Journal of Pharmaceutical Investigation

  • 제33권3호
  • /
  • Pages.179-185
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  • 2003
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  • 2093-5552(pISSN)
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  • 2093-6214(eISSN)
한국약제학회 (The Korean Society of Pharmaceutical Sciences and Technology)
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멜라토닌이 함유된 다층 코팅 펠렛의 방출 및 특성분석

Release and Characterization of Multiple Coated Pellets Containing Melatonin

  • 강복기 (전북대학교 고분자공학과) ;
  • 강길선 (전북대학교 고분자공학과) ;
  • 김종민 (전북대학교 유기신물질공학과) ;
  • 정상영 (한국화학연구원 생체의료고분자팀) ;
  • 이해방 (한국화학연구원 생체의료고분자팀) ;
  • 조선행 (한국화학연구원 생체의료고분자팀)
  • Kang, Bok-Ki (Department of Polymer Science and Technology, Chonbuk National University) ;
  • Khang, Gil-Son (Department of Polymer Science and Technology, Chonbuk National University) ;
  • Kim, Jong-Min (Department of Advanced Organic Materials Engineering, Chonbuk National University) ;
  • Jeung, Sang-Young (Nanobiomaterials Laboratory, Korea Research Institute of Chemical Technology) ;
  • Lee, Hai-Bang (Nanobiomaterials Laboratory, Korea Research Institute of Chemical Technology) ;
  • Cho, Sun-Hang (Nanobiomaterials Laboratory, Korea Research Institute of Chemical Technology)
  • 발행 : 2003.09.20
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초록

Melatonin (MT) is an indole amide pineal hormone. It has not only very short half-life but also pH-sensitive property. The sustained release dosage form which delivers MT in a circadian fashion over 8 h is clinical value. The purpose of this study is to prepare sugar beads using multiple coating methods and enteric-coated in a sustained release to evaluate in vitro release characteristics in simulated gastric and intestinal fluids. The $Eudragit^{\circledR}$ as a polymer, sustained release membrane, and triethylcitrate (TEC) as a plasticzer were used. Multi-coated melatonin delivery system was composed of sugar, various excipients, $Eudragit^{\circledR}$ and enteric materials (e.g. hydroxy propyl methyl cellulose phthalate, HPMCP), and prepared by fluid bed coater. The dissolution test was carried out using the basket method at a stirring speed of 100 rpm at $37^{\circ}C$ in simulated gastric (pH 1.2) and intestinal fluid (pH 7.4). The released amount of MT was determined by High performance liquid chromatography method. The morhologies of surface and cross section of multi-coated beads were observed by scanning electron microscope. Size of multi-coated sugar beads was ranged over $1000{\sim}1300\;{\mu}m$. The release rate of MT from coated beads was limited in simulated gastric fluid (pH 1.2), but it was sustained in intestinal fluid (pH 7.4) during $3{\sim}8$ hours. The MT beads may provide small-intestine-targeted device for oral delivery. Studies on animal and relative experiment are in process.

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