Platform solubility and stability

平台溶解度和稳定性

• 批准号: 10023883
• 金额: $ 0.96万
• 依托单位: INNOVATE PHARMACEUTICALS LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10023883
• 关键词: Platform; solubility; stability

One of the most widely taken medications are Proton Pump Inhibitors(PPI) for the reduction of stomach acid. At present only solid forms or very limited stability suspensions are available. These suspensions often block feeding tubes in hospitalised patients with these tubes having to be replaced at considerable cost and discomfort for the patient. The development of a liquid alternative is therefore a major step forward and would have considered benefit to both health care providers and ultimately to the patient.The major issue with PPI's is that they are notoriously unstable and will rapidly degrade when exposed to a wide range of external influences such as heat, oxygen, light and acid environments. As it is an orally ingested medication the problem of acid degradation in the stomach has previously been overcome by placing them in a 'gastro-protective' coating that allows the PPI to pass through the stomach and be absorbed in the less acidic lower gut. This causes other issues such as speed of absorption.The aim of this project is to improve on the stability work already carried out by the company using their unique solubilisation platform. It is important to look at the products to define the presence of precipitates or crystal formation and what size they may be to determine their effect on stability and to understand the possibility of using filtering techniques to remove them.Once this has been completed we will be able to look at other factors effecting overall stability and improve the shelf-life of the products while being assured that we have a 'pure liquid' that will not stick to or block tubes and so improve the life of patients and healthcare workers.

最广泛服用的药物之一是质子泵抑制剂（PPI），用于减少胃酸。目前只有固体形式或非常有限的稳定性悬浮液可用。这些悬浮液经常阻塞住院患者的喂食管，这些管不得不以相当大的成本和患者的不适进行更换。因此，液体替代品的开发是向前迈出的一大步，并被认为对医疗保健提供者和最终对患者都有利。PPI的主要问题是它们非常不稳定，当暴露在热、氧、光和酸环境等广泛的外部影响下会迅速降解。由于它是一种口服药物，胃酸在胃中的降解问题已经被克服了，方法是将它们放在“胃保护”涂层中，使PPI通过胃，并被酸性较低的下肠吸收。这就导致了吸收速度等其他问题。该项目的目的是改进公司使用其独特的溶解平台已经开展的稳定性工作。重要的是要观察产品，以确定沉淀或晶体形成的存在，以及它们的大小，以确定它们对稳定性的影响，并了解使用过滤技术去除它们的可能性。一旦完成这项工作，我们将能够研究影响整体稳定性的其他因素，并提高产品的保质期，同时确保我们的“纯液体”不会粘住或堵塞管道，从而改善患者和医护人员的生活。