Delivery devices and methods for making the same

Abstract

In an example of a method for making a pulsatile delivery device, one type of charges are generated on a polymeric layer, and charges opposite the one type of charges are generated on a delivery layer including a film forming material and a predetermined substance dispersed throughout the film forming material. The charged polymeric and delivery layers are placed into contact to form a bi-layer structure. A stack with at least two bi-layer structures is formed so that the polymeric layers and the delivery layers are alternating throughout the stack. The stack is sealed so that one of the polymeric layers remains exposed.

1 - 18 . (canceled) 
     
     
         19 . A pulsatile delivery device, comprising:
 a stack of at least two bi-layer structures, each bi-layer structure including:
 a delivery layer including:
 a first polymer having an uncharged backbone selected from the group consisting of alginate, polyethylene glycol, collagen, gelatin, hyaluronic acid, starch, glycogen, cellulose, caragena, dextran, chitin, chitosan, pectin, heparin, heparan sulfate, copolymers thereof; and 
 a predetermined substance dispersed throughout the first polymer; 
 
 first charges generated at a surface of the delivery layer; 
 a polymeric layer including a second polymer having an uncharged backbone selected from the group consisting of poly(lactide-co-glycolide) (PLGA), polyglycolic acid (PGA), poly(L-lactic acid) (PLLA), polyanhydrides, poly(ortho esters), polycaprolactone, poly(hydroxy butyrate), poly(phosphoesters), poly(propylene fumarate), polyphosphazenes, polycarbonates, and polyurethane; 
 second charges generated at a surface of the polymeric layer; 
 wherein the first and second charges are opposite each other, and are electrostatically attached to each other; and 
   a sealant partially surrounding the stack so that one of the polymeric layers of the stack is exposed.   
     
     
         20 . The pulsatile delivery device as defined in  claim 19 , wherein the electrostatic attachment substantially eliminates air gaps between the layers of each bi-layer structure. 
     
     
         21 . The pulsatile delivery device as defined in  claim 19 , wherein the polymeric layer is polyanhydride, the predetermined substance is parathyroid hormone, and the film forming material is alginate. 
     
     
         22 . The pulsatile delivery device as defined in  claim 19 , wherein the predetermined substance is selected from the group consisting of a drug, a vaccine, a protein, a peptide, a growth factor, a hormone, a nucleic acid, and combinations thereof. 
     
     
         23 . The pulsatile delivery device as defined in  claim 22 , wherein:
 the predetermined substance is the drug, and the drug is a chemotherapy drug; or   the predetermined substance is the hormone, and the hormone is selected from the group consisting of parathyroid hormone (PTH), luteinizing hormone release hormone (LHRH), 17β-estradiol, estriol, progesterone, testosterone, cortisol, and insulin; or   the predetermined substance is the nucleic acid, and the nucleic acid is DNA or RNA.   
     
     
         24 . The pulsatile delivery device as defined in  claim 19 , wherein the predetermined substance is selected from the group consisting of chemokine ligand  2 , chemokine ligand  7 , interleukin  4 , interleukin  13 , transforming growth factor—beta, fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF), chemoattractant, bone morphogenetic protein (BMP), botulinum toxin, derivatives thereof, and combinations thereof. 
     
     
         25 . The pulsatile delivery device as defined in  claim 19 , wherein:
 positive charges are generated on the polymeric layer; and   negative charges are generated on the delivery layer.   
     
     
         26 . The pulsatile delivery device as defined in  claim 19 , wherein:
 negative charges are generated on the polymeric layer; and   positive charges are generated on the delivery layer.   
     
     
         27 . The pulsatile delivery device as defined in  claim 19 , wherein the sealant is selected from the group consisting of polycaprolactone , poly(glycolide-co-caprolactone), poly(lactide-cocaprolactone), Poly(glycerol sebacate), polyurethane, poly(diol citrate), and elastin.