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Platform solubility and stability

Platform solubility and stability
平台溶解度和稳定性
批准号:
10023883
负责人:
金额:
$0.96万
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
项目状态:
已结题
起止时间:
2022 至 --

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中文摘要
翻译
最广泛使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饲管,这些管必须以相当大的成本和患者的不适来更换。因此,液体替代品的开发是向前迈出的重要一步,并将考虑到医疗保健提供者和最终患者的利益。PPI的主要问题是,它们是众所周知的不稳定,当暴露于广泛的外部影响,如热,氧,光和酸性环境时,会迅速降解。由于它是一种口服药物,胃中酸降解的问题以前已经通过将它们置于“胃保护”涂层中来克服,该涂层允许PPI通过胃并在酸性较低的下消化道中吸收。该项目的目的是改善公司已经使用其独特的增溶平台进行的稳定性工作。重要的是查看产品以确定沉淀物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,我们将能够查看影响整体稳定性的其他因素并改善货架。我们确保产品的使用寿命,同时确保我们有一种“纯液体”,不会粘在或堵塞管道,从而改善患者和医护人员的生活。
英文摘要
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.
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