Drug intelligence / Profile preview

ibuprofen + diphenhydramine + aluminum magnesium simethicone

Development stage
Unknown
Lead developer
Qazvin University of Medical Sciences
Modality
Small Molecules
Administration
Topical
01

Overview

This investigational topical mouthwash formulation was developed by **Qazvin University of Medical Sciences** for the treatment of **recurrent aphthous stomatitis (RAS)**. The combination therapy consists of three active components: **ibuprofen**, a nonsteroidal anti-inflammatory drug (NSAID); **diphenhydramine**, an antihistamine with local anesthetic properties; and **aluminum magnesium simethicone (AlMgS)**, an antacid and anti-foaming agent that acts as a mucosal protective coating. The formulation is designed to provide symptomatic relief by reducing pain and inflammation associated with oral ulcers. Ibuprofen functions by inhibiting cyclooxygenase (COX) enzymes to decrease prostaglandin synthesis, while diphenhydramine targets histamine H1 receptors. The therapy was evaluated in a Phase 2 double-blind randomized clinical trial (NCT01293968) to determine if the addition of ibuprofen to a standard diphenhydramine and AlMgS mixture offered superior symptom relief when applied topically three times daily.

Other names
Ibuprofen, Diphenhydramine and Aluminium MgSIbuprofen + Diphenhydramine + AlMgS mouthwash
02

Targets

PTGS2 (Prostaglandin-Endoperoxide Synthase 2)PGHS-1 (Prostaglandin G/H Synthase 1)HRH1 (Histamine H1 Receptor)

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