Inhalable formulations for treating pulmonary hypertension and methods of using same

摘要

The present invention is directed to an inhalable formulation for the treatment of pulmonary hypertension in a mammal (e.g., humans), wherein the formulation comprises at least one hypertension reducing agent, including but not limited to an angiotensin converting enzyme inhibitor, angiotensin receptor blocker, beta-blocker, calcium-channel blocker or vasodilator, or any combination thereof. The formulations of the present invention may be a solution or suspension, and preferably are suitable for administration via nebulization. The present invention is also directed to a method and kit for treating a mammal suffering from pulmonary hypertension.

主权项

1. An inhalable formulation for the treatment of pulmonary hypertension, said formulation consisting essentially of about 0.001 mg/ml to about 0.5 mg/ml of a hypertension reducing agent, a complexing agent, and about 0.001% to about 10% by weight emulsifying agent, said hypertension reducing agent consists of a calcium-channel blocker, said formulation is adapted for localized delivery to the lungs of a mammal via oral inhalation such that the formulation is deposited into the lungs of a patient and absorption of the hypertension reducing agent into the systemic blood circulation is less than the absorption of the hypertension reducing agent into the systemic blood circulation when administered intravenously or orally to the gastrointestinal tract and systemic side-effects associated with the hypertension reducing agent are less than the systemic side-effects realized when administered intravenously or orally to the gastrointestinal tract, said formulation is isotonic and has a pH of about 3 to about 8, said formulation is free of a preservative yet sterile and exhibits greater than 80% of the calcium-channel blocker originally present in the formulation after storage for 12 months at a temperature between 15 to 30° C., and said complexing agent is sodium edetate.