US 11,957,790 B1 · Combination lyophilization and dispensing syringe assembly and methods of using same

Abstract

Herein described is a syringe assembly configured for the in situ lyophilization of an initial liquid preparation into a lyophilized product as well as the subsequent sealing of the lyophilized product for storage and transport, user reconstitution of the lyophilized product, and dispensing of the lyophilized product in rehydrated form to a patient in a medical setting, all in the same syringe. The combination lyophilization and dispensing syringe assemblies of the present invention greatly enhance the efficiency of the lyophilization process and find particular utility in conjunction with the dedicated lyophilization apparatus and methods described in U.S. Pat. Nos. 11,536,512 and 11,723,870. In particularly preferred embodiments, the present invention provides for shortened lyophilization cycles in a syringe barrel optionally fitted with a sealing Luer lock cap at its distal end and a vented stopper at its proximal end. During lyophilization, gas may flow out of the syringe barrel and through the stopper. After lyophilization, the stopper slid to its sealed position, thereby forming an airtight syringe whose contents are insulated from surrounding atmosphere and potential contamination. During the life cycle of the filled syringe, from seal to storage to transport, the lyophilized material is never exposed to the atmosphere. In addition, at time of use, an elongate stem may be threaded into the stopper to form a dispensing plunger in which the stopper acts as a sealing piston element In this manner, the assembly of syringe barrel, stopper and elongated stem constitute a fully functioning syringe that may be used to rehydrate and dispense the medicament of interest.

Claims20

Dependent claims

A lyophilization syringe configured for both in situ lyophilization of an initial liquid preparation into a lyophilized product and subsequent reconstitution and dispensing of the lyophilized product in rehydrated form, said syringe comprising an elongate central barrel characterized by:

a. a plurality of distinct lateral walls joined together to define an exterior surface, an interior surface, and a hollow interior bore configured to retain both an initial product and a product in lyophilized forms,
b. an open distal tip configured to engage a hypodermic needle assembly;
and
c. an open proximal end configured to removably receive a stopper;
wherein said central barrel has a non-uniform or non-circular cross-section.

2 more elements

A method of using a single syringe to both lyophilize a liquid preparation into a lyophilized product and subsequently rehydrate and dispense the lyophilized product in rehydrated form, said method comprising the steps of:

a. introducing said liquid preparation into a hollow interior bore of a lyophilization syringe comprising an elongate central barrel characterized by an exterior surface, an interior surface, and a hollow interior bore configured to retain said liquid preparation and said lyophilized product, an open distal tip configured to engage a hypodermic needle assembly;
and an open proximal end configured to removably receive a stopper;
and
b. affixing a distal cap to said open distal tip;
c. partially inserting a stopper into the open proximal end of said elongate central barrel to a first axial position so as to form a passage whereby gas may flow out from the central barrel and through a member, wherein said stopper comprises (i) at least one vent channel disposed along a lateral surface that serves as said passage whereby gas may flow out from the central barrel and through said member, (ii) at least one sealing rib circumferentially disposed about said lateral surface at a position that is proximal to a distal end of said at least one vent channel;
and (iii) optionally a threaded socket formed in a proximal surface of the stopper;
d. lyophilizing said liquid preparation into said lyophilized product in situ;
e. axially sliding the stopper along the barrel in a distal direction to a second axial position wherein said at least one vent channel is closed and said lyophilized product is sealed within said central barrel.

5 more elements

Dependencies are inferred from the claim text.

Combination lyophilization and dispensing syringe assembly and methods of using same

Life of this patent

Combination lyophilization and dispensing syringe assembly and methods of using same

Life of this patent

Abstract

Claims20