Thyroid hormone oral dosage forms and methods of using the same

• US 10,406,108 B1
• Filed: 01/25/2019
• Issued: 09/10/2019
• Est. Priority Date: 03/23/2018
• Status: Active Grant

• Current Assignee: Genus Lifesciences, Inc. (Vyteris, Inc.)
• Original Assignee: Genus Lifesciences, Inc. (Vyteris, Inc.)
• Inventors: Phadke, Shivaji, Parikh, Vaishnavi
• Primary Examiner(s): Tran, Susan T
• Assistant Examiner(s): Craigo, William
• Application Number:
  US16/257,755
• Time in Patent Office: 228 Days
• Field of Search: None
• CPC Class Codes: A61J 1/00 Containers specially adapted for medical or pharmaceutical purposes capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00

Abstract

Novel thyroid hormone oral dosage forms and methods of making and using the thyroid hormone oral dosage forms are disclosed.

Claims

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 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.

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 when the about 900 to about 1000 oral solid dosage forms and the at least about 6 grams of desiccant are placed in the container of about 225 cm³ to about 360 cm³ 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 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 and

about 0.1% to about 8% HPMC; 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.

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.

9. The packaged immediate release oral solid dosage form product of claim 8, wherein the container is induction sealed with the sealing closure after the container is purged with the inert gas.

10. The packaged immediate release oral solid dosage form product of claim 6, 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 cm³ to about 125 cm³ 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 three months.

11. The packaged immediate release oral solid dosage form product of claim 6, wherein the immediate release oral solid dosage form further comprises a lubricant.