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Zero-order Delivery of Alfuzosin Hydrochloride with Hydrophilic Polymers

  • Received : 2010.07.21
  • Accepted : 2010.10.12
  • Published : 2010.10.20

Abstract

Manufacturing a multi-layered tablet such as Xatral XL$^{(R)}$ is more complex and expensive than monolayered tablets, but mono-layered tablets may have less favorable release properties depending on the pharmacodynamics and pharmacokinetics of the active ingredient. We therefore sought to develop a monolayer tablet with a similar dissolution profile to the commercial alfuzosin sustained-release triple layered tablet (Xatral XL$^{(R)}$). We prepared four different mono-layered alfuzosin tablets with different concentrations of hydroxypropyl methycellulose and PVP K-90. Fomulation III with alfuzosion/mg-stearate/ HPMC/ PVP K-90 (10/5/110/95 mg/tab) has a similar dissolution rate to Xatral XL$^{(R)}$, with a similarity factor score of 81.4. However, the swelling and erosion rates of the two formulations were different, and NIR analysis showed differences in the mechanisms of drug release. Thus, although formulation III and Xatral XL$^{(R)}$ show similar dissolution rates, the mechanisms of drug release are different.

Keywords

References

  1. Bourne DWA, 2002. Pharmacokinetics. In: Banker G.S., Rhodes C.T., Modern Pharmaceutics, 4th ed., marcel Dekker Inc., New York, 67-92.
  2. Buzelin, J.M., Hebert, M., Blondin, P., te Prazalf Group, 1993. Alpha blocking treatment with alfuzosin in symptomatic benign prostatic hyperplasia: comparative study with prazosin, Br. J. Urol. 72, 922-927. https://doi.org/10.1111/j.1464-410X.1993.tb16298.x
  3. Costa, P., Lobo, J., 2001. Modeling and comparison of dissolution profile, Eur. J. Pharm. 13, 123-133. https://doi.org/10.1016/S0928-0987(01)00095-1
  4. Hadjiioannou, T.P., Christian, G.D., Koupparis, M.A., Macheras, P.E., 1993. Quantitative Calculations in Pharmaceutical Practice and Reserarch, VCH Publishers inc., New York, 345-348.
  5. Higuchi, T., 1963. Mechanism of sustained action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J. Pharm.Sci., 52, 1145-1149. https://doi.org/10.1002/jps.2600521210
  6. Hixson, A.W., Crowell, J.H., 1931. Dependence of reaction velocity upon surface and agitation (I) theoretical consideration. Ind. Eng. Chem., 23, 923-931. https://doi.org/10.1021/ie50260a018
  7. Jardin, A.H., Bensadoun, H., Delauche-Cavaller, M.C., Attali, P., The BPH-ALF Group, 1993. Long term treatment of benign prostatic hypertropy with alfuzosin: a 12-18 month assessment. ., 72, 615-620. https://doi.org/10.1111/j.1464-410X.1993.tb16220.x
  8. Jardin, A.H., Bensadoun, H., Delauche-Cavaller, M.C., Attali, P., The BPH-ALF Group, 1999. Long term treatment of benign prostatic hypertropy with alfuzosin: a 24-30 month survey. Br. J. Urol. 74, 579-584. https://doi.org/10.1111/j.1464-410X.1994.tb09187.x
  9. Jardin, A.H., Bensadoun, H., Delauche-Cavaller, M.C.., Attali, P., The BPH-ALF Group, 1991. Alfuzosin for treatment of benign prostatic hypertrophy. Lancet 337, 1457-1461. https://doi.org/10.1016/0140-6736(91)93140-5
  10. JENN-CHIANG MACHINERY Homepage http://www.jcmco.com.tw/ dh.htm
  11. Korsmeyer, R.W., Gurny, R., Doelker, E., Buri, P., Peppas, N.A., 1983. Mechanisms of solute release from porous hydrophilic polymers. Int. J. pharm., 15, 25-35. https://doi.org/10.1016/0378-5173(83)90064-9
  12. Maggi, L., Conte, U., Grenier, P., Vergnault, G., Dufour, A., Jarreau, F.X., Rauch-Desant, C., 2000. Tablet with controlled release of alfuzosine chlorhydrate, US Patent 6, 149,940.
  13. Moore, J.W., Flanner, H.H., 1996. Mathematical comparison of dissolution profile, Pharm. Tech. 20, 64-74.
  14. Shoaib, M.H., Tazeen, J., Merchant, H.A., Yousuf, R.I., 2006. Evaluation of drug release kinetics from Ibuprofen matrix tablet using HPMC. Pak. J. Pharm. Sci., 19, 119-124.
  15. Tahara, K., Yamamoto, K., Nishihata, T., 1995. Overall mechanism behind matrix sustained release (SR) tablet prepared with hydroxypropyl methylcellulose 2910, J. Control. Release 35, 59-66. https://doi.org/10.1016/0168-3659(95)00021-Y
  16. Teillac, P., Delauche-Cavallier, M.C., Attali, P., The Dualf Group, 1992. Urinary flow assessment after a single oral administration of alfuzosin, a new alpha1, blocker, in patients with benign prostatic hypertrophy, Br. J. Urol. 70, 58-64. https://doi.org/10.1111/j.1464-410X.1992.tb15665.x
  17. Vueba, M.L., Batista, de Carvalho, L.A.E., Veiga, F., Sousa, J.J., Pina, M.E., 2004. Influence of cellulose ether polymers on ketoprofen release from hydrophilic matrix tablets, Eur. J. Pharm. Biopharm. 58, 51-59. https://doi.org/10.1016/j.ejpb.2004.03.006

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