Liothyronine sodium and levothyroxine sodium combination
First Claim
1. A solid solution of levothyroxine sodium and liothyronine sodium wherein molecules of liothyronine sodium are contained within the crystal lattice of levothyroxine sodium crystals.
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Abstract
Novel formulations useful for thyroid hormone replacement and suppression therapy are described herein. While dosage formulations containing iodinated thyronines, levothyroxine sodium (T4) or liothyronine sodium (T3), as the active pharmaceutical ingredient (API) dispersed in a polymeric solid are known, manufacturing such formulations with acceptable dose content uniformity is difficult due to the high biological activity of T4 and T3. Described herein is the preparation of a single API formulation containing both T4 and T3 in a pharmaceutically effective ratio, wherein the dose content uniformity is the same for T3 as for T4 even if the T3 dose is extremely low. The present invention provides a method for the preparation of an API wherein T3 is uniformly distributed within the crystal lattice of T4 to form a solid solution by cooling suitable solutions of levothyroxine sodium and liothyronine sodium, a pharmaceutical composition containing such an API, and a method to use such an API in the treatment of thyroactive disorders.
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20 Claims
- 1. A solid solution of levothyroxine sodium and liothyronine sodium wherein molecules of liothyronine sodium are contained within the crystal lattice of levothyroxine sodium crystals.
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10. A process for the preparation of a solid solution of levothyroxine sodium and liothyronine sodium wherein molecules of liothyronine sodium are contained within the crystal lattice structure of levothyroxine sodium which comprises
d. dissolving a mixture of levothyroxine and liothyronine in a solvent mixture of water, an alcohol and sodium carbonate at a temperature between about room temperature and 100° - C.;
e. cooling the mixture; and
f. obtaining the resulting product. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
- C.;
Specification