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Claims for Patent: 6,127,425

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Claims for Patent: 6,127,425

Title: Oral liquid medicine solution
Abstract:Found is a pharmaceutical preparation which provides Tamoxifen Citrate in a liquid dosage form, viz. as an oral solution. The finding is based on a solvent comprising the following components: (a) of from 10% to 20% by weight of ethanol, (b) of from 10% to 60% by weight of a glycol; and (c) water, optionally containing additives, in a volume percentage adding up to 100% by volume. A preferred additive is sorbitol.
Inventor(s): Tully; Roger Edward (Ilkley, GB)
Assignee: Akzo Nobel N.V. (Arnhem, NL)
Application Number:09/106,172
Patent Claims: 1. A pharmaceutical preparation which provides a dosage form of Tamoxifen, wherein the dosage form comprises at least 1.5 mg/ml of Tamoxifen Citrate, in the absence of a complexing agent, in a pharmaceutically acceptable solution which is administered orally.

2. A pharmaceutical preparation according to claim 1, wherein the solution comprises a solvent comprising the following components: (a) from about 10% to 20% by weight of ethanol; (b) from about 10% to 60% by weight of glycol; and (c) water in a volume percentage adding up to 100% by volume.

3. A pharmaceutical preparation according to claim 2, wherein the glycol component is a mixture of propylene glycol and glycerol.

4. A pharmaceutical preparation according to claim 3, wherein the water component (c) contains a bulk-sweetening agent.

5. A pharmaceutical preparation according to claim 4, wherein the bulk-sweetening agent is from 15% to 25% by weight of sorbitol.

6. A pharmaceutical preparation according to claim 5, wherein the solvent comprises the following components: 15% by weight of ethanol, 10% by weight of propylene glycol, 50% by weight of glycerol, 20% by weight of a solution of 70% by weight of sorbitol in water, and water in a volume percentage adding up to 100% by volume.

7. A process for the preparation of the solution according to claim 2, comprising dissolving the Tamoxifen Citrate in a mixture of the ethanol and glycol components, and then adding the water component and any other additives.

8. A process for the preparation of a solution according to claim 2, comprising the steps of first dispersing Tamoxifen Citrate in the glycol component and then adding the ethanol component and the water component.

9. A process for the preparation of a solution in accordance with claim 3, comprising dispersing Tamoxifen Citrate in the propylene glycol to form a dispersion, adding the dispersion to the glycerol, then adding the ethanol component thereto to form a solution, and then adding the water component.

10. A pharmaceutical preparation according to claim 2, wherein the water component (c) contains additive(s) selected from the group consisting of flavors, sweeteners, and coloring agents.

11. A process according to claim 9, wherein the water component contains additive(s) selected from the group consisting of flavors, sweeteners and coloring agents.
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