YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Pharmacokinetics of Acebrophylline Containing Double-layered Sustained Release Tablet in Mini Pigs

미니피그를 이용한 아세브로필린 이중정의 약동학적 평가 (아세브로필린 이중정 개발)

  • Received : 2013.09.13
  • Accepted : 2013.11.19
  • Published : 2013.12.31
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Abstract

The aim of the present study was to improve commercial twice-a-day Acebrophylline formulation to once-a-day new formulation to improve patient compliances. To develop the double-layered tablet, the sustained release layer was prepared using Eudragit$^{(R)}$ L100-55 and Carnauba wax. The sustained release layer has shown delayed release rates in pH 1.2 which comparable to that of performed in pH 6.8 buffer. In the comparative pharmacokinetic study with commercialized Surfolase$^{(R)}$, the present double-layered Acebrophylline tablet has shown similar pharmacokinetic parameters of AUC, $C_{max}$ and $T_{max}$ values.

Keywords

References

  1. Coppi, G. and Silingardi, S. : Ambroxol plasma level, pharmacokinetic parameters and pulmonary level in rats after intravenous and oral administration of acebrophylline and ambrxol. Ital. J. Chest Dis. 5, 91 (1992).
  2. Scaglione, F., Martini, G. De., Gattei, G. and Fraschini, F. : Mechanism of action of acebrophylline: Regulator effect on the production of leukotrienes. Giorn. It. Mal. Tor. 1, 73 (1992).
  3. Lee, T. W., Jeong, R. S., Jeong, S. A., Kim, J. H., Shim, Y. H., Kim, I. K. and Park, C. W. : Development of dissolution test method for acebrophylline capsules and bromhexine hydrochloride tablets in korean pharmaceutical codex. J. Pharm. Soc. Korea 57, 226 (2013).
  4. Maggi, L., Machiste, E. O., Torre, M. L. and Conte, U. : Formulation of biphasic release tablets containing slightly soluble drugs. Eur. J. Pharm. Biopharm. 48, 37 (1999). https://doi.org/10.1016/S0939-6411(99)00019-3
  5. Zaghloul, A. A., Vaithiyalingam, S. R., Faltinek, J., Reddy, I. K. and Khan, M. A. : Response surface methodology to obtain naproxen controlled release tablets from its microspheres with Eudragit L100-55. J. Microencapsul. 18, 651 (2001). https://doi.org/10.1080/02652040110055630
  6. Corti, G., Cirri, M., Maestrelli, F., Mennini, N. and Mura, P. : Sustained-release matrix tablets of metformin hydrochloride in combination with triacetyl-b-cyclodextrin. Eur. J. Pharm. Biopharm. 68, 303 (2008). https://doi.org/10.1016/j.ejpb.2007.06.004
  7. Mulani, H. T., Patel, B. and Shah, N. J. : Development of pHindependent matrix type sustained release drug delivery system of propranolol hydrochloride. J. Appl. Pharm. Sci. 1, 83 (2011).
  8. Walia, P. S., Stout, P. J. and Turton, R. : Preliminary evaluation of an aqueous wax emulsion for controlled release coating. Pharm. Dev. Technol. 3, 103 (1998). https://doi.org/10.3109/10837459809028484
  9. Zhang, Y. E., Tchao, R. and Schwartz, J. B. : Effect of processing methods and heat treatment on the formation of wax matrix tablets for sustained drug release. Pharm. Dev. Technol. 6, 131 (2001). https://doi.org/10.1081/PDT-100000736
  10. Pandey, V. P., Kannappan, N., Manavalan, R. and Subburaj, T. : Sustaining pattern of phenformin hydrochloride using various polymers and waxes. Boll. Chim. Farm. 141, 361 (2002).
  11. Ahmed, I., Roni, M. A., Kibria, G., Islam, M. R. and Jalil, R. U. : In vitro release kinetics study of ambroxol hydrochloride pellets developed by extrusion spheronization techique followed by acrylic polymer coating. Dhaka Univ. J. Pharm. Sci. 7, 75 (2008).
  12. Kibria, G., Islam, K. A. and Jalil, R. U. : Stability study of ambroxol hydrochloride sustained release pellets coated with acrylic polymer. Pak. J. Pharm. Sci. 22, 36 (2009).
  13. Wen, A., Hang, T., Chen, S., Wang, Z., Ding, L.,Tian, Y., Zhang, M. and Xu, X. : Simultaneous determination of amoxicillin and ambroxol in human plasma by LC-MS/MS: Validation and application to pharmacokinetic study. J. Pharm. Biomed. Anal. 48, 829 (2008). https://doi.org/10.1016/j.jpba.2008.05.032
  14. Kim, H. H., Yoo, J. Y., Han, S. B., Lee, H. J. and Lee, K. R. : Determination of ambroxol in human plasma using LC-MS/ MS. J. Pharm. Biomed. Anal. 32, 209 (2003). https://doi.org/10.1016/S0731-7085(03)00059-1
  15. Hang, T. J., Zhang, M., Song, M., Shen, J. P. and Zhang, Y. D. : Simultaneous determination and pharmacokinetic study of roxithromycin and ambroxol hydrochloride in human plasma by LC-MS/MS. Clin. Chim. Acta. 382, 20 (2007). https://doi.org/10.1016/j.cca.2007.03.015
  16. Cho, H. Y., Park, E. J., Kang, H. A., Kim, S. M., Park, C. H. Oh, I. J., Lim, D. K., Lee, M. H. and Lee, Y. B. : Bioequivalence of burophil capsule to surfolase capsule. J. Pharm. Soc. Korea 35, 179 (2005).
  17. Lee, J. S., Choi, S. J., Ryu, J. H., Seo, J. H., Lee, M. J., Kang, J. M., Tak, S. K., Kang, J. Y. and Lee, K. T. : Bioequivalence of LesacinTM Tablet to Jeil CravitTM Tablet (Levofloxacin 100 mg) by liquid chromatography-electrospray tandem mass spectrometry. J. Kor. Pharmaceut. Sci. 38, 269 (2008).