NOVEL BIOADHESIVE MICROSPHERES

新型生物粘附微球

• 批准号: 2539055
• 负责人: GLENN T HONG
• 金额: $ 8.36万
• 依托单位: APHIOS CORPORATION
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-01-01 至 1998-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2539055
• 关键词: adhesions; biomedical equipment development; drug delivery systems; drug design /synthesis /production; fluid; glycolates; hydropathy; lactates; microcapsule; oral administration

The recent discovery that bioadhesive microspheres may open a whole new range of therapeutic agents to oral delivery is indeed exciting. The bringing of such useful products to commercial reality can be significantly accelerated if concerns such as product purity and sterility can be mitigated. We believe that supercritical fluid processing has much to offer in this regard. We plan to evaluate a novel, cost effective process to formulate hydrophobic microspheres for the controlled release of therapeutic agents. We will replace organic solvents such as methylene chloride used in the conventional formation of polymeric microspheres with easily separated, non-toxic supercritical fluids. Therefore, the number of processing steps, processing time and manufacturing cost will be greatly reduced. In addition, adverse effects of exposing the bioactive compounds to potentially harmful organic solvents will be eliminated. The supercritical fluid process is very amenable to scale up. In addition to improving product quality, the elimination of organic solvents provides benefit to the global environment. PROPOSED COMMERCIAL APPLICATION At a commercial scale, benefits of the proposed process may include environmental advantages due to a reduction in the use of organic solvents, improved product quality with less residual solvent contamination, improved product purity, improved sterility and formulation properties and improved process economics.

最近的发现，生物粘附微球可能会打开一个全新的 从治疗药物到口服给药的范围确实令人兴奋。 的 将这些有用的产品带入商业现实可以 如果考虑到产品纯度和 可以减轻无菌性。 我们相信超临界流体 加工业在这方面大有可为。我们计划评估一个 制备用于治疗糖尿病的疏水微球的新的、成本有效的方法 治疗剂的控制释放。 我们将取代有机 溶剂如用于常规形成的二氯甲烷 高分子微球与易分离、无毒的超临界 流体. 因此，处理步骤的数量、处理时间和 制造成本将大大降低。此外，不利影响 将生物活性化合物暴露在潜在有害的有机物中 溶剂将被淘汰。 超临界流体过程非常 适合扩大规模。 除了提高产品质量外， 有机溶剂的消除为全球带来了好处 环境 建议的商业应用 在商业规模上，所提出的方法的益处可包括 由于减少有机物的使用， 溶剂，提高产品质量，减少残留溶剂 污染、提高产品纯度、提高无菌性和 配方性能和改进的工艺经济性。