Phloroglucinol Formulations And Methods Of Use

A pharmaceutical composition comprising a total amount of about 50 mg to about 1000 mg of an active pharmaceutical ingredient (API) that is phloroglucinol, trimethylphloroglucinol, a pharmaceutically acceptable salt thereof, or a combination thereof, wherein the pharmaceutical composition comprises:

• an immediate release portion comprising about 20 to about 40% by weight of the total amount of the API, wherein at least about 90% by weight of the API in the immediate release portion is released from the pharmaceutical composition within about 2 hours, as measured by the USP 2 paddle method at about 50 rpm in about 750 mL of an aqueous solution comprising about 0.1N HCl solution at about 37° C.;
• a first modified release portion comprising about 20 to about 40% by weight of the total amount of the API, wherein at least about 90% by weight of the API in the first modified release portion is released from the pharmaceutical composition after at least about 2 hours to about 4 hours, as measured by the USP 2 paddle method at about 50 rpm in about 750 mL of an aqueous solution comprising about 0.1N HCl solution at about 37° C.;
• and
• a second modified release portion comprising about 20 to about 40% by weight of the total amount of the API, wherein at least about 90% by weight of the API in the second modified release portion is released from the pharmaceutical composition after about 4 or more hours, as measured by the USP 2 paddle method at about 50 rpm in about 750 mL of an aqueous solution comprising about 0.1N HCl solution at about 37° C.