A thermostable oral insulin tablet was developed [1]. Using freeze drying to form a heat stable tablet in a single-step process, hydroxypropyl beta cyclodextrin (HP-β-CD) encapsulated lipophilic ion-pair complex of insulin using bile salt achieves demonstrated intestinal absorption and sustained glucose levels. The tablets produced using this simple approach with only two excipients offer protection from enzymatic and stomach acid degradation and facilitate insulin uptake, without any need for specialized drug manufacturing or enteric coating. Insulin in this innovative formulation is thermotolerant, capable of maintaining stability even under heat stress at 30-40°C/65-75% RH. The convenient presentation of insulin as a thermostable oral tablet presents a low-cost scalable manufacturing method that simplifies the logistics of storage, transport, and distribution in any setting, including areas where cold storage maybe limited or unavailable.
The earlier literature was reviewed in Cyclodextrin News: March 2018. Vol.32. No. 03. Cyclodextrin-enabled Insulin Delivery. The featured image shows the hexameric structure of human insulin (Wikipedia)
[1] Manshun Lai, Changcheng Zhu, Jaclyn Delarosa, Manjari Lal (2025) A unique two-excipient heat stable tablet formulation of oral insulin: preliminary results. Biorxiv, https://doi.org/10.1101/2025.01.29.635377