A unique two-excipient heat stable tablet formulation of oral insulin: preliminary results

Today’s cyclodextrin is about stabilizing insulin.

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.

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.


Read the full paper from Manshun Lai, Changcheng Zhu, Jaclyn Delarosa, and Manjari Lal PhD here: A unique two-excipient heat stable tablet formulation of oral insulin: preliminary results | bioRxiv

Insulin formulation and methods of using same in preterm infants

Today’s cyclodextrin is an excellent example of using CDs (in this particular case, HPBCD) in peptide/protein formulations. ELGAN Pharma‘s patent concerns combining insulin, cyclodextrins, and other components, where the role of the CD is stabilization and cryopreservation.

As we see more examples of CD-protein combinations in research and clinical practice, I am convinced that this use will shape future applications.

Espacenet – US2024165205A1