Effect of Spinacia oleracea on In Vitro Disintegration and Dissolution of Clopid...

연구 요약

Effect of Spinacia oleracea on In Vitro Disintegration and Dissolution of Clopidogrel Bisulfate Tablets.

Pharmacology research & perspectives 학술지에 발표된 이 연구는 Sadaqa D, Naseef HA, Radwan A 외 연구팀이 수행하였습니다.

이 연구는 'Effect of Spinacia oleracea on In Vitro Disintegration and Dissolution of Clopidogrel Bisulfate Tablets.'에 대한 과학적 분석을 제공합니다.

핵심 내용

Drug-food interactions may compromise therapeutic efficacy, particularly for life-saving medications such as anticoagulants. Changes in gastric fluid properties, including pH modification and surface film formation, can alter drug dissolution and release. This study evaluated a potential interaction between clopidogrel and spinach and explored the underlying mechanisms. In vitro disintegration and dissolution studies were conducted using HCl and phosphate buffers with and without 5% and 7.5% spinach extract. Drug release was quantified by high-performance liquid chromatography (HPLC), with six media conditions analyzed in triplicate. Disintegration testing was performed in simulated gastric and intestinal fluids and in the presence of spinach leaves to assess the effect of film formation on tablet wetting and disintegration. In vitro-in vivo extrapolation (IVIVE) was assessed using GastroPlus software. Clopidogrel dissolution decreased with increasing spinach concentration in both media. In HCl buffer, dissolution declined from 99% to 94% and 89%, while in phosphate buffer it decreased from 71% to 66% and 56%. These effects were associated with increased pH (HCl: 1.91, 2.83, 2.98; phosphate: 6.81, 8.83, 6.84), increased solution viscosity, 17.63 to 17.67 and 17.70 in HCl buffer, and from 17.44 to 17.50 and 17.54 in phosphate buffer. Moreover, reduced fluid penetration was due to spinach leaves coverage. IVIVE analysis showed weak correlations (R2 = 0.74 in HCl and 0.69 in phosphate buffer). Spinach reduced clopidogrel dissolution in vitro, with statistically significant effects at 5% spinach in HCl buffer (ANOVA test, p-value 0.019) and 7.5% in phosphate buffer (ANOVA test, p-value < 0.001). This interaction appears to be mediated by pH alteration, physical film formation, and potentially metal-drug complexation. Confirmation through in vivo studies is warranted.

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: 41685910)

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