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Claims for Patent: 7,723,390

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Claims for Patent: 7,723,390

Title:Pharmaceutical formulations for thyroid hormones
Abstract:The present invention provides for pharmaceutical formulations based on thyroid hormones enabling a safe and stable oral administration in the framework of the strict therapeutic index prescribed in case of thyroid disorders.
Inventor(s): Garavani; Alberto (Ponte Capriasca, CH), Marchiorri; Maurizio (Valbrona, IT), Di Martino; Alessandro (Milan, IT), Mateo Echanagorria; Angel (Milan, IT)
Assignee: Altergon S.A. (Lugano, CH)
Application Number:10/188,467
Patent Claims: 1. A pharmaceutical composition comprising thyroid hormones or their sodium salts in the form of either: a) a soft elastic capsule consisting of a shell of gelatin material containing a liquid or half-liquid inner phase comprising said thyroid hormones or their salts in a range between 0.001 and 1% by weight of said inner phase, dissolved in gelatin and/or glycerol, and optionally ethanol, said liquid or half-liquid inner phase being in direct contact with said shell without any interposed layers, or b) a swallowable uniform soft-gel matrix comprising glycerol and said thyroid hormones or their salts in a range between 0.001 and 1% by weight of said matrix.

2. The composition according to claim 1, wherein said thyroid hormones are selected from the group consisting of T3, T4 and their sodium salts.

3. The composition according to claim 1, wherein said swallowable uniform soft-gel matrix further comprises gelatin of A type or B type.

4. The composition according to claim 1, wherein said liquid or half-liquid inner phase of said soft elastic capsules comprises a vehicle consisting of ethanol, glycerol or mixtures thereof.

5. The composition according to claim 1, wherein said swallowable uniform soft gel matrix comprises a glycerol/ethanol mixture.

6. The pharmaceutical composition according to claim 1, having an enteric coating enabling the release of thyroid hormones in the small intestine.

7. The pharmaceutical composition according to claim 1, having an outer coating which simplifies ingestion.

8. The pharmaceutical composition according to claim 1, wherein the material of the capsule contents or the swallowable uniform soft-gel matrix includes a plasticizer to control its hardness.

9. The pharmaceutical composition according to claim 8, wherein said plasticizer is selected from the group consisting of glycerol, 1,2-propylene glycol, a solution of sorbitol/sorbitanes and combinations thereof.

10. A pharmaceutical composition according to claim 1, wherein said liquid or half-liquid inner phase comprises gelatin, glycerol and ethanol.
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