Maria Clementine Martin Klosterfrau Vertriebsgesellschaft mbH
发明人:
GREVE, Harald
申请号：
ES12766592
公开号：
ES2612652T3
申请日:
2012.09.25
申请国别(地区):
ES
年份:
2017
代理人:
摘要：
Pharmaceutical composition with improved stability for topical application for the treatment of rhinitis, the composition being presented as an aqueous composition and wherein the composition contains: a) at least one imidazoline-based alpha-sympathomimetic or its physiologically safe salt, wherein the alpha- Sympathomimetic based on imidazoline is chosen from xylometazoline and wherein the composition contains component a), referred to the composition, in an amount of 0.02 to 1.0% by weight； b) pantothenol (dexpanthenol), wherein the composition contains component b), based on the composition, in an amount of 0.5 to 8% by weight； and c) at least one preservative agent and / or disinfection agent, the preservative agent and / or benzalkonium chloride disinfection agent being chosen, and wherein the composition contains component c), referred to the composition, in an amount of 0.001 at 10% by weight； wherein the pH value of the composition is adjusted and / or kept constant in the range of 5.2 to 5.9, the adjustment and / or constant maintenance of the pH value of the composition taking place at the less a chemical buffer system, using as a chemical buffer system a dihydrogen phosphate / monohydrogen phosphate buffer system ("(system) buffer H2PO4 - / HPO4 2-)" or "(system (phosphate buffer)"), where the composition it contains a content in degradation product or products of the active substance a) of at most 2% by weight, based on the active substance a), also after storage of the composition at temperatures in the range of 20 ° C to 50 ° C, at a pressure of 1,013.25 mbar and a relative humidity of the air in the range of 50% to 90% for at least 6 months, and wherein the composition contains a content in degradation product or products of the active substance b) of in each case a at most 5% by weight, based on the principle a c) b, also after storage of the composition at temperatures in the range of 20 ° C to 50 ° C, at a pressure of 1,013.25 mbar and at a relativ
