Product

Ibuprofen

Pharmaceutical Form

Tablets

Strengths

800 mg

Release Characteristics

Sustained Release (like Boots – UK – BRUFEN RETARD 800 mg tablets)

Posology

Two tablets (= 1.600 mg) once daily

Raw Material

DMF available

Chemical Pharmaceutical Dossier

Available in CTD format

Parmacokinetics

Multiple dose (steady state – 6 days) two-way crossover bioequivalence study vs. Boots (UK) BRUFEN RE-TARD, Ibuprofen sustained release 800 mg tablets. Single dose four-way crossover fast-ing/non-fasting bioequivalence study on 24 healthy volunteers vs. Abbott (UK) BRUFEN RETARD 800 mg tab-lets.

Registration underway

Egypt, Greece, New Zealand, Repu-blic of South Africa, United Kingdom.

Marketing

Croatia, Ecuador, Finland, Spain.

Notes

Free Sale Certificate available