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. |
