Thyroid hormone oral dosage forms and methods of using the same
First Claim
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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 cm3 to about 125 cm3 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.
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Abstract
Novel thyroid hormone oral dosage forms and methods of making and using the thyroid hormone oral dosage forms are disclosed.
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Citations
8 Claims
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1. A packaged immediate release oral solid dosage form product comprising:
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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 cm3 to about 125 cm3 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. - View Dependent Claims (2, 3, 4, 5)
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6. A packaged immediate release oral solid dosage form product comprising:
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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 cm3 to about 360 cm3 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. - View Dependent Claims (7, 8)
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Specification