Drug intelligence / Profile preview

ibuprofen 600 mg ER

Development stage
Unknown
Lead developer
Pfizer Consumer Healthcare
Modality
Small Molecules
Administration
Oral
01

Overview

This drug is an immediate-release/extended-release (IR/ER) formulation of ibuprofen developed by Pfizer Consumer Healthcare for the treatment of post-operative dental pain. The formulation contains 600 mg of ibuprofen per tablet, consisting of a 200 mg immediate-release component for rapid onset and a 400 mg extended-release component for sustained relief, designed for dosing every 12 hours. As a nonsteroidal anti-inflammatory drug (NSAID), it works by inhibiting cyclooxygenase (COX) enzymes, thereby reducing the synthesis of prostaglandins that mediate pain and inflammation. Pfizer conducted Phase 2 clinical trials (such as NCT00913627) evaluating different manufacturing formulations (roller compaction and wet granulation) of this prototype in patients with moderate to severe pain following third molar extraction, demonstrating rapid onset and sustained analgesia over 12 hours.

Brand names
Aktren
Other names
ibuprofen IR/ERibuprofen 600 mg extended releaseibuprofen600 mg extended releaseibuprofen-600 mg extended releaseibuprofen 600 mg ER prototypeibuprofen600 mg ER prototypeibuprofen-600 mg ER prototype
02

Targets

PGHS-1 (Prostaglandin G/H Synthase 1)PTGS2 (Prostaglandin-Endoperoxide Synthase 2)

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