Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Preparation and Release Characterization of Osmotic Granule Nifedipine Delivery System

니페디핀 삼투성 과립 시스템의 제조와 약물 방출 특성

  • Jeong, Sung-Chan (Department of Polymer Engineerng, Pukyung National University) ;
  • Cho, Young-Ho (Department of Polymer.Nano Science and Technology, Chonbuk National University) ;
  • Lee, Soo-Young (Department of Polymer Engineerng, Pukyung National University) ;
  • Lee, Bong (Department of Polymer Engineerng, Pukyung National University) ;
  • Kim, Moon-Suk (Nanobiomaterials Laboratory, Korea Research Institute of Chemical Technology) ;
  • Kang, Gil-Son (Department of Polymer.Nano Science and Technology, Chonbuk National University) ;
  • Lee, Hai-Bang (Nanobiomaterals Laboratory, Korea Research Institute of Chemical Technology)
  • 정성찬 (부경대학교 고분자공학과) ;
  • 조영호 (전북대학교 고분자.나노공학과) ;
  • 이수영 (부경대학교 고분자공학과) ;
  • 이봉 (부경대학교 고분자공학과) ;
  • 김문석 (한국화학연구원 생체의료고분자팀) ;
  • 강길선 (전북대학교 고분자.나노공학과) ;
  • 이해방 (한국화학연구원 생체의료고분자팀)
  • Published : 2006.02.20
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Abstract

The objective of this study was to confirm the effect of the type of dissolution media and paddle speed on nifedipine (ND) release profile from osmotic granule and the storage stability. Osmotic granule was manufactured by fluidized bed coating method. At each coating step, morphology of osmotic granule was differed. The size of osmotic granule was $750\;{\mu}m$ at 3 wt% membrane thickness. ND release was changed in diverse dissolution media, paddle speed. ND release is governed by not only osmotic pressure but diffusion from osmotic granule. ND release from osmotic granule decreased as storage period increased. These may be caused by liquid excipient which has low molecular weight. Storage stability of osmotic granule could be improved by removing liquid excipient from semipermeable membrane.

Keywords

References

  1. I. Niopas and A.C. Daftsios, Determination of nifedipine in human plasma by solid-phase extraction and high-performance liquid chromatography: validation and application to pharmacokinetic studies, J. Pharm. Biomed. Anal., 32, 1213-1218 (2003) https://doi.org/10.1016/S0731-7085(03)00162-6
  2. P.S.L. Wong, B.L. Barclay, J.C. Deters and F. Theeuwes, Osmotic device for administering certain drugs, U.S. Patent 4,765,989 (1986)
  3. L. Liu, G Khang, J.M. Rhee and H.B. Lee, Preparation and characterization of cellulose acetate membrane for monolitic osmotic tablet, Korea Polym. J., 7, 289-296 (1999)
  4. L. Liu, G Khang, J.M. Rhee and H.B. Lee, Osmotic-suspending delivery of monolitic tablet of nifedipine, Biomater. Res., 3, 47-53 (1999)
  5. L. Liu, G Khang, J.M. Rhee and H.B. Lee, Sandwiched osmotic tablet core for nifedipine controlled delivery, Bio-Med. Mater. Eng., 9, 297-310 (1999)
  6. L. Liu, G Khang, J.M. Rhee and H.B. Lee, Monolitic osmotic tablet system for nifedipine delivery, J. Control. Rel., 67, 309-322 (2000) https://doi.org/10.1016/S0168-3659(00)00222-4
  7. L. Liu, J. Ku, G Khang, B. Lee, J.M. Rhee and H.B. Lee, Nifedipine controlled delivery by sandwiched osmotic tablet system, J. Control. Rel., 68, 145-150 (2000) https://doi.org/10.1016/S0168-3659(00)00243-1
  8. G Khang, J. Ku, B. Lee, and H.B. Lee, Controlled release of nifedipine by osmotic tablet, Biomater. Res., 4, 20-24 (2000)
  9. D. H. Lee, G Khang, and H.B. Lee, Squeeze osmotic tablet for nifedipine controlled release, Biomater. Res., 5, 1-9 (2001)
  10. L. Lui, G Khang, J.M. Rhee and H.B. Lee, Sandwiched osmotic pump tablet for controlled release of water-insoluble drug, Acta Pharm. Sinica, 38(8), 620-623 (2003)
  11. L. Lui, Q. Xu, G Khang, J.M. Rhee and H.B. Lee, Unitarycore osmotic pump tablet for controlled release of water-insoluble drug, Acta Pharm. Sinica, 38, 966-967 (2003)
  12. J. Siepmann, F. Lecomte and R. Bodmeirer, Diffusion-controlled drug delivery systems: calculation of the required composition to achieve desired release profiles, J. Control. Rel., 60, 379-389 (1999) https://doi.org/10.1016/S0168-3659(99)00093-0
  13. P. Rama Rao, and P.V. Diwan, Permeability studies of cellulose acetate free films for transdermal use: Influence of plasticizers, Pharm. Acta Helv., 72, 47-51 (1997) https://doi.org/10.1016/S0031-6865(96)00060-X
  14. M.F. Saettone, G Perini, P. Rijli, L. Rodriguez, and M. Cini, Effect of different polymer-plasticizer combinations on 'in vitro' release of theophylline from coated pellets, Int. J. Pharm., 126, 83-88 (1995) https://doi.org/10.1016/0378-5173(95)04099-4
  15. R.C. Rowe, A.D. Kotaras, and E.F.T. White, An evaluation of the plasticizing efficiency of the dialkyl phthalates in ethyl cellulose films using the torsional braid pendulum, Int. J. Pharm., 22, 57-62 (1984) https://doi.org/10.1016/0378-5173(84)90045-0
  16. J.C. Gutierrez-Rocca, and J.W. McGinity, Influence of water soluble and insoluble plasticizers on the physical and mechanical properties of acrylic resin copolymers, Int. J. Pharm., 103, 293-301 (1994) https://doi.org/10.1016/0378-5173(94)90180-5
  17. S.C. Jeong, S.K. Chon, Y.H. Jo, M.S. Kim, B. Lee, G Khang and H.B. Lee, The effect of bead size and drug solubility on drug release from osmotic granule delivery system for nifedipine, Polymer(Korea), 29(3), 288-293 (2005)