Thyroid hormone oral dosage forms and methods of using the same
View Patent ↗Novel 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 0.1% to 1% levothyroxine salt;
about 0.1% to about 8% HPMC; and
about 0.01% to about 5% BHA; and
a container closure system comprising a container of about 55 cm 3 to about 125 cm 3 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 23° C. to about 27° C. and a relative humidity ranging from about 55% to about 65% for six 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 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 when the about 90 to about 100 oral solid dosage forms and the at least about 6 grams of desiccant are placed in the container of about 55 cm 3 to about 125 cm 3 sealed with the sealing closure, 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 up to about three months.
6. A packaged immediate release oral solid dosage form product comprising:
an immediate release oral solid dosage form including, by weight,
about 0.1% to 1% levothyroxine salt;
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 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 23° C. to about 27° C. and a relative humidity ranging from about 55% to about 65% for six months.
7. The packaged immediate release oral solid dosage form product of claim 6 , wherein the container is purged with an inert gas prior to sealing with the sealing closure.
8. The packaged immediate release oral solid dosage form product of claim 7 , wherein the inert gas comprises nitrogen.