Development and optimization of a novel oral controlled delivery system for tamsulosin hydrochloride using response surface methodology

International Journal of Pharmaceutics

Volumn 341, Issue 1-2, 2007, Pages 97-104

  Kim, Min Soo ^a   Kim, Jeong Soo ^a   You, Yeon Hee ^a   Park, Hee Jun ^a   Lee, Sibeum ^a   Park, Jeong Sook ^a   Woo, Jong Soo ^b   Hwang, Sung Joo ^a  

^a Chungnam National University   (South Korea)

^b Hanmi Pharmaceutical Co Ltd   (South Korea)

Author keywords

Box Behnken design; HPMC; HPMCP; Surelease ; Tamsulosin hydrochloride

Indexed keywords

ETHYL CELLULOSE; HARUNAL; HYDROXYPROPYLMETHYLCELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE PHTHALATE; TAMSULOSIN; UNCLASSIFIED DRUG;

ARTICLE; CONTROLLED DRUG RELEASE; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; PRIORITY JOURNAL; RESPONSE SURFACE METHOD;

ADMINISTRATION, ORAL; ADRENERGIC ALPHA-ANTAGONISTS; CELLULOSE; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; DRUG CARRIERS; DRUG COMPOUNDING; FACTOR ANALYSIS, STATISTICAL; KINETICS; METHYLCELLULOSE; MODELS, CHEMICAL; SOLUBILITY; SULFONAMIDES; TECHNOLOGY, PHARMACEUTICAL;

EID: 34547100779     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2007.03.051     Document Type: Article

References (33)

1. Bodmeier R., and Paeratakul O. The effect of curing on drug release and morphological properties of ethylcellulose pseudolatex-coated beads. Drug Dev. Ind. Pharm. 20 (1994) 1517-1533
2. Chan L.W., Ong K.T., and Heng W.S. Novel film modifiers to alter the physical properties of composite ethylcellulose films. Pharm. Res. 22 (2005) 476-489
3. Chapple C., and Andersson K.E. Tamsulosin: an overview. World J. Urol. 19 (2002) 397-404
4. Costa P., and Sousa Lobo J.M. Modelling and comparison of dissolution profiles. Eur. J. Pharm. Sci. 13 (2001) 123-133
5. Gupta V.K., Assmus M.W., Beckert T.E., and Price J.C. A novel pH- and time-based multi-unit potential colonic drug delivery system. II. Optimization of multiple response variables. Int. J. Pharm. 213 (2001) 93-102
6. Hamed E., and Sakr A. Application of multiple response optimization technique to extended release formulations design. J. Control. Release 73 (2001) 329-338
7. Iyer R.M., Augsburger L.L., and Parikh D.M. Evaluation of drug layering and coating: effect of process mode and binder level. Drug Dev. Ind. Pharm. 19 (1993) 981-998
8. Jee, U.K., Hwang, S.J., Park, J.K., Park, K.L., Moon, Y.G., Lee, S., Kwon, Y.J., 2004. WO Patent Appl. PCT/KR03/00660.
9. Kim M.-S., Jun S.W., Lee S., Lee T.-W., Park J.-S., and Hwang S.-J. The influence of Surelease and sodium alginate on the in-vitro release of tamsulosin hydrochloride in pellet dosage form. J. Pharm. Pharmacol. 57 (2005) 735-742
10. Kim M.-S., Park G.-D., Jun S.W., Lee S., Park J.-S., and Hwang S.-J. Controlled release tamsulosin hydrochloride from alginate beads with waxy materials. J. Pharm. Pharmacol. 57 (2005) 1521-1528
11. Kim M.-S., Kim J.-S., Lee S., Jun S.W., Park J.-S., Woo J.-S., and Hwang S.-J. Optimization of tamsulosin hydrochloride controlled release pellets coated with Surelease and neutralized HPMCP. J. Pharm. Pharmacol. 58 (2006) 1611-1616
12. Kim, M.-S., Kim, J.-S., Kang, S.-H., Yoo, Y.-H., Lee, S., Park, J.-S., Woo, J.-S., Hwang, S.-J. Influence of water soluble additives and HPMCP on drug release from Surelease-coated pellets containing tamsulosin hydrochloride. Arch. Pharm. Res., submitted for publication.
13. Ko J.A., Park H.J., Park Y.S., Hwang S.-J., and Park J.B. Chitosan microparticle preparation for controlled drug release by response surface methodology. J. Microencapsulation 20 (2004) 791-797
14. Korsmeyer R.W., Gurny R., Doelker E., Buri P., and Peppas N.A. Mechanisms of solute release from porous hydrophilic polymers. Int. J. Pharm. 15 (1983) 25-35
15. Lecomte F., Siepmann J., Walther M., MacRae R.J., and Bodmeier B. pH-sensitive polymer blends used as coating materials to control drug release from spherical beads: elucidation of the underlying mass transport mechanisms. Pharm. Res. 22 (2005) 1120-1141
16. Lee K., Choi S.-U., Jeon H., Lee B., Kim H.-I., Lee J., and Choi Y.W. Controlled release of tamsulosin from enteric coated sustained-release matrices with aqueous microchannels. J. Kor. Pharm. Sci. 34 (2004) 471-475
17. Lee S., Kim M.-S., Jun S.-W., Park J.-S., and Hwang S.-J. Preparation and controlled release spheronized beads by a simple extrusion and modified spheronization process. Arch. Pharm. Res. 28 (2005) 619-625
18. Matsushima H., Kamimura H., Soeishi Y., Watanabe T., Higuchi S., and Tsunoo M. Pharmacokinetics and Plasma Protein Binding of Tamsulosin Hydrochloride in Rats, Dogs, and Humans. Drug Metab. Dispos. 26 (1998) 240-245
19. Moore J.W., and Flanner H.H. Mathematical comparison of dissolution profiles. Pharm. Technol. 20 (1996) 64-75
20. Myers R.H., and Montgomery D.C. Response Surface Methodology: Process and Product Optimization Using Designed Experiments (2002), John Wiley & Sons, New York pp. 273-286
21. Nutan M.T.H., Soliman M.S., Taha E.I., and Khan M.A. Optimization and characterization of controlled release multi-particulate beads coated with starch acetate. Int. J. Pharm. 294 (2005) 89-101
22. O'Leary M.P. Tamsulosin: current clinical experience. Urology 58 (2001) 42-48
23. Ofori-Kwakye K., and Fell J.T. Leaching of pectin from mixed films containing pectin, chitosan and HPMC intended for biphasic drug delivery. Int. J. Pharm. 250 (2003) 251-257
24. Rohera B.D., and Parikh N.H. Influence of type and level of water-soluble additives on drug release and surface and mechanical properties of Surelease films. Pharm. Dev. Technol. 7 (2002) 421-432
25. Sadeghi F., Ford J.L., and Rajabi-Siahboomi A. The influence of drug type on the release profiles from Surelease-coated pellets. Int. J. Pharm. 254 (2003) 123-135
26. Sadeghi F., Ford J.L., Rubinstein M.H., and Rajabi-Siahboomi A.R. Comparative study of drug release from pellets coated with HPMC or Surelease. Drug Dev. Ind. Pharm. 26 (2000) 651-660
27. Sadeghi F., Ford J.L., Rubinstein M.H., and Rajabi-Siahboomi A.R. Study of drug release from pellets coated with Surelease containing hydroxypropylmethylcellulose. Drug Dev. Ind. Pharm. 27 (2001) 419-430
28. Segurola J., Allen N.S., Edge M., and McMahon A. Design of eutectic photoinitiator blends for UV/visible curable acrylated printing inks and coatings. Prog. Org. Coat. 37 (1999) 23-37
29. Semdé R., Amighi K., Devleeschouwer M.J., and Moës A.J. Effect of pectinolytic enzymes on the theophylline release from pellets coated with water insoluble polymers containing pectin HM or calcium pectinate. Int. J. Pharm. 197 (2000) 169-179
30. Seo S.M., Lee H.S., Lee J., Lee H.Y., Lee B., Lee H.B., and Cho S.H. Controlled release of tamsulosin from nanopore-forming granules. J. Kor. Pharm. Sci. 36 (2006) 39-44
31. Van Hoogdalem E.J., Kamimura H., and Higuchi S. Pharmacokinetics of the α1A-adrenoreceptor antagonist tamsulosin in man, and interspecies scaling versus preclinical data. Euro. J. Pharm. Sci. 4 (1996) S60
32. Wilde M.I., and McTavish D. Tamsulosin. A review of its pharmacological properties and therapeutic potential in the management of symptomatic benign prostatic hyperplasia. Drugs 52 (1996) 883-898
33. Yuen K.H., Deshmukh A.A., and Newton J.M. Development and in vitro evaluation of a multiparticulate sustained release theophylline formulation. Drug Dev. Ind. Pharm. 19 (1993) 855-874