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公开(公告)号:US20240000711A1
公开(公告)日:2024-01-04
申请号:US18348675
申请日:2023-07-07
摘要: Herein described are an assembly, apparatus, and method for lyophilization that utilizes a thermal block made from a conductive material, the block having multiple wells designed and dimensioned to receive containers carrying material to be lyophilized in situ. In preferred embodiments, a vented silicone pad covers the wells and secures the containers therein, and a similarly vented rigid plate in turn secures the silicone pad by fastening it to the thermal block. The assembly can be turned up to 90 degrees resulting in the turning of the containers from an upright position to a horizontal position, a position in which the distance through which sublimation must progress is drastically reduced so as to greatly enhance the efficiency of the lyophilization process.
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公开(公告)号:US20240148655A1
公开(公告)日:2024-05-09
申请号:US18542834
申请日:2023-12-18
摘要: 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.
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公开(公告)号:US20230240995A1
公开(公告)日:2023-08-03
申请号:US18066107
申请日:2022-12-14
摘要: Herein described are an assembly, apparatus and method for lyophilization that utilizes a thermal block made from a conductive material, the block having multiple wells designed and dimensioned to receive containers carrying material to be lyophilized in situ. In preferred embodiments, a vented silicone pad covers the wells and secures the containers therein, and a similarly vented rigid plate in turn secures the silicone pad by fastening it to the thermal block. The assembly can be turned up to 90 degrees resulting in the turning of the containers from an upright position to a horizontal position, a position in which the distance through which sublimation must progress is drastically reduced so as to greatly enhance the efficiency of the lyophilization process.
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