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用于口服递送双层囊泡的固体剂型平台的开发。

Development of a solid dosage platform for the oral delivery of bilayer vesicles.

作者信息

Wilkhu Jitinder S, McNeil Sarah E, Anderson David E, Kirchmeier Marc, Perrie Yvonne

机构信息

School of Life and Health Sciences, Aston University, Aston Triangle, Birmingham, B4 7ET, UK.

Variation Biotechnologies, 222 Third Street, Suite 2241, Cambridge, MA 02142, USA.

出版信息

Eur J Pharm Sci. 2017 Oct 15;108:71-77. doi: 10.1016/j.ejps.2017.06.014. Epub 2017 Jun 12.

Abstract

Within this work, we develop vesicles incorporating sub-unit antigens as solid dosage forms suitable for the oral delivery of vaccines. Using a combination of trehalose, dextran and mannitol, freeze-dried oral disintegrating tablets were formed which upon rehydration release bilayer vesicles incorporating antigen. Initial studies focused on the optimisation of the freeze-dry cycle and subsequently excipient content was optimised by testing tablet hardness, disintegration time and moisture content. The use of 10% mannitol and 10% dextran produced durable tablets which offered strong resistance to mechanical damage yet appropriate disintegration times and dispersed to release niosomes-entrapping antigen. From these studies, we have formulated a bilayer vesicle vaccine delivery system as rapid disintegrating tablets and capsules.

摘要

在这项工作中,我们开发了包含亚单位抗原的囊泡作为适合口服疫苗递送的固体剂型。通过结合使用海藻糖、右旋糖酐和甘露醇,制成了冻干口腔崩解片,该片剂复水后会释放出包裹抗原的双层囊泡。初步研究集中在冻干周期的优化上,随后通过测试片剂硬度、崩解时间和水分含量来优化辅料含量。使用10%的甘露醇和10%的右旋糖酐制成的片剂耐用,对机械损伤具有很强的抵抗力,同时具有合适的崩解时间,并能分散以释放包裹抗原的非离子型表面活性剂囊泡。通过这些研究,我们已将双层囊泡疫苗递送系统制成快速崩解片和胶囊。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fba/5611758/dba88c68b21d/fx1.jpg

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