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1. 发明申请

WO2008033023A2 GRANULATE CONTAINING A PHARMACEUTICALLY ACTIVE SUBSTANCE AND METHOD FOR ITS MANUFACTURE 审中-公开
标题翻译：含有药物活性物质的颗粒及其制造方法
公开(公告)号：WO2008033023A2
公开(公告)日：2008-03-20
申请号：PCT/NL2007/050448
申请日：2007-09-14
申请人： FEYECON DEVELOPMENT & IMPLEMENTATION B.V. , PELLIKAAN, Hubert Clemens , VERMEULEN, Pieter Sebastiaan , BENDER, Johannes Caspar Mathias Elizabeth , FERNANDEZ CID, Maria, Vanesa
发明人： PELLIKAAN, Hubert Clemens , VERMEULEN, Pieter Sebastiaan , BENDER, Johannes Caspar Mathias Elizabeth , FERNANDEZ CID, Maria, Vanesa
CPC分类号： A61K9/2059 , A61K9/1617 , A61K9/1623 , A61K9/1694 , A61K9/2013 , A61K9/2018
摘要： One aspect of the present invention relates to a granulate having a volume weighted mean diameter of 1-200 m and containing: at least 0.1 wt.% of a pharmaceutically active substance; at least 10 wt.% of emulsifier selected from the group consisting of sugar fatty acid esters, mono-glycerides, di-glycerides, diacetyl tartaric acid ester of monoglyceride, diacetyl tartaric acid esters of diglyceride, polyglycerol esters, calcium stearoyl lactylate, sodium stearoyl lactylate and combinations thereof; and 0-89.9 wt.% of a water-dispersible saccharide; the combination of the pharmaceutically active substance, the emulsifier and the water-dispersible saccharide together represening at least 60 wt.% of the granulate; wherein the granulate is monophasic or wherein the granulate comprises a dispersed phase containing the pharmaceutically active substance, said dispersed phase having a volume weighted mean diameter of less than 300 nm. The granulates of the present invention enable the manufacture of transmucosal dosage units that exhibit improved solubility and/or bioavailability of the pharmaceutically active substance. Another aspect of the invention relates to a process for the preparation of a granulate containing a pharmaceutically active substance, which process employs: a pumpable emulsion comprising (i) a continuous phase containing a polar solvent and (ii) a dispersed phase containing an emulsifier and a pharmaceutically active substance; an extractant comprising a supercritical, subcritical or liquefied gas; said solvent being substantially more soluble in the extractant than said emulsifier; the process comprising the successive steps of : a. combining the pumpable emulsion with the extractant under mixing conditions; b. allowing the formation of granules containing the emulsifier and the pharmaceutically active substance; c. collect ing the granules and separating them from the extractant.
摘要翻译：本发明的一个方面涉及体积加权平均直径为1-200μm并含有至少0.1wt％的药物活性物质的颗粒; 至少10重量％的选自糖脂肪酸酯，单甘油酯，二甘油酯，甘油单酯的二乙酰酒石酸酯，甘油二酯的二乙酰酒石酸酯，聚甘油酯，硬脂酰乳酸钙，硬脂酰基硬脂酸钠乳酸盐及其组合; 和0-89.9重量％的水分散性糖; 药物活性物质，乳化剂和水分散性糖的组合共同表示至少60重量％的颗粒; 其中所述颗粒是单相的或其中所述颗粒包含含有所述药物活性物质的分散相，所述分散相的体积加权平均直径小于300nm。本发明的颗粒能够制造显示改善的药物活性物质的溶解度和/或生物利用度的经粘膜剂量单位。本发明的另一方面涉及一种制备含有药物活性物质的颗粒的方法，该方法采用：可泵送乳液，其包含（i）含有极性溶剂的连续相和（ii）含有乳化剂的分散相和药物活性物质; 包括超临界，亚临界或液化气体的萃取剂; 所述溶剂比所述乳化剂在萃取剂中更可溶; 该过程包括以下连续步骤：a。将可泵送乳液与萃取剂在混合条件下结合; 湾允许形成含有乳化剂和药物活性物质的颗粒; C。收集颗粒并将其与萃取剂分离。

2. 发明申请

WO2007024133A1 PROCESS FOR THE PREPARATION OF ENCAPSULATES THROUGH PRECIPITATION 审中-公开
标题翻译：通过降解制备包囊的方法
公开(公告)号：WO2007024133A1
公开(公告)日：2007-03-01
申请号：PCT/NL2006/050208
申请日：2006-08-23
申请人： FEYECON DEVELOPMENT & IMPLEMENTATION B.V. , WOERLEE, Geert Feye , HOFLAND, Gerard Willem , VERMEULEN, Pieter Sebastiaan
发明人： WOERLEE, Geert Feye , HOFLAND, Gerard Willem , VERMEULEN, Pieter Sebastiaan
IPC分类号： B01J13/16
CPC分类号： B01J13/04
摘要： The present invention relates to a process for the preparation of encapsulates, which process employs: • a pumpable emulsion comprising (i) a continuous phase containing a solvent and a matrix-forming solute dissolved in said solvent and (ii) a dispersed phase; • an extractant comprising supercritical, subcritical or liquefied gas; said solvent being substantially more soluble in the extractant than said matrix-forming solute and said process comprising the successive steps of: a. combining the pumpable emulsion with the extractant under mixing conditions; b. allowing the formation of particulate encapsulates in which the dispersed phase is encased in a solid matrix of the matrix-forming solute; c. collecting the encapsulates and separating them from the extractant. The present processes is particularly suitable for producing particles containing active ingredients that are very sensitive, e.g. ingredients whose activity is adversely affected by exposure to oxygen, light, moisture, heat and/or friction.
摘要翻译：本发明涉及一种制备包封物的方法，该方法采用：可泵送乳液，其包含（i）含有溶剂和溶解在所述溶剂中的基质形成溶质的连续相和（ii）分散相; 包括超临界，亚临界或液化气体的萃取剂; 所述溶剂在所述萃取剂中比所述基质形成溶质基本上更易溶，所述方法包括以下连续步骤：a。将可泵送乳液与萃取剂在混合条件下结合; 湾允许形成其中分散相被包裹在基质形成溶质的固体基质中的颗粒包封物; C。收集封装物并将其与萃取剂分离。本发明方法特别适用于生产含有非常敏感的活性成分的颗粒，例如，活性受到暴露于氧气，光线，水分，热量和/或摩擦力的不利影响的成分。

3. 发明授权

EP1917098B1 PROCESS FOR THE PREPARATION OF ENCAPSULATES THROUGH PRECIPITATION 失效
标题翻译：用于生产封装BY降水
公开(公告)号：EP1917098B1
公开(公告)日：2010-07-07
申请号：EP06783954.8
申请日：2006-08-23
申请人： Feyecon Development & Implementation B.V.
发明人： WOERLEE, Geert Feye , HOFLAND, Gerard Willem , VERMEULEN, Pieter Sebastiaan
IPC分类号： B01J13/16
CPC分类号： B01J13/04

4. 发明公开

EP1917098A1 PROCESS FOR THE PREPARATION OF ENCAPSULATES THROUGH PRECIPITATION 失效
标题翻译：用于生产封装BY降水
公开(公告)号：EP1917098A1
公开(公告)日：2008-05-07
申请号：EP06783954.8
申请日：2006-08-23
申请人： Feyecon Development & Implementation B.V.
发明人： WOERLEE, Geert Feye , HOFLAND, Gerard Willem , VERMEULEN, Pieter Sebastiaan
IPC分类号： B01J13/16
CPC分类号： B01J13/04
摘要： The present invention relates to a process for the preparation of encapsulates, which process employs: • a pumpable emulsion comprising (i) a continuous phase containing a solvent and a matrix-forming solute dissolved in said solvent and (ii) a dispersed phase; • an extractant comprising supercritical, subcritical or liquefied gas; said solvent being substantially more soluble in the extractant than said matrix-forming solute and said process comprising the successive steps of: a. combining the pumpable emulsion with the extractant under mixing conditions; b. allowing the formation of particulate encapsulates in which the dispersed phase is encased in a solid matrix of the matrix-forming solute; c. collecting the encapsulates and separating them from the extractant. The present processes is particularly suitable for producing particles containing active ingredients that are very sensitive, e.g. ingredients whose activity is adversely affected by exposure to oxygen, light, moisture, heat and/or friction.

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