用USP仪器2和4进行速尿非专利产品体外释放研究的比较

IF 1 4区 医学 Q4 PHARMACOLOGY & PHARMACY Dissolution Technologies Pub Date : 2021-01-01 DOI:10.14227/DT280121P14
Jose Raul MEDINA-LÓPEZ, Alexander Domínguez-Reyes, Marcela Hurtado
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引用次数: 1

摘要

溶出度研究对于比较仿制药和参比药的质量至关重要。本研究的目的是在正式溶出条件下,利用细胞流动法评价速尿片的体外释放度。为此,使用了两个USP设备:设备2(桨转速50 rpm)含有900 mL pH为5.8的磷酸盐缓冲溶液,设备4(流式细胞速度16 mL/min)使用相同的介质。用紫外分光光度法在274 nm波长下测定溶出药的溶出度,测定时间为60 min,虽然单个时间点的溶出度符合Q = 80%的接受标准,但仿制药的溶出度曲线与参比品的溶出度曲线并不相似。相似因子(f2 < 50)、平均溶出时间、溶出效率、t50%、t80%和Td值证实了各剖面之间的差异(p < 0.05)。体外释放试验表明,在墨西哥可买到的呋塞米片剂,仿制制剂的性能与参比制剂不同。这些差异会影响体内吸收,从而产生不同的治疗效果。需要对墨西哥生产的非专利速尿片进行更多的评价。
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Comparison of Generic Furosemide Products by In Vitro Release Studies using USP Apparatus 2 and 4
Dissolution studies are essential for comparing the quality of generic drugs to their reference products. The objective of this work was to evaluate the in vitro release of furosemide in tablets under official dissolution conditions and using the flow-through cell method. To this end, two USP apparatus were used: apparatus 2 (paddle at 50 rpm) containing 900 mL of phosphate buffer solution pH 5.8, and apparatus 4 (flow-through cell at 16 mL/min) with the same medium. The dissolved drug was quantified by UV spectrophotometry at 274 nm for 60 min. Although the results at a single time point met the acceptance criterion of Q = 80% at 60 min, the dissolution profiles of generic drugs were not similar to the reference product. The similarity factor (f2 < 50), mean dissolution time, dissolution efficiency, t50%, t80%, and Td values corroborate the difference between the profiles (p < 0.05). In vitro release testing demonstrates that, for furosemide tablets available in Mexico, the generic formulations perform differently from the reference products. These differences could affect in vivo absorption, which could yield different therapeutic effects. More evaluation of generic furosemide tablets manufactured in Mexico is needed.
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来源期刊
Dissolution Technologies
Dissolution Technologies 医学-药学
CiteScore
1.20
自引率
33.30%
发文量
14
审稿时长
3 months
期刊介绍: Dissolution Technologies is a peer reviewed quarterly publication reporting ongoing, useful information on dissolution testing of pharmaceuticals. It provides an international forum for dissolution analysts to receive and exchange information on various dissolution topics. Dissolution Technologies welcomes submissions related to dissolution, in vitro release, and disintegration testing. These topics should be the major focus of the article. Do not submit articles where the focus is formulation development with dissolution testing as one of many tests.
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