Cover plate for use in lyophilization

• US 20020114737A1
• Filed: 01/22/2002
• Published: 08/22/2002
• Est. Priority Date: 03/27/2000
• Status: Active Grant

• Current Assignee: Tolmar Therapeutics, Inc. (TOLMAR Holding, Inc.)
• Original Assignee: Atrix Laboratories, Inc. (TOLMAR Holding, Inc.)
• Inventors: Barrett, Christopher J., Yarborough, Cody L., Bawa, Rajan, Madril, Dominic G.
• Granted Patent: US 6,610,252 B2
• Time in Patent Office: Days
• US Class Current: 422/99
• 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 cover plate that covers one or more delivery containers (e.g., syringe) during lyophilization. The cover plate includes a lid region and one or more protuberances which project perpendicularly from the lid region. The one or more protuberances are adapted to fit in the one or more delivery containers. The cover plate permits the escape of vapor from the one or more delivery containers during the lyophilization process. In addition, the cover plate prevents the escape of lyophilizate from the one or more delivery containers during the lyophilization process. The present invention also provides a system for lyophilizing a solution that contains a pharmaceutical. The system includes one or more delivery containers. The one or more delivery containers contains the solution that contains the pharmaceutical. The system also includes a cover plate used to cover the one or more delivery containers during the lyophilization. The present invention also provides a method for lyophilizing a solution that contains a pharmaceutical. The method includes depositing the solution in one or more delivery containers, covering the one or more delivery containers with a cover plate, and lyophilizing the solution comprising the pharmaceutical.

Claims

1. A cover plate suitable for use to cover one or more delivery containers during a lyophilization process 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 cover plate permits the escape of vapor from the one or more delivery containers during the lyophilization process, and wherein the cover plate prevents the escape of lyophilizate from the one or more delivery containers during the lyophilization process.

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

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

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

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

6. The cover plate of claim 4 wherein the upper region is tapered.

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

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

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

10. The cover plate of claim 4 wherein the upper region is cylindrically shaped, the lower region is cylindrically shaped and the lower region is tapered.

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

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

13. The cover plate of claim 12 wherein the syringe is plastic.

14. The cover plate of claim 12 wherein the syringe is disposable.

16. The system of claim 15 wherein the one or more delivery containers is a syringe.

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

18. The system of claim 15 wherein the syringe is disposable.

20. The method of claim 19 further comprising removing the cover plate from the one or more delivery containers after the lyophilizing.

21. The method of claim 19 wherein the lyophilizing is carried out until the pharmaceutical is free of solvent.

22. The method of claim 19 further comprising sealing the one or more delivery containers containing the pharmaceutical.

23. The method of claim 19 wherein the one or more delivery containers is a pre-packaged and pre-sterilized syringe.

24. The method of claim 23 wherein the syringe is positioned in a rack.

15. 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 cover plate permits the escape of vapor from the one or more delivery containers during the lyophilization process, and wherein the cover plate prevents the escape of lyophilizate from the one or more delivery containers during the lyophilization process.

19. A method for lyophilizing a pharmaceutical solution comprising:

depositing the solution in one or more delivery containers;

covering the one or more delivery containers with a cover plate, 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 cover plate permits the escape of vapor from the one or more delivery containers during the lyophilization process, and wherein the cover plate prevents the escape of lyophilizate from the one or more delivery containers during the lyophilization process;

positioning the cover plate over the one or more delivery containers such that the one or more protuberances of the cover plate are positionally aligned with the one or more delivery containers, and

placing the cover plate and the one or more delivery containers inside the lyophilizing apparatus or placing the one or more delivery containers and the cover plate inside the lyophilizing apparatus and positioning the cover plate over the one or more delivery containers such that the one or more protuberances of the cover plate are positionally aligned with the one or more delivery containers; and

lyophilizing the solution comprising the pharmaceutical.