In-cheek delivery of peptide-analogue therapies
What we do
Delivering peptide-analogues (large molecules used in medicine) orally is a big problem for pharmaceutical researchers. Only five peptide-analogues have been made into tablets or capsules for oral delivery, but they all have difficulties like low bioavailability (how much of the drug gets into the body), controlling the dosage, inconvenient patient administration, and food interactions.
To solve these problems, the BUCCAL-PEP group will work together to create a patch made of biomaterials that can be placed in the cheek to deliver peptide-analogue treatments. This patch will be the first of its kind and will overcome these difficulties by combining a permeation enhancer (SDC) with biomaterials and a peptide-analogue.
At BUCCAL-PEP, patients are our top priority. We believe that our technology will improve their quality of life and reduce the burden of their condition. That’s why we’re actively involving patients in our work from the beginning, ensuring that their needs and requirements are considered throughout the development process. By working together with patients, we’re creating a technology that is both effective and user-friendly, with the potential to revolutionize the way peptide drugs are delivered.
This work package aims to develop a patch that can deliver semaglutide through the buccal or sub-lingual route by optimizing the combination of different materials and ratios. The performance of at least 10 prototypes will be assessed in vitro, ex vivo, and in vivo in porcine models before selecting a candidate patch for further testing.
The project will perform in vivo absorption tests on two lead patch prototypes developed in WP1 on the buccal or sub-lingual mucosa in pigs. They will analyze PK-PD data from blood samples collected during intravenous administration and buccal absorption tests and provide feedback to WP3. The study will also evaluate the safety of buccal and sub-lingual mucosa using histological analysis in cross-over pig studies.
This work package will optimize the three-layer design of the patch, including the concentrations of components, layer thickness, mucoadhesion, and maximum loadings, and select a scalable process for production. They will assess the selected process using ex vivo flux of semaglutide from loaded films and establish target specifications for the patch for the in vivo porcine study.
This work package’s main objective is to develop a business plan for the proposed technology platform by conducting a health economics and market assessment. This includes analyzing the target population segment, assessing the commercial viability and return of investment compared to the standard of care, and developing a comprehensive business plan for the first target indication while also exploring the technology’s potential for other indications of interest.
The objective of this work package is to ensure effective communication and dissemination of the project’s developments to stakeholders, including scientific community, industry, clinical experts, patients, and caregivers. The goals are to engage all stakeholders, consider their needs, communicate project progress and results to the general public, and develop a solid foundation for the exploitation strategy of the novel technology.
The main objective of work package 6 is to ensure productive project execution and realisation of main objectives in time and within budget. It is also important to ensure performance of activities by project partners and reporting according to EC regulations.