John Lopez,Peter Draper,Sankalp Vashishtha,Nancy Klassen,Christina Armstrong
申请号：
US15285968
公开号：
US20170020832A1
申请日:
2016.10.05
申请国别(地区):
US
年份:
2017
代理人:
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.
