Development of generic formulations with cyclodextrins for oral delivery has been neglected for several decades, since the CD-enabled formulations often showed different PK profiles compared to “traditional” products and were not able to pass the bioequivalance tests.
While this situation is still unchanged, more and more companies are using these excipients not to copy a current formulation, but to create a superior one, that could replace the exisiting products. For these improvements to public health, they are of course willing to go through all phases of the clinical studies and in some cases use APIs known for several years in practice. A recent example that we can hear a lot about is Axsome’s SBECD- enabled (Dexolve, Captisol) meloxicam formulation which is already in advanced stage of development. One of the main improvements of the formulation according to the communications is the faster acting and shorter Tmax compared to the reference products.
Do you think these approaches are encouraging and we should put more efforts to develop new and better products for existing APIs instead of putting all our efforts to create something new?