| abstract |
IT REFERS TO A SOLID PARTICULATE COMPOSITION THAT INCLUDES A HYGROSCOPIC AND / OR DELIQUESCENT DRUG AND AT LEAST ONE NON-HYGROSCOPIC POLYMER, IN WHICH SAID PHARMACY AND NON-HYGROSCOPIC POLYMER ARE IN INTIMATE ASSOCIATION, MAKING NO INCREASED HIGROSCOPIC COMPOSITION, MAKING A HIGROSCOPIC COMPOSITION, NOT ACCEPTING A HIGROSCOPIC COMPOSITION. OF NO MORE THAN APPROXIMATELY 10% WHEN EXPOSED TO 40% RELATIVE HUMIDITY AT 21-23 ° C FOR 24 HOURS OR DURING A SUFFICIENT PERIOD OF TIME FOR THE COMPOSITION TO REACH BALANCE. THE DRUG IS AN iNOS INHIBITOR, SPECIFICALLY S- [2 - [(1-IMINOETHYL) AMINO] ETHYL] -2-METHYL-L-CYSTEINE, AND IS PRESENT IN AN AMOUNT OF APPROX. 10% TO 80%. BY WEIGHT OF THE COMPOSITION AND THE NON-HYGROSCOPIC POLYMER IS A CELLULOSIC POLYMER. IT ALSO REFERS TO A PROCEDURE TO PREPARE SAID COMPOSITION THAT INCLUDES A FIRST STAGE OF DISPERSION OF THE HYGROSCOPIC AND / OR DELIQUESCENT DRUG AND AT LEAST ONE NON-HYGROSCOPIC POLYMER IN AN AQUEOUS LIQUID TO FORM THE DISPERSION OF THE DISPERSION AND A SECOND DISPERSION OF THE DISPERSION. DRYING BY ATOMIZATION, LYOPHILIZATION, TEMPERATURE RAISE OR VACUUM FILTRATION |