고온용융압출과 3D 프린팅을 이용한 위체류 정제의 개발 (The Development of Gastro-Retentive Tablet using Hot Melt Extrusion and 3D Printing Technology)

서지정보

· 발행기관 : 대한약학회
· 수록지 정보 : 약 학 회 지 / 66권 / 2호 / 76 ~ 89페이지
· 저자명 : 이수환, 조영호, 이계원

초록

In this study, a three-dimensional (3D) printed gastro-retentive tablet (3DPGRT) containing sarpogrelate HCl wasprepared by changing the amount of the polymers (Eudagit®L100-55 (EuL), pectin, and polyethylene oxide (PEO)) bycoupling hot melt extrusion (HME) and 3D printing technology. The study aims to evaluate the swelling and dissolutionbehavior for application as a gastro-retentive drug delivery system and optimize the formulation of 3DPGRT based on thedesign of experiment using central composite design. The flexibility and elasticity of the extruded filaments were affectedby EuL, pectin, and PEO, which either showed a linear or quadratic pattern. 3DPGRT containing sarpogrelate HCl wasfabricated successfully by coupling HME and a fused deposition modeling 3D printer without being affected by EuL, pectin,and PEO. Compatibility studies of the drug-excipient through FT-IR and DSC revealed the absence of any interactionbetween the drug and polymers. The developed 3DPGRT possessed the ability to float over 10 h. The dissolution rate ofsarpogrelate HCl was significantly affected by the interaction between EuL and pectin. The results confirmed that themechanism of drug release of 3DPGRT is caused by a combination of non-Fickian diffusion and dilatation, which fits wellwith the Higuchi and Korsmeyer-Peppas model. The optimized formulation have been obtained by numerical optimization,which yielded excellent floating properties and a desirable swelling ratio with controlled drug release. This study showedthe application of quality by design in the formulation development of 3DPGRT coupled with HME, which can be used tocontrol the swelling characteristics and dissolution behavior through the interaction between EuL and pectin.

영어초록

In this study, a three-dimensional (3D) printed gastro-retentive tablet (3DPGRT) containing sarpogrelate HCl wasprepared by changing the amount of the polymers (Eudagit®L100-55 (EuL), pectin, and polyethylene oxide (PEO)) bycoupling hot melt extrusion (HME) and 3D printing technology. The study aims to evaluate the swelling and dissolutionbehavior for application as a gastro-retentive drug delivery system and optimize the formulation of 3DPGRT based on thedesign of experiment using central composite design. The flexibility and elasticity of the extruded filaments were affectedby EuL, pectin, and PEO, which either showed a linear or quadratic pattern. 3DPGRT containing sarpogrelate HCl wasfabricated successfully by coupling HME and a fused deposition modeling 3D printer without being affected by EuL, pectin,and PEO. Compatibility studies of the drug-excipient through FT-IR and DSC revealed the absence of any interactionbetween the drug and polymers. The developed 3DPGRT possessed the ability to float over 10 h. The dissolution rate ofsarpogrelate HCl was significantly affected by the interaction between EuL and pectin. The results confirmed that themechanism of drug release of 3DPGRT is caused by a combination of non-Fickian diffusion and dilatation, which fits wellwith the Higuchi and Korsmeyer-Peppas model. The optimized formulation have been obtained by numerical optimization,which yielded excellent floating properties and a desirable swelling ratio with controlled drug release. This study showedthe application of quality by design in the formulation development of 3DPGRT coupled with HME, which can be used tocontrol the swelling characteristics and dissolution behavior through the interaction between EuL and pectin.

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