Claims for Patent: 10,537,538

Summary for Patent: 10,537,538

Title:	High-stability packaged solutions of T4 thyroid hormone
Abstract:	The invention relates to highly stable alcohol-free, water-glycerol solutions of T4 thyroid hormone, with a reduced amount of T3 impurity, packaged via specific container arrangements. The containers are multi-barrier ones, in which a number of layers of specific materials separate the solution from contact with the external environment.
Inventor(s):	Fossati; Tiziano (Moltrasio, IT), Bellorini; Lorenzo (Comerio, IT), Pizzutti; Marco (Sorengo, CH)
Assignee:	Altergon SA (Lugano, CH)
Application Number:	15/445,900
Patent Claims:	1. A ready-to-use pharmaceutical preparation of T4 thyroid hormone packaged in a single dose container which is pre-filled with a liquid pharmaceutical composition consisting essentially of: T4 thyroid hormone dissolved in an alcohol-free solution of 85% glycerol in water, and optionally T3 thyroid hormone in an amount of less than 2.5%, wherein the single dose container is a one-component LDPE plastic container, placed in a sealed sachet consisting of laminated films made of a plurality of different materials selected from the following: polyethylene, aluminum, polyethylene terephthalate, ionomer resins, paper, ethylene vinyl alcohol, copolymer resins, propylene, and fluorinated-chlorinated resins. 2. The pharmaceutical preparation of claim 1, wherein the composition is capable of storage in the single-dose container whereby the composition demonstrates less than 2.5% conversion of T4 hormone to T3 thyroid hormone for 12 months at 25.degree. C..+-.2.degree. C. and 60%.+-.5% relative humidity. 3. The pharmaceutical preparation of claim 2, wherein the composition is capable of storage in the single-dose container whereby the composition demonstrates less than 1.5% conversion of T4 hormone to T3 thyroid hormone after 12 months at 25.degree. C..+-.2.degree. C. and 60%.+-.5% relative humidity. 4. The pharmaceutical preparation of claim 1, wherein the composition is capable of storage in the single-dose container whereby the composition demonstrates less than or equal to 2.4% conversion of T4 hormone to T3 thyroid hormone after 12 months at 30.degree. C..+-.2.degree. C. and 65%.+-.5% relative humidity. 5. The pharmaceutical preparation of claim 1, wherein the composition is capable of storage in the single-dose container whereby the composition demonstrates less than 1.2% conversion of T4 hormone to T3 thyroid hormone after 6 months at 25.degree. C..+-.2.degree. C. and 60%.+-.5% relative humidity. 6. The pharmaceutical preparation of claim 1, wherein the composition is capable of storage in a single-dose container whereby the composition demonstrates less than 2.0% conversion of T4 hormone to T3 thyroid hormone after 6 months at 30.degree. C..+-.2.degree. C. and 65%.+-.5% relative humidity. 7. The pharmaceutical preparation of claim 1, wherein the T4 thyroid hormone to glycerol weight ratio in the alcohol-free solution is in the range from about 4 to about 400 ppm. 8. The pharmaceutical preparation of claim 1, wherein a single dose unit is 5 to 250 .mu.g of T4 thyroid hormone.