Utilizing the dynamic gastrointestinal model (DGM) to evaluate the gastric integ...

연구 요약

Utilizing the dynamic gastrointestinal model (DGM) to evaluate the gastric integrity of Capsugel® Enprotect® capsules in fasted and fed states.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V 학술지에 발표된 이 연구는 Knopp MM, Jannin V, Gonzalez V 외 연구팀이 수행하였습니다.

이 연구는 'Utilizing the dynamic gastrointestinal model (DGM) to evaluate the gastric integrity of Capsugel® Enprotect® capsules in fasted and fed states.'에 대한 과학적 분석을 제공합니다.

핵심 내용

This study aimed to evaluate if the Dynamic Gastrointestinal Model (DGM) is able to simulate the gastro-resistant behavior of Capsugel® Enprotect® capsules under physiologically relevant fasted and fed states. Enprotect® capsules were filled with a caffeine powder blend and tested under three conditions: fasted state, a light meal (∼500 kcal), and a high-fat meal (∼900 kcal). Results showed that the capsules remained intact in the stomach across all conditions and released their contents only after intestinal entry. Dissolution and pharmacokinetic predictions closely aligned with published clinical data for the fasted state and light meal. The extended gastric residence and elevated pH of the high-fat meal did not compromise capsule integrity possibly due to a combination of capsule floating and acid pocket formation on the top of the digesting meal. These findings confirm the robustness of Enprotect® capsules and demonstrate the utility of the DGM in predicting oral dosage form behavior and performance under physiologically relevant gastrointestinal conditions.

일반인을 위한 해석

구체적인 실천 사항은 담당 의사 또는 약사와 상담하시기 바랍니다.

실천 사항

• 현재 복용 중인 약물이나 영양제에 대해 궁금한 점이 있다면 담당 의사 또는 약사와 상담하시기 바랍니다
• 약물이나 영양제의 용법·용량을 임의로 변경하지 마세요
• 이상 반응이 나타나면 즉시 전문가에게 문의하세요

의사/약사의 전문적 판단을 대체하지 않습니다 (PMID: 41386382)