Flexible, multiple-compartment drug container and method of making and using same

A flexible container for separately storing and mixing liquid diluent and medicament, the container comprising:

• a multi-layer laminate rear sheet including an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer, an opaque high-barrier intermediate layer, and an outer high temperature resistant mold release layer;
• a flexible front sheet constructed of a single layer film of a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer interfacing with the rear sheet, the front sheet sealed to the rear sheet along a common peripheral edge;
• at least two peelable seals extending between two parallel sides of the common peripheral edge and separably joining the front and rear sheets to define at least three compartments in the container including a first compartment containing a powdered medicament;
• a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sealed to extend over the medicament compartment;
• and
• an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.

A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

• a flexible front sheet;
• a flexible rear sheet sealed to the front sheet at a common peripheral edge;
• a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;
• and
• a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment, wherein the peelable seals are constructed to provide a uniform resistance characteristic to hydraulic pressure against the seal caused by manipulation of the container, the uniform resistance characteristic causing the seal to peel at an applied pressure in the range of from about 3 to about 5 lbs per square inch.

A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

• a flexible rear sheet;
• a flexible front sheet sealed to the rear sheet along a common peripheral edge;
• a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;
• a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment;
• and
• a third peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby a sacrificial moisture vapor barrier compartment which is intermediate the diluent compartment and the medicament compartment.

A flexible container for combined storage and administration of medicaments and diluent for IV solutions, the container comprising:

• a flexible front sheet;
• a flexible rear sheet sealed to the front sheet along a common peripheral edge;
• a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;
• a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing medicament which is intermediate the outlet compartment and an diluent compartment, wherein the peelable seals are rupturable by hydraulic pressure against the seal caused by manipulation of the container;
• an opaque high-barrier protective film separably sealed to the front sheet, the covering sized to extend over the medicament compartment, whereby the opaque high-barrier protective film contacts only a portion of the surface of the medicament compartment, the strength of attachment of the high-barrier protective film being directly proportional to the are of surface contact;
• a locking tab integrally formed and extending from an edge of the container;
• and
• a mating receptacle integrally formed with an extending from the same edge of the container as said locking tab, wherein the container is folded-over adjacent the first peelable seal thereby moving the locking tab into position for engagement with the mating receptacle for securing the container in a folded-over condition.

A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

• a flexible front sheet comprising a single layer film constructed of a polypropylene-polyethylene co-polymer blended with styrene ethylene-butylene styrene elastomer in an about 80%/20% wt/wt ratio;
• a flexible rear sheet sealed to the front sheet along a common peripheral edge, the rear sheet constructed of a multi-layer laminate including;
• an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene ethylene-butylene styrene elastomer in about an 80%/20% wt/wt ratio interfacing with the front sheet;
• an intermediate layer of aluminum foil;
• and
• an outer thermo plastic layer having a higher melting point than said inner layer;
• a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;
• a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment, wherein the peelable seals are rupturable by hydraulic pressure against the seal caused by manipulation of the container;
• a clear, transparent multi-layer high-barrier film laminate disposed adjacent the medicament compartment, the transparent high-barrier film laminate including;
• a polypropylene inner layer adjacent the front sheet in the region of the medicament compartment;
• an outer layer comprising polyester;
• a clear, transparent high moisture barrier film layer between the inner and outer layers;
• a clear, transparent high oxygen barrier film layer disposed intermediate the polypropylene layer and the polyester-containing thermoplastic layer;
• an opaque, peelable, multi-layer laminate separably sealed to the transparent high-barrier film laminate, wherein the opaque multi-layer laminate comprises;
• a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate;
• a polyester polymer layer having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface of said laminate;
• and
• an aluminum foil layer intermediate the modified ethylenevinylacetate and polymer layers.

A flexible container for combined storage and administration of IV solutions, the container comprising:

• a flexible front sheet;
• a flexible, rear sheet, the front and rear sheets sealed together at a common peripheral edge so as to define a volume enclosure;
• and
• at least one removable sacrificial port interposed a between the front and rear sheets along a common peripheral edge and in communication with the volume enclosure to thereby form a filling path adapted to allow the volume enclosure to be filled aseptically.

A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

• a flexible rear sheet;
• a flexible front sheet sealed to the rear sheet along a common peripheral edge;
• a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;
• a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment;
• an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film including;
• a modified ethylenevinylacetate polymer layer comprising the inwardly facing surface of said laminate;
• a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface of said laminate;
• and
• an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.

A flexible container for combined storage and administration of medicaments and diluents for IV solutions, the container comprising:

• a flexible rear sheet;
• a flexible front sheet sealed to the rear sheet along a common peripheral edge;
• a first peelable seal extending between two sides of the common peripheral edge and separably joining the front and rear sheets to form a compartment containing a diluent;
• a second peelable seal extending between the two sides of the common peripheral edge and separably joining the front and rear sheets to form thereby an outlet compartment and a compartment containing a medicament which is intermediate the outlet compartment and the diluent compartment;
• a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment, the film comprising a polypropylene inner layer adjacent a container front sheet, an outer layer comprising polyester, and a clear, transparent high-moisture barrier between the inner and outer layers;
• and
• an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment.

A flexible container for separately storing and mixing liquid diluent and medicament, the container comprising:

• a multi-layer laminate rear sheet including an inner layer of a polypropylene-polyethylene co-polymer blended with a styrene butadiene elastomer, an opaque high-barrier intermediate layer, and an outer high temperature resistant mold release layer;
• a flexible front sheet constructed of a single layer film of a polypropylene-polyethylene co-polymer blended with styrene butadiene elastomer interfacing with the rear sheet, the front sheet sealed to the rear sheet along a common peripheral edge;
• at least two peelable seals extending between two parallel sides of the common peripheral edge and separably joining the front and rear sheets to define at least three compartments in the container including a first compartment containing a powdered medicament;
• a clear high-barrier laminate film sealed to the front sheet, the high-barrier laminate film sized to extend over the medicament compartment;
• and
• an opaque high-barrier protective film separably sealed to the clear high-barrier laminate film, the opaque film sized to extend over the high-barrier laminate film and the medicament compartment, the opaque film comprising;
• a modified ethylenevinylacetate polymer layer comprising an inwardly facing surface;
• a polyester polymer layer, having a higher melting temperature than said modified ethylenevinylacetate polymer layer, comprising the outwardly facing surface;
• and
• an aluminum foil layer intermediate the modified ethylenevinylacetate and polyester layers.