Development of a multifunctional biomaterial patch for buccal delivery of peptide-analogue treatments

肽类似物（一种大分子）的口服递送是药学研究的重大挑战之一。到目前为止，只有五种肽类似物被转化为口服制剂，如片剂/胶囊，它们都面临着明显的挑战，包括低生物利用度、剂量控制、患者给药不便和使用限制（例如不良的食物相互作用）。buccal - pep联盟将携手开发一种多功能生物材料贴片，该贴片首次允许颊部（脸颊）递送肽类似物疗法，从而通过独特的渗透增强剂（SDC）与生物材料和肽类似物的整合来克服这些挑战。新配方使多肽能够扩散穿过粘膜多层，从而有效地实现其预期的药理学反应。这种新方法将改善患者的生活质量，增加治疗依从性。在该项目中，该联盟将设计、选择和制造一种先导产品（以2型糖尿病为展示适应症），该产品将在体内大型动物研究中进行性能验证。此外，还将进行卫生技术评估，以支持以证据为基础的价值主张的发展，并协助制定商业化战略。该项目的最终交付成果是临床前验证的贴片，并准备在所需的展示适应症中进行临床试验。总的来说，BUCCAL-PEP项目将为多肽类似物的口腔粘膜递送提供一个平台技术，该技术将适用于广泛的实验性和已批准的多肽类似物治疗多种疾病适应症。BUCCAL-PEP将使新的基于肽的治疗出现，否则这些治疗可能由于与目前可用的给药途径不相容而无法进入市场

Oral delivery of peptide-analogues (a macromolecule) is one of the great challenges in pharmaceutical research. Thus far, only five peptide-analogues have been converted to oral formulations such as tablets/capsules and all face distinct challenges including low bioavailability, dosage control, patient administration inconvenience and restrictions in use (e.g. undesirable food interactions). The BUCCAL-PEP consortium will join hands to develop a multifunctional biomaterial patch which allows, for the first time, buccal (in the cheek) delivery of peptide-analogue therapies, thereby overcoming these challenges through unique integration of a permeation enhancer (SDC) with biomaterials and a peptide-analogue. The novel formulation enables peptides to diffuse across the mucosal multilayer, thereby effectively achieving their intended pharmacological response. The novel approach will result in an improved quality of patient life and increased treatment compliance. Within this project, the consortium will design, select and manufacture a lead product (with Type 2 Diabetes as showcase indication) that will be validated for performance in in vivo large animal studies. Additionally, a Health Technology Assessment will be performed to support the development an evidence-based value proposition and aid in the development of a commercialisation strategy. The final deliverable of the project is a patch that is pre-clinically validated and ready for clinical trials in the desired showcase indication. Overall, the BUCCAL-PEP project will provide a platform technology for oromucosal delivery of peptide-analogues that will be suitable for a broad range of experimental- and approved peptides-analogues therapies across a multitude of disease indications. BUCCAL-PEP will enable novel peptide-based treatments to emerge, which otherwise might not have reached the market due to incompatibility with the currently available administration routes