Research progress on the application of excipients for orally disintegrating tablets based on association rule analysis

The association rule analysis is a model that describes the correlation between two or more things. The Apriori algorithm is a classic method of association rule analysis used to discover frequent item sets from large-scale datasets. In this review, the Apriori algorithm was used to analyze the usage rules of excipients from 28 formulations of commercially available orally disintegrating tablets (ODTs) and 77 formulations of ODTs collected from literatures. Statistical analyses were conducted on the usage frequency of excipients, preparation processes, and tablet weight of the ODTs. Meanwhile, the influence of mannitol on the taste of ODTs was explored. The results show that commercially available ODTs focus on the addition of flavoring and taste-masking agents as well as colorants to improve compliance. ODTs in literatures focus on adding glidants and flavoring agents to improve the quality of ODTs. Powder direct compression is currently the mainstream process for preparing ODTs. Mannitol, microcrystalline cellulose, and magnesium stearate are the core excipients for the composition of ODTs prepared by this method. Crospovidone is the most commonly used super-disintegrating agent, and aspartame is the most commonly used flavoring agent. Moreover, mannitol can improve the taste of ODTs to a certain extent and reduce the addition of sweeteners. Finally, the development of excipients for ODTs was prospected. Through statistics, analysis and induction, this review aims to provide references for the formulation design of ODTs as well as application and development of excipients for ODTs.