Pharmaceutical formulations for thyroid hormones
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.
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.