알긴산 나트륨에 포접된 란소프라졸 장용성 경질캡슐의 특성분석

백종선; 김진수; 김원경; 김다윗; 송정은; 강길선; Jong Seon Baek; Jin Su Kim; Won Kyung Kim; David Kim; Jeong Eun Song; Gilson Khang

Polymer(Korea), Vol.43, No.3, 415-419, May, 2019

DOI10.7317/pk.2019.43.3.415 Export Citation

알긴산 나트륨에 포접된 란소프라졸 장용성 경질캡슐의 특성분석

Evaluation of Lansoprazole Enteric Hard Capsule Encapsulated by Sodium Alginic Acid

백종선, 김진수, 김원경, 김다윗, 송정은 , 강길선 ^†

전북대학교 BIN융합공학과, 고분자나노공학과, 고분자융합소재연구소

Jong Seon Baek, Jin Su Kim, Won Kyung Kim, David Kim, Jeong Eun Song , and Gilson Khang^†

Dept. of BIN Convergence Tech & Dept. of PolymerNanoSci Tech, Chonbuk National University, 567 Baekje-daero, Jeonju 54896, Korea

E-mail:

초록

소화성 궤양 및 역류성 식도염을 치료하는 효과적인 약물 치료제로는 양성자펌프 억제제(proton pump inhibitor, PPI)가 있다. 란소프라졸은 PPI계열 약물로 복용 후 낮은 pH에 노출되면 용출률이 저해되어 재석출이 일어난다. 따라서 본 연구에서는 란소프라졸의 약물방출을 제어하기 위하여, 알긴산 나트륨과 습식과립 공정을 이용한 장용성 용질캡슐을 제조하였다. 이 제형은 위액의 산성조건에서 방출이 억제되고, 장액의 중성이나 약 알칼리 조건에서 급속한 약물방출이 일어나는 것을 목표로 하였다. 제조된 경질캡슐의 특성분석을 위해 DSC, XRD, FTIR, SEM을 실행하였다. 이 후 제형이 제대로 설계되었는지 확인하기 위하여 생체 외 용출거동을 통해 변화된 용출률을 확인하였다. 이러한 결과를 토대로 알긴산나트륨이 포접된 란소프라졸 장용성 캡슐은 소화성 궤양 및 역류성 식도염 치료제로 사용 가능함을 확인할 수 있다.

An effective drug treatment for peptic ulcer and reflux esophagitis is the proton pump inhibitor (PPI) such as lansoprazole. However when the lansoprazole is exposed to low pH, its dissolution rate becomes low and thus re-precipitation occurs. Therefore an enteric solute capsule was prepared using sodium alginate and wet granulation process. This formulation aimed to inhibit release in acidic conditions of stomach fluid and to cause rapid drug release under conditions of intense, neutral or weakly alkaline conditions. DSC, XRD, FTIR, and SEM were performed to characterize the manufactured hard capsules. In order to confirm that the formulation was properly designed, the dissolution rate was confirmed through in vitro dissolution behavior. Based on these results, it can be confirmed that lansoprazole enteric capsules containing sodium alginate can be used as a treatment for peptic ulcer and reflux esophagitis.

Keywords:lansoprazole;sodium alginic acid;enteric hard capsule;wet granules

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[1] Marshall BJ, Warren JR, The Lancet, 323, 1311 (1984)

[2] Malfertheiner P, Chan FKL, McColl KEL, The Lancet, 374, 1449 (2009)

[3] Vigneri S, Termini R, Leandro G, Badalamenti S, Pantalena M, Savarino V, Mario FD, Battaglia G, Mela GS, Pilotto A, Plebani M, Davi G, N. Engl. J. Med., 333, 1106 (1995)

[4] Dodds WJ, Dent J, Hogan WJ, Helm JF, Hauser R, Patel GK, Egide MS, N. Engl. J. Med., 307, 1547 (1982)

[5] Richardson P, Hawkey DJ, Stack WA, Drugs, 56, 307 (1998)

[6] Yamada S, Kawakami T, Nakatsugawa Y, Suzuki T, Fujii H, Tomatsuri N, Nakamura H, Sato H, Okuyama Y, Kimura H, Yoshida N, World J. Gastrointest. Pharmacol. Ther., 7, 550 (2016)

[7] Iwahi T, Satoh H, Nakao M, Iwasaki T, Yamazaki T, Kubo K, Tamura T, Imada A, Antimicrob. Agents Chemother., 35, 490 (1991)

[8] Nagaya H, Inatomi N, Nohara A, Satoh H, Biochem. Pharmacol., 42, 1875 (1991)

[9] Chey WD, Woods M, Scheiman JM, Nostrant TT, DelValle J, Am. J. Gastroenterol., 92, 446 (1997)

[10] Shimizu T, Sugaya M, Nakano Y, Izutsu D, Mizukami Y, Okochi K, Tabata T, Hamaguchi N, Igari Y, Chem. Pharm. Bull., 51, 1121 (2003)

[11] Muthusamy K, Govindarazan G, Ravi TK, Indian J. Pharm. Sci., 67, 75 (2005)

[12] Reddy P, Jayaprakash BM, Sivaji K, Jyothesh GT, Kuamr EC, Reddy S, Reddy BR, IJABPT, 1, 683 (2010)

[13] Prasanna B, Reddy K, Reddy YR, Ramachandran D, EJ. Chem., 6, 489 (2009)

[14] Zhang XW, Sun NY, Wu BJ, Lu Y, Guan TZ, Wu W, Powder Technol., 182(3), 480 (2008)

[15] Daemi H, Barikani M, Sci. Iran., 19, 2023 (2012)

[16] Jivraj M, Martini LG, Thomson CM, Pharm. Sci. Technol. Today, 3, 58 (2000)

[17] Zhang XW, Sun NY, Wu BJ, Lu Y, Guan TZ, Wu W, Powder Technol., 182(3), 480 (2008)

[18] Shabir A, Alhusban F, Perrie Y, Mohammed AR, J. Basic Clin. Pharm., 2, 71 (2011)

[19] Sarmento B, Ferreira D, Veiga F, Ribeiro A, Carbohydr. Polym., 66, 1 (2006)