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US 10,537,538 B2Granted
High-stability packaged solutions of T4 thyroid hormone
AssigneeAltergon S.A.
InventorsTiziano Fossati, Lorenzo Bellorini, Marco Pizzutti
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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.
Claims8
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.
Dependencies are inferred from the claim text.