Atrix Laboratories, Inc.

Qlt Usa, Inc.

Tolmar Therapeutics, Inc.

Artix Laboratories, Inc.

Rajan Bawa

Cody L Yarborough

Dominic G Madril

Christopher J Barrett

Michael R Duncan

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.

Method for lyophilizing an active agent

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.

Process and delivery container for lyophilizing active agent

A syringe assembly is provided which includes a hollow barrel that has an interior wall. The interior wall defines a chamber that retains medication. The hollow barrel also includes a distal end and a proximal end. The distal end of the hollow barrel has a passageway that is in contact with the chamber. The proximal end of the hollow barrel has an aperture. The syringe assembly also includes a primary plunger tip that is slidably positioned, in fluid tight engagement, with the interior wall. The primary plunger tip has a receptor to engage an engager of an elongated tip plunger rod. The syringe assembly also includes a secondary plunger tip that is slidably positioned, in fluid tight engagement, with the interior wall. The secondary plunger tip also has a receptor to engage an engager of a tip plunger rod. The secondary plunger tip is disposed between the primary plunger tip and the proximal end of the hollow barrel. The syringe assembly also includes a tip plunger rod, which facilitates operation of the secondary plunger tip, engaged to the secondary plunger tip. The present invention also provides a process for providing a lyophilized medication (i.e., lyophilizate) in a syringe assembly and also provides a process for reconstituting a medication in a syringe assembly.

Stoppering method to maintain sterility

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.

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

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.

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Ft. Collins, CO, United States of America

Rajan Bawa