Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Disintegrating Behavior of A Rapidly Disintegrating Famotidine Tablet Formulation

  • Published : 2007.10.21
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Abstract

A rapidly disintegration famotidine tablet formulation in the oral cavity was developed using microcrystalline cellulose (MCC) and low-substituted hydroxypropyl cellulose (L-HPC), or additionally cropovidone as an internal disintegrant. Effects of disintegrants on the disintegration time in vitro and hardness were evaluated. Average wetting time of the tablets prepared in scale-up manufacturing process was less than 15 sec. Among the formulations tested, the tablet prepared with crospovidone as an internal disintegrant and Emcocel $90M^{(R)}$ as an external disintegrant showed fastest disintegration. These results may suggest that crospovidone and Emcocel $90M^{(R)}$ possessed excellent wetting nature, which result in the rapid disintegration of tablet.

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References

  1. A. Watanabe, T. Hanawa and M. Suginara, Application of Glycerogelatin as oral dosage form for the elderly, Yakuzaigaku, 54, 77-87 (1994)
  2. T. Hanawa, A. Watanabe, T. Tsuchiya, R. Ikoma, M. Hidaka and M. Sugihara, New oral dosage form for elderly patients: preparation and characterization of silk fibroin gel. Chem. Pharm. Bull., 43, 284-288 (1995) https://doi.org/10.1248/cpb.43.284
  3. M. T. Maya, N. J. Goncalves, N. E. Silva, A. E. Filipe, J. A. Morais, M.C. Caturla and M. Rovira, Comparative bioavailability of two immediate release tablets of enalapril/hydrochlorothiazide in healthy volunteers, Eur. J. Drug Metab. Pharmacokinet., 27, 91-99 (2002) https://doi.org/10.1007/BF03190422
  4. M. Lohitnavy, O. Lohitnavy, S. Wittaya-areekul, K. Sareekan, S. Polnok and W. Chaiyaput. Average bioequivalence of clarithromycin immediate released tablet formulations in healthy male volunteers, Drug Dev. Ind Pharm., 29, 653-659 (2003) https://doi.org/10.1081/DDC-120021314
  5. J. Carpay, J. Schoenen, F. Ahmad, F. Kinrade and D. Boswell, Efficacy and tolerability of sumatriptan tablets in a fast-disintegrating, rapid-release formulation for the acute treatment of migraine: results of a multicenter, randomized, placebo-controlled study, Clin. Ther., 26, 214-223 (2004) https://doi.org/10.1016/S0149-2918(04)90020-3
  6. G. H. Junnarkar and S. Stavchansky, Isothermal and nonisothermal decomposition of famotidine in aqueous solution, Pharm. Res., 12, 599-604 (1995) https://doi.org/10.1023/A:1016222501079
  7. V. Mummaneni and R. C. Vasavadam, Solubilization and dissolution of famotidine from solid glass dispersions of xylitol, Int. J. Pharm., 66, 71-77 (1990) https://doi.org/10.1016/0378-5173(90)90386-I
  8. M. A. Hassan, M. A. Suleiman and N. M. Najib, Imrpovement of the in vitro dissolution characteristics of famotidine by inclusion in beta-cyclodextrin, Int. J. Pharm., 58, 19-24 (1990) https://doi.org/10.1016/0378-5173(90)90282-9
  9. M. S. Islam and M. M. Narurkar, Effect of 2-hydroxypropylbeta-cyclodextrin on the solubility, stability and dissolution rate of famotidine, Drug Dev. Ind Pharm., 17, 1229-1239 (1991) https://doi.org/10.3109/03639049109043856
  10. F. Hirayama, Z. Wang and K. Uekama, Effect of 2-hydroxypropyl-beta-cyclodextrin on crystallization and polymorphic transition of nifedipine in solid state, Pharm. Res., 11, 1766-1770 (1994) https://doi.org/10.1023/A:1018971501909
  11. Y. Bi, H. Sunada, Y. Yonezawa, K. Danjo, A. Otsuka and K. Iida, Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity, Chem. Pharm. Bull. (Tokyo), 44,2121-2127 (1996) https://doi.org/10.1248/cpb.44.2121
  12. G Abdelbary, P. Prinderre, C. Eouani, J. Joachim, J. P. Reynier and Ph. Piccerelle, The preparation of oraaly disintegrating tablets using a hydrophilic waxy binder, Int. J. Phar., 278, 423-433 (2004) https://doi.org/10.1016/j.ijpharm.2004.03.023
  13. J. Fukami, E. Yonemochi, Y. Yoshihashi and K. Terada, Evaluation of rapidly disintegrating tablets containing glycine and carboxymethylcellulose, Int. J. Pharm., 310, 101-109 (2006) https://doi.org/10.1016/j.ijpharm.2005.11.041
  14. Y. Watanabe, T. Ishikawa, B. Mukai, S. Shiraishi, N. Utoguchi, M. Fujii and M. Matsumoto, New compressed tablet rapidly disintegrating in saliva in the mouth using crystalline cellulose and a disintegrant. Bio. Pharm. Bull., 18,1308-1310 (1995) https://doi.org/10.1248/bpb.18.1308
  15. Y. Bi, Y. Yorinobu and H. Sunada, Rapidly disintegrating tablets prepared by wet compression method: mechanism and optimization. J. Pharm. Sci., 88, 1004-1010 (1999) https://doi.org/10.1021/js990061z
  16. H. Sunada and Y. Bi, Preparation, evaluation and optimization of rapidly disintegrating tablets, Powder Technol., 122, 188198 (2002) https://doi.org/10.1016/S0032-5910(01)00415-6
  17. R. K. Chang, X. Guo, B. Burnside and R. Couch, Fast-Dissolving Tablets, Pharm. Technol., 24, 52-58 (2000)
  18. T. Mizumoto, Y. Masuda, and M. Fukui, Intrabuccally dissolving compressed mouldings and production process thereof. US Patent 5 576 014 (1996)
  19. K. Muraoka and M. Fukui, Granules for the preparation of fast disintegrating and fast dissolving compositions containing a high amount of drug. US Patent 0 058 372 9/2A (1996)