Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Formulation and Evaluation of Sustained Release Preparation of Ibuprofen Fast-Disintegrating Tablet (FDT)

  • Received : 2010.12.10
  • Accepted : 2011.02.08
  • Published : 2011.02.20
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Abstract

The objective of this study was to enhance the utilitization of Ibuprofen (IBU) by introducing the fast-disintegrating tablet (FDT) form. Presently, IBU is being widely used as a tablet or syrup form. But in contrast to these two formulations, IBU as FDT is not only convenient but also increases the control over the time release of the drug, noted by using Alginate beads. This study was carried out with Sodium Alginate and IBU at the ratios of 1:0, 1:0.5, 1:1, and 1:2 in order to produce a series of beads with different ratios. During the drying process of the beads, talc was added in beads to compare the effects with and without the talc. The final product was scanned with SEM imaging to determine the difference in the surface of the beads. The parameters assessed were the diameter, content assay, dissolution test and effectiveness of time-release. Direct compression method was used to prepare FDT containing IBU bead. The properties of FDT, such as hardness, disintegration time, were investigated. The dissolution profiles of FDT were tested using KP dissolution apparatus 1 (basket method). The results suggest addition of talc and drying the beads made the surface smooth and less vulnerable to clutter into chunks. The size of beads was less than 300 ${\mu}m$ which did not create a sandy feeling in the mouth. Thus, the beads formulation model made the sustained release of the drug possible, the hardness of FDT (1.25~1.50 $Kg/cm^2$) was acceptable and all the values of dissolving period were less than 30 seconds. The dissolution profile of FDT was same as that of IBU bead. The efficient dissolution profile and low price of IBU bead containing Sodium Alginate, the FDT formulation prepared from IBU bead can save the expenses and can improve the convenience of application of this drug.

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References

  1. Bi, Y., Sunada, H., Yonezawa, Y., Danjo, K., 1999. Evaluation of rapidly disintegrating tablets prepared by a direct compression method. Drug Dev. Ind. Pharm. 25, 571-581. https://doi.org/10.1081/DDC-100102211
  2. Bi Y., Sunada H., Yonezawa Y., Danjo K., Otsuka A., Iida K., 1996. Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity. Chem. Pharm. Bull. 44, 2121-2127. https://doi.org/10.1248/cpb.44.2121
  3. Bodmeir R., Paeratakul O., 1989. Spherical agglomerate of waterinsoluble drugs, J. Pharm. Sci., 78, 964-966. https://doi.org/10.1002/jps.2600781117
  4. Chang R-K., Guo X., Burnside B.A., Couch R.A., 2000. Fast-dissolving tablets. Pharm. Technol. Eur., 12, 52-58.
  5. Dobetti L., 2000. Fast-melting tablets: developments and technolgies. Pharm. Technol. Eur., 12, 32-42.
  6. Fu C.H., Melethil S., Mason W.D., 1991. Pharmacokinetics of aspirin in rats and the effect of buffer, J. Pharmacokinet. Biopharm., 19, 157-173. https://doi.org/10.1007/BF01073867
  7. Gadalla M.A., Ismail A.A., El-Hameed M.H.Abd., 1989. In vivo evaluation of different types of commercial aspirin tablets, Drug Dev. Ind. Pharm., 15, 447-472. https://doi.org/10.3109/03639048909040223
  8. Geisslinger G., Manzel S., Zoller O., Cheng Z.H., Brune K., 1994. Absorption and distribution of ibuprofen and acetylsalicylic acid formulations, Drug Invest., 1, 52-55.
  9. Geisslinger G., Menel S., Wissel K., Brune K., 1993. Single dose pharmacokinetics of different formulations of ibuprofen and aspirin, Drug Invest. 5, 238-242. https://doi.org/10.1007/BF03258452
  10. Greenblatt D.J., Abernethy D.R., Matlis R., Harmatz J.S., 1984. Absorption and distribution of ibuprofen in the elderly arthritis rheumatitis, Clin. Pharm., 27, 1066-1069.
  11. Jung S. H., Park K., 2008. Development of sustained release fastdisintegrating tablets using various polymer-coated ionexchange resin complexes, Int. J. Pharm. 353, 195-204. https://doi.org/10.1016/j.ijpharm.2007.11.033
  12. Kendall M.J., Jubb R., Bird H.A., Gallez P.Le., Rau R., 1990. Pharmacokinetic comparison of ibuprofen sustained-release tablets given to young and elderly patients. J. Clin. Pharm. Ther., 15, 35-40. https://doi.org/10.1111/j.1365-2710.1990.tb00353.x
  13. Luckow V., Krammer R., Traub R., 1992. Investigation of comparative bioavailability of two different ibuprofen grannules, Arzneim-Forsch., 42, 1339-1342.
  14. Marshall K., Rudnic E.M., 1990. Tablet dosage forms. In: Modern Pharmaceutics. Marcel Dekker Inc., New York.
  15. Mason W.D., 1984. Kinetics of aspirin absorption following oral administration of six aqueous solutions with different buffer capacities, J. Pharm. Sci., 73, 1258-1261. https://doi.org/10.1002/jps.2600730917
  16. Orjales-Venero A., Beascoa-Alzola E., Lucero de Pablo M.L., 1993. Process to prepare water-dispersable tablets containing diclofenac. EP., 0, 599.
  17. Sameer G.L., Yi-Ying Y., Ajay K.B., 2009. Effects of disintegration-promoting agent, lubricants and moisture treatment on optimized fast disintegrating tablets, Int. J. Pharm. 365, 4-11. https://doi.org/10.1016/j.ijpharm.2008.08.010
  18. Simone S., Peter C.S., 2002. Fast dispersible ibuprofen tablets, EUR. J. Pharm. Sci., 15, 295-305. https://doi.org/10.1016/S0928-0987(02)00011-8
  19. Small R.E., Wood J.H., 1989. Influence of racial differences on effects of ranitidine and cimetidine in ibuprofen pharmacokinetics, Clin. Pharm., 8, 471-472.
  20. Watanabe Y., Koizumi K., Zama Y., Kiriyama M., Matsumoto Y., Matsumoto M., 1995. New compressed tablet rapidly disintegrating in saliva in the mouth using crystalline cellulose and a disintegrant. Biol. Pharm. Bull. 18, 1308-1310. https://doi.org/10.1248/bpb.18.1308