• Journal of Pharmaceutical Investigation
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• 제38권6호
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• pp.387-392
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• 2008

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.

• 폴리머
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• 제34권3호
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• pp.269-273
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• 2010

본 연구는 염산 알푸조신의 서방화를 위한 과립제의 최적 구성을 찾기 위해 수행되었으며, 이에 따라 고분자의 점도에 따른 염산 알푸조신 과립정제를 제조하였다. 사용된 고분자는 경구를 통한 약물전달 시스템 설계에 가장 널리 사용되는 하이드록시프로필메틸셀룰로오스(HPMC)이며, HPMC의 팽윤성은 가장 중요한 특성으로 약물의 방출에 큰 영향을 미친다. 염산 알푸조신 과립정제의 구조변화를 확인하기 위하여 적외선분광법(FTIR)을 분석하였으며, 결정학적 특성을 알아보기 위해 X선 회절분석법(XRD)을 이용하여 분석하였다. 과립정제를 제조하여 인공장액에서의 방출거동을 알아보았으며, 본 연구를 통해 첨가제로 사용된 HPMC의 점도에 따라 모델약물인 염산 알푸조신의 방출거동을 조절할 수 있었다.

• Journal of Pharmaceutical Investigation
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• 제40권5호
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• pp.285-289
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• 2010

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.