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Formulation and Preparation of Sustained Release Pellet for Alfuzosin HCI Using Fluid-bed coater

유동층 코팅기를 이용한 염산알푸조신의 서방형 과립 설계 및 제조

  • Na, Jin-Sang (Kyunghee University Graduate School of East-West Medical Science & College of Oriental Medicine) ;
  • Yoon, Yang-No (College of Pharmacy, Sungkyunkwan University) ;
  • Seo, Hui (College of Pharmacy, Chungnam National University) ;
  • Jeong, Sang-Young (College of Pharmacy, Chungnam National University) ;
  • Park, Eun-Seok (College of Pharmacy, Sungkyunkwan University) ;
  • Hwan, Sung-Joo (College of Pharmacy, Chungnam National University) ;
  • Shin, Byung-Cheol (Korea Research Institute of Chemical Technology Drug Discovery Division) ;
  • Kim, Sung-Hoon (Kyunghee University Graduate School of East-West Medical Science & College of Oriental Medicine) ;
  • Cho, Sun-Hang (Korea Research Institute of Chemical Technology Drug Discovery Division)
  • 나진상 (경희대학교 한의과대학.동서의학대학원) ;
  • 윤양노 (성균관대학교 약학대학) ;
  • 서희 (남대학교 약학대학) ;
  • 정상영 (남대학교 약학대학) ;
  • 박은석 (성균관대학교 약학대학) ;
  • 황성주 (남대학교 약학대학) ;
  • 신병철 (한국화학연구원 신약연구단) ;
  • 김성훈 (경희대학교 한의과대학.동서의학대학원) ;
  • 조선행 (한국화학연구원 신약연구단)
  • Published : 2008.12.20

Abstract

Alfuzosin, an Alphal-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 $Eudragit^{(R)}$ 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, $Eudragit^{(R)}$ and HPMC (hydroxy propyl methyl cellulose), Cellulose Acetate were prepared by fluid-bed coater. Membrane layer were used $Eudragit^{(R)}$ 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 ($XATRAL^{(R)}$ XL). The release rate of drug from coated beads was higher than that from $XATRAL^{(R)}$ XL in pH 6.8.

Keywords

References

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