Evaluation of Aluminum and Magnesium Absorption Following the Oral Administration of an Antacid Suspension Containing Magaldrate in Healthy Women Under Fed Conditions.

IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Maria Juliana Burgos Castillo, Maria Juliana Cruz Palacios, Kamila Iorgatchof Xavier, Silvana Aparecida Calafatti Carandina, Isaac Arbeláez Quintero, Leandro do Prado Assunção
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Abstract

Introduction: Antacids are commonly used during pregnancy, and they are approved for the relief of symptoms of gastroesophageal reflux disease (GERD) during pregnancy. However, there are no reports of the quantification of the absorption of aluminum and magnesium in the antacid magaldrate in women. The aim of this study was to quantify the rate and magnitude of absorption of aluminum and magnesium in magaldrate.

Methods: An open-label, controlled, randomized, one-treatment study with a two-group design was conducted in healthy women in a fed state. The volunteers had a standard breakfast, and 30 min later, they were given a single-medication sachet containing 500 mg of sodium alginate, 267 mg of sodium bicarbonate, 800 mg of magaldrate, and 120 mg of simethicone (group A, n = 8) or no medication (group B, n = 2). Blood samples were obtained 36 h before and up to 12 h after antacid administration. The method used for quantification was inductively coupled plasma-mass spectrometry.

Results: There was no absorption of aluminum in any of the blood samples from the healthy volunteers who received the drug or in those from the control group. Magnesium was detected at normal concentrations.

Conclusion: These findings suggest that the use of this antacid is safe and without risk in healthy women, including pregnant women.

Clinical trial registration: Clinicaltrials.gov registration: NCT06367452.

Abstract Image

评估健康女性在进食条件下口服含镁砂的抗酸剂悬浮液后对铝和镁的吸收。
简介:抗酸剂是孕期常用的药物,已被批准用于缓解孕期胃食管反流病(GERD)的症状。然而,目前还没有关于妇女对抗酸剂麦角酸盐中铝和镁的吸收进行量化的报道。本研究的目的是量化麦角酸盐中铝和镁的吸收率和吸收量:方法:在处于进食状态的健康女性中开展了一项采用两组设计的开放标签、对照、随机、单一治疗研究。志愿者先吃一顿标准早餐,30 分钟后给她们服用一袋含有 500 毫克海藻酸钠、267 毫克碳酸氢钠、800 毫克镁醛酸盐和 120 毫克西米替丁的单一药物(A 组,n = 8)或不服用药物(B 组,n = 2)。在服用抗酸剂前 36 小时和服用后 12 小时内采集血液样本。采用电感耦合等离子体质谱法进行定量:结果:接受药物治疗的健康志愿者和对照组的血液样本中都没有铝的吸收。镁的浓度正常:这些研究结果表明,这种抗酸剂对健康妇女(包括孕妇)是安全和无风险的:临床试验注册:Clinicaltrials.gov 注册:临床试验注册:Clinicaltrials.gov 注册:NCT06367452。
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来源期刊
Advances in Therapy
Advances in Therapy 医学-药学
CiteScore
7.20
自引率
2.60%
发文量
353
审稿时长
6-12 weeks
期刊介绍: Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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