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Thyroid hormone oral dosage forms and methods of using the same

  • US 10,231,931 B1
  • Filed: 03/23/2018
  • Issued: 03/19/2019
  • Est. Priority Date: 03/23/2018
  • Status: Active Grant
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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