| abstract |
DOES IT REFER TO A PHARMACEUTICAL COMPOSITION THAT INCLUDES ANHYDROUS ARIPIPRAZOLE B CRYSTALS, WITH CHARACTERISTIC DIFFRACTION PEAKS IN X-RAYS A 2? = 11.1, 16.6, 19.3, 20.3 AND 22.1, LOW HYGROSCOPICITY, WITH A DEGREE OF HUMIDITY OR LESS 0.40% HUMIDITY. PLACE SAID CRYSTALS FOR 24 HOURS IN A DISCERATOR AT 60ºC AND A HUMIDITY LEVEL OF 100%. IT ALSO REFERS TO A CHARACTERIZED PREPARATION PROCESS OF a) WET GRANULATION; b) DRYING THE GRANULES AT 70-100ºC; c) CLASSIFICATION OF THE SAME BY SIZE AND d) DRYING OF THE GRANULES AT 70-100ºC; AND OF THE PROCESS OF PREPARING THE CRYSTALS, THE SAME WHICH WILL NOT BECOME A HYDRATE OR LOSE THEIR SOLUBILITY. THE COMPOSITION IS IN THE FORM OF AN ORAL TABLET THAT HAS A DISSOLUTION RATE OF 60% OR MORE WITH pH 4.5 AFTER 30 MINUTES, 70% OR MORE WITH pH 4.5 AFTER 60 MINUTES AND 55% OR MORE WITH pH 5.0 AFTER 60 MINUTES AND MAY CONTAIN OTHER ARIPIPRAZOLE CRYSTALS, SUCH AS ARIPIPRAZOLE CRYSTALS C ANHYDRO, E ANHYDRO, G ANHYDRO, AMONG OTHERS. SUCH COMPOSITION IS USEFUL IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM DISORDERS, SUCH AS SCHIZOPHRENIA, ANXIETY, AMONG OTHERS |