Method for lyophilizing an active agent

• US 9,003,676 B2
• Filed: 06/17/2008
• Issued: 04/14/2015
• Est. Priority Date: 11/12/1998
• Status: Expired due to Fees

• Current Assignee: Tolmar Therapeutics, Inc. (TOLMAR Holding, Inc.)
• Original Assignee: Tolmar Therapeutics, Inc. (TOLMAR Holding, Inc.)
• Inventors: Yarborough, Cody L., Madril, Dominic G., Bawa, Rajan
• Primary Examiner(s): Lu, Jiping
• Application Number:
  US12/140,519
• Publication Number:
  US 20080244923A1
• Time in Patent Office: 2,492 Days
• Field of Search: 342/87, 342/85, 342/84, 342/37, 342/96, 342/38, 342/86, 215/305, 206/439, 422/942, 422/943
• US Class Current: 34/287
• CPC Class Codes: A61J 1/1412 Containers with closing means, e.g. caps
• CPC Class Codes: A61M 2202/06 Solids
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/008 Racks for supporting syringes or needles A61M5/001 takes precedence
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/31 Details
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: F26B 5/06 the process involving freezing
• CPC Class Codes: Y10T 436/25 including sample preparation
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

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.

Claims

1. A process for producing a first group of containers with lyophilized leuprolide acetate comprising

depositing uniform portions of a solution into the containers of the first and a second groups, each container having an opening, each portion of solution containing the same amount of dissolved leuprolide acetate dissolved in a solvent;

aligning a covering plate with an underside and with protuberances attached to the underside of the cover plate so that the protuberances fit through the openings of, and inside of, each of the containers of the first and second groups, the protuberances being adapted to fit inside without contacting any part of the containers of the first and second groups;

placing the first and second groups with fitted cover plate into a lyophilizing apparatus;

at least partially lyophilizing the solution by cooling the solution to a frozen solid, applying a vacuum to the frozen solid and forming a lyophilizate of leuprolide acetate retained in the containers of the first and second groups;

removing the covering plate from the containers of the first and second groups after lyophilization;

examining the covering plate underside and protuberances for escaped leuprolide acetate lyophilizate and identifying containers corresponding to the undersides and protuberances with escaped leuprolide acetate lyophilizate thereby identifying the second group; and

discarding the second group;

maintaining the first group of containers identified by the absence of escaped leuprolide acetate lyophilizate on the corresponding undersides and protuberances associated with the first group of containers.

2. The process according to claim 1 wherein the solution contains about 38 mg/ml of leuprolide acetate.

3. The process according to claim 2 wherein the uniform portion of solution deposited into the containers of the first and second groups is about 0.3 ml of aqueous leuprolide acetate.