Thyroid hormone oral dosage forms and methods of using the same
Thyroid hormone oral dosage forms and methods of making and using the thyroid hormone oral dosage forms are disclosed.
1. A packaged immediate release oral solid dosage form product comprising:
an immediate release oral solid dosage form including, by weight,
about 0.01% to 1% levothyroxine salt and
about 0.1% to about 8% HPMC; and
a container closure system comprising a container of about 225 cm 3 to about 360 cm 3 and a sealing closure;
provided that the container comprises high density polyethylene;
provided that about 900 to about 1000 of the oral solid dosage forms and at least about 16 grams of desiccant are enclosed in the container and sealed with the sealing closure; and
provided that each oral solid dosage form enclosed in the container retains at least 95% of an initial amount of the levothyroxine salt when stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80% for three months.
2. The packaged immediate release oral solid dosage form product of claim 1 , wherein the container is purged with an inert gas prior to sealing with the sealing closure.
3. The packaged immediate release oral solid dosage form product of claim 2 , wherein the inert gas comprises nitrogen.
4. The packaged immediate release oral solid dosage form product of claim 3 , wherein the container is induction sealed with the sealing closure after the container is purged with the inert gas.
5. The packaged immediate release oral solid dosage form product of claim 1 , provided that each oral solid dosage form enclosed in the container retains at least 97% of an initial amount of the levothyroxine salt when stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80% for three months.
6. The packaged immediate release oral solid dosage form product of claim 1 , provided that about 900 to about 1000 of the oral solid dosage forms and at least about 18 grams of desiccant are enclosed in the container and sealed with the sealing closure.
7. The packaged immediate release oral solid dosage form product of claim 6 , provided that each oral solid dosage form enclosed in the container retains at least 97% of an initial amount of the levothyroxine salt when stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80% for three months.
8. The packaged immediate release oral solid dosage form product of claim 7 , provided that each oral solid dosage form enclosed in the container contains less than 1% total impurities after the oral solid dosage forms enclosed in the container have been stored at the temperature ranging from about 38° C. to about 42° C. and the relative humidity ranging from about 70% to about 80% for the three months.
9. A packaged immediate release oral solid dosage form product comprising:
an immediate release oral solid dosage form including, by weight,
about 0.01% to 1% levothyroxine salt and
about 0.1% to about 8% HPMC; and
a container closure system comprising a container of about 55 cm 3 to about 125 cm 3 and a sealing closure;
provided that the container comprises high density polyethylene;
provided that about 90 to about 100 of the oral solid dosage forms and at least about 6 grams of desiccant are enclosed in the container and sealed with the sealing closure; and
provided that each oral solid dosage form enclosed in the container retains at least 95% of an initial amount of the levothyroxine salt when stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80% for three months.
10. The packaged immediate release oral solid dosage form product of claim 9 , wherein the container is purged with an inert gas prior to sealing with the sealing closure.
11. The packaged immediate release oral solid dosage form product of claim 10 , wherein the inert gas comprises nitrogen.
12. The packaged immediate release oral solid dosage form product of claim 11 , wherein the container is induction sealed with the sealing closure after the container is purged with the inert gas.
13. A packaged immediate release oral solid dosage form product comprising:
an immediate release oral solid dosage form including, by weight,
about 0.01% to 1% levothyroxine salt and
about 0.1% to about 8% HPMC; and
a container closure system comprising a container of about 55 cm 3 to about 125 cm 3 and a sealing closure;
provided that the container comprises high density polyethylene;
provided that about 90 to about 100 of the oral solid dosage forms and at least about 6 grams of desiccant are enclosed in the container and sealed with the sealing closure; and
provided that each oral solid dosage form enclosed in the container retains at least 95% of an initial amount of the levothyroxine salt when stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80% for three months.
14. The packaged immediate release oral solid dosage form product of claim 13 , wherein the container is purged with an inert gas prior to sealing with the sealing closure.
15. The packaged immediate release oral solid dosage form product of claim 14 , wherein the inert gas comprises nitrogen.
16. The packaged immediate release oral solid dosage form product of claim 15 , wherein the container is induction sealed with the sealing closure after the container is purged with the inert gas.
17. The packaged immediate release oral solid dosage form product of claim 13 , provided that each oral solid dosage form enclosed in the container contains less than 1% total impurities after the oral solid dosage forms enclosed in the container have been stored at the temperature ranging from about 38° C. to about 42° C. and the relative humidity ranging from about 70% to about 80% for the three months.
18. The packaged immediate release oral solid dosage form product of claim 13 , provided that each oral solid dosage form enclosed in the container retains at least 95% of an initial amount of the levothyroxine salt when stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80% for four months.
19. The packaged immediate release oral solid dosage form product of claim 14 , provided that each oral solid dosage form enclosed in the container retains at least 97% of an initial amount of the levothyroxine salt when stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80% for four months.
20. The packaged immediate release oral solid dosage form product of claim 19 , provided that each oral solid dosage form enclosed in the container contains less than 1% total impurities after the oral solid dosage forms enclosed in the container have been stored at the temperature ranging from about 38° C. to about 42° C. and the relative humidity ranging from about 70% to about 80% for the four months.