Packaging for rapidly infusing composition
A container for a lyophilized rapidly infusing composition is described. The container comprises a planar lidding layer attached to a well layer comprising pockets for the therapeutic product. The lidding layer may comprise an aluminum layer, a thermoplastic polymer layer, and a labeling layer. The well layer may comprise an aluminum layer, two polyamide layers, and two thermoplastic polymer layers. A drug product assembly is also disclosed, which includes at least one therapeutic product sealed within the at least one pocket of the container.
1. A container for a therapeutic product, comprising:
a substantially planar lidding layer, and
a well layer,
wherein the lidding layer comprises, in order from an exterior lid side to an interior lid side:
a labeling layer;
a thermoplastic polymer lidding layer; and
an aluminum lidding layer:
wherein the interior lid side is removably attached to an interior well side,
wherein the well layer is shaped to form one or more pockets between the interior lid side and the interior well side, each pocket configured to enclose the therapeutic product,
wherein the one or more pockets each comprise a substantially flat portion in the center of the pocket and the substantially flat portion of the one or more pockets is connected to the top of the pocket by a sidewall comprising two or more sections, wherein a lower section of the sidewall exhibits a greater degree of concavity than an upper section of the sidewall, and
wherein the well layer comprises, in order from the interior well side to an exterior well side:
a first thermoplastic polymer well layer;
a first polyamide layer;
an aluminum well layer;
a second polyamide layer; and
a second thermoplastic polymer well layer.
2. The container of claim 1 , wherein the lidding layer and/or the well layer further comprise adhesive interlayers.
3. The container of claim 1 , wherein the lidding layer and the well layer each independently have:
a moisture vapor transmission rate of less than 0.05 g/m 2 /day measured at 38° C. and 90% relative humidity, and/or
an oxygen transmission rate of less than 0.01 mL/m 2 /day measured at 23° C. and 50% relative humidity.
4. The container of claim 1 , wherein the lidding layer further comprises a lacquer layer at the interior lid side.
5. The container of claim 1 , wherein the thermoplastic polymer lidding layer, the first thermoplastic polymer well layer, and the second thermoplastic polymer well layer each independently comprise at least one polymer selected from the group consisting of polyvinylchloride, polyethylene terephthalate, polyamide, polyethylene, poly(lactic-co-glycolic acid), polytetrafluoroethylene, polyvinylidene fluoride, polylactic acid, polypropylene, polystyrene, polyvinyl acetate, and polyvinylidene chloride.
6. The container of claim 5 , wherein the first and second thermoplastic polymer well layers consist essentially of polyvinylchloride.
7. The container of claim 1 , wherein the first and second polyamide layers comprise oriented polyamide.
8. The container of claim 1 , wherein the labeling layer comprises paper.
9. The container of claim 1 , wherein the lidding layer has an average layer thickness in a range of 90-130 μm, and
wherein the well layer has an average layer thickness in a range of 190-300 μm.
10. The container of claim 1 , having one or more edges or corners where the lidding laver and the well layer are not attached to each other.
11. The container of claim 1 , wherein the one or more pockets includes at least two pockets, and
wherein the lidding layer and the well layer have a perforated line between the at least two pockets.
12. The container of claim 1 , wherein the one or more pockets includes at least three pockets separated by at least two perforated lines, and
wherein each adjacent two perforations are spaced by a distance in a range of 20-50 mm.
13. The container of claim 1 , wherein the lidding layer and/or the well layer are knurled where the interior lid side is removably attached to the interior well side of the well layer.
14. The container of claim 1 , wherein the one or more pockets are each rotationally symmetric about a central axis and have a non-convex cross-sectional profile.
15. The container of claim 1 , wherein the substantially flat portion in the center of the pocket includes a raised or lowered portion(s) to deboss or emboss a logo or other information into the therapeutic product.
16. The container of claim 1 , wherein the one or more pockets each has a volume in a range of 0.3-4.0 cm 3 .
17. The container of claim 1 , wherein the one or more pockets each has a vertical depth in a range of 3-10 mm.
18. The container of claim 1 , wherein the lower section of the sidewall and the upper section of the sidewall each comprises a plurality of planar faces.
19. The container of claim 18 , wherein the substantially flat portion in the center of the pocket is octagonal in shape.
20. A drug product container assembly, comprising:
the container of claim 1 , and
at least one therapeutic product in the at least one pocket,
wherein the at least one therapeutic product is a rapidly infusing composition.
21. The drug product container assembly of claim 20 , wherein the rapidly infusing composition has a disintegration time of approximately 1 to 30 seconds in deionized water maintained at 37° C.±2° C.
22. The drug product container assembly of claim 20 , wherein the rapidly infusing composition has a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37° C.±2° C.
23. The drug product container assembly of claim 20 , wherein the rapidly infusing composition comprises a pharmaceutically acceptable binder and/or excipient system comprising gelatin and a sugar alcohol.
24. The drug product container assembly of claim 23 , wherein the sugar alcohol comprises mannitol.
25. The drug product container assembly of claim 20 , wherein the rapidly infusing composition is lyophilized.
26. The drug product container assembly of claim 20 , wherein the rapidly infusing composition comprises a therapeutically effective amount of cannabidiol or a derivative/analog thereof.
27. The drug product container assembly of claim 26 , wherein the rapidly infusing composition comprises a therapeutically effective amount of cannabidiol.
28. The drug product container assembly of claim 25 , wherein the rapidly infusing composition comprises a therapeutically effective amount of a derivative/analog of cannabidiol.
29. The drug product container assembly of claim 27 wherein the derivative/analog of cannabidiol is cannabidiolic acid methyl ester.
30. The container of claim 15 , wherein the substantially flat portion in the center of the pocket comprises a raised portion forming an identifiable feature.
31. The container of claim 15 , wherein the substantially flat portion in the center of the pocket comprises a depressed portion forming an identifiable feature.