In Vitro and In Vivo Evaluation of 3D Printed Capsules with Pressure Triggered Release Mechanism for Oral Peptide Delivery

In this study a 3D printed capsule designed to break from the physiological pressures in the antropyloric region was evaluated for its ability to deliver the synthetic octapeptide octreotide in beagle dogs when co-formulated with the permeation enhancer sodium caprate. The pressure sensitive capsules were compared to traditional enteric coated hard gelatin capsules and enteric coated tablets. Paracetamol, which is completely absorbed in dogs, was included in the formulations and used as an absorption marker to give information about the in vivo performance of the dosage forms. The pressure sensitive capsules released drug in 50% of the dogs. In the cases where drug was released, there was no difference in octreotide bioavailability or C-max compared to the enteric coated dosage forms. When comparing all dosage forms, a correlation was seen between paracetamol C-max and octreotide bioavailability, suggesting that a high drug release rate may be beneficial for peptide absorption when delivered together with sodium caprate. (C) 2020 Published by Elsevier Inc.

Automated summary

In this study, a 3D printed capsule designed to break under physiological pressures in the antropyloric region was evaluated for delivering synthetic octapeptide octreotide in beagle dogs co-administered with sodium caprate. The pressure sensitive capsules showed drug release in 50% of dogs, with no difference in octreotide bioavailability compared to enteric coated dosage forms. A correlation was observed between paracetamol C-max and octreotide bioavailability, indicating a potential benefit of high drug release rate for peptide absorption with sodium caprate.