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KMID : 0369820080380060387
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Jorunal of Korean Pharmaceutical Sciences
2008 Volume.38 No. 6 p.387 ~ p.392
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Formulation and Preparation of Sustained Release Pellet for Alfuzosin HCI Using Fluid-bed coater
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Na Jin-Sang
Yoon Yang-No
Seo Hui
Jeong Sang-Young
Park Eun-Seok
Hwang Sung-Joo
Shin Byung-Cheol
Kim Sung-Hoon
Cho Sun-Hang
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Abstract
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Alfuzosin, an Alpha1-adrenoceptor antagonist is used for the treatment of patients with voiding and in a lesser extent storage lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH). The objective of this study was to formulate sustained release alfuzosin HCl granules and assess their formulation variables. The EudragitR as a polymer, sustained release membrane, and dibutyl sebacate (DBS) as a plasticizer were used. Multi-coated alfuzosin
HCl delivery systems composed of sugar sphere, various excipients, EudragitR and HPMC (hydroxy propyl methyl ellulose), Cellulose Acetate were prepared by fluid-bed coater. Membrane layer were used EudragitR RS PO and NE 30D.
And the alfuzosin HCl coated beads were coated immediate release drug layer for initial burst. Its dissolution test was carried out compared to conventional products (XATRALR XL). The release rate of drug from coated beads was higher than that from XATRALR XL in pH 6.8.
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KEYWORD
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Alfuzosin HCl, Fluid-bed coater, EudragitR RS PO, EudragitR NE 30D, Sustained-release pellet
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