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Last Updated: May 4, 2024

Claims for Patent: 11,096,913


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Summary for Patent: 11,096,913
Title:High-stability packaged solutions of T4 thyroid hormone
Abstract: The invention relates to highly stable alcohol-free, water-glycerol solutions of T4 thyroid hormone, with a reduced amount of T3 impurity, packaged via specific container arrangements. The containers are multi-barrier ones, in which a number of layers of specific materials separate the solution from contact with the external environment.
Inventor(s): Fossati; Tiziano (Moltrasio, IT), Bellorini; Lorenzo (Comerio, IT), Pizzutti; Marco (Sorengo, CH)
Assignee: ALTERGON SA (Lugano, CH)
Application Number:16/697,924
Patent Claims: 1. A pharmaceutical preparation of T4 thyroid hormone comprising a container pre-filled with a liquid pharmaceutical composition consisting essentially of: T4 thyroid hormone dissolved in an alcohol-free and preservative-free solution of 85% glycerol in water, and optionally T3 thyroid hormone in an amount of less than 2.5%; wherein the container is a single dose plastic container.

2. The pharmaceutical preparation of claim 1, wherein the liquid pharmaceutical composition contains optionally T3 thyroid hormone in an amount of less than 2.0%.

3. The pharmaceutical preparation of claim 2, wherein the liquid pharmaceutical composition contains optionally T3 thyroid hormone in an amount of less than 1.8%.

4. The pharmaceutical preparation of claim 1, wherein the T4 thyroid hormone to glycerol weight ratio in the alcohol-free solution is in the range from about 4 to about 400 ppm.

5. The pharmaceutical preparation of claim 1, wherein a single dose unit is 5 to 350 .mu.g of T4 thyroid hormone.

6. The pharmaceutical preparation of claim 5, wherein a single dose unit is 5 to 250 .mu.g of T4 thyroid hormone.

7. The pharmaceutical preparation of claim 1, wherein the plastic container has a thickness of between about 150 and about 1000 .mu.m.

8. The pharmaceutical preparation of claim 7, wherein the plastic container has a thickness of between about 200 and about 800 .mu.m.

9. The pharmaceutical preparation of claim 1, wherein the plastic container is made of one-component LDPE plastic.

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