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1. (WO2017062027) MODIFIED RELEASE FORMULATION OF NAPROXEN SODIUM

Pub. No.:    WO/2017/062027    International Application No.:    PCT/US2015/054873
Publication Date: Fri Apr 14 01:59:59 CEST 2017 International Filing Date: Sat Oct 10 01:59:59 CEST 2015
IPC: A61K 9/24
A61K 31/192
Applicants: BAYER HEALTHCARE LLC
Inventors: SIRIHORACHAI, Rachan
ROSAR, Paul
Title: MODIFIED RELEASE FORMULATION OF NAPROXEN SODIUM
Abstract:
The present invention is a formulation of naproxen having a release profile that provides immediate pain relief equivalent to taking 440 mg (or 2 tablets of 220 mg) naproxen sodium and also extended pain relief for 24 hours. In particular, the present invention is a single solid-dose combining a unique ratio of an immediate release naproxen sodium product with an extended release naproxen sodium layer. More particularly, the present invention is a single bilayer tablet that immediately releases 300-320 mg of naproxen sodium and thereafter gradually releases 450-480 mg of naproxen sodium. This product is capable of providing 24 hours of pain relief when administered as a single bilayer tablet. The single bilayer tablet provides immediate release (IR) of naproxen sodium for initial pain relief from one layer followed by continuous release of the remaining naproxen sodium from the other layer to maintain extended pain relief up to 24 hours.