System for use in lyophilization comprising delivery containers and a cover plate

• US 6,610,252 B2
• Filed: 01/22/2002
• Issued: 08/26/2003
• Est. Priority Date: 03/27/2000
• Status: Expired due to Term

• Current Assignee: Tolmar Therapeutics, Inc. (TOLMAR Holding, Inc.)
• Original Assignee: Atrix Laboratories, Inc. (TOLMAR Holding, Inc.)
• Inventors: Barrett, Christopher J., Bawa, Rajan, Madril, Dominic G., Yarborough, Cody L
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): GAKH, YELENA G
• Application Number:
  US10/054,624
• Publication Number:
  US 20020114737A1
• Time in Patent Office: 581 Days
• Field of Search: 422/99-104
• US Class Current: 422/501
• CPC Class Codes: A61M 5/008 Racks for supporting syringes or needles A61M5/001 takes precedence
• 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

The present invention provides a system for lyophilization comprising one or more delivery containers, e.g. syringes, and a cover plate, which covers them during lyophilization. The cover plate includes a lid region and one or more protuberances, which project perpendicularly from the lid region and fit delivery containers such that the protuberances are not in complete and continuous contact with sidewalls of the delivery containers. The cover plate permits the escape of vapor from the delivery containers during lyophilization process through an annular gap between each protuberance and a sidewall of each container when the cover plate is resting on the top of the delivery containers. At the same the cover plate prevents the escape of lyophilizate, in particular a pharmaceutical, from the containers during lyophilization.

Claims

1. A system for lyophilizing a pharmaceutical solution comprising:

one or more delivery containers suitable for containing the pharmaceutical solution and

a cover plate suitable for use to cover the one or more delivery containers during a lyophilization process, the cover plate comprising;

a lid region and

one or more protuberances which project perpendicularly from the lid region, wherein the one or more protuberances are adapted to fit in the one or more delivery containers, wherein the one or more protuberances are not in complete and continuous contact with the delivery containers such that the cover plate permits the escape of vapor from the one or more delivery containers during the lyophilization process through an annular gap between each protuberance and a side wall of each container when the cover plate is resting on the top of the one or more delivery containers, and wherein the cover plate prevents the escape of lyophilizate from the one or more delivery containers during the lyophilization process.

2. The system of claim 1 wherein the one or more protuberances are capable of retaining lyophilizate that contacts the protuberance during the lyophilization process.

3. The system of claim 1 wherein the one or more protuberances are conically shaped, spherically shaped, or cylindrically shaped.

4. The system of claim 1 wherein the one or more protuberances comprise an upper region and a lower region.

5. The system of claim 4 wherein the upper region is cylindrically shaped.

6. The system of claim 4 wherein the upper region is tapered, such that the cross-section of the upper region of the protuberance becomes greater toward the lid region.

7. The system of claim 4 wherein the lower region is cylindrically shaped.

8. The system of claim 4 wherein the lower region is conically shaped.

9. The system of claim 4 wherein the lower region is tapered.

10. The system of claim 4 wherein the upper region is cylindrically shaped and the lower region is conical.

11. The system of claim 4 wherein any cross-section of the upper region is wider than any cross-section of the lower region.

12. The system of claim 1 wherein the one or more delivery containers is a syringe.

13. The system of claim 12 wherein the syringe is plastic.

14. The system of claim 12 wherein the syringe is disposable.

15. The system of claim 12 wherein the syringe is plastic.

16. The system of claim 12 wherein the syringe is disposable.

17. The system of claim 1 wherein the length of each of the protuberances is independently at least about 25% of the length of the delivery containers.