| 摘要 |
The invention relates to a controlled release composition comprising a combination of isosorbide dinitrate and hydralazine, such as hydralazine hydrochloride, that in operation delivers the drug in a pulsed or multi-modal manner for the treatment of angina, ischaemic heart disease, arterial hypertension and related disease conditions. Preferably, the isosorbide dinitrate and hydralazine hydrochloride can be released from the dosage form in an erodable, diffusion and/or osmotic-controlled release profile. |
| 主权项 |
1. A solid pharmceutical composition for oral administration comprising:
(i) a first component comprising (a) a first population of active ingredient containing particles comprising isosorbide dinitrate, or a salt thereof, mannitol, and sugar spheres; and (b) a second population of active ingredient containing particles comprising hydralazine, or a salt thereof, sugar spheres, and at least one stabilizer selected from the group consisting of edetic acid and salts thereof, and citric acid and salts thereof; and (ii) a second component comprising (c) a third population of active ingredient containing particles comprising isosorbide dinitrate, or a salt thereof, mannitol, and sugar spheres, and a modified release component comprising a modified-release coating, a modified release matrix material or a combination thereof; and (d) a fourth population of active ingredient containing particles comprising hydralazine, or a salt thereof, sugar spheres, at least one stabilizer selected from the group consisting of edetic acid and salts thereof, citric acid and salts thereof, and a modified-release component comprising a modified-release coating, a modified-release matrix material or a combination thereof; wherein the amount of isosorbide dinitrate contained therein is in an amount of from about 0.1 mg to about 1 g; and wherein the amount of hydralazine contained therein is in an amount of from about 0.1 mg to about 1 g. |
