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Evolution of the Patent for Osmotic Drug Delivery

삼투정을 이용한 약물전달기술 특허의 진화과정

  • Lee, Hai-Bang (Biomaterials Laboratory, Korea Research Institutes of Chemical Technology) ;
  • Lee, Dong-Hun (Department of Polymer Science and Technology, Chonbuk National University) ;
  • Kang, Bok-Ki (Department of Polymer Science and Technology, Chonbuk National University) ;
  • Jeung, Sang-Young (Biomaterials Laboratory, Korea Research Institutes of Chemical Technology) ;
  • Khang, Gil-Son (Department of Polymer Science and Technology, Chonbuk National University)
  • 이해방 (한국화학연구원 생체의료고분자팀) ;
  • 이동헌 (전북대학교 고분자공학과) ;
  • 강복기 (전북대학교 고분자공학과) ;
  • 정상영 (한국화학연구원 생체의료고분자팀) ;
  • 강길선 (전북대학교 고분자공학과)
  • Published : 2002.12.20

Abstract

Such osmotic drug delivery systems are based on osmosis, the diffusion of water transversely from a medium with a low osmotic pressure to a medium with a high osmotic pressure for the controlled delivery of active agents. In this review, U.S. Patents on osmotic drug delivery analyze 261 patents until December 2001. These devices form now a major market of drug delivery products. Because of their advantage and innovate idea, it appears that the future of oral drug delivery mark,εt in Korea is promising.

Keywords

References

  1. L. Perkins, C. Peer and V. Fleming, Pumps/osmotic-alzet system : In Encyclopedia of Controlled Drug Delivery, Vol. 2, E. Mathiowitz (Ed.), Wiley, New York, U.S.A, pp. 900-906 (1999).
  2. J. Magruder, Pumps/osmotic-VITS veterinary implant : In Encyclopedia of Controlled Drug Delivery, Vol. 2, E. Mathiowitz (Ed.), Wiley, New York, U.S.A, pp. 906-909 (1999).
  3. J.C. Wright, C.L. Stevenson and G.R. Stewart, Pumps/osmotic-DUROS osmotic implant for humans : In Encyclopedia of Controlled Drug Delivery, Vol. 2, E. Mathiowitz (Ed.), Wiley, New York, U.S.A, pp. 909-915 (1999)
  4. J. Wright, Pumps/osmotic-ruminal osmotic bolus : In Ency- clopedia of Controlled Drug Delivery, Vol. 2, E. Mathiowitz (Ed.), Wiley, New York, U.S.A, pp. 915-920 (1999)
  5. F. Theeuwes, P.S.L. Wong, T.L. Burkoth and D.A. Fox, Osmotic systems for colon-targeted drug delivery : In Colonic Drug Absorption and Metabolism, P.R. Bieck (Ed.), Marcel Dekker, New York, U.S.A, pp. 137-158 (1993)
  6. A. Amkraut, J.B. Eckenhoff and K. Nichols, Osmotic delivery of peptides and macromolecules, Adv. Drug Deliv. Rev., 4, 255-276 (1990) https://doi.org/10.1016/0169-409X(89)90021-5
  7. G. Santus and R.W. Baker, Osmotic drug delivery: A review of the patent literature, J. Control. Release, 35, 1-21 (1995) https://doi.org/10.1016/0168-3659(95)00013-X
  8. B. Eckenhoff, F. Theeuwes and J. Urquhart, Osmotically actuated dosage forms for rate-controlled drug delivery, Pharm. Tech., 5, 35-44 (1981)
  9. F. Theeuwes, Elementary osmotic pump, J. Pharm. Sci., 64, 1987-1991 (1975) https://doi.org/10.1002/jps.2600641218
  10. F. Theeuwes, D. Swanson, P. Wong, P. Bonsen, V. Place, K. Heimlich and K.C. Kwan, Elementary osmotic pump for indomethacin, J. Pharm. Sci., 72, 253-258 (1983) https://doi.org/10.1002/jps.2600720313
  11. F. Theeuwes, D.R. Swanson, G. Guittard, A. Ayer and S. Khanna, Osmotic delivery systems for the beta-adrenoceptor antagonists metoprolol and oxprenolol: design and evaluation of systems for once-daily administration, Br. J. Clin. Pharmacol., 19, 69-76 (1985) https://doi.org/10.1111/j.1365-2125.1985.tb02745.x
  12. R.K. Verma, B. Mishra and S. Garg, Osmotically controlled oral drug delivery, Drug Dev. Ind. Pharm., 26, 695-708 (2000) https://doi.org/10.1081/DDC-100101287
  13. D.R. Swanson, B.L. Barclay, P.S.L. Wong and F. Theeuwes, Nifedipine gastrointestinal therapeutic system, Am. J. Med. (Suppl. 6B), 83, 3-9 (1987)
  14. G.M. Zentner, G.S. Rork and K.J. Himmelstein, The controlled porosity osmotic pump, J. Control. Release, 1, 269-282 (1985) https://doi.org/10.1016/0168-3659(85)90003-3
  15. P. Schultz, I. Tho and P. Kleinebudde, A new multiparticulate delayed release system. Part II. Coating formulation and properties of free films, J. Control. Release, 47, 191-199 (1997) https://doi.org/10.1016/S0168-3659(97)01635-0
  16. S.M. Herbig, J.R. Cardinal, R.W. Korsmeyer and K.L. Smith, Asymmetric membrane tablet coatings for osmotic drug delivery, J. Control. Release, 35, 127-136 (1995) https://doi.org/10.1016/0168-3659(95)00028-7
  17. A.G. Thombre, J.R. Cardinal, A.R. DeNoto, S.M. Herbig and K.L. Smith, Asymmetric membrane capsules for osmotic drug delivery I. Development of a manufacturing process, J. Control. Release, 57, 55-64 (1999) https://doi.org/10.1016/S0168-3659(98)00100-X
  18. A.G. Thombre, J.R. Cardinal, A.R. DeNoto and D.C. Gibbes, Asymmetric membrane capsules for osmotic drug delivery II. In vitro and in vivo drug release performance, J. Control. Release, 57, 65-73 (1999) https://doi.org/10.1016/S0168-3659(98)00101-1
  19. G.M. Zentner, G.S. Rork and K.J. Himmelstein, Osmotic flow through controlled porosity films: An approach to delivery of water soluble compounds, J. Control. Release, 2, 217-229 (1985) https://doi.org/10.1016/0168-3659(85)90047-1
  20. G.A. McClelland, S.C. Sutton, K. Engle and G.M. Zentner, The solubility-modulated osmotic pump: In vitro/in vivo release of diltiazem hydrochloride, Pharm. Res., 8, 88-92 (1991) https://doi.org/10.1023/A:1015890525495
  21. G.M. Zentner, G.A. McClelland and S.C. Sutton, Controlled porosity solubility- and resin-modulated osmotic drug delivery systems for release of diltiazem hydrochloride, J. Control. Release, 16, 237-244 (1991) https://doi.org/10.1016/0168-3659(91)90047-H
  22. R.K. Verma and B. Mishra, Studies on formulation and evaluation of oral osmotic pumps of nimesulide, Pharmazie, 54, 74-75 (1999).
  23. A.G. Thombre, A.R. DeNoto and D.C. Gibbes, Delivery of glipizide from asymmetric membrane capsules using encap- sulated excipients, J. Control. Release, 60, 333-341 (1999) https://doi.org/10.1016/S0168-3659(99)00086-3
  24. K. Okimoto, R.A. Rajewski and V.J. Stella, Release of testosterone from an osmotic pump tablet utilizing $(SBE)-_{7m}$ $\beta$-CD as both a solubilizing and an osmotic pump agent, J. Control. Release, 58, 29-38 (1999) https://doi.org/10.1016/S0168-3659(98)00142-4
  25. K. Okimoto, M. Miyake, N. Ohnishi, R.A. Ragewski, V.J. Stella, T. Irie and K. Uekama, Design and evaluation of an osmotic pump tablet (OPT) for prednisolone, a poorly water soluble drug, using $(SBE)-_{7m}$ $\beta$-CD, Pharm. Res., 15, 1562-1568 (1998) https://doi.org/10.1023/A:1011955117026
  26. K. Okimoto, A. Ohike, R. Ibuki, O. Aoki, N. Ohnishi, T. Irie, K. Uekama, R.A. Rajewski and V.J. Stella, Design and evaluation of an osmotic pump tablet (OPT) for chlor- promazine using (SBE)-7m--CD, Pharm. Res., 16, 549-554 (1999) https://doi.org/10.1023/A:1018827214223
  27. 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. Release, 68, 145-156 (2000) https://doi.org/10.1016/S0168-3659(00)00243-1
  28. L. Liu, G. Khang, J.M. Rhee and H.B. Lee, Monolithic osmotic tablet system for nifedipine delivery, J. Control. Release, 67, 309-322 (2000) https://doi.org/10.1016/S0168-3659(00)00222-4
  29. N. Ozdemir and J. Sahin, Design of a controlled release osmotic pump system of ibuprofen, Int. J. Pharm., 158, 91-97 (1997) https://doi.org/10.1016/S0378-5173(97)00250-0
  30. S. Mohammadi-Samani, M. Adrangui, M.R. Siahi-Shaddbad and A. Nokhodchi, An approach to controlled-release dosage form of propranolol hydrochloride, Drug Dev. Ind. Pharm., 26, 91-94 (2000) https://doi.org/10.1081/DDC-100100332
  31. S.V. Sastry, I.K. Reddy and M.A. Khan, Atenolol gastrointestinal therapeutic system: optimization of formura- tion variables using response surface methodology, J. Control. Release, 45, 121-130 (1997) https://doi.org/10.1016/S0168-3659(96)01553-2
  32. S.V. Sastry, M.D. DeGennaro, I.K. Reddy, and M.A. Khan, Atenolol gastrointestinal therapeutic system. I. Screening of formulation variables, Drug Dev. Ind. Pharm., 23, 157-165 (1997) https://doi.org/10.3109/03639049709149789
  33. S.V. Sastry and M.A. Khan, Aqueous-based polymeric dispersion: Face-centered cubic design for the development of atenolol gastrointestinal therapeutic system, Pharm. Dev. Tech., 3, 423-432 (1998) https://doi.org/10.3109/10837459809028623
  34. L.E. Appel and G.M. Zentner, Use of modified ethyl cellulose lattices for microporous coating of somotic tablets, Pharm. Res., 8, 600-604 (1991) https://doi.org/10.1023/A:1015800606298
  35. M. Kelbert and S.R. Büchard, Evaluation of cellulose acetate (CA) latex as coating material for controlled release products, Drug Dev. Ind. Pharm., 18, 519-538 (1992) https://doi.org/10.3109/03639049209043709
  36. J.L. Jensen, L.E. Appel, J.H. Clair and G.M. Zentner, Variables that affect the mechanism of drug release from osmotic pumps coated with acrylate/methacrylate copolymer latexes, J. Pharm. Sci., 84, 530-533 (1995) https://doi.org/10.1002/jps.2600840503
  37. J. Yuan and S.H. Wu, Sustained-release tablets via direct compression: A feasibility study using cellulose acetate and cellulose acetate butyrate, Pharm. Tech., 24, 92-106 (2000)
  38. B. Lindstedt, G. Ragnarsson and J. Hjartstam, Osmotic pumping as a release mechanism for membrane-coated drug formulations, Int. J. Pharm., 56, 261-268 (1989) https://doi.org/10.1016/0378-5173(89)90023-9
  39. B. Lindstedt, M. Sjorberg and J. Hjartstam, Osmotic pumping release from KCl tablets coated with porous and nonporous ethyl cellulose, Int. J. Pharm., 67, 21-27 (1991) https://doi.org/10.1016/0378-5173(91)90261-L
  40. A.G. Ozturk, S.S. Ozturk, B.O. Palsson, T.A. Wheatley and J.B. Dressman, Mechanism of release from pellets coated with an ethylcellulose-based film, J. Control. Release, 14, 203-213 (1990) https://doi.org/10.1016/0168-3659(90)90160-U
  41. J. Guo, Effects of plasticizers on water permeation and mechanical properties of cellulose acetate: Antiplasticization in slightly plasticized polymer film, Drug Dev. Ind. Pharm., 19, 1541-1555 (1993) https://doi.org/10.3109/03639049309069325
  42. J. Guo, An investigation into the formation of plasticizer channels in plasticized polymer films, Drug Dev. Ind. Pharm., 20, 1883-1893 (1994) https://doi.org/10.3109/03639049409050215
  43. L. Liu, G. Khang, J.M. Rhee and H.B. Lee, Preparation and characterization of cellulose acetate membrane for monolithic tablet, Korea Polym. J., 7, 289-296 (1999)
  44. K. Okimoto, A. Ohike, R. Ibuki, O. Aoki, N. Ohnishi, R.A. Rajewski, V.J. Stella, T. Irie and K. Uekama, Factors affecting membrane-controlled drug release for an osmotic pump tablet (OPT) utilizing (SBE)-7m--CD as both a solubilizer and osmotic agent, J. Control. Release, 60, 311-319 (1999) https://doi.org/10.1016/S0168-3659(99)00077-2
  45. C. Bindschaedler, R. Gurny and E. Doelker, Mechanically strong films produced from cellulose acetate latexes, J. Pharm. Pharmacol., 39, 335-338 (1987) https://doi.org/10.1111/j.2042-7158.1987.tb03394.x
  46. C. Bindschaedler, R. Gurny and E. Doelker, Osmotic water transport through cellulose acetate membranes produced from a latex system, J. Pharm. Sci., 76, 455-460 (1987) https://doi.org/10.1002/jps.2600760609