Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
권호 표지
DOI QR코드

DOI QR Code

Development of 13C-urea-containing capsule for diagnosis of H. pylori

헬리코박터 파이로리 균 진단용 13C-요소 캅셀의 개발

  • Published : 2002.03.20
Download PDF
⟨ Previous Next ⟩

Abstract

The purpose of this study was to develop a new $^{l3}C-urea-containing$ capsule for diagnosis of H. pylori. The urea-containing capsules were prepared with various diluents such as polyethylene glycol (PEG), microcrystalline cellulose, sodium lauryl sulfate and citric acid. The dissolution test, $^{l3}C-urea$ breath test and stability test were then performed on the capsules. Microcrystalline cellulose and sodium lauryl sulfate retarded the initial dissolution rates of urea. However, PEG increased the initial dissolution rates of urea. Furthermore, two formulae composed of PEG, [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] and [$^{l3}C-urea/PEG/citric$ acid (38/1.9/1.9 mg/cap)] had the maximum DOB value, about 16 at 20 mim, while the formula composed of only 38 mg $^{l3}C-urea$ had the maximum DOB value at 30 min. The results indicated that PEG improved the, sensitivity of $^{l3}C-urea$ in the human volunteers. The capsule [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] was stable for at least six months in 25 and $37^{\circ}C$. Thus, a PEG-containing capsule, [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] would be a more economical, sensitive and stable preparation for diagnosis of H. pylori.

Keywords

References

  1. D.O. Faigel, M. Childs, E.E. Furth, A. Alavi and D.C. Metz, New noninvasive tests for Helicobacter pylori gastritis. Comparison with tissue-based gold standard, Digest. Dis. Sci., 41, 740-748 (1996) https://doi.org/10.1007/BF02213130
  2. C.E. Grimley, A. Penny, M. O'sullivan, M. Shebani, J.R. Lismore, R. Cross, R.C. Illing, D.E. Loft and C.U. Nwokolo, Comparison of two 3-day Helicobacter pylori eradication regimens with a standard 1-week regimen, Aliment Pharm. Therap., 13, 869-873 (1999) https://doi.org/10.1046/j.1365-2036.1999.00574.x
  3. F. Lerang, J.B. Haug, B. Moum, P. Mowinckel, T. Berge, E. Ragnhildstveit and A. Bjorneklett, Accuracy of IgG serology and other tests in confirming Helicobacter pylori eradication, Scand. J. Gastroentero., 33, 710-715 (1998) https://doi.org/10.1007/s005350050159
  4. E.J. Prewett, Y.W. Luk, A.G. Fraser, W.M. Lam and R.E. Pounder, Comparison of one-day oral dosing with three bismuth compounds for the suppression of Helicobacter pylori assessed by the 13C-urea breath test, Aliment Pharm. Therap., 6, 97-102 (1992) https://doi.org/10.1111/j.1365-2036.1992.tb00549.x
  5. W. Bielanski and S.J. Konturek, New approach to 13C-urea breath test: capsule-based modification with low-dose of 13C-urea in the diagnosis of Helicobacter pylori infection, J. Physiol. Pharmacol., 47, 545-553 (1996)
  6. F. Parente and P.G. Bianchi, The (13)C-urea breath test for non-invasive diagnosis of Helicobacter pylori infection: which procedure and which measuring equipment?, Eur. J. Gastroen. Hepat., 13, 803-806 (2001) https://doi.org/10.1097/00042737-200107000-00007
  7. A.K. Hamlet, K.I. Erlandsson, L. Olbe, A.M. Svenne- rholm, V.E. Backman and A.B. Pettersson, A simple, rapid, and highly reliable capsule-based $^1^4$C urea breath test for diagnosis of Helicobacter pylori infection, Scand. J. Gas- troentero., 30, 1058-1063 (1995)
  8. A. Hamlet, L. Stage, H. Lonroth, C. Cahlin, C. Nystrom and A. Pettersson, A novel tablet-based $^1^3$C urea breath test for Helicobacter pylori with enhanced performance during acid suppression therapy, Scand. J. Gastroentero., 34, 367-374 (1999)
  9. V. Savarino, S. Vigneri and G. Celle, The 13C urea breath test in the diagnosis of Helicobacter pylori infection, Gut, 45, S118-S122 (1999)
  10. H.G. Choi, C.S. Yong and C.K. Kim, Development of terfenadine-pseudoephedrine double layered tablet dissolution-equivalent to core tablet, Drug Dev. Ind. Pharm., 26, 605-611 (2000) https://doi.org/10.1081/DDC-100101275
  11. D.Y. Graham, H.M. Malaty, R.A. Cole, R.F. Martin and P.D. Klein, Simplified 13C-urea breath test for detection of Helicobacter pylori infection, Am. J. Gastroentero., 96, 1741-1745 (2001) https://doi.org/10.1111/j.1572-0241.2001.03867.x
  12. H.G. Choi, Y.K. Oh and C.K. Kim, In situ-gelling and mucoadhesive liquid suppository containing acetaminophen : Enhanced bioavailability, Int. J. Pharm., 165, 23-32 (1998) https://doi.org/10.1016/S0378-5173(97)00385-2
  13. R.P.H. Logan, Urea breath tests in the management of Helicobactor pylori infection, Gut, 43, S47-S50 (1998) https://doi.org/10.1136/gut.43.2008.S47
  14. R.H. Eggers, A. Kulp, R. Tegeler, F.E. Ludke, G. Lepsien, B. Meyer and F.E. Bauer, A methodological analysis of the (13)C-urea breath test for detection of Helicobactor pylori infections : high sensitivity and specificity within 30 min using 75 mg of (13)C-urea, Eur. J. Gastroen. Hepat., 2, 437-444 (1990)
  15. G.D. Bell, K.U. Powell, S.M. Burridge, G. Spencer, G. Bolton, K. Purser, S. Brooks, S. Prosser, G. Harrison and P.W. Gant, Short report: omeprazole plus antibiotic com-binations for the eradication of metronidazole-resistant Helicobacter pylori, Aliment Pharm. Therap., 6, 751-758 (1992) https://doi.org/10.1111/j.1365-2036.1992.tb00740.x
  16. D.A. Peura, D.J. Pambianco, K.R. Dye, C. Lind, H.F. Frierson, S.R. Hoffman, M.J. Combs, E. Guilfoyle and B.J. Marshall, Microdose $^{13}C$-urea breath test offers diagnosis of Helicobacter pylori in 10 minutes, Am. J. Gastroenterol., 91, 233-238 (1996)
  17. K. Yamamoto, M. Nakano, T. Arita, Y. Takayama and Y. Nakai, Dissolution behavior and bioavailability of phenytoin from a ground mixture with microcrystalline cellulose, J. Pharm. Sci., 65, 1484-1488 (1976) https://doi.org/10.1002/jps.2600651017
  18. E.J. Lee, S.W. Lee, H.G. Choi and C.K. Kim, Bioavailability of cyclosporin A dispersed in sodium lauryl sulfate-dextrin based solid microspheres, Int. J. Pharm., 218, 125-131 (2001) https://doi.org/10.1016/S0378-5173(01)00621-4
  19. C. Rouchotas, O.E. Cassidy and G. Rowley, Comparison of surface modification and solid dispersion techniques for drug dissolution, Int. J. Pharm., 195, 1-6 (2000) https://doi.org/10.1016/S0378-5173(99)00350-6
  20. S. Stavchansky and W.G. Gowan, Evaluation of the bioavaila- bility of a solid dispersion of phenytoin in polyethylene glycol 6000 and a commercial phenytoin sodium capsule in the dog, J. Pharm. Sci., 73, 733-736 (1984) https://doi.org/10.1002/jps.2600730607