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.
Claims21
A pharmaceutical preparation of T4 thyroid hormone, in ready-to-use packaging, consisting of a container pre-filled with an alcohol-free water-glycerol solution of hormone T4, said container being selected from:
- (a) 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, aluminium, polyethylene terephthalate, ionomer resins, paper, ethylene vinyl alcohol, copolymer resins, propylene, and fluorinated-chlorinated resins;
- or
- (b) a multi-component laminated plastic container, said container comprising multiple layers of plastic materials selected from:
- polyethylene, ethylene vinyl alcohol copolymer resins, polyvinyl chloride, polyvinylidene chloride;
- polyvinyl acetate, fluorinated-chlorinated resins, ionomer resins, cyclic olefin copolymers, polyamide, polystyrene, polycarbonate, laminated metals and aluminium bonded to plastics.
A pharmaceutical preparation comprising:
- (a) a composition of an alcohol-free water/glycerol solution of T4 thyroid hormone;
- (b) a single-dose container for containing the solution;
- whereby less than 2.5% of the T4 thyroid hormone in the solution converts to T3 thyroid hormone after 12 months under Long Term Storage Conditions.
A pharmaceutical composition comprising an alcohol-free water/glycerol solution of T4 thyroid hormone that is capable of storage in a single-dose container whereby the pharmaceutical composition demonstrates less the 2.5% conversion of T4 thyroid hormone to T3 thyroid hormone for 12 months under Long Term Storage Conditions.
A ready-to-use pharmaceutical preparation of T4 thyroid hormone packaged in a container which is pre-filled with an alcohol-free water-glycerol solution of hormone T4, said. container being selected from:
- (a) a one-component LDPE plastic container, placed in a sealed sachet consisting of laminated films made of a plurality of materials selected from the following:
- polyethylene, aluminium, polyethylene terephthalate, ionomer resins, paper, ethylene vinyl alcohol, copolymer resins, propylene, and fluorinated-chlorinated resins;
- or
- (b) a multi-component laminated plastic container comprising a plurality of layers of plastic materials selected from the group consisting of:
- polyethylene, ethylene vinyl alcohol copolymer resins, polyvinyl chloride, polyvinylidene chloride, polyvinyl acetate, fluorinated-chlorinated resins, ionomer resins, cyclic olefin copolymers, polyamide, polystyrene, polycarbonate, laminated metals, aluminium bonded to plastics, and combinations thereof.
A ready-to-use package of a pharmaceutical preparation of T4 thyroid hormone, the package comprising a container which is pre-filled with an alcohol-free water-glycerol solution of hormone T4, wherein the container is selected from:
- (a) a one-component LDPE plastic container, placed in a sealed sachet formed from laminated films comprising a plurality of materials selected from the following:
- polyethylene, aluminium, polyethylene terephthalate, ionomer resins, paper, ethylene vinyl alcohol, copolymer resins, propylene, and fluorinated-chlorinated resins;
- or
- (b) a multi-component laminated plastic container comprising a plurality of layers of plastic materials selected from the group consisting of:
- polyethylene, ethylene vinyl alcohol copolymer resins, polyvinyl chloride, polyvinylidene chloride, polyvinyl acetate, fluorinated-chlorinated resins, ionomer resins, cyclic olefin copolymers, polyamide, polystyrene, polycarbonate, laminated metals, aluminium bonded to plastics, and combinations thereof.
Dependencies are inferred from the claim text.