A packaged, sealed container system for stable storage of a formulation of an oxygen-sensitive pharmaceutical compound, the packaged, sealed container system comprising a primary container including therein a formulation of an oxygen-sensitive pharmaceutical compound, a secondary outer container comprising a first flexible sheet layer, an opposing second flexible sheet layer, and a seal disposed along a common peripheral edge of the first and second flexible sheet layers, such that the primary container is disposed between and enclosed by the first and second flexible sheet layers of the secondary outer container. An oxygen scavenger is also disposed between and enclosed by the first and second flexible sheet layers of the secondary outer container. The oxygen scavenger is in fluid communication with the contents of the primary container.

The present disclosure is directed to compositions and film structures suitable for heat seal production. The heat sealable flexible film structure includes: a layer (A) comprising a propylene-based plastomer or elastomer (PBPE) and a low density polyethylene; a layer (B), adjacent to layer (A), comprising at least 50 percent by weight of the layer (B) of an ethylene-based polymer; and an outermost layer (C) comprising a material having a melting point greater than 140 C. Weight percents are based on the total weight of the respective layer. The heat sealable flexible film structure is used to make a flexible container (10) having one or more heat seals (12). The heat seal (12) can be a frangible heat seal, a hard heat seal, or a combination thereof.

The present disclosure is directed to compositions and film structures suitable for heat seal production. The heat sealable flexible film structure includes: a layer (A) comprising a propylene-based plastomer or elastomer (PBPE) and a low density polyethylene; a layer (B), adjacent to layer (A), comprising at least 50 percent by weight of the layer (B) of an ethylene-based polymer; and an outermost layer (C) comprising a material having a melting point greater than 140 C. Weight percents are based on the total weight of the respective layer. The heat sealable flexible film structure is used to make a flexible container (10) having one or more heat seals (12). The heat seal (12) can be a frangible heat seal, a hard heat seal, or a combination thereof.

A sealed single-dose break-open package having: a first sheet of semi-rigid plastic material; a second sheet of flexible plastic material superimposed on and sealed to the first sheet of semi-rigid plastic material to define a sealed pocket containing a dose of a product; and a pre-weakened area, which extends transversely and is obtained in a central area of the first sheet, so as to guide, following a folding of the sealed package, a controlled breakage of the first sheet in correspondence to the pre-weakened area; the pre-weakened area has a single inner incision, which is oriented transversely and is obtained through an inner surface of the first sheet, and a single outer incision, which is oriented transversely, is obtained through an outer surface of the first sheet, and is transversely staggered relative to and longitudinally aligned with the inner incision.

A sealed single-dose break-open package having: a first sheet of semi-rigid plastic material; a second sheet of flexible plastic material superimposed on and sealed to the first sheet of semi-rigid plastic material to define a sealed pocket containing a dose of a product; and a pre-weakened area, which extends transversely and is obtained in a central area of the first sheet, so as to guide, following a folding of the sealed package, a controlled breakage of the first sheet in correspondence to the pre-weakened area; the pre-weakened area has a single inner incision, which is oriented transversely and is obtained through an inner surface of the first sheet, and a single outer incision, which is oriented transversely, is obtained through an outer surface of the first sheet, and is transversely staggered relative to and longitudinally aligned with the inner incision.

A tube has left and right edges spaced by a length, semi-cylindrical top and bottom edges spaced by a height, and upper and lower faces spaced from and parallel with each other at a central section. The central section is equally spaced from the left edge and the right edge. The upper and lower faces are in facing contact with each other adjacent to the left edge and adjacent to the right edge.

A tube has left and right edges spaced by a length, semi-cylindrical top and bottom edges spaced by a height, and upper and lower faces spaced from and parallel with each other at a central section. The central section is equally spaced from the left edge and the right edge. The upper and lower faces are in facing contact with each other adjacent to the left edge and adjacent to the right edge.

A process for producing a flexible container is provided. The process includes: A. providing a rear panel web, a front panel web, a first folded gusset panel web, and a second folded gusset panel web, each panel web having peripheral edges and a bottom face, each bottom face having two opposing tapered edges meeting at a bottom end; B. placing the folded gusset panel webs between the rear panel web and the front panel web, the gusset panel webs opposing each other, the panel webs configured to form a common periphery and the bottom seal area including the bottom end of each panel; C. first sealing the peripheral edges, the tapered edges, and the bottom seal area under a set of heat seal conditions; D. second sealing a portion of the bottom seal area under a second heat seal condition; and E. forming a flexible container.

A process for producing a flexible container is provided. The process includes: A. providing a rear panel web, a front panel web, a first folded gusset panel web, and a second folded gusset panel web, each panel web having peripheral edges and a bottom face, each bottom face having two opposing tapered edges meeting at a bottom end; B. placing the folded gusset panel webs between the rear panel web and the front panel web, the gusset panel webs opposing each other, the panel webs configured to form a common periphery and the bottom seal area including the bottom end of each panel; C. first sealing the peripheral edges, the tapered edges, and the bottom seal area under a set of heat seal conditions; D. second sealing a portion of the bottom seal area under a second heat seal condition; and E. forming a flexible container.

A packaged, sealed container system for stable storage of a formulation of an oxygen-sensitive pharmaceutical compound, the packaged, sealed container system comprising a primary container including therein a formulation of an oxygen-sensitive pharmaceutical compound, a secondary outer container comprising a first flexible sheet layer, an opposing second flexible sheet layer, and a seal disposed along a common peripheral edge of the first and second flexible sheet layers, such that the primary container is disposed between and enclosed by the first and second flexible sheet layers of the secondary outer container. An oxygen scavenger is also disposed between and enclosed by the first and second flexible sheet layers of the secondary outer container. The oxygen scavenger is in fluid communication with the contents of the primary container.