Lyophilized Pharmaceutical compositions comprising N - hydroxy - 3 - 4 - 2 - (methyl) - 1H indole - 3 - yl) - ethyl amino methyl phenyl - 2E - 2-propenamide and processes for their Preparation

摘要

Pharmaceutical compositions comprising a poorly water soluble Compound Therapeutic, an aqueous Solvent / Antioxidant, a chelating Agent, a pH Regulator, a component or a pH Regulating Agent, and Volume. The pharmaceutical compositions can be administered parenterally or orally ingested can be.The pharmaceutical compositions are also pharmaceutically acceptable Lyophilized to form a cake that can be administered orally, for example as a Solid oral dosage form; or it can be reconstituted and administered parenterally, such as a single bolus intrav ENOSo or an intravenous infusion, or may be given orally.For example, as a solution to drink. 1. - a Pharmaceutical composition, which comprises: N - hydroxy - 3 - [4 - [[2 - (methyl) - 1H indole - 3 - yl) - ethyl] amino] methyl] phenyl] - 2E - 2-propenamide, or a pharmaceutically acceptable Salt of the same a pH Regulator, pH Regulator or a Component; and an agent Volume. 2.- the composition of claim 1, which also includes a chelating / Antioxidant. 3. - the composition of claim 1, wherein the volume mentioned Agent is selected from sucrose, Trehalose, dextran, and hpbcd. 4. - the composition of claim 1, wherein the Binder / Antioxidant Disodium EDTA is mentioned. 5.- the composition of claim 1, wherein the PH Regulator or the component of the mentioned pH Regulator is selected from a Regulator or a Regulator lactate, lactic acid, Phosphoric Acid or phosphate, and a combination of both. The Composition of claim 1, wherein the composition is a pharmaceutically acceptable Cake after freeze-drying.