基于4,4′-(丙二胺)二苯甲酸钠缓释片的SeDeM预测

Q3 Pharmacology, Toxicology and Pharmaceutics
Михаил Игоревич Коцур, Ю. М. Ладутько, Артем Наркевич, Julia M. Kotsur, Julia M. Ladytko, I. Narkevich, E. Flisyuk
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引用次数: 3

摘要

介绍直接压缩技术是最常见的平板电脑技术之一。众所周知,如果不添加特殊赋形剂,许多活性药物成分就不适合这种技术。确定粉末材料适用于直接压缩技术的一个有用工具是基于设计质量概念的沉积物输送模型(SeDeM)方法。所提出的方法不仅可以评估材料是否适合直接压缩,而且有助于预测片剂形式的固体剂型的组成,这反过来又大大减少了新药开发中的实验工作。目标用SeDeM数学建模方法直接压缩得到的缓释4,4'-(丙二氨基)二苯甲酸钠基质片的成分预测。材料和方法。研究对象是原始物质4,4'-(丙二氨基)二苯甲酸钠,以及一些辅助物质,包括用于缓释剂型的聚合物、除尘成分硬脂酸镁和填料乳糖一水合物。根据《俄罗斯联邦国家药典》第十四版和EP第九版的要求,对原料药、炸药、所得片剂混合物和片剂的理化性质和工艺性质进行了研究。结果和讨论。根据SeDeM方法评估物质和赋形剂的性质。研究发现,4,4'-(丙二氨基)二苯甲酸钠物质由于流动性差和压缩性低,不适合直接压制。羟丙甲纤维素-甲基纤维素K4M具有良好的压缩性,但不具有足够的流动性。其他测试的聚合物对于直接压缩技术具有令人满意的性能。使用SeDeM方法计算片剂混合物的组成,所获得的片剂混合物具有通过直接压缩获得片剂的令人满意的工艺特性。实验得到的片剂也符合药典要求。结论采用SeDeM法对以4,4’-(丙二氨基)二苯甲酸钠为原料的缓释片的组成进行了预测。结果表明,该方法适用于4,4’-(丙二氨基)二苯甲酸钠片剂的开发。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Prediction of the composition of prolonged release tablets based on 4,4'-(propandiamido) sodium dibenzoate using the SeDeM method
Introduction. Direct compression technology is one of the most common tablet technologies. As known, many active pharmaceutical ingredients are not suitable for this technology without the addition of special excipients. A useful tool for determining the suitability of powdered materials for direct compression technology is the Sediment Delivery Model (SeDeM) method, based on the concept of Quality by Design. The presented method allows not only to assess the suitability of a material for direct compression, but also helps to predict the composition of a solid dosage form in the form of a tablet, which, in turn, leads to a significant reduction in experimental work carried out in the development of a new drug.Aim. Prediction of the compositions of matrix tablets based on sodium 4,4'-(propanediamido)dibenzoate with prolonged release, obtained by direct compression using the method of mathematical modeling SeDeM.Materials and methods. The objects of the study were the original substance sodium 4,4'-(propanediamido)dibenzoate, as well as a number of auxiliary substances, which included polymers used for dosage forms with prolonged release, a dusting component – magnesium stearate, and a filler – lactose monohydrate. Physicochemical and technological properties of APIs, explosives, obtained tablet mixtures and tablets were studied in accordance with the requirements of the State Pharmacopoeia of the Russian Federation XIV ed. and EP 9th ed.Results and discussion. The properties of the substance and excipients were assessed in accordance with the SeDeM method. It was found that the substance 4,4'-(propanediamido) sodium dibenzoate is not suitable for direct pressing due to poor flowability and low compressibility. Hypromellose Methocel K4M had good compressibility, but it did not have sufficient flowability. The other tested polymers had satisfactory properties for the direct compression technology. The composition of the tablet mixtures was calculated using the SeDeM method, the obtained tablet mixtures had satisfactory technological characteristics for obtaining tablets by direct compression. The tablets obtained as a result of the experiment also met the pharmacopoeial requirements.Conclusion. Prediction of the composition of sustained-release tablets based on the original substance sodium 4,4'-(propanediamido)dibenzoate was carried out using the SeDeM method. It was found that this method is suitable for the development of the composition of tablets based on sodium 4,4'-(propanediamido)dibenzoate.
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来源期刊
Drug Development and Registration
Drug Development and Registration Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
1.20
自引率
0.00%
发文量
61
审稿时长
8 weeks
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