[EN] A NASAL COMPOSITION CONTAINING SEA WATER AS STABILITY-IMPROVING EXCIPIENT<br/>[FR] COMPOSITION NASALE CONTENANT DE L'EAU DE MER EN TANT QU'EXCIPIENT D'AMÉLIORATION DE STABILITÉ
申请人:JADRAN GALENSKI LAB D D
公开号:WO2016102984A1
公开(公告)日:2016-06-30
The invention discloses a nasal composition of improved stability, their use, and process for production. The nasal composition consists of: xylometazoline hydrochloride (1), 0.01-0.1% w/w; ipratropium bromide (2), 0.01-0.1% w/w; and pharmaceutical excipients required to form final dosage forms selected from the group consisting of: nasal drops, liquid nasal sprays, or nasal washes. Said nasal composition comprises the content of purified sea water as functional, stability-improving excipient, in amounts of 5-25% w/w. A nasal composition has osmolality within the range 270-820 mOsm/kg, the pH value within the range 3-7, preferably within the range 3-4.2 or 5.8-7.0, and most preferably within the range 3.2-4.2 where shows improved stability.