TISSUE DISTRIBUTION;

EID: 84901819075     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2014.05.009     Document Type: Article

References (28)

1. A. Aoki, T. Ogawa, H. Sumino, H. Kumakura, Y. Takayama, S. Ichikawa, and K. Nitta Long-term effects of telmisartan on blood pressure, the renin-angiotensin-aldosterone system, and lipids in hypertensive patients Heart Vessels 25 2010 195 202
2. K. Datta, A. Achari, and M. Eswaramoorthy Aminoclay: a functional layered material with multifaceted applications J. Mater. Chem. A 1 2013 6707 6718
3. R. Dukeck, P. Sieger, and P. Karmwar Investigation and correlation of physical stability, dissolution behaviour and interaction parameter of amorphous solid dispersions of telmisartan: a drug development perspective Eur. J. Pharm. Sci. 49 2013 723 731
4. H.K. Han, Y.C. Lee, M.Y. Lee, A.J. Patil, and H.J. Shin Magnesium and calcium organophyllosilicates: synthesis and in vitro cytotoxicity study ACS Appl. Mater. 3 2011 2564 2572
5. S.C. Holmström, A.J. Patil, M. Butler, and S. Mann Influence of polymer co-intercalation on guest release from aminopropyl-functionalized magnesium phyllosilicate mesolamellar nanocomposites J. Mater. Chem. 17 2007 3894 3900 (Pubitemid 47429127)
6. D. Hörter, and J. Dressman Influence of physicochemical properties on dissolution of drugs in the gastrointestinal tract Adv. Drug Deliv. Rev. 46 2001 75 87
7. Y. Kawabata, K. Wada, M. Nakatani, S. Yamada, and S. Onoue Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system: Basic approaches and practical applications Int. J. Pharm. 420 2011 1 10
8. Y.C. Lee, E.J. Kim, D.A. Ko, and J.W. Yang Water-soluble organo-building blocks of aminoclay as a soil-flushing agent for heavy metal contaminated soil J. Hazard. Mater. 196 2011 101 108
9. Y.C. Lee, E.J. Kim, J.W. Yang, and H.J. Shin Removal of malachite green by adsorption and precipitation using aminopropyl functionalized magnesium phyllosilicate J. Hazard. Mater. 192 2011 62 70
10. P. Lepek, W. Sawicki, K. Wlodarski, Z. Wojnarowska, M. Paluch, and L. Guzik Effect of amorphization method on telmisartan solubility and the tableting process Eur. J. Pharm. Biopharm. 83 2013 114 121
11. S. Li, S. Wong, S. Sethia, H. Almoazen, Y.M. Joshi, and A.T. Serajuddin Investigation of solubility and dissolution of a free base and two different salt forms as a function of pH Pharm. Res. 22 2005 628 635 (Pubitemid 40603261)
12. N. Marasini, T.H. Tran, B.K. Poudel, H.J. Cho, Y.K. Choi, S.C. Chi, H.G. Choi, C.S. Yong, and J.O. Kim Fabrication and evaluation of pH-modulated solid dispersion for telmisartan by spray-drying technique Int. J. Pharm. 441 2013 424 432
13. J.E. Martin, A.J. Patil, M.F. Butler, and S. Mann Guest-molecule-directed assembly of mesostructured nanocomposite polymer/organoclay hydrogels Adv. Funct. Mater. 21 2011 674 681
14. Nakatani, M., Ohki, T., Takeshi, S., Toyoshima, K., 2003. Solid telmisartan pharmaceutical formulations. US Patent 2004/0110813 A1.
15. J. Park, W. Cho, K.-H. Cha, J. Ahn, K. Han, and S.-J. Hwang Solubilization of the poorly-water soluble drug, telmisartan, using supercritical anti-solvent (SAS) process Int. J. Pharm. 441 2012 50 55
16. A.J. Patil, M. Li, E. Dujardin, and S. Mann Novel bioinorganic nanostructures based on mesolamellar intercalation or single-molecule wrapping of DNA using organoclay building blocks Nano Lett. 7 2007 2660 2665 (Pubitemid 47522418)
17. A.J. Patil, E. Muthusamy, and S. Mann Synthesis and self-assembly of organoclay-wrapped biomolecules Angew. Chem. Int. Ed. 43 2004 4928 4933 (Pubitemid 39312144)
18. T. Riis, A. Bauer-Brandl, T. Wagner, and H. Kranz pH-independent drug release of an extremely poorly soluble weakly acidic drug from multiparticulate extended release formulations Eur. J. Pharm. Biopharm. 65 2007 78 84 (Pubitemid 44827687)
19. S. Sadasivan, A.J. Patil, K.M. Bromley, P.G.R. Hastie, G. Banting, and S. Mann Novel protein-inorganic nanoparticles prepared by inorganic replication of self-assembled clathrin cages and triskelia Soft Matter 4 2008 2054 2058
20. M. Shimasaki, K. Yamashita, R. Imanishi, K. Yokoyama, M. Kuritani, Y. Oiwa, and T. Igarashi Pharmacokinetics of 14C-telmisatran (1). Absorption, distribution and protein binding of 14C-telmisartan after a single oral administration to rats Drug Metab. Pharmacokinet. 14 1999 425 431
21. M. Sangwai, and P. Vavia Amorphous ternary cyclodextrin nanocomposites of telmisartan for oral drug delivery: improved solubility and reduced pharmacokinetic variability Int. J. Pharm. 453 2013 423 432
22. S. Siepe, B. Lueckel, A. Kramer, A. Ries, and R. Gurny Strategies for the design of hydrophilic matrix tablets with controlled microenvironmental pH Int. J. Pharm. 316 2006 14 20 (Pubitemid 44226313)
23. P.H.L. Tran, H.T.T. Tran, and B.-J. Lee Modulation of microenvironmental pH and crystallinity of ionizable telmisartan using alkalizers in solid dispersions for controlled release J. Control. Release 129 2008 59 65
24. P.H. Tran, T.T. Tran, K.H. Lee, D.J. Kim, and B.J. Lee Dissolution-modulating mechanism of pH modifiers in solid dispersion containing weakly acidic or basic drugs with poor water solubility Expert Opin. Drug Deliv. 7 2010 647 661
25. P.H.-L. Tran, T.T.-D. Tran, J.-B. Park, D.H. Min, H.-G. Choi, H.-K. Han, Y.-S. Rhee, and B.-J. Lee Investigation of physicochemical factors affecting the stability of a pH-modulated solid dispersion and a tablet during storage Int. J. Pharm. 414 2011 48 55
26. T. Vasconcelos, B. Sarmento, and P. Costa Solid dispersions as strategy to improve oral bioavailability of poor water soluble drugs Drug Discov. Today 12 2007 1068 1075 (Pubitemid 350186132)
27. L. Yang, S.-K. Choi, H.-J. Shin, and H.-K. Han 3-Aminopropyl functionalized magnesium phyllosilicate as an organoclay based drug carrier for improving the bioavailability of flurbiprofen Int. J. Nanomed. 8 2013 4147
28. Y. Zhang, Z. Zhi, T. Jiang, J. Zhang, Z. Wang, and S. Wang Spherical mesoporous silica nanoparticles for loading and release of the poorly water-soluble drug telmisartan J. Control. Release 145 2010 257 263