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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.

The Project

For Patients

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.

Our approach

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.

Our latest news

The Charles Institute Seminar Series with Prof. David Brayden

On Thursday, October 31st 2024, the Charles Institute Seminar Series will take place. Our Project Coordinator Prof. David Brayden will present the BUCCAL-PEP project during this seminar. The Charles Institute Seminar Series 🗣️ Creating devices to administer macromoleculesvia the Buccal Epithelium: The EU BUCCAL-PEP consortium By Prof. David Brayden, Ph.D.,

Read More »
October 21, 2024

BUCCAL-PEP at the CÚRAM Summit!

📢 BUCCAL-PEP attends the CÚRAM, SFI Research Centre for Medical Devices Summit at the University of Galway! 👉 Last month, project members Sandeep Karki and Dr. Sahil Malhotra represented BUCCAL-PEP on all 3 days of the CÚRAM Summit in Galway, standing as the 10th anniversary celebration of CÚRAM. They participated

Read More »
July 1, 2024

   In-cheek delivery of peptide-analogue therapies

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Funding statement

This project has received funding from the European Union’s Horizon Europe research and innovation programme under grant number 101071054. Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the European Union or European Innovation Council. Neither the European Union nor the granting authority can be held responsible for them.

Susie Birney

Patient Advocate

Susie lives in Dublin and volunteers her time to help advocate for others who live with obesity and Type 2 Diabetes. Most recently Susie was involved with Diabetes Ireland in the drafting of the “Talking about Diabetes : Language Matters” Guide. Addressing stigma for either Diabetes or Obesity which Susie has lived experience of,  is high on the list of her priorities and being involved in advisory boards is one example of how to do this by being involved throughout the research process from beginning to end.

Maura Murphy

Retired Civil Servant but currently Voluntary Secretary at ICPO the Irish Coalition for People Living with Obesity

Maura thinks it is important to treat the patient holistically. Over the years, she has been visiting several hospitals for different conditions, and these silos can be exhausting. She is passionate about learning about obesity since she discovered that it is a disease in 2019. Prior to that, her self-blame and stigma held her back. She has learned that obesity is a gateway to other diseases, and she knows this firsthand because she lives with Type 2 Diabetes, Hypertension, Gout, Fluid Retention, and Osteoarthritis. She attends a Chronic Disease Clinic in Ballina every six months, which has thankfully eliminated the silo appointments to three different hospitals and their various departments.

Mary Frances White

Social Care Worker within the community care system/ committee & patient representative for ICPO

Mary Frances is married with one adult child. She has worked for many years as a Social Care worker within Adult services for those with intellectual disabilities. She is SAM’s trained as she dispenses medication on a daily basis (SAM’s = Safe Administering of Medication).

She is also one of the first committee members and a patient representative for an ICPO. They give talks to medical students of many disciplines regarding respect and dignity for people living with obesity. They also hold weekly support meetings and face-to-face meetings when possible. The subject of medications that are becoming available for those who are living with obesity is very topical at present.

Ken Tait

Psychotherapist & International Diabetes Advocate

As a psychotherapist, Ken helps people navigate emotional problems. As a Diabetes Advocate, he supports individuals living with diabetes and advocates for the help and support they need. He serves on many local diabetes boards and gives talks both nationally and internationally to help people and healthcare professionals understand what living with type 2 diabetes is like.

The reason that he joined BUCCAL-PEP was that he likes to keep abreast of what is happening for people with diabetes and how they can manage their diabetes Additionally, he recognizes that some people dislike needles, and this BUCCAL-PEP approach could provide an alternative to help them.

Ken Tait

Psychotherapist & International Diabetes Advocate

As a psychotherapist, Ken helps people navigate emotional problems. As a Diabetes Advocate, he supports individuals living with diabetes and advocates for the help and support they need. He serves on many local diabetes boards and gives talks both nationally and internationally to help people and healthcare professionals understand what living with type 2 diabetes is like.

The reason that he joined BUCCAL-PEP was that he likes to keep abreast of what is happening for people with diabetes and how they can manage their diabetes Additionally, he recognizes that some people dislike needles, and this BUCCAL-PEP approach could provide an alternative to help them.

Javier O. Morales, Ph.D.

Biosketch

Dr. Javier O. Morales is an Associate Professor at the University of Chile, specializing in pharmaceutical science and technology. He heads the Center of New Drugs for Hypertension (CENDHY) and is an Associate Researcher in the Advanced Center for Chronic Diseases (ACCDiS). With a Ph.D. from The University of Texas at Austin, he focuses on innovative drug delivery systems, particularly for peptides, proteins, and poorly water-soluble drugs. His research explores nanoencapsulation and alternative routes of administration. Dr. Morales has a keen interest in buccal absorption and 2D/3D printing for drug delivery. He joined BUCCAL-PEP’s SAB to advance less invasive diabetes treatments and explore synergies with his own research.

Giovanni Traverso, MB, BChir, PhD

MIT and Harvard

Prof. Giovanni Traverso is the Director of the Laboratory for Translational Engineering at MIT and Harvard, an Associate Professor of Mechanical Engineering at MIT, an Associate Physician in Gastroenterology at Brigham and Women’s Hospital, Harvard Medical School, and an Associate Member of the Broad Institute. He received his undergraduate and medical degrees from Cambridge and a PhD from Johns Hopkins, where he pioneered non-invasive cancer detection. His postdoctoral research at MIT focused on advanced drug delivery and gastrointestinal sensing. His current work drives next-generation drug delivery systems and ingestible devices for physiological monitoring.

Prof. Ljiljana Fruk

University of Cambridge

Prof. Ljiljana Fruk is a Professor of Bionano Engineering at the Department of Chemical Engineering and Biotechnology at University of Cambridge.  Her research encompasses the design and development of nanoscale materials for biomedical applications, including design of drug nanocarriers for solid tumours and biosensors for early detection of cancer. She is particularly interested in development of nature-inspired structures, and has also made significant contributions to development of hybrid bio-nano materials and their application in photocatalysis and sustainable manufacturing. She is one of the co-founders of Senesys Bio, Cambridge spinout developing therapeutic formulations for senescent cell removal. Prof Fruk is an active science popularizer, art-science curator, and the co-author of the field-establishing Molecular Aesthetics book (MIT Press 2013), and the first textbook on Bionanotechnology (Cambridge University Press 2021).

Dr. Eva Roblegg

University of Graz

Dr. Eva Roblegg is a full professor at the University of Graz, specializing in pharmaceutical technology and biopharmacy. She leads the Drug Delivery and Advanced Manufacturing group and focuses on the development of nano drug delivery systems (nanoDDS) for the treatment of oral diseases, such as oral mucositis. To better understand the relationship between nanoDDS and buccal/sublingual tissues, her group has developed in vitro cell and tissue models that mimic healthy and inflamed human oral mucosa. Eva Roblegg works closely with the Research Center Pharmaceutical Engineering, a center of excellence in Graz, Austria, where she is involved in advanced technologies for the continuous manufacturing and conversion of (nano-)drug delivery systems into final dosage forms. Given her research interest in this area and the opportunity to create further synergies with her own research, she has joined BUCCAL-PEP’s SAB.

Dr. Andrew Muddle

MedPharm

Dr. Andrew Muddle, founder and former CEO of MedPharm, brings over 30 years of pharmaceutical industry experience in drug delivery. He played a pivotal role in PowderJect Pharmaceuticals plc’s early development and IPO, and his career includes positions at Elan Corporation, Ethical Pharmaceuticals Ltd (U.K.), Controlled Therapeutics (Scotland), and Ciba-Geigy (now Novartis). Dr. Muddle excels in managing projects to commercialization, specializing in transdermal and topical products. He joined BUCCAL-PEP due to the challenge of oral peptide delivery.