MIKA Pharma Gesellschaft für die Entwicklung und Vermarktung pharmazeutischer Produkte mbH
发明人:
SEIGFRIED, Bernd
申请号：
ES10757384
公开号：
ES2622097T3
申请日:
2010.07.16
申请国别(地区):
ES
年份:
2017
代理人:
摘要：
Process for the development of a liquid pharmaceutical composition to be applied as a foam on the skin, in which the liquid composition, which can be foamed has at least one solvent, at least one pharmaceutical active ingredient as well as at least one foam forming agent phospholipid, characterized in that a) the phospholipid foam forming agent is a phospholipid foam forming agent isolated from soybeans, which contains phosphatidylcholine in a concentration of between 50% by weight and 95% by weight, the phosphatidylcholine having an acid number of a maximum of 10, a peroxide index of a maximum of 10 and an oil concentration of a maximum of 6% by weight, with respect to the dry weight of the phosphatidylcholine, because b) the foam volume and foam stability are determined of the foam generated according to the SITA measurement procedure described in the exemplary embodiments without using an expanding agent, foaming in e l SITA measuring procedure 250 ml of the liquid composition with a rotor speed of 2,000 rpm by means of five rotor cycles of in each case 20 seconds with maintenance in each case of a measurement pause of approximately 15 seconds between the cycles of rotor and the respective foam volume being recorded through needle detectors every 50 seconds for a period of 35 minutes, and because c) in the liquid composition the at least one foam forming agent, the at least one solvent and the At least one pharmaceutical active ingredient is varied in terms of its chemical type and / or its concentration until the foam thus generated by the SITA measurement procedure d) has a foam density between 0.05 g / ml and 0.8 g / ml, e) has a foam volume between 450 ml and 1,400 ml and f) has a foam stability such that the foam has after a residence time of up to five minutes even at least 50% of the vo Foam lumen that was originally present immediately after the generation of the foam.Procedimiento para el desarrollo de una composición farmacéutica líquida que va a aplica
