Orally disintegrating tablets (ODTs) are a novel oral dosage form designed to disintegrate rapidly in the mouth without the need for chewing. Upon contact with saliva, these tablets dissolve quickly, allowing for easy swallowing and subsequent passage into the stomach.With advantages such as ease of administration, rapid onset of action, and minimal gastrointestinal side effects, it has gained immense popularity in the market.
Currently, both domestically and internationally, the direct compression method is commonly employed to produce this dosage form, which imposes stringent quality requirements on pharmaceutical excipients, such as excellent compressibility, flowability, and rapid disintegration properties.
The excipients in ODTs can be primarily categorized into three components: disintegrants, fillers, and flavoring agents. Among these, disintegrants play a crucial role in the ODT formulation, while fillers and flavoring agents are used to adjust the tablet weight and enhance palatability, respectively. Consequently, this article will focus on the various types of disintegrants.
微晶纤维素（MCC）可压型好，遇水会破坏分子链之间的氢键，片剂得以迅速崩解，但不会吸水溶胀，通常与其它溶胀性能强的辅料配合使用，以增强崩解性。如微晶纤维素与交联聚乙烯吡咯烷酮联合应用加快口腔崩解片的崩解过程。
交联羧甲纤维素钠的崩解机制是强溶胀性和孔隙率，交联羧甲纤维素钠保留纤维素的β折叠结构，用量小时，也能发生毛细管作用导致的崩解。强吸水溶胀性也保证其高效崩解能力。研究发现，内加2%的交联羧甲纤维素钠作为崩解剂可大大缩短崩解时间，同时片剂的硬度和脆碎度也不会受到影响。
交联聚维酮能在水中能迅速溶胀，崩解性能优越，常用作高效崩解剂。有研究报道，当加人5-8%的交联聚乙烯吡咯烷酮时，润湿时间缩短，而加人量在8-15%间，反而会延长其润湿时间。其原因可能是高浓度的交联聚乙烯吡咯烷酮增加溶液黏度，抑制水分子的渗透，从而延缓了片剂的解体。
羧甲淀粉钠具有良好的膨胀性和吸水性，膨胀后的体积增大至原来的200-300倍，膨胀作用均匀而充分并且不会形成胶体溶液。其可压性好，多用于直接压片，能够增加片剂的硬度，改善片剂的成形性且不影响其崩解性能，一般用量在4-8%之间。
Co-processed excipients have gradually evolved into disintegrants, including the co-processed combination of microcrystalline cellulose and colloidal silicon dioxide, mannitol, fructose, cross-linked polyvinylpyrrolidone, as well as starch-lactose and mannitol-lactose complexes, which serve as solutions for excipients in oral disintegrating tablets.
原文始发于微信公众号（雾化科技展）：Introduction to Disintegrants in Orally Disintegrating Tablets
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