公开(公告)号：US09480667B2

公开(公告)日：2016-11-01

申请号：US13574159

申请日：2011-01-19

申请人： John Lopez ,  Peter Draper ,  Sankalp Vashishtha ,  Nancy Klassen ,  Christina Armstrong

发明人： John Lopez ,  Peter Draper ,  Sankalp Vashishtha ,  Nancy Klassen ,  Christina Armstrong

IPC分类号： A61K31/192 ,  A61K31/4402 ,  A61K31/405 ,  A61K9/48 ,  A61K45/06

CPC分类号： A61K31/192 ,  A61K9/0053 ,  A61K9/48 ,  A61K9/4833 ,  A61K9/4858 ,  A61K9/4866 ,  A61K45/06 ,  A61K2300/00

摘要： An NSAID formulation for encapsulation into a soft gel capsule with increased stability, concentration and bioavailability of the NSAID. The preferred NSAIDS are naproxen, ibprofen, indomethacin and diclofenac, which are provided in both an acidic and basic form in the fill formulation. The pH values of fill formulations may be adjusted without additional process steps. A process for increasing the achievable concentration of an NASAID pharmaceutical ingredient in a fill composition for dosage units is also provided. The highly concentrated NASAID formulation permits a reduction in the fill volume or dosage unit size or an increase in concentration of the NSAID in each dosage it.

摘要翻译： NSAID制剂用于将NSAID的稳定性，浓度和生物利用度提高到软胶囊中。 优选的NSAIDS是萘普生，ibprofen，吲哚美辛和双氯芬酸，其在填充制剂中以酸性和碱性形式提供。 填充制剂的pH值可以在没有附加工艺步骤的情况下进行调整。 还提供了用于增加用于剂量单位的填充组合物中的NASAID药物成分的可实现浓度的方法。 高度浓缩的NASAID制剂允许减少每种剂量的NSAID的填充体积或剂量单位大小或浓度的增加。

公开(公告)号：US20170020832A1

公开(公告)日：2017-01-26

申请号：US15285968

申请日：2016-10-05

申请人： John Lopez ,  Peter Draper ,  Sankalp Vashishtha ,  Nancy Klassen ,  Christina Armstrong

发明人： John Lopez ,  Peter Draper ,  Sankalp Vashishtha ,  Nancy Klassen ,  Christina Armstrong

IPC分类号： A61K31/192 ,  A61K9/00 ,  A61K9/48

CPC分类号： A61K31/192 ,  A61K9/0053 ,  A61K9/48 ,  A61K9/4833 ,  A61K9/4858 ,  A61K9/4866 ,  A61K45/06 ,  A61K2300/00

摘要： This invention relates to a naproxen formulation suitable for encapsulation into a soft gel dosage unit by increasing the stability, concentration, and bioavailability of naproxen. Fill formulations of the invention may include other active pharmaceutical ingredients and combinations of two or more active pharmaceutical ingredients. This invention also provides for adjusting pH values of fill formulations without additional process steps. A process for increasing the achievable concentration of an active NSAID pharmaceutical ingredient, such as naproxen, relative to fill composition for dosage units is also provided. The highly concentrated formulation of this invention permits a reduction in the fill volume or dosage unit size, or an increase in concentration of the active pharmaceutical ingredient per dosage form. The invention also relates to a formulation of optimal stability suitable for supporting a fill composition compatible with the soft gel dosage unit.

摘要翻译： 本发明涉及一种适于通过增加萘普生的稳定性，浓度和生物利用度来包囊入软凝胶剂量单位的萘普生制剂。 本发明的填充制剂可以包括其它活性药物成分和两种或更多种活性药物成分的组合。 本发明还提供了在没有附加工艺步骤的情况下调节填充制剂的pH值。 还提供了相对于剂量单位的填充组合物增加活性NSAID药物成分（例如萘普生）可实现浓度的方法。 本发明的高度浓缩的制剂允许每剂量形式的活性药物成分的填充体积或剂量单位大小的减少或活性药物成分的浓度增加。 本发明还涉及适合于支持与软凝胶剂量单位相容的填充组合物的最佳稳定性的制剂。

公开(公告)号：US20130011470A1

公开(公告)日：2013-01-10

申请号：US13574159

申请日：2011-01-19

申请人： John Lopez ,  Peter Draper ,  Sankalp Vashishtha ,  Nancy Klassen ,  Christina Armstrong

发明人： John Lopez ,  Peter Draper ,  Sankalp Vashishtha ,  Nancy Klassen ,  Christina Armstrong

IPC分类号： A61K31/192 ,  A61K31/4402 ,  A61P29/00 ,  A61K31/405 ,  A61K31/196 ,  A61K31/485 ,  A61K9/48

CPC分类号： A61K31/192 ,  A61K9/0053 ,  A61K9/48 ,  A61K9/4833 ,  A61K9/4858 ,  A61K9/4866 ,  A61K45/06 ,  A61K2300/00

摘要： An NSAID formulation for encapsulation into a soft gel capsule with increased stability, concentration and bioavailability of the NSAID. The preferred NSAIDS are naproxen, ibprofen, indomethacin and diclofenac, which are provided in both an acidic and basic form in the fill formulation. The pH values of fill formulations may be adjusted without additional process steps. A process for increasing the achievable concentration of an NASAID pharmaceutical ingredient in a fill composition for dosage units is also provided. The highly concentrated NASAID formulation permits a reduction in the fill volume or dosage unit size or an increase in concentration of the NSAID in each dosage it.

摘要翻译： NSAID制剂用于将NSAID的稳定性，浓度和生物利用度提高到软胶囊中。 优选的NSAIDS是萘普生，ibprofen，吲哚美辛和双氯芬酸，其在填充制剂中以酸性和碱性形式提供。 填充制剂的pH值可以在没有附加工艺步骤的情况下进行调整。 还提供了用于增加用于剂量单位的填充组合物中的NASAID药物成分的可实现浓度的方法。 高度浓缩的NASAID制剂允许减少每种剂量的NSAID的填充体积或剂量单位大小或浓度的增加。