Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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The Effect of Sodium Alginate Coating on the Storage Stability and Dissolution Rate of Enteric Coated Lansoprazole

알긴산 나트륨이 장용코팅된 란소프라졸 제제의 저장안정성 및 용출률에 미치는 영향에 관한 연구

  • Kim, Jung-Hoon (Department of Advanced Organic Materials Engineering, Chonbuk National University) ;
  • Oh, Jung-Min (Department of Advanced Organic Materials Engineering, Chonbuk National University) ;
  • Khang, Gil-Son (Department of Advanced Organic Materials Engineering, Chonbuk National University) ;
  • Jeong, Je-Kyo (Research Center, Samchundang Pharm. Co. Ltd.) ;
  • Lee, Jung-Sik (Research Center, Samchundang Pharm. Co. Ltd.) ;
  • Jeung, Sang-Young (Biomaterials Laboratory, Korea Research Institute of Chemical Technology) ;
  • Lee, Hai-Bang (Biomaterials Laboratory, Korea Research Institute of Chemical Technology)
  • 김정훈 (전북대학교 유기신물질공학과) ;
  • 오정민 (전북대학교 유기신물질공학과) ;
  • 강길선 (전북대학교 유기신물질공학과) ;
  • 정제교 (삼천당제약 중앙연구소) ;
  • 이정식 (삼천당제약 중앙연구소) ;
  • 정상영 (한국화학연구원 생체의료고분자팀) ;
  • 이해방 (한국화학연구원 생체의료고분자팀)
  • Published : 2002.12.20
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Abstract

Lansoprazole, pharmaceutics for acid-related diseases, is unstable in low pH environments and generally coated with enteric polymer to obtain gastroresistance in stomach. Because its storage stability is influenced by acidic substitutes of enteric polymer, alkaline chemicals wεre generally addεd to dosage form as a stabilizer. In this experience, we coated lansoprazole bead with sodium alginate and evaluated the effect of bead size and sodium alginate coating on the storage stability and dissolution profile of lansoprazole. Sodium alginate solution containing lansoprazole was sprayed as a droplet into 3% (w/v) $CaCl_2$ solution and the resultant bead was coated with starch, sodium alginate, and hydroxypropyl methylcellulose phthalate. The content of lansoprazole granule not coated with sodium alginate decreased to 57.96% of initial content when stored at a severe condition for 4 weeks, but that of lansoprazole granule coated with sodium alginate before enteric coating decreased little and as the thickness of sodium alginate film increased, the content of bead didn't decreased for 4 weeks. Sodium alginate film also improved the gastroresistance without much influencing the maximum dissolution rate.

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References

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