Claims for Patent: 11,241,382

Summary for Patent: 11,241,382

Title:	Administration regimen of compositions of T4 thyroid hormone with high oral absorption
Abstract:	New administration regimens of the T4 thyroid hormone are described, characterized by the use of alcohol-free, water-glycerol solutions of said hormone, administered at short temporal distance, i.e. within less than 30 minutes, typically between 15 and less than 30 minutes, from the closest consumed meal.
Inventor(s):	Fossati Tiziano, Mautone Giuseppe, Scarsi Claudia
Assignee:	ALTERGON SA
Application Number:	US16421373
Patent Claims:	1. A method of treating a disease associated with deficiency of one or more thyroid hormones in a patient in need thereof , comprising:administering an effective amount of an oral solution pharmaceutical composition comprising T4 thyroid hormone in an alcohol-free, water-glycerol solution,wherein said composition is administered within a temporal distance of less than 30 minutes from the closest meal consumed by the patient.2. The method of claim 1 , wherein said composition is administered at a temporal distance between 15 minutes and less than 30 minutes from said meal.3. The method of claim 2 , wherein said composition is administered at a temporal distance between 15 minutes and less than 30 minutes before said meal.4. The method of claim 3 , wherein said meal is breakfast.5. The method of claim 3 , wherein said meal provides fewer than 750 calories.6. The method of claim 3 , wherein said water-glycerol solution has a w/w concentration of glycerol in water between 40 and 99%.7. The method of claim 3 , wherein said water-glycerol solution is in the form of a dosage unit claim 3 , comprising 5 to 1000 μg T4 thyroid hormone.8. The method of claim 3 , wherein said water-glycerol solution is in the form of a dosage unit claim 3 , comprising 10 to 500 μg T4 thyroid hormone.9. The method of claim 3 , wherein said T4 thyroid hormone is contained in an amount by weight between 2 and 2500 ppm with respect to glycerol.10. The method of claim 3 , wherein said composition is free from stabilizing agents.11. The method of claim 1 , wherein said composition is administered at a temporal distance between 15 minutes and less than 30 minutes before said meal.12. The method of claim 11 , wherein said meal is breakfast.13. The method of claim 1 , wherein said meal provides fewer than 750 calories.14. The method of claim 1 , wherein said water-glycerol solution has a w/w concentration of glycerol in water between 40 and 99%.15. The method of claim 1 , wherein said water-glycerol solution is in the form of a dosage unit claim 1 , comprising 5 to 1000 μg T4 thyroid hormone.16. The method of claim 1 , wherein said water-glycerol solution is in the form of a dosage unit claim 1 , comprising 10 to 500 μg T4 thyroid hormone.17. The method of claim 1 , wherein said T4 thyroid hormone is contained in an amount by weight between 2 and 2500 ppm with respect to glycerol.18. The method of claim 1 , wherein said composition is free from stabilizing agents.19. The method of claim 1 , wherein the oral solution pharmaceutical composition consists essentially of T4 thyroid hormone in an alcohol-free solution of water and glycerol claim 1 , and optionally T3 thyroid hormone.20. The method of claim 1 , wherein the oral solution pharmaceutical composition is administered from a single dose container.