Protein drugs, including insulin, have been difficult to deliver orally due to their rapid degradation in the stomach. However, the new oral capsule technology developed by the Melbourne-based team has shown promising results in pre-clinical studies. The team tested the capsules with both fast-acting and slow-acting insulin, which are commonly used in combination to manage blood sugar levels in diabetics. The results for slow-acting insulin were particularly encouraging, with absorption rates approximately 50% better than injection delivery for the same amount of insulin.
TAILORED DOSING POSSIBLE
While the capsules also showed good absorption results for fast-acting insulin, the lag in the insulin's onset of action compared to injection delivery may make it less practical for this particular application. However, the team believes that the oral capsules could potentially be designed to allow dosing over specific time periods, similar to injection delivery, and further investigation and rigorous testing in human trials are needed.
One of the key features of the oral capsules is a special coating that protects the drug inside, allowing it to safely pass through the stomach and dissolve in the small intestine where the pH levels are higher. The drug is packaged within a fatty nanomaterial within the capsule, similar to the approach used in the Pfizer and Moderna COVID vaccines, which helps maintain the drug's stability and effectiveness during delivery.
In addition to insulin, the team believes that the new oral capsule technology could also be used for other protein drugs, such as monoclonal antibodies used in the treatment of inflammatory conditions, cancer, and other diseases. The projected market value of these protein drugs is estimated to reach $400 billion by 2030.
Dr. Céline Valéry, a pharmaceutical scientist from RMIT and study co-author, highlighted that the use of the same amount of insulin in the oral capsules and injection delivery sets this technology apart from previous approaches that required higher levels of insulin for oral formulations, making it a potentially more cost-effective method for protein drug delivery.
This breakthrough in drug delivery could offer a cheaper and more efficient alternative to injections for protein drugs, including insulin, and has the potential to transform the treatment of various diseases. The team has filed an international patent application for their technology and is conducting further research and clinical trials to fully explore its capabilities.