Liapunova A. Pharmaceutical development and standardization of topical semisolid preparations of mometasone furoate for the treatment of dermatoses

The influence of stress factors on the stability of MF has been investigated by HPLC method. The particle size distribution for MF anhydrous and for MF monohydrate has been determined by laser diffraction method, and their crystalline structures have been identified by the X-ray powder diffraction method. It has been shown that solubility of MF depended on its crystalline structure, as well as on the nature, composition and structure of solvents. The substances have been chosen for the development of semi-solid preparations. The density and molar volume, kinematic viscosity and thermodynamics of viscous flow as well as the surface-active properties of mixed solvents water – HG have been established. The use of solvents in semi-solid preparations has been justified. An influence of the structure of aggregates of o/w and w/o emulsifiers on the rheological properties of o/w and w/o emulsions has been established. The mechanism of stabilization of o/w and w/o emulsions has been found out. The influence of the emulsion type on the osmotic activity of HG and PG is established. The partitioning and dispersion state of steroid spin probes and MF in o/w and w/o emulsions have been identified. The dynamics of anti-inflammatory action of MF with o/w and w/o emulsions as vehicles have been studied using two models of acute paw edema in rats. Pharmaceutical development and standardization of the preparation Mometasone cream 0,1 % with o/w emulsion as vehicle as well as of two preparations Moleskin® cream 0,1 % and Moleskin® ointment 0,1 % with w/o emulsion as vehicle have been performed; these preparations have been registered and implemented into manufacture. Their sales in Ukraine exceeded the sales of the medicinal products Elocom® cream 0,1 % and Elocom® ointment 0,1 %.