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

多肽类似物(一种大分子)的口服给药是药物研究中的一大挑战。到目前为止，只有五种多肽类似物被转换为片剂/胶囊等口服制剂，所有这些都面临着明显的挑战，包括生物利用度低、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)。口腔-PEP联盟将携手开发一种多功能生物材料贴片，首次允许口腔(脸颊)传递多肽类似物疗法，从而通过渗透促进剂(SDC)与生物材料和多肽类似物的独特集成来克服这些挑战。这种新的配方使多肽能够在粘膜多层中扩散，从而有效地实现其预期的药理反应。这种新的方法将导致患者生活质量的改善和治疗依从性的提高。在该项目中，该联盟将设计、选择和制造一种主导产品(以2型糖尿病为示范适应症)，该产品将在体内大型动物实验中进行性能验证。此外，将进行健康技术评估，以支持以证据为基础的价值主张的发展，并帮助制定商业化战略。该项目的最终成果是一个经过预先临床验证的补丁，并准备好在所需的展示适应症中进行临床试验。总体而言，口腔-PEP项目将为口腔粘膜递送多肽类似物提供一种平台技术，该技术将适用于多种疾病适应症的广泛实验和批准的多肽类似物疗法。口腔-PEP将使新的基于多肽的治疗方法出现，否则可能由于与当前可用的给药路线不兼容而无法进入市场

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