Blister package for pharmaceutical cartridges
A blister packaging for a pharmaceutical cartridge or capsule and methods of forming same are disclosed.
1. A method of manufacturing a high moisture barrier blister package for a cartridge containing a pharmaceutical formulation comprising a diketopiperazine, comprising:
creating a blister in an ACLAR base sheet using heat between 120 degrees C. and about 150 degrees C., pressure between about 4 bars and about 7 bars, 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 further wherein the Water Vapor Transmission Rate of the blister is less than 0.015 grams H 2 O per blister per day.
2. The method of claim 1 , wherein the creating occurs at a predetermined cycle.
3. The method of claim 2 , wherein the predetermined cycle is between 10 cycles per min and about 30 cycles per min.
4. The method of claim 1 , further comprising placing the cartridge in the blister.
5. The method of claim 1 , further comprising providing a lid material.
6. The method of claim 1 , further comprising pulling the lid material and the base sheet together.
7. The method of claim 1 , further comprising sealing the lid to the base sheet.
8. The method of claim 1 , further comprising die cutting the sealed lid and base sheet to form the blister package.
9. The method of claim 1 , wherein the diketopiperazine is bis-3,6-(N-fumaryl-4-aminobutyl)-2,5-diketo-diketopiperazine.
10. The method of claim 1 , wherein the pharmaceutical formulation includes a peptide, protein, a small molecule or a nucleic acid.
11. The method of claim 1 , wherein the pharmaceutical formulation includes insulin, glucagon like peptide 1 , glucagon, oxytocin, oxyntomodulin, peptide YY, sumatriptan, a peptidyl peptidase IV inhibitor, parathyroid hormone, deoxyribonuclease I and active fragments or analogs thereof, neurotransmitter agonist, neurotransmitter antagonists, or a combination thereof.
12. A method of manufacturing a high moisture barrier blister package for a cartridge containing a pharmaceutical formulation comprising an active agent and a diketopiperazine, comprising:
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 H 2 O per blister per day.
13. The method of claim 12 , wherein the diketopiperazine is bis-3,6-(N-fumaryl-4-aminobutyl)-2,5-diketo-diketopiperazine.
14. The method of claim 12 , wherein the active ingredient is a peptide, protein, a small molecule or a nucleic acid.
15. The method of claim 12 , wherein the active ingredient is selected from the group consisting of insulin, glucagon like peptide 1 , glucagon, oxytocin, oxyntomodulin, peptide YY, sumatriptan, a peptidyl peptidase IV inhibitor, parathyroid hormone, deoxyribonuclease I and active fragments or analogs thereof, neurotransmitter agonist, neurotransmitter antagonists, or a combination thereof.