Oral dosage forms for oxygen-containing active agents and oxyl-containing polymer

A method for treating a subject, said method comprising administering to a subject a pharmaceutical composition having codeine and chlorpheniramine, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition provides therapeutic levels of codeine and chlorpheniramine to said subject for about twelve hours and wherein said pharmaceutical composition has two, three, four, or five of the following characteristics:

• (i) single-dose administration to a subject under fasted conditions provides a mean Cmax for each of codeine and chlorpheniramine that is 70% to 135% of the respective mean Cmax provided by administering an immediate release oral dosage form to a subject under fasted conditions every 4 to 6 hours over a 12 hour time period, wherein the cumulative dosage amount administered over the 12 hour time period of codeine and chlorpheniramine in the immediate release oral dosage is equivalent to the respective amount of codeine and chlorpheniramine in said pharmaceutical composition;
• (ii) single-dose administration to a subject under fasted conditions every twelve hours provides a mean Cmax for each of codeine and chlorpheniramine that is 70% to 135% of the respective mean Cmax provided by administering the same oral dosage to the subject under fed conditions every twelve hours;
• (iii) single-dose administration to a subject under fed conditions provides a mean Cmax for each of the codeine and the chlorpheniramine that is 70% to 135% of a respective mean Cmax provided by administering an immediate release oral dosage to a subject under fed conditions every 4 to 6 hours over a 12 hour time period, wherein the cumulative dosage amount administered over the 12 hour time period of codeine and chlorpheniramine in the immediate release oral dosage is equivalent to the respective amount of codeine and chlorpheniramine in the pharmaceutical composition;
• (iv) when placed in a USP type 2 dissolution apparatus at 50 rpm in 900 mL of 0.1 N hydrochloric acid solution in water at 37° C., the ratio of the amount of codeine released to the chlorpheniramine released at a single time point between 1 hour and 4 hour is from about 0.8:1 and about 1.2:1;
• (iv) single-dose administration to a subject under fasted conditions, provides a mean Tmax for codeine in the range of about 2.2 hours to about 3.4 hours and a mean Tmax for chlorpheniramine in the range of about 5 hours about 14 hours;
• (v) further comprises a release rate controlling non-ionic oxyl-containing hydrophilic polymer;
• and
• (vi) the codeine is resin free or pharmaceutical composition is resin free.