Method for avoiding the growth by recristalization of any partially soluble medicinal drug in the excipient, incorporated to different galenic forms (Machine-translation by Google Translate, not legally binding)

摘要

Method for preventing growth by recrystallization of any drug partially soluble in the excipient incorporated in different galenic forms, consisting essentially of incorporating the effect of solvating the drug in a solvent in which said drug is partially soluble, in order to form the corresponding crystalline solvate, for which the drug is preferably placed in a hermetically sealed container capable of withstanding high pressures, using for solvation as volatile substance solvents, with low vapor pressures, bringing the temperature of said container successively and alternately, for several consecutive days at -20ºC and 50º c, after which the mass of crystals obtained by recrystallizations and successive solvations is treated by means of a colloidal mill or the like with recycling, at a temperature of -20ºC to 20º c, depending on the solvent, repeating the operation so many times com or it is necessary to obtain particles no greater than 5 microns, repeating said operations again in the same container and under the same temperature conditions for several more days, then treating the product again by the colloidal or similar mill, to the torque that increases the temperature during recycling until reaching 3-5ºc below the boiling point of the most volatile component. (Machine-translation by Google Translate, not legally binding)