FIELD: pharmaceutics.
SUBSTANCE: invention relates to a pharmaceutical composition for local application, containing as a therapeutically active ingredient calcipotriol or monohydrate of calcipotrol, included in form of a solid solution or dispersion in lipid nanoparticles, wherein said lipid nanoparticles are solid at room temperature and contain 60-92 % by weight of a first lipid with melting point higher than body temperature, where said first lipid is a wax selected from a group consisting of cetyl palmitate, C14-28 fatty alcohol, hydrogenated palm oil and triglycerides with acid number equal to 0.1 or less, and 1-40 % by weight of lipid nanoparticles of a second lipid which is oil at room temperature, miscible with first lipid, wherein said second lipid is selected from a group consisting of medium-chain triglycerides, such as triglycerides of caprylic/capric acid, or long-chain triglycerides, such as castor oil, wherein said lipid nanoparticles additionally contain 2-22 % by weight of a pharmaceutically acceptable surfactant selected from a group consisting of poloxamers.
EFFECT: invention provides improved chemical stability of active substance in composition, including stability during storage, as well as possibility of increasing drug load.
11 cl, 4 ex, 14 dwg
Authors
Dates
2016-11-10—Published
2012-03-23—Filed