Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Preparation and Dissolution Characteristics of Sustained Release Granules Containing Indapamide

인다파마이드가 함유된 서방형 과립의 제조 및 용출 특성

  • Park, Ji-Seon (College of Pharmacy, Chungnam National University) ;
  • Seo, Hui (College of Pharmacy, Chungnam National University) ;
  • Kim, Byung-Jin (Center for Drug Discovery Technologies, Korea Research Institute of Chemical Technology) ;
  • Jeong, Sang-Young (College of Pharmacy, Chungnam National University) ;
  • Shin, Byung-Cheol (Center for Drug Discovery Technologies, Korea Research Institute of Chemical Technology) ;
  • Yuk, Sun-Hong (Center for Drug Discovery Technologies, Korea Research Institute of Chemical Technology) ;
  • Hwang, Sung-Joo (College of Pharmacy, Chungnam National University) ;
  • Cho, Sun-Hang (Center for Drug Discovery Technologies, Korea Research Institute of Chemical Technology)
  • 박지선 (충남대학교 약학대학 제제공학실) ;
  • 서희 (충남대학교 약학대학 제제공학실) ;
  • 김병진 (한국화학연구원 신약기반기술연구센터) ;
  • 정상영 (충남대학교 약학대학 제제공학실) ;
  • 신병철 (한국화학연구원 신약기반기술연구센터) ;
  • 육순홍 (한국화학연구원 신약기반기술연구센터) ;
  • 황성주 (충남대학교 약학대학 제제공학실) ;
  • 조선행 (한국화학연구원 신약기반기술연구센터)
  • Published : 2008.04.21
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Abstract

Indapamide (4-chloro-N-(2-methyl-1-indolinyl)-3-sulfamoyl-benz-amide) is an oral antihypertensive diuretic agent indicated for the treatment of hypertensive. The diuretic and natriuretic effects are mainly due to the structure of o-chlorobenzenesulfonamide. The objective of this study was to formulate sustained release indapamide granules and assess their formulation variables. Granules were prepared by fluid bed coating method and consist of drug layer and membrane layer. The granules were coated with HPC and ethyl cellulose along with plasticizer dibuthyl sebacate. The release of indapamide depended on the type of Eudragit such as RS and NE 30 D used in the formulation controlled release layer. These results obtained clearly suggest that the sustained release oral delivery system for indapamide could be designed with satisfying drug release profile approved.

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References

  1. G. Khang, J.C. Cho, J.W. Lee, J.M. Rhee and H.B. Lee, Preparation and characterization of Japanese encephalitis virus vaccine loaded poly(L-lactide-co-glycolide) microspheres for oral immunization, Bio-Med. Mater. Eng., 9, 49-59 (1999)
  2. J.C. Cho, G. Khang, H.S. Choi, J.M. Lee and H.B. Lee, Preparation of biodegradable PLGA microspheres for sustained local anesthesia and their in vitro release behavior, polymer (Korea), 24(5), 728-735 (2000)
  3. G. Khang, H.S Choi, J.C. Cho, S.C. Yoon, J.M. Rhee and H.B. Lee, Controlled release of gentamicin sulfate from poly(3-hydroxy -butyrate-co-3-hydroxyvalenrate) wafers for the treatment of osteomyelitis, Korea polymer J., 8(6), 253-260 (2000)
  4. G. Khang, S.W. Kim, J.C. Cho, J.M. Rhee, S.C. Yoon, and H.B. Lee, Preparation and characterization of poly(3-hydroxybutyrate-co-3-hydroxyvalenrate) microspheres for the sustained release of 5-fluorouracil, Bio-Med. Mater. Eng., 11, 89-103 (2001)
  5. D. Stephens, L. Li, D. Robinson, S. Chen, H. Chang, R.M. Liu, Y. Tian, E.J. Ginsburg, X. Gao and T. Stultz, Investigation of the in vitro release of gentamicin from a polyanhydride matrix, J. Control. Rel., 63, 305-317 (2000) https://doi.org/10.1016/S0168-3659(99)00205-9
  6. Y. Ikada, S. H. Hyon, K. Jamshidi, S. Higashi, T. Yamamuro, Y. Katutani and T. Kitsugi, Release of antibiotic from composites of hydroxyapatite and poly(lactic acid), J. Control. Rel., 2, 179-186 (1985) https://doi.org/10.1016/0168-3659(85)90043-4
  7. G. Khang, J.H. Lee, J.W. Lee, J.C. Cho, and H.B. Lee, Preparation and characterization of poly(L-lactide-coglycolide) microspheres for the sustained release of AZT, Korea polymer J., 8(2), 80-88 (2000)
  8. S.W. Kim, G. Khang, J.M. Rhee and H.B. Lee, Effect of cosolvents on release profiles of 5-fluorouracil loaded poly(3-hydro-xybutyrate-co-3-hydroxyvarelate) microspheres, Macromol. Chem. Symp., 14, 108-119 (2001)
  9. M.K. Choi, G. Khang, I.W. Lee, J.M. Rhee and H.B. Lee, Fabrication and characterization of porous PLLA scaffolds with gentamicin sulfate release system, Polymer(Korea), 3, 318-326 (2001)
  10. B.J. Lee and G.H. Min, Oral controlled released of melatonin using polymer reinforced and coated alginate beads, Int. J. Pharm., 212, 63-71 (2001) https://doi.org/10.1016/S0378-5173(00)00598-6
  11. T.-J. Hang, W. Zhao, J. Liu, M. Song, Y. Xie, Z. Zhang, J. Shen and Y. Zhang, A selective HPLC method for the determination of indapamide in human whole blood: Application to a bioequivalence study in Chinese volunteers, J. Pharmaceutical and Biomedical Analysis, 40, 202-205 (2006) https://doi.org/10.1016/j.jpba.2005.06.035
  12. I. Suslu and S. Altinoz, Two derivative spectrophotometric determinations of indapamide in pharmaceutical dosage forms, J. Pharmaceutical and Biomedical Analysis, 30, 357-364 (2002) https://doi.org/10.1016/S0731-7085(02)00328-X
  13. D. Zendelovska, T. Stafilov and M. Stefova, Optimization of a solid-phase extraction method for determination of indapamide in biological fluids using high-performance liquid chromatography, J. Chromatography B., 788, 199-206 (2003) https://doi.org/10.1016/S1570-0232(02)01017-6
  14. D. S. Jane, G. Subbaiah, M. Sanyal, U. C. Pande and P. Shrivastav, Liquid chromatography-tandem mass spectrometry validated method for the estimation of indapamide in human whole blood, J. Chromatography B., 834, 149-154 (2006) https://doi.org/10.1016/j.jchromb.2006.02.040