Amrita Banerjee, post-doctoral scholar, University of California Santa Barbara talks oral insulin and needle-free delivery of protein
Amrita Banerjee, post-doctoral scholar, University of California Santa Barbara
EPM: Who are you and what do you do?
AB: I am a postdoctoral scholar in the department of chemical engineering at the University of California Santa Barbara. My research is geared towards development of novel platforms for delivery of protein and peptide drugs, especially for the treatment of diabetes.
This includes development of both nanotechnology-based parenteral formulations as well as oral drug delivery device for needle-free delivery of protein drugs.
EPM: What have you focused on recently?
AB: The focus of my work recently is to develop an oral delivery device for insulin. There are many barriers to oral delivery of protein/peptide drugs such as low intestinal permeability and instability in the gastrointestinal tract due to stomach acid and proteolytic enzymes present in the intestine.
The oral drug delivery device that has been developed in the laboratory addresses all the oral delivery concerns of protein and peptide drugs.
It consists of insulin loaded mucoadhesive patches that are placed in enteric-coated capsules for site-specific delivery to the intestine.
Enteric coating on the capsules prevents capsules to break open in the stomach while mucoadhesive polymers in the patches enable strong adhesion of patches to intestinal mucosa that eventually swell and release insulin in a controlled fashion.
The patches not only prevent access of proteolytic enzyme to breakdown insulin but also provide a large depot of the drug for higher concentration gradient dependent transport across the intestine.
The patches are coated on all but one side with a water impermeable backing layer that prevents drug loss into intestinal lumen from the sides that are not attached to the intestine.
To facilitate transport further, I have included a permeation enhancer in the patches that improve paracellular uptake of insulin at the intestine.
In vitro characterisation studies have demonstrated complete release of insulin and permeation enhancer from the patches and strong mucoadhesion of patches to intestinal mucosa.
Preliminary pre-clinical studies have indicated significant improvement in therapeutic efficacy of the oral device compared to other oral formulation controls.
EPM: What is your latest service/innovation?
AB: Over the past few months I have been working to further improve the efficacy of the device for oral delivery of insulin.
I have miniaturised the patch design to bring about rapid drug release and obtain faster acting formulations.
In addition, I have incorporated specific or non-specific protease inhibitors in the device to further prevent proteolytic degradation of insulin in the gut.
The formulations are currently being evaluated for their efficacy in pre-clinical experiments.
EPM: How can you benefit the pharmaceutical sector?
AB: There is a big impetus within the pharmaceutical sector to develop effective oral delivery systems for peptide/protein drugs.
Needle-free technology is a painless method of drug administration especially for management of chronic diseases such as diabetes.
This makes it a more patient compliant alternative to insulin injections, especially for people with needle phobia.
The drug delivery device developed in our laboratory, if successful, will not only provide a much needed platform to the pharmaceutical industry for efficient oral delivery of peptide/protein drugs but also significantly improve the quality of lives of thousands of patients around the world that are suffering from diabetes or other chronic diseases requiring regular parenteral drug administration for disease management.
EPM: What are your future plans?
AB: Future plans include further testing of the devices and optimising the patches to obtain higher oral bioavailability of loaded drugs.
This includes using novel mucoadhesive polymers in the patches for stronger mucoadhesion to the intestinal mucosa and higher permeation enhancement effect.