Process and delivery container for lyophilizing active agent

• US 20010042317A1
• Filed: 07/20/2001
• Published: 11/22/2001
• Est. Priority Date: 11/12/1998
• Status: Active Grant

• Current Assignee: Tolmar Therapeutics, Inc. (TOLMAR Holding, Inc.)
• Original Assignee: Atrix Laboratories, Inc. (TOLMAR Holding, Inc.)
• Inventors: Yarborough, Cody L., Bawa, Rajan, Madril, Dominic Gregory
• Granted Patent: US 6,722,054 B2
• Time in Patent Office: Days
• US Class Current: 34/287
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: F26B 5/06 the process involving freezing

Abstract

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

Claims

1. A process for lyophilizing a solution of an active agent, comprising:

depositing the solution into a delivery container;

covering the container with a covering plate;

placing the container and covering plate inside a lyophilizing apparatus; and

lyophilizing to dryness by radiation, convection or both.

2. The process of

claim 1

, wherein the active agent comprises leuprolide acetate.

3. The process of

claim 1

, wherein the delivery container is made of plastic.

4. The process of

claim 1

, wherein the delivery container is a syringe.

5. The process of

claim 1

, wherein the delivery container is a plastic syringe.

6. The process of

claim 1

, wherein the delivery container comprises a single enclosed compartment.

7. The process of

claim 1

, further comprising removing the delivery container and covering plate from the lyophilizing apparatus.

8. The process of

claim 7

, further comprising removing the covering plate from the delivery container after lyophilization.

9. The process of

claim 8

, further comprising examining each area of the covering plate which covered the delivery container for captured lyophilizate and discarding the delivery container from which any such captured lyophilizate came.

10. The process of

claim 9

, further comprising sealing any undiscarded delivery container.

11. The process of

claim 5

, whereby the lyophilization is conducted using an array of pre-packaged, pre-sterilized syringes on a plastic rack in a plastic tub.

12. The process of

claim 11

, wherein the syringes are filled before they are placed into the plastic rack in the plastic tub.

13. The process of

claim 11

, wherein the syringes are filled after they are placed into the plastic rack in the plastic tub.

17. A device made by the process of

claim 1

.

14. An active agent plastic administration device, comprising:

a single enclosed compartment, further comprising an active agent in the form of lyophilized cake.

15. The device of

claim 14

, wherein the active agent comprises leuprolide acetate.

16. The device of

claim 14

, wherein the device is a syringe.

18. An array of active agent plastic administration devices, comprising:

an arrangement of administration devices, each having a single enclosed compartment,

wherein the compartment contains an active agent in the form of lyophilized cake.

19. The array of

claim 18

, wherein the active agent comprises leuprolide acetate.

20. The array of

claim 18

, wherein the array of active administration devices consists of pre-packaged, pre-sterilized, plastic syringes on a plastic rack in a plastic tub.

21. The array of

claim 20

, wherein the active agent comprises leuprolide acetate.

22. A covering plate used to cover an opening of a delivery container during lyophilization, comprising a substantially planar shape.

24. The covering plate of

claim 22

, further comprising an array of circular flanges which fit around the openings of multiple delivery containers.

23. The covering plate of

claim 23

, further comprising a circular flange which fits around the opening of the delivery container.