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首页> 外文期刊>Nature reviews neuroscience >Application of Texture Analysis Technique in Formulation Development of Lyophilized Orally Disintegrating Tablets Containing Mannitol, Polyvinylpyrrolidone and Amino Acids
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Application of Texture Analysis Technique in Formulation Development of Lyophilized Orally Disintegrating Tablets Containing Mannitol, Polyvinylpyrrolidone and Amino Acids

机译：纹理分析技术在含甘露醇，聚乙烯吡咯烷酮和氨基酸的冻干口腔崩解片的制剂中的应用

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Orally disintegrating tablets (ODTs) attract a great attention as this easy swallowing dosage form often improves patient compliance. In the current work, orally disintegrating tablets comprising mannitol, polyvinylpyrrolidone (PVP) and an amino acid (alanine, glycine or serine) with various PVP-to-amino acid ratios were formulated. The combination of mannitol and an amino acid was aimed to use the advantages of mannitol, the matrix-supporting and disintegration agent, and to reduce the total amount of sugar/polyol in tablets. Tablets were manufactured by freeze-drying and their properties (appearance, internal structure, disintegration, mechanical and texture properties, moisture uptake, shrinkage, thermal properties) were assessed. In the work, great emphasis was placed on illustrating the applicability of the Texture Analysis of the freeze-dried cakes directly in vials in formulation development. The results show that the appearance, mechanical properties, disintegration and shrinkage of the freeze-dried ODTs depend significantly on the excipient composition with PVP playing the leading role. Partial mannitol replacement with an amino acid has a limited impact on the tablet properties. The presence of an amino acid also has no impact on the PVP-mannitol interaction. The mechanical and texture properties of freeze-dried ODTs depend non-linearly on the PVP content. The transition between the different types of textures occurs in a narrow range of PVP concentrations regardless of the type of amino acid in a formulation. The non-linear effect of PVP on various tablet properties should be taken into account when designing ODT formulations as it can compromise the robustness of the manufacturing process.
机译：口服崩解片剂（ODTS）吸引了很大的关注，因为这种易吞咽剂量形式通常会改善患者的顺应性。在当前的工作中，配制了包含甘露醇，聚乙烯吡咯烷酮（PVP）和氨基酸（丙氨酸，甘氨酸或丝氨酸）的口服崩解片被配制出各种PVP - 氨基酸比。甘露醇和氨基酸的组合旨在使用甘露醇，基质载体和崩解剂的优点，并减少片剂中的糖/多元醇的总量。通过冷冻干燥和它们的性质（外观，内部结构，崩解，机械和质地性能，水分吸收，收缩，热性能）制造片剂。在工作中，大量重点是说明在制剂开发中直接在小瓶中直接冻干蛋糕的纹理分析的适用性。结果表明，冷冻干燥的Odts的外观，机械性能，崩解和收缩依赖性依赖于赋形剂组合物与PVP发挥主导作用。用氨基酸替代的部分甘露醇对片剂性质的影响有限。氨基酸的存在也没有对PVP-甘露醇相互作用的影响。冷冻干燥的ODTS的机械和质地性能在PVP含量上非线性地依赖于线性。不同类型的纹理之间的过渡发生在窄的PVP浓度范围内，无论制剂中的氨基酸的类型如何。在设计ODT制剂时，应考虑PVP对各种片剂性质的非线性效果，因为它可以损害制造过程的鲁棒性。

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