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1. 发明申请

US20070065513A1 Stable lansoprazole formulation 审中-公开
标题翻译：稳定的兰索拉唑制剂
公开(公告)号：US20070065513A1
公开(公告)日：2007-03-22
申请号：US10575809
申请日：2004-11-01
申请人： Avi Avramoff , Valerie Azoulay
发明人： Avi Avramoff , Valerie Azoulay
IPC分类号： A61K31/4439 , A61K9/26
CPC分类号： A61K9/5078 , A61K9/5026 , A61K9/5042 , A61K9/5047 , A61K31/4439
摘要： A stable composition comprising a substrate comprising lansoprazole (preferably in the base form), without any alkaline agent; a subcoating layer containing alkaline agent; and an enteric coating layer. The substrate is preferably an inert core with an active layer (containing lansoprazole) layered over it.
摘要翻译：一种稳定的组合物，其包含不含任何碱性试剂的兰索拉唑（优选为碱形式）的底物; 含有碱性试剂的底涂层; 和肠溶衣层。基底优选为在其上分层的活性层（含有兰索拉唑）的惰性核。

2. 发明申请

US20070196485A1 Stable benzimidazole formulation 有权
公开(公告)号：US20070196485A1
公开(公告)日：2007-08-23
申请号：US11785300
申请日：2007-04-17
申请人： Raffael Lahav , Erica Lahav , Valerie Azoulay
发明人： Raffael Lahav , Erica Lahav , Valerie Azoulay
IPC分类号： A61K31/4439 , A61K9/24
CPC分类号： A61K9/2866 , A61K9/0053 , A61K9/2031 , A61K9/284 , A61K9/5078 , A61K31/4184 , A61K31/4439
摘要： A stable composition with a benzimidazole derivative, such as Omeprazole, which does not contain a separating layer between the active compound and an enteric coating layer. Instead, the enteric coating layer is applied as a solution with a pH value of at least 6.5, and more preferably in a range of from about 7 to about 10, directly to the benzimidazole derivative substrate. This solution, with the optional addition of a plasticizer, can be directly coated onto the substrate without any necessity for an intermediate layer. Furthermore, in this pH range, the enteric coating is optionally applicable in an aqueous solution, thereby obviating the need for organic solvents for dissolving the enteric coating material. The resultant formulation maintains the stability of the benzimidazole derivative during storage and at the same time protects the product during passage through the acidic environment of the stomach. The problem of interaction between the enteric coat and the alkaline core is thus completely eliminated as the enteric coat at this stage is no longer acidic.

3. 发明授权

US07255878B1 Stable benzimidazole formulation 有权
标题翻译：稳定的苯并咪唑制剂
公开(公告)号：US07255878B1
公开(公告)日：2007-08-14
申请号：US10018992
申请日：2000-06-21
申请人： Erica Lahav, legal representative , Valerie Azoulay
发明人： Raffael Lahav, deceased
IPC分类号： A61K9/16 , A61K9/00 , A61K9/14 , A61K9/20 , A61K9/22
CPC分类号： A61K9/2866 , A61K9/0053 , A61K9/2031 , A61K9/284 , A61K9/5078 , A61K31/4184 , A61K31/4439
摘要： A stable composition with a benzimidazole derivative, such as Omeprazole, which does not contain a separating layer between the active compound and an enteric coating layer. Instead, the enteric coating layer is applied as a solution with a pH value of at least 6.5, and more preferably in a range of from about 7 to about 10, directly to the benzimidazole derivative substrate. This solution, with the optional addition of a plasticizer, can be directly coated onto the substrate without any necessity for an intermediate layer. Furthermore, in this pH range, the enteric coating is optionally applicable in an aqueous solution, thereby obviating the need for organic solvents for dissolving the enteric coating material. The resultant formulation maintains the stability of the benzimidazole derivative during storage and at the same time protects the product during passage through the acidic environment of the stomach. The problem of interaction between the enteric coat and the alkaline core is thus completely eliminated as the enteric coat at this stage is no longer acidic.
摘要翻译：具有苯并咪唑衍生物如奥美拉唑的稳定组合物，其在活性化合物和肠溶衣层之间不含有分离层。相反，将肠溶衣层作为pH值至少为6.5，更优选在约7至约10的范围内直接施用于苯并咪唑衍生物底物的溶液施用。这种可选择地添加增塑剂的溶液可以直接涂覆在基材上，而不需要中间层。此外，在该pH范围内，肠衣可以任选地应用于水溶液中，从而避免了溶解肠溶衣材料的有机溶剂的需要。所得制剂在保存期间保持苯并咪唑衍生物的稳定性，同时在通过胃的酸性环境的过程中保护产物。因此肠衣和碱性核心之间的相互作用的问题被完全消除，因为该阶段的肠衣不再是酸性的。

4. 发明授权

US09023391B2 Stable benzimidazole formulation 有权
标题翻译：稳定的苯并咪唑制剂
公开(公告)号：US09023391B2
公开(公告)日：2015-05-05
申请号：US11785300
申请日：2007-04-17
申请人： Valerie Azoulay , Erica Lahav
发明人： Raffael Lahav , Valerie Azoulay
IPC分类号： A61K9/00 , A61K9/14 , A61K31/4439 , A61K9/24 , A61P1/04 , B05D7/00 , A61K31/4184 , A61K9/20 , A61K9/28 , A61K9/50
CPC分类号： A61K9/2866 , A61K9/0053 , A61K9/2031 , A61K9/284 , A61K9/5078 , A61K31/4184 , A61K31/4439
摘要： A stable composition with a benzimidazole derivative, such as Omeprazole, which does not contain a separating layer between the active compound and an enteric coating layer. Instead, the enteric coating layer is applied as a solution with a pH value of at least 6.5, and more preferably in a range of from about 7 to about 10, directly to the benzimidazole derivative substrate. This solution, with the optional addition of a plasticizer, can be directly coated onto the substrate without any necessity for an intermediate layer. Furthermore, in this pH range, the enteric coating is optionally applicable in an aqueous solution, thereby obviating the need for organic solvents for dissolving the enteric coating material. The resultant formulation maintains the stability of the benzimidazole derivative during storage and at the same time protects the product during passage through the acidic environment of the stomach. The problem of interaction between the enteric coat and the alkaline core is thus completely eliminated as the enteric coat at this stage is no longer acidic.
摘要翻译：具有苯并咪唑衍生物（例如奥美拉唑）的稳定组合物，其在活性化合物和肠溶衣层之间不含有分离层。相反，将肠溶衣层作为pH值至少为6.5，更优选在约7至约10的范围内直接施用于苯并咪唑衍生物底物的溶液施用。这种可选择地添加增塑剂的溶液可以直接涂覆在基材上，而不需要中间层。此外，在该pH范围内，肠衣可以任选地应用于水溶液中，从而避免了溶解肠溶衣材料的有机溶剂的需要。所得制剂在保存期间保持苯并咪唑衍生物的稳定性，同时在通过胃的酸性环境的过程中保护产物。因此肠衣和碱性核心之间的相互作用的问题被完全消除，因为该阶段的肠衣不再是酸性的。

5. 发明申请

US20120244219A1 STABLE BENZIMIDAZOLE FORMULATION 审中-公开
标题翻译：稳定的苯并咪唑配方
公开(公告)号：US20120244219A1
公开(公告)日：2012-09-27
申请号：US13456411
申请日：2012-04-26
申请人： RAFFAEL LAHAV , ERICA LAHAV , VALERIE AZOULAY
发明人： RAFFAEL LAHAV , ERICA LAHAV , VALERIE AZOULAY
IPC分类号： A61K9/00 , B05D7/00 , A61K9/14 , A61P1/04 , A61K31/4439 , A61K9/28
CPC分类号： A61K9/2866 , A61K9/0053 , A61K9/2031 , A61K9/284 , A61K9/5078 , A61K31/4184 , A61K31/4439
摘要： A stable composition with a benzimidazole derivative, such as Omeprazole, which does not contain a separating layer between the active compound and an enteric coating layer. Instead, the enteric coating layer is applied as a solution with a pH value of at least 6.5, and more preferably in a range of from about 7 to about 10, directly to the benzimidazole derivative substrate. This solution, with the optional addition of a plasticizer, can be directly coated onto the substrate without any necessity for an intermediate layer. Furthermore, in this pH range, the enteric coating is optionally applicable in an aqueous solution, thereby obviating the need for organic solvents for dissolving the enteric coating material. The resultant formulation maintains the stability of the benzimidazole derivative during storage and at the same time protects the product during passage through the acidic environment of the stomach.
摘要翻译：具有苯并咪唑衍生物如奥美拉唑的稳定组合物，其在活性化合物和肠溶衣层之间不含有分离层。相反，将肠溶衣层作为pH值至少为6.5，更优选在约7至约10的范围内直接施用于苯并咪唑衍生物底物的溶液施用。这种可选择地添加增塑剂的溶液可以直接涂覆在基材上，而不需要中间层。此外，在该pH范围内，肠衣可以任选地应用于水溶液中，从而避免了溶解肠溶衣材料的有机溶剂的需要。所得制剂在保存期间保持苯并咪唑衍生物的稳定性，同时在通过胃的酸性环境的过程中保护产物。

6. 发明申请

US20110038933A1 STABLE BENZIMIDAZOLE FORMULATION 审中-公开
标题翻译：稳定的苯并咪唑配方
公开(公告)号：US20110038933A1
公开(公告)日：2011-02-17
申请号：US12866255
申请日：2009-05-05
申请人： Valerie Azoulay , Avi Avramoff , Adel Penhasi , Maxim Gomberg
发明人： Valerie Azoulay , Avi Avramoff , Adel Penhasi , Maxim Gomberg
IPC分类号： A61K9/28 , A61K9/00 , A61K9/14 , A61K31/4439 , A61P1/04
CPC分类号： A61K9/2095 , A61K9/1676 , A61K9/282 , A61K9/2866 , A61K9/5042 , A61K31/4439
摘要： A benzimidazole formulation which lacks an intermediate layer and yet which is stable both during storage and during the passage through the stomach, and which has low levels of residual volatile excipients, including but not limited to residual alkalinizing agents and/or residual solvents.
摘要翻译：一种苯并咪唑制剂，其缺乏中间层，而且在储存期间和在通过胃期间都是稳定的，并且具有低水平的残留挥发性赋形剂，包括但不限于残留的碱化剂和/或残留溶剂。

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