| abstract |
WHICH CAN BE ADMINISTERED BY INHALATION OF A LONG-ACTING BETA 2 AGONIST AND WHICH INCLUDES: 1) AN ACTIVE INGREDIENT SELECTED FROM: FORMOTEROL, A STEREOISOMER, A SALT OR SOLVATE ACCEPTABLE FOR THE PHYSIOLOGICAL USE OF THE SAME PROVIDED, IN A SOLVENT OF LYPHA , SUCH AS: FUMARATE OF (R, R) - (+/-) - FORMOTEROL IN A CONCENTRATION INCLUDED BETWEEN 0.003 AND 0.192% w / v; AND, 2) A CO-SOLVENT SUCH AS ETHANOL IN ANHYDROUS FORM; WHERE, THE QUANTITY OF WASTE WATER IS LESS THAN 1500 ppm, OVER THE TOTAL WEIGHT OF THE FORMULATION. WHERE, THE FRACTION OF PARTICLES WITH A DIAMETER EQUAL TO OR LESS THAN 1.1 um ADMINISTERED WHEN THE INHALER IS ACTIVATED IS GREATER OR EQUAL THAN 30%. IT ALSO REFERS TO A METHOD FOR PREPARING THE DESCRIBED FORMULATION, WHICH INCLUDES: a) PREPARING A SOLUTION OF ONE OR MORE ACTIVE INGREDIENTS IN (2); b) OPTIONALLY ADJUST THE pH OF THE SOLUTION; c) FILL THE DEVICE WITH THE SOLUTION; d) APPLY VALVES AND GASIFY; AND, e) ADD A PROPELLANT CONTAINING A HYDROFLUOROALKANE (HFA) |