Article of manufacture containing lyophilized leuprolide acetate

Abstract

A process for lyophilizing a solution of an active agent in a container is provided. Solution of active agent is deposited into a container, the container is covered with a covering plate and placed inside a lyophilizing apparatus. Lyophilization can be conducted to dryness by radiation, convection or both. Also provided is a device made by this process, an active agent-plastic administration device (e.g., a syringe), containing an active agent in the form of lyophilized cake, and an array of such administration devices.

1 . (canceled) 
     
     
         2 . An article of manufacture comprising first and second groups of containers, each container having at least an open top, each container containing a portion of lyophilized leuprolide acetate;
 a cover plate having an underside with protuberances attached to the underside, the protuberances being adapted to fit through the open tops of the containers and into the insides of the containers without contacting the inner surfaces of the containers, and the cover plate being juxtaposed with the containers so as to cover the containers of the first and second groups with the protuberances projecting into the insides of the containers;   and the first group of containers being distinguished from the second group by the absence of any visible amount of lyophilized leuprolide acetate on the protuberances or corresponding cover plate undersides associated with the first group of containers.   
     
     
         3 . An article of manufacture according to  claim 2  wherein all portions of the first group are essentially the same quantity. 
     
     
         4 . An article of manufacture according to  claim 2  consisting of the first group. 
     
     
         5 . An article of manufacture according to  claim 3  consisting of the first group. 
     
     
         6 . An article of manufacture according to  claim 5  further comprising a collection of kits for administration of leuprolide acetate to patients in need of such treatment wherein each container of the first group is a component of each member of the collection of kits, each kit also including a second container containing a mixture of N-methyl pyrrolidone and poly (lactide-co-glycolide). 
     
     
         7 . An article of manufacture according to  claim 2  consisting of the second group wherein each container of the second group is marked by a visible amount of lyophilized leuprolide acetate on the corresponding protuberance or corresponding cover plate underside. 
     
     
         8 . An article of manufacture according to  claim 7  wherein the second group is an intermediate for manufacture of lyophilized leuprolide acetate. 
     
     
         9 . An article of manufacture according to  claim 5  wherein the containers are syringes. 
     
     
         10 . An Article of manufacture according to  claim 9  further comprising seals for the syringes of the first group. 
     
     
         11 . An Article of manufacture according to  claim 10  wherein the seals of the first group comprise plungers for insertion into the syringe barrels of the first group. 
     
     
         12 . An Article of manufacture according to  claim 11  wherein the syringes are male syringes of a syringe-to-syringe assembly and the plungers are inserted into the barrels of the male syringes. 
     
     
         13 . An Article of manufacture according to  claim 9  wherein the syringes are plastic. 
     
     
         14 . An Article of manufacture according to  claim 12  wherein the syringes and plungers are plastic. 
     
     
         15 . An article of manufacture according to  claim 12  wherein each portion of the first group is about  11 . 4  mg of leuprolide acetate. 
     
     
         16 . An article of manufacture consisting of an individual kit according to  claim 6 .