中文摘要：本发明提供了一种抗原的粘膜传递系统的组成及其制备方法，主要应用于口腔、肠道、鼻腔粘膜系统。该粘膜传递系统由一种或一种以上粘附蛋白以及所要传递的抗原组成。粘附蛋白主要来源于铁传递蛋白和黏蛋白家族。本发明同时公开了该粘膜传递系统的制备方法。
外文摘要：Compositions and methods for mucosal delivery of agents are provided. The compositions are intended for administration to mucosal surface, such as oral, gastrointestinal and nasal mucosa. The compositions provided contain one or more mucoid hesive proteins and an agent to be delivered. Methods for delivery of agents using the compositions provided herein are also provided.
NOVELTY - Emulsion composition comprises: (a) an agent for delivery, where agent is a protein or composition susceptible to degradation in the presence of water; (b) a delivery vehicle associated with the agent, where delivery vehicle is selected from micelle, inverse micelle, liposome, cubosome and its mixture; and (c) a mucoadhesive protein associated with the delivery vehicle and/or agent. The mucoadhesive protein is present at a concentration of 1-50 wt.% of the total weight of the composition. The mucoadhesive protein is selected from family of transferrins and family of mucin proteins.
USE - The composition is useful for mucosal delivery of agent; and for treating or supplementing diet of subject (all claimed) e.g. with diabetes. 
ADVANTAGE - The vitamin E derivative compositions that contain more dimer form are more effective in solubilizing non-polar additives (non-polar com pounds) than compositions that contain the monomer form and very little dimer form. In addition, the higher dimer-containing water-soluble vitamin E derivative mixtures (compositions) permit dissolution of higher concentrations of non-polar ingredients while retaining the clarity and stability of the resulting compositions. The compositions advantageously permit formulation of agents that are sensitive to water or degrade in water.
主权项：Emulsion composition comprises: (a) an agent for delivery, where the agent is a protein or composition susceptible to degradation in the presence of water; (b) a delivery vehicle associated with the agent, where the delivery vehicle is selected from among a micelle, inverse micelle, liposome, cubosome and its mixture; and (c) a mucoadhesive protein associated with the delivery vehicle and/or agent. The mucoadhesive protein is present at a concentration of 1-50 wt.% of the total weight of the composition. The mucoadhesive protein is selected from fa mily of transferrins and family of mucin proteins. The composition can adsorb to the mucosa for effecting systemic delivery of the agent. The mucoadhesive protein is associated with the delivery vehicle and/or the agent via a chemical or physical bond. The composition is formulated as an emulsion and is formulated for mucosal delivery to the oral or gastrointestinal tract mucosa. Emulsion comprises an oil phase, and a polar phase comprising a polar protic solvent other than water. INDEPENDENT CLAIMS are:
(1) a method for mucosal delivery of an agent or use of the composition for mucosal delivery of an agent, comprising contacting the composition with a mucosal surface of a subject, where the agent is delivered into the circulatory system of the subject;
(2) a method for making composition comprising dissolving components of the composition in the oil phase and polar phase; and mixing the two phases at a predetermined temperature and pressure, where the mucoadhesive protein is associated with the delivery vehicle;
(3) a method of treating a subject or providing a supplement or use of a composition for treating or supplementing the diet of a subject, comprising administering the composition to the subject;
(4) a powder composition produced by spray-drying any of the compositions, where the composition comprises polyethylene glycol (PEG)-derivative of vitamin E; or a powder composition, comprising PEG-derivative of vitamin E mixture, and a mucoadhesive protein;
(5) a pre-spray emulsion composition, comprising PEG-derivative of vitamin E, a mucoadhesive protein and a polar protic solvent;
(6) a method for producing a powder composition, comprising adding d-alpha tocopheryl polyethylene glycol succinate (TPGS) to a composition comprising a mucoadhesive protein and spray drying the resulting composition; where the composition is the pre-spray emulsion composition ; and
(7) an emulsion, comprising a polar phase and an oil p hase, wh ere the polar phase contains 50-65 wt.% polar protic solvent; 1-5 wt.% PEG-derivative of vitamin E; and 1-5 wt.% mucoadhesive protein; and the oil phase contains 5-15 wt.% probiotic; 1-5 wt.% cosolvent; and 1-10 wt.% PEG-derivative of vitamin E.
申请号：WO2016US52256
公开/公告号：WO2017049162A1
申请日：2016-09-16
公开/公告日：2017-03-23
申请/专利权人：VIRUN INC (VIRU-N)
发明/设计人：BROMLEY, P J;RAHIM, N;LAM, K Z
分类号：A61K31/401; A61K35/744; A61K35/745; A61K35/747; A61K38/063; A61K38/225; A61K38/27; A61K38/40; A61K47/10; A61K47/12; A61K47/14; A61K47/22; A61K47/24; A61K47/42; A61K47/44; A61K9/107; A61K9/127; A61K9/1617; A61K9/1641
主分类号：A61K47/42; A61K9/107; A61K9/127
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