Cyclohexyl beta-hydroxy alkyl amines and medical uses thereof
US-2024390298-A1 · Nov 28, 2024 · US
US9782365B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-9782365-B2 |
| Application number | US-201214006183-A |
| Country | US |
| Kind code | B2 |
| Filing date | Mar 15, 2012 |
| Priority date | Mar 21, 2011 |
| Publication date | Oct 10, 2017 |
| Grant date | Oct 10, 2017 |
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The present invention relates to solid preparations containing ambroxol which are obtainable by melt extrusion of the mixture consisting of a) 30 to 80% by weight of ambroxol hydrochloride, b) 2 to 68% by weight of at least one hydrogenated vegetable oil, c) 2 to 68% by weight of at least one mixture containing fatty acid ester and/or hydroxy fatty acid ester and d) 0 to 66% by weight of one or more pharmaceutical adjuvants, based in each case on the total amount of the preparation and its use for secretolytic treatment in acute and chronic bronchopulmonary diseases.
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The invention claimed is: 1. A solid formulation containing ambroxol, prepared by the process of melt extrusion of a mixture consisting of a) 70-80% by weight of ambroxol hydrochloride, b) 5-20% by weight of hydrogenated castor oil having a melting point of 70 to 90° C., c) 5-20% by weight of carnauba wax having a melting point of 55 to 90°, and d) 0-5% by weight of one or more pharmaceutical excipients, based in each case on the total amount of the preparation. 2. A method of preparing a solid formulation comprising ambroxol hydrochloride comprising melt extruding a composition consisting of: a) 70-80% by weight of ambroxol hydrochloride, b) 5-20% by weight of hydrogenated castor oil having a melting point of 70 to 90° C., c) 5-20% by weight of carnauba wax having a melting point of 55 to 90° C., and d) 0-5% by weight of one or more pharmaceutical excipients, wherein the amount of each of the components a) to d) is based on the total amount of the solid formulation. 3. A pharmaceutical formulation consisting of a) 70-80% by weight of ambroxol hydrochloride, b) 5-20% by weight of hydrogenated castor oil having a melting point of 70 to 90° C., c) 5-20% by weight of carnauba wax having a melting point of 55 to 90° C., and d) 0-5% by weight of one or more pharmaceutical excipients, based in each case on the total amount of the formulation. 4. The pharmaceutical formulation of claim 3 , wherein the one or more pharmaceutical excipients comprises stearyl alcohol that is present in the formulation. 5. A method of using the formulation according to claim 3 for secretolytic treatment in acute and chronic bronchopulmonary diseases.
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