药物的互换性和与水以外的液体服用药物的生物药学意义:布洛芬案例研究

Pub Date : 2023-06-26 DOI:10.1590/s2175-97902023e22725
N. Pajić, Irma Mureškić, Božana Jevđenić, A. Račić, Biljana Gatarić
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引用次数: 0

摘要

本研究的目的是比较波斯尼亚和黑塞哥维那市售布洛芬固体口服剂型的溶出特性,并估计溶出介质组成对药物释放的影响。8种产物(A-H)采用USP42-NF37所述的实验条件进行体外溶出试验。对所选产品在酒精(22.2% v/v)和果汁(22.2% v/v)存在下的溶出性能进行了研究。标有B-H的产品符合药典标准。产物B的溶出曲线与产物D、E、F和G的溶出曲线相似,产物A-D、C-G、D-G和E-F的溶出曲线相似。大多数被测制剂的药物释放最符合Weibull动力学模型。在培养基中有酒精存在时,溶解了更多的布洛芬。相反,布洛芬在果汁中的溶解量明显较低。所研究的制剂的溶出谱的差异表明,它们的互换性应该被额外考虑,并通过体内生物等效性研究来证明。培养基中不同物质的存在会影响布洛芬的溶出特性,强调患者依从性的重要性。
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Interchangeability of medications and biopharmaceutical implication of taking drugs with fluids other than water: ibuprofen case study
The aim of this study was to compare the dissolution properties of ibuprofen solid oral dosage forms commercially available in Bosnia and Herzegovina and to estimate the influence of dissolution medium composition on the drug release. Eight products (A-H) were subjected to in vitro dissolution test using experimental conditions described in USP42–NF37. Dissolution properties of one selected product were examined in the presence of alcohol (22.2% v/v) and fruit juice (22.2% v/v). Products marked B-H complied with the pharmacopeial criteria. Dissolution profile of product B was similar with dissolution profiles of products D, E, F and G and similarity was also found between products A-D, C-G, D-G and E-F. Drug release from most of the examined preparations fitted best to the Weibull kinetic model. In the presence of alcohol in the medium, higher amount of ibuprofen was dissolved. Contrary, ibuprofen dissolved in the presence of fruit juice was significantly lower. Differences in the dissolution profiles of investigated preparations suggest that their interchangeability should be additionally considered and demonstrated with in vivo bioequivalence studies. Presence of different substances in the medium can affect dissolution properties of ibuprofen, emphasizing the importance of the patient’s compliance.
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