Sealed single-dose container of levothyroxine aqueous solution suitable for oral administration

Abstract

The present invention relates to blow-fill-seal (BFS) sealed single-dose containers comprising a pharmaceutical composition of an aqueous solution for use in oral administration, which composition comprises levothyroxine or liothyronine or a pharmaceutically acceptable salt thereof, preferably levothyroxine sodium, water and one or more co-solvents and is alcohol-free, exhibits a pH from 8,1 to 8,7, an average density from 1,18 to 1,23 grams per milliliter (g / ml), and viscosity from 20 to 60 cps.

Description

Abstract This invention relates to a blow-fill-seal (BFS) sealed single-dose container comprising a pharmaceutical composition containing an aqueous solution for oral administration, said composition comprising levothyroxine or iodine or a pharmaceutically acceptable salt thereof, water and one or more cosolvents and being alcohol-free, exhibiting a pH of 8.1 to 8.7, an average density of 1.18 to 1.23 g / mL and a viscosity of 20 to 60 cps, wherein the pharmaceutically acceptable salt is preferably levothyroxine sodium.

Claims

Claims1. Blow-fill-seal (BFS) sealed single-dose container comprising a pharmaceutical composition of an aqueous solution for use in oral administration, which composition comprises levothyroxine or liothyronine or a pharmaceutically acceptable salt thereof, preferably levothyroxine sodium, water and one or more co-solvents and is alcohol- free, exhibits a pH from 8,1 to 8,7, an average density from 1,18 to 1,23 grams per milliliter (g / mL), and viscosity from 20 to 60 cps.

2. Sealed single-dose container according to claim 1, wherein the concentration of levothyroxine or liothyronine or salts thereof ranges from 0,0005% to 0,2% weight by volume (w / v) of the final solution.

3. Sealed single-dose container according to any of the claims 1 to 2, which is made of low-density polyethylene and placed in aluminum sachets.

4. Sealed single-dose container according to any of the claims 1 to 3, wherein the co-solvents are preferably selected from polyols, such as alkanetriols, alkanediols and polyethylene glycol, acetone, benzyl benzoate, phthalates, such as dibutyl phthalate, diethyl phthalate, dimethyl phthalate, dimethyl sulfoxide, dimethylacetamide, glycofurol, isopropyl myristate, isopropyl palmitate, propylene carbonate, pyrrolidine, glycerin triacetate, triethyl citrate, trilein, or a combination of two or more thereof, preferably the co-solvent comprises glycerin and more preferably the co-solvent is only glycerin.

5. Sealed single-dose container according to any of the claims 1 to 4, wherein the percentage of glycerin in the composition ranges from 85% to 95% weight by volume (w / v) of the total amount of the solution.

6. Sealed single-dose container according to any of the claims 1 to 5, wherein the composition is free of preservatives, for example methyl p-hydroxybenzoate and / orpropyl p-hydroxybenzoate, and / or antioxidants, for example ethylenediaminetetraacetic acid.

7. Sealed single-dose container according to any of the claims 1 to 6, wherein the composition comprises pH buffers, which pH buffers are preferably selected from metal hydroxides and / or citric acid and / or salts thereof.

8. Sealed single-dose container according to any of the claims 1 to 7, wherein the composition comprises a pharmaceutically acceptable flavoring agent preferably selected from strawberry, banana, apricot, cherry, orange, lemon, caramel and / or coffee.

9. Sealed single-dose container according to any of the claims 1 to 8, for use in the management, treatment or prevention of hypothyroidism in neonatal, pediatric, adult and geriatric patients, of goitre, of nodular thyroid disease, of thyroid cancer, of subclinical hypothyroidism and of myxoedematous coma.