Cover plate for use in lyophilization

• US 6,566,144 B1
• Filed: 03/27/2000
• Issued: 05/20/2003
• 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:
  US09/535,846
• Time in Patent Office: 1,149 Days
• Field of Search: 436/174-180, 422/99-104, 342/84--99
• US Class Current: 436/177
• 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 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 resting on the top of the one or more delivery containers, 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, 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;

positioning the cover plate on 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 on 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

at least partially lyophilizing the solution comprising the pharmaceutical.

2. The method of claim 1 further comprising removing the cover plate from the one or more delivery containers after the lyophilizing.

3. The method of claim 1 wherein the lyophilizing is carried out until the pharmaceutical is free of solvent.

4. The method of claim 1 further comprising sealing the one or more delivery containers containing the pharmaceutical.

5. The method of claim 1 wherein the one or more delivery containers is a pre-packaged and pre-sterilized syringe.

6. The method of claim 5 wherein the syringe is positioned in a rack.

7. The method of claim 1, further comprising positioning an array of protuberances over the delivery containers.

8. The method of claim 1, further comprising positioning at least a portion of the length of the protuberances within the delivery containers.

9. The method of claim 1, further comprising positioning an entire length of the protuberances within the delivery containers.

10. The method of claim 1, further comprising positioning a tapered portion of the one or more protuberances within the delivery containers.