COMPOSITIONS AND PHARMACEUTICAL FORMS FOR THE ORAL ADMINISTRATION OF THYROID HORMONES ABLE TO COMBAT THE ACTION OF SEQUESTRANTS IN THE GASTROINTESTINAL TRACT

• US 20100247637A1
• Filed: 04/23/2009
• Published: 09/30/2010
• Est. Priority Date: 03/24/2009
• Status: Abandoned Application

• Current Assignee: Altergon SA
• Original Assignee: Altergon SA
• Inventors: Mazzucchelli, Paoio, Riva, Marta, Zoppetti, Giorgio
• Application Number:
  US12/428,550
• Publication Number:
  US 20100247637A1
• Time in Patent Office: Days
• US Class Current: 424/456
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61K 9/4858 Organic compounds

Abstract

The invention concerns the use of a substance chosen among animal or vegetable gelatine, peptones, dextrins, native or modified cyclodextrins, starch, and starch hydrolysates in the preparation of pharmaceutical forms for the oral administration of thyroid hormones to combat the action of sequestrant agents present in the gastrointestinal tract, and related pharmaceutical forms.

Claims

1. Use of a substance chosen among animal or vegetable gelatine, peptones, dextrins, native or modified cyclodextrins, starch, and starch hydrolysates in the preparation of pharmaceutical forms for the oral administration of thyroid hormones to combat the action of sequestrant agents present in the gastrointestinal tract.

2. Use according to claim 1 where the said substance is gelatine, for the preparation of soft gelatine capsules.

3. Use according to claim 1 for the preparation of a liquid form in solution to be administered in drops.

4. Use according to claim 1 for the preparation of a liquid form in single-dose solution.

5. Pharmaceutical form for the oral administration of thyroid hormones to combat the action of sequestrant agents present in the gastrointestinal tract, characterised by containing a substance chosen from animal or vegetable gelatine, peptones, dextrins, native or modified cyclodextrins, starch, and starch hydrolysates.

6. Pharmaceutical form according to claim 5 characterised by being a soft gelatine capsule.

7. Pharmaceutical form according to claim 6 characterised by the fact that said soft gelatine capsule includes a shell obtained from a mix of gelatine, glycerine and water, and an inner phase, or fill, obtained from a mix of gelatine, glycerine, water and sodium levothyroxine (T4).

8. Pharmaceutical form according to claim 5 characterised by the fact of being a solution to be administered in drops.

9. Pharmaceutical form according to claim 5 characterised by the fact of being a single-dose solution.

10. Pharmaceutical form according to claim 5 characterised by the fact of being a glycerol-ethanol solution of sodium levothyroxine (T4) with the addition of gelatine.

11. Pharmaceutical form according to claim 5 characterised by the fact of being a glycerol-ethanol solution of sodium levothyroxine (T4) with the addition of starch hydrolysate.

12. Method of combatting the action of sequestrant agents present in the gastrointestinal tract of patients in need of thyroid hormones which would depress their bioavailability and therapeutic action, wherein the said thyroid hormones are prepared in pharmaceutical forms for oral administration to which a substance chosen among animal or vegetable gelatine, peptones, dextrins, native or modified cyclodextrins, starch, and starch hydrolysates is added.

13. Method according to claim 12 where the said substance is gelatine and a soft gelatine capsule is prepared.

14. Method according to claim 12 wherein a liquid form in solution to be administered in drops is prepared.

15. Method according to claim 12 wherein a liquid form in single-dose solution is prepared.