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Publication Number
US-12128177-B2
Publication Date
2024-10-29
Expiration Date
Abstract
A blister packaging for a pharmaceutical cartridge or capsule and methods of forming same are disclosed.
Core Innovation
The disclosed invention provides a method of manufacturing a high moisture barrier blister package for a cartridge containing a pharmaceutical formulation comprising a diketopiperazine. A blister is created in an ACLAR base sheet using heat, pressure, and a plug, and each blister includes a dome structure and a shelf having an exterior surface configured to hold the cartridge having a cup and a lid, wherein the shelf includes an indentation in the exterior surface.
The method requires that the Water Vapor Transmission Rate of the blister is less than 0.015 grams H2O per blister per day. The package is configured to hold a cartridge in the blister shelf structure, and the blister geometry includes a dome and a shelf with an indentation. The sealing and segmentation features are described as part of achieving the high moisture barrier behavior for the blister package.
The disclosed invention also includes manufacturing a high moisture barrier blister package in which a film is bonded to a blistered ACLAR base sheet, with cavities molded on a base sheet comprising at least three layers selected from polyvinyl chloride and fluoropolymer. The cartridge comprises a container and a top and is in the cavities when the film is bonded to the blistered base sheet, and the blistered base sheet is perforated to segment the cavities from one another.
Claims Coverage
Two independent claims are identified. Each independent claim focuses on manufacturing a high moisture barrier blister package with a Water Vapor Transmission Rate below 0.015 grams H2O per blister per day, while defining blistered ACLAR base sheet structures and specified packaging steps for cartridges containing diketopiperazine formulations.
High moisture barrier blister package manufacturing in ACLAR with dome and shelf indentation
creating a blister in an ACLAR base sheet using heat, pressure, and a plug, wherein each blister includes a dome structure and a shelf having an exterior surface configured to hold the cartridge having a cup and a lid, wherein the shelf includes an indentation in the exterior surface; and wherein the Water Vapor Transmission Rate of the blister is less than 0.015 grams H2O per blister per day
Bonding film to blistered ACLAR base sheet with molded multilayer cavities segmented by perforations
bonding a film to a blistered ACLAR base sheet, wherein cavities are molded on a base sheet comprising at least three layers selected from polyvinyl chloride and fluoropolymer; wherein the cartridge comprises a container and a top and is in the cavities when the film is bonded to the blistered base sheet; and wherein the blistered base sheet is perforated to segment the cavities from one another; and further wherein the Water Vapor Transmission Rate of the blister is less than 0.015 grams H2O per blister per day
Across the independent claims, the core coverage is the manufacturing of high moisture barrier blister packages using blistered ACLAR base sheets with specified blister and cavity structures and a Water Vapor Transmission Rate less than 0.015 grams H2O per blister per day.
Stated Advantages
High moisture barrier characterized by Water Vapor Transmission Rate of the blister being less than 0.015 grams H2O per blister per day.
Documented Applications
Not explicitly described in patent.
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