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Claims for Patent: 6,399,101

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Claims for Patent: 6,399,101

Title: Stable thyroid hormone preparations and method of making same
Abstract:Provided is a pharmaceutical preparation of thyroid hormone and a process of making a tablet formulation of the pharmaceutical preparation using direct compression. In a preferred embodiment, the pharmaceutical preparation comprises levothyroxine sodium and silicified microcrystalline cellulose.
Inventor(s): Frontanes; Ramon A. (Caguas, PR), Bruno; Maria S. (Guaynabo, PR), Garcia; Hector L. (Cidra, PR), Simamora; Pahala (Cardova, TN), Perez; Maria A. (Aguas Buenas, PR)
Assignee: Mova Pharmaceutical Corp. (Caguas, PR)
Application Number:09/538,461
Patent Claims: 1. A stabilized pharmaceutical preparation comprising a therapeutically effective amount of levothyroxine sodium and silicified microcrystalline cellulose.

2. The preparation of claim 1, further comprising a disintegrant and a lubricant.

3. The preparation of claim 2, wherein the disintegrant is sodium starch glycolate.

4. The preparation of claim 2, wherein the lubricant is magnesium stearate.

5. A stabilized pharmaceutical preparation comprising a stabilizing matrix consisting essentially of silicified microcrystalline cellulose and a therapeutically effective amount of levothyroxine sodium particles, which particles are captured and protected within the stabilizing matrix.

6. The preparation of claim 5, further comprising a disintegrant, a lubricant and a coloring agent.

7. The preparation of claim 6, wherein the disintegrant is sodium starch glycolate, pregelatinized starch or cellulose.

8. The preparation of claim 6, wherein the lubricant is magnesium stearate, calcium stearate, talc or stearic acid.

9. The preparation of claim 6, wherein the disintegrant is sodium starch glycolate and the lubricant is magnesium stearate.

10. The preparation of claim 1, wherein the stabilized pharmaceutical preparation is in the form of a tablet.

11. A stabilized pharmaceutical preparation comprising a therapeutically effective amount of a thyroid hormone and silicified microcrystalline cellulose.

12. A method for the manufacture of a pharmaceutical tablet preparation comprising the steps of:

(a) forming an active blend by blending in intimate admixture silicified microcrystalline cellulose and a therapeutic agent comprising one or more thyroid hormone or hormones;

(b) forming a color blend by blending in intimate admixture one or more pharmaceutically acceptable dyes and silicified microcrystalline cellulose;

(c) combining the active blend, the color blend and a disintegrate in a preblend;

(d) adding a lubricant to the preblend to form a final blend; and

(e) compressing the final blend to form a stabilized pharmaceutical tablet preparation.

13. The method of claim 12, wherein the thyroid hormone is levothyroxine sodium.

14. The method of claim 13, wherein the disintegrant is sodium starch glycolate.

15. The method of claim 13, wherein the lubricant is magnesium stearate.
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