Package for a Pharmaceutical Product
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Abstract
The invention relates to a package for a pharmaceutical product, particularly a tube or a dropper bottle assembly used to dispense liquids, aerosols or strings, and a method of sterilizing said package,
50 Citations
21 Claims
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1-14. -14. (canceled)
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15. A method for sterilizing a closed squeezable pharmaceutical package wherein the package is selected from the group consisting of a tube comprising a laminated polypropylene foil with a cap and a polypropylene bottle with a cap, the bottle comprising a nozzle tip, wherein the cap consists of a material with a modulus of elasticity different from the tube or bottle, and wherein the pharmaceutical package is suitable for the controlled dispensation of an ophthalmic liquid, ophthalmic gel, or ophthalmic ointment, the method comprising the steps of:
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disposing an amount of a member selected from the group consisting of an ophthalmic liquid, gel, or ointment within the package;
closing the package to yield a closed package;
placing the closed package into an autoclaving chamber; and
increasing temperature and pressure in the chamber until the temperature in the chamber reaches at least 121°
C.;
thereby avoiding deformation of the package and avoiding the formation of a seal between the nozzle tip and the cap. - View Dependent Claims (16, 18)
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19. A method for sterilizing a closed, squeezable pharmaceutical package wherein the package comprises a polypropylene bottle with a cap, the bottle comprising a nozzle tip, wherein the cap consists of a material with a modulus of elasticity different from the bottle, and wherein the pharmaceutical package is suitable for the controlled dispensation of an ophthalmic liquid and an ophthalmic gel, the method comprising the steps of:
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disposing an amount of a member selected from the group consisting of an ophthalmic liquid and an ophthalmic gel within the package;
closing the package with the cap to yield a closed package;
placing the closed package into an autoclaving chamber; and
increasing temperature and pressure in the chamber until the temperature in the chamber reaches at least 121°
C.;
thereby avoiding deformation of the package and avoiding the formation of a seal between the nozzle tip and the cap.
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- 20. The method of claim 20, wherein the polypropylene bottle has a wall thickness in the range of 0.3 mm to 0.6 mm.
Specification