Therapeutic agents containing thyroid hormones

• US 5,753,254 A
• Filed: 07/31/1996
• Issued: 05/19/1998
• Est. Priority Date: 02/01/1994
• Status: Expired due to Term

• Current Assignee: Abbvie Deutschland GmbH & Company KG (Abbvie Incorporated)
• Original Assignee: Knoll AG (BASF SE)
• Inventors: Smith, Alan, Khan, Karrar Ahmad
• Primary Examiner(s): Levy, Neil S.
• Application Number:
  US08/682,783
• Time in Patent Office: 657 Days
• Field of Search: 424/400, 424/407, 424/439, 424/442, 424/484, 424/485, 424/488, 514/561, 574/5, 574/554, 574/561
• US Class Current: 424/439
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61P 5/02 of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin

Abstract

There is disclosed a solid fast dispersing dosage form of a pharmaceutical composition suitable for oral administration comprising: a therapeutic agent which comprises one or more compound thyroid hormone or hormones; from about 80% to about 99.9% of disintegrating agent by mass; from about 0.01% to about 10% of flavoring agent by mass; and from about 0.1% to about 5% mass of lubricating agent by mass; which has utility in the treatment of disorders associated with the improvement of the thyroid hormone function in animals including human beings.

Claims

1. A solid dispersing dosage form of a pharmaceutical composition for oral administration which disintegrates in the mouth, the dosage form comprising:

a therapeutic agent which comprises 0.1 μ

g to about 10,000 μ

g of one or more thyroid hormone or hormones;

an effective amount of from about 80% to about 99.9% of disintegrating agent by mass;

from about 0.01% to about 10% of flavoring agent by mass; and

from about 0.1% to about 5% of lubricating agent by mass.

2. A dosage form as claimed in claim 1;

in which the thyroid hormone comprises

L-3,5,3'"'"',5'"'"'-tetraiodothyronine;

L-3,5,3'"'"'-triiodothyronine;

L-3,3'"'"',5'"'"'-triiodothyronine;

L-3,5-diiodothyronine;

pharmaceutically acceptable salts thereof;

or any mixtures thereof.

3. A dosage form as in claim 1, in which the disintegrating agent comprises a blend of at least two components.

4. A dosage form as in claim 3, in which each component independently comprises an ingredient selected from pharmaceutically acceptable starch, modified starch, methyl cellulose, agar, bentonite, cellulose, microcrystalline cellulose, alginic acid, guar gum, carboxymethylcellulose and sodium lauryl sulphate.

5. A dosage form as in claim 1, in which composition comprises an ingredient or ingredients which induces the formation of saliva.

6. A method of treating disorders associated with an impairment of the thyroid hormone function in animals including human beings, which comprises the administration to a patient in need thereof a therapeutically effective amount of a solid oral dosage form which disintegrates in the mouth, said dosage form containing from about 0.1 μ

g to about 10,000 μ

g of one or more thyroid hormone or hormones;

an effective amount of from about 80% to about 99.9% of disintegrating agent by mass based on the mass of the dose;

from about 0.01% to about 10% of flavoring agent by mass based on the mass of the dose; and

from about 0.1% to about 5% of lubricating agent by mass based on the mass of the dose.

7. A method for the manufacture of a solid oral dosage form, comprising the steps of:

(a) forming a first mixture by blending in intimate admixture one or more disintegrant or disintegrants with a therapeutic agent comprising one or more thyroid hormone or hormones;

(b) forming a second mixture by blending in intimate admixture one or more disintegrant or disintegrants with a flavouring agent and a lubricating agent;

(c) combining the first and second mixtures to form a pharmaceutical composition; and

(d) compressing the composition from step (c) to form a fast dispersing solid oral dosage form.

8. A method of preparing a solid dispersing dosage form of a pharmaceutical composition for oral administration, the method comprising:

combining a therapeutic agent which comprises one or more thyroid hormones, and an effective amount of from about 80% to about 99.9% by mass of disintegrating agent based on the mass of the dose; and

from about 0.01% to about 10% by mass of flavoring agent based on the mass of the dose;

followed by from about 0.1% to about 5% by mass of lubricating agent based on the mass of the dose.

9. A method as in claim 8;

in which the thyroid hormone comprises

L-3,5,3'"'"',5'"'"'-tetraiodothyronine;

L-3,5,3'"'"'-triiodothyronine;

L-3,3'"'"',5'"'"'-triiodothyronine;

L-3,5-diiodothyronine;

pharmaceutically acceptable salts thereof;

or any mixtures thereof.

10. A method as in claim 8, in which the disintegrating agent comprises a blend of at least two components.

11. A method as in claim 10, in which each component independently comprises an ingredient selected from pharmaceutically acceptable starch, modified starch, methyl cellulose, agar, bentonite, cellulose, microcrystalline cellulose, alginic acid, guar gum, carboxymethylcellulose and sodium lauryl sulphate.

12. A method as in claim 8, in which an ingredient or ingredients which induces the formation of saliva is added to the composition.