A Multiple Unit Abuse-deterrent Dosage Form Based on Sodium Alginate

European Pharmaceutical Journal Pub Date : 2023-09-15 DOI:10.2478/afpuc-2023-0020

M. Papadakos, M. Špaglová, M. Čuchorová, M. Hanko

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Abstract

Abstract There are several approaches for the formulation of abuse-deterrent, tamper-resistant, or alcohol-resistant dosage forms. This work is specifically focused on the formulation of microforms and multiple unit dosage forms with the mentioned resistant features. We prepared microcapsules based on sodium alginate by Ca 2+ -induced gelation, containing caffeine as a model drug. The prepared microcapsules were dried either by hot air or freeze-dried and the resistance in an alcoholic environment and the resistance against mechanical stress were observed. Subsequently, swelling studies were conducted to predict the behavior of prepared microcapsules during dissolution testing. Differences in the behavior of microcapsules during dissolution testing were strongly related to the different abilities of Ca 2+ -alginate microcapsules to swell in an acidic and alkaline environment. Alginate microcapsules exhibited gastro-resistant properties due to excellent swelling in an alkaline environment and poor swelling in a gastric environment. The addition of ethanol did not influence the swelling behavior of alginate microcapsules in the gastric fluid; rather, it showed the opposite effect, where swelling was slightly suppressed. Therefore, we conclude that alginate microcapsules are alcohol resistant. Also, they showed high mechanical strength, and therefore, grinding the microcapsules into a powder was impossible.

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基于海藻酸钠的多单位防滥用剂型研究

有几种方法来制定滥用威慑，抗篡改，或抗酒精剂型。本工作特别关注具有上述耐药特征的微制剂和多单位剂型的配方。以海藻酸钠为基材，采用ca2 +诱导凝胶法制备了以咖啡因为模型药物的微胶囊。采用热风干燥和冻干两种方法对制备的微胶囊进行干燥，观察其在酒精环境下的抗逆性和对机械应力的抗逆性。随后，进行了溶胀研究，以预测制备的微胶囊在溶解测试中的行为。溶解试验中微胶囊行为的差异与Ca 2+ -海藻酸盐微胶囊在酸性和碱性环境中的不同膨胀能力密切相关。海藻酸盐微胶囊在碱性环境中具有良好的溶胀性，而在胃环境中溶胀性差，因此具有抗胃功能。乙醇的加入对海藻酸盐微胶囊在胃液中的溶胀行为没有影响;相反，它显示出相反的效果，肿胀被轻微抑制。因此，我们认为海藻酸盐微胶囊具有抗酒精性。此外，它们表现出很高的机械强度，因此，将微胶囊研磨成粉末是不可能的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Pharmaceutical Journal Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)

CiteScore

0.60

自引率

0.00%

发文量

期刊介绍： European Pharmaceutical Journal publishes only original articles not previously published and articles that are not being considered or have not been submitted for publication elsewhere. If parts of the results have been published as conference abstract or elsewhere, it should be stated in references. The ethical standards of the Helsinki-Tokio Declaration should be kept. This should be mentioned in the Methods of manuscript. Reviews are published only on request. Authors, whose submitted research work was performed with the support of a company, should indicate this in Conflict of Interest.