Abstract：
UNASSIGNED: Orally disintegrating tablets (ODTs) are designed to dissolve in the oral cavity within 3 min, providing a convenient option for patients as they can be taken without water. Direct compression is the most common method used for ODTs formulations. However, the availability of single composite excipients with desirable characteristics such as good compressibility, fast disintegration, and a good mouthfeel suitable for direct compression is limited.
UNASSIGNED: This research was proposed to develop a co-processed excipient composed of xylitol, mannitol, and microcrystalline cellulose for the formulation of ODTs.
UNASSIGNED: A total of 11 formulations of co-processed excipients with different ratios of ingredients were prepared, which were then compressed into ODTs, and their characteristics were thoroughly examined. The primary focus was on evaluating the disintegration time and hardness of the tablets, as these factors are important in ensuring the ODTs meet the desired criteria. The model drug, Mirtazapine was then incorporated into the chosen optimized formulation.
UNASSIGNED: The results showed that the formulation comprised of 10% xylitol, 10% mannitol and 80% microcrystalline cellulose demonstrated the fastest disintegration time (1.77 ± 0.119 min) and sufficient hardness (3.521 ± 0.143 kg) compared to the other formulations. Furthermore, the drug was uniformly distributed within the tablets and fully released within 15 min.
UNASSIGNED: Therefore, the developed co-processed excipients show great potential in enhancing the functionalities of ODTs, offering a promising solution to improve the overall performance and usability of ODTs in various therapeutic applications.
UNASSIGNED: This research was proposed to develop a co-processed excipient composed of xylitol, mannitol, and microcrystalline cellulose for the formulation of ODTs.
UNASSIGNED: A total of 11 formulations of co-processed excipients with different ratios of ingredients were prepared, which were then compressed into ODTs, and their characteristics were thoroughly examined. The primary focus was on evaluating the disintegration time and hardness of the tablets, as these factors are important in ensuring the ODTs meet the desired criteria. The model drug, Mirtazapine was then incorporated into the chosen optimized formulation.
UNASSIGNED: The results showed that the formulation comprised of 10% xylitol, 10% mannitol and 80% microcrystalline cellulose demonstrated the fastest disintegration time (1.77 ± 0.119 min) and sufficient hardness (3.521 ± 0.143 kg) compared to the other formulations. Furthermore, the drug was uniformly distributed within the tablets and fully released within 15 min.
UNASSIGNED: Therefore, the developed co-processed excipients show great potential in enhancing the functionalities of ODTs, offering a promising solution to improve the overall performance and usability of ODTs in various therapeutic applications.
摘要：
■口腔崩解片（ODT）旨在在3分钟内溶解在口腔中，为患者提供了一个方便的选择，因为他们可以采取没有水。直接压缩是用于ODT制剂的最常用方法。然而,具有良好可压缩性等理想特性的单一复合赋形剂的可用性，快速解体，适合直接压缩的良好口感是有限的。
■这项研究被提议开发一种由木糖醇组成的共加工赋形剂，甘露醇,和微晶纤维素用于ODT的配方。
■共制备了11种具有不同成分比例的共加工赋形剂配方，然后被压缩成ODT，并彻底检查了它们的特征。主要重点是评估片剂的崩解时间和硬度，因为这些因素对于确保ODT符合所需标准很重要。模型药物，然后将米氮平掺入所选择的优化制剂中。
■结果表明，该制剂包含10％木糖醇，与其他制剂相比,10%甘露醇和80%微晶纤维素表现出最快的崩解时间(1.77±0.119分钟)和足够的硬度(3.521±0.143kg)。此外，药物在片剂中均匀分布，并在15分钟内完全释放。
■因此，开发的共加工赋形剂在增强ODT的功能方面显示出巨大的潜力，提供了一个有前途的解决方案，以提高ODT在各种治疗应用中的整体性能和可用性。
■这项研究被提议开发一种由木糖醇组成的共加工赋形剂，甘露醇,和微晶纤维素用于ODT的配方。
■共制备了11种具有不同成分比例的共加工赋形剂配方，然后被压缩成ODT，并彻底检查了它们的特征。主要重点是评估片剂的崩解时间和硬度，因为这些因素对于确保ODT符合所需标准很重要。模型药物，然后将米氮平掺入所选择的优化制剂中。
■结果表明，该制剂包含10％木糖醇，与其他制剂相比,10%甘露醇和80%微晶纤维素表现出最快的崩解时间(1.77±0.119分钟)和足够的硬度(3.521±0.143kg)。此外，药物在片剂中均匀分布，并在15分钟内完全释放。
■因此，开发的共加工赋形剂在增强ODT的功能方面显示出巨大的潜力，提供了一个有前途的解决方案，以提高ODT在各种治疗应用中的整体性能和可用性。
