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% hydrophilic polymer, wherein all hydrophilic polymer in the oral solid dosage form consists of one or more of hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose (HPC), and polyethylene oxide (PEO); and
a container closure system comprising a high density polyethylene container and a sealing closure;
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.
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 2 , 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 , wherein all of the hydrophilic polymer in the oral solid dosage form consists of hydroxypropylcellulose.
6. The packaged immediate release oral solid dosage form product of claim 1 , wherein all of the hydrophilic polymer in the oral solid dosage form consists of polyethylene oxide.
7. The packaged immediate release oral solid dosage form of claim 1 , wherein the container is about 55 cm 3 to about 125 cm 3 .
8. The packaged immediate release oral solid dosage form product of claim 1 , provided that each oral solid dosage form 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.
9. The packaged immediate release oral solid dosage form product of claim 1 , wherein the oral solid dosage form further includes a lubricant.
10. The packaged immediate release oral solid dosage form product of claim 9 , wherein the lubricant is magnesium stearate.
11. 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,
about 0.1% to about 8% hydrophilic polymer, wherein all hydrophilic polymer in the oral solid dosage form consist of one or more of hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose (HPC), polyethylene oxide (PEO); and
a container closure system comprising a high density polyethylene container and a sealing closure;
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.
12. The packaged immediate release oral solid dosage form product of claim 11 , wherein the container is purged with an inert gas prior to sealing with the sealing closure.
13. The packaged immediate release oral solid dosage form product of claim 12 , wherein the inert gas comprises nitrogen.
14. The packaged immediate release oral solid dosage form product of claim 12 , wherein the container is induction sealed with the sealing closure after the container is purged with the inert gas.
15. The packaged immediate release oral solid dosage form product of claim 11 , wherein all of the hydrophilic polymer in the oral solid dosage form consists of hydroxypropylcellulose.
16. The packaged immediate release oral solid dosage form product of claim 11 , wherein all of the hydrophilic polymer in the oral solid dosage form consists of polyethylene oxide.
17. The packaged immediate release oral solid dosage form of claim 11 , wherein the container is about 225 cm 3 to about 360 cm 3 .
18. The packaged immediate release oral solid dosage form product of claim 11 , provided that each oral solid dosage form 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.
19. The packaged immediate release oral solid dosage form product of claim 11 , wherein the oral solid dosage form further includes a lubricant.
20. The packaged immediate release oral solid dosage form product of claim 19 , wherein the lubricant is magnesium stearate.