Closure container for single dose disposable pharmaceutical delivery system

Abstract

Provided herein is a single dose disposable pharmaceutical delivery apparatus and methods of use and manufacture thereof. One aspect provides a single dose disposable pharmaceutical delivery apparatus that includes a needle hub seal attached to a needle hub and a bladder that can contain a pharmaceutical composition. Another aspect provides for dispensing a pharmaceutical composition from the delivery apparatus by rupturing the needle hub seal and fluidically connecting the needle and the bladder. Another aspect provides manufacturing the delivery apparatus according to steps including attaching a needle hub and a needle hub seal and combining the bladder and the needle hub, thereby forming an apparatus described herein.

1 . A single dose disposable pharmaceutical delivery apparatus comprising:
 a bladder to contain a pharmaceutical composition;   a needle;   a needle hub; and   a needle hub seal;   wherein:
 the needle is secured to the needle hub; 
 the needle is in a stationary position relative to the bladder; 
 the needle hub seal is attached to the needle hub; and 
 dispensing the pharmaceutical composition comprises rupturing the needle hub seal and fluidically connecting the needle and the bladder. 
   
     
     
         2 . The apparatus of  claim 1 , wherein the apparatus does not contain a bladder seal connected to the bladder and the needle is fluidically connected with the bladder when the needle hub seal is ruptured. 
     
     
         3 . The apparatus of  claim 1 , comprising a bladder seal, wherein the bladder seal is positioned between the bladder and the needle; and the needle is fluidically connected with the bladder upon rupture of the bladder seal and the needle hub seal. 
     
     
         4 . The apparatus of  claim 1 , comprising a needle cap, wherein the needle cap fluidically seals the needle and removal of the needle cap fluidically unseals the needle. 
     
     
         5 . The apparatus of  claim 1  wherein the needle is fixedly attached to and extending from the needle hub. 
     
     
         6 . The apparatus of  claim 1  wherein the needle is rigidly attached to and extending from the needle hub. 
     
     
         7 . The apparatus of  claim 1 , wherein the needle is about 22 gauge to about 29 gauge. 
     
     
         8 . The apparatus of  claim 1 , wherein the needle comprises an exposed portion distal to the needle hub and the exposed portion of the needle is about 0.25 inches to about 1.0 inch in length. 
     
     
         9 . The apparatus of  claim 8 , wherein the needle is suitable for intradermal or subcutaneous injections. 
     
     
         10 . The apparatus of  claim 1 , wherein the bladder comprises a volume of about 0.5 cc to about 3.0 cc. 
     
     
         11 . The apparatus of  claim 1 , wherein the bladder comprises a polyethylene or a polypropylene material. 
     
     
         12 . The apparatus of  claim 1 , comprising an envelope, the envelope comprising an anterior sheet and a posterior sheet; wherein, the envelope encompasses the bladder. 
     
     
         13 . The apparatus of  claim 12 , wherein the anterior sheet and the posterior sheet form the bladder. 
     
     
         14 . The apparatus of  claim 12 , wherein the bladder is formed separately from the anterior sheet or the posterior sheet. 
     
     
         15 . The apparatus of  claim 12 , wherein,
 the envelope comprises a first envelope portion and a second envelope portion;   the first envelope portion comprising the bladder;   the second envelope portion comprising a needle cap; and   the needle cap fluidically seals the needle and removal of the needle cap fluidically unseals the needle.   
     
     
         16 . The apparatus of  claim 12 , wherein separating the first envelope portion and the second envelope portion removes the needle cap and fluidically unseals the needle. 
     
     
         17 . The apparatus of  claim 1 , comprising a fill port, wherein the fill port facilitates filling of the bladder with the pharmaceutical. 
     
     
         18 . A method of manufacturing the apparatus of  claim 1 , comprising:
 attaching a needle hub and a needle hub seal; and   combining the bladder and the needle hub;   thereby forming an apparatus according to  claim 1 .   
     
     
         19 . The method of  claim 19 , comprising one or more of the following:
 filling the bladder with a pharmaceutical composition;   securing the needle to the needle hub;   encompassing the bladder with an envelope;   forming the bladder from an anterior sheet and a posterior sheet thereby forming an envelope comprising the bladder;   attaching a bladder seal to the bladder; and   attaching a needle cap to the needle.   
     
     
         20 . A method of using the apparatus of  claim 1  to deliver a pharmaceutical composition comprising:
 applying pressure to the bladder; 
 rupturing the needle hub seal; and 
 dispensing the pharmaceutical composition from the bladder and through the needle.