Granted Patent B2

US 12,611,642 · App. 17/960,027 · Granted Apr 28, 2026

Inventors: Claudia Lee (Merion Station, PA); Michael Sullivan (Birdsboro, PA); Rajiv Kumar (Chester Springs, PA); Daniel E. Delvecchio (Scottsdale, AZ); James Guthlein (Malvern, PA)

Assignee: West Pharmaceutical Services, Inc.

B01F33/301A61K47/6929B01F23/405B01F23/45B01F25/4331B01F35/75425B01F2101/22

Abstract

Claims (52)

1 . An adapter comprising:

a body;

a first port configured to connect with a first container;

a second port configured to connect with a second container; and

a third port configured to connect with a third container, wherein:

the body defines a mixing channel extending from a first end, in fluid communication with the third port, to a second end,

the mixing channel comprises a pathway that is cylindrically shaped,

the mixing channel comprises dimples that extend radially outwardly beyond the pathway and into the body, and

fluid follows a tortuous path along a longitudinal axis of the adapter into and out of the dimples and the pathway when the fluid flows through the mixing channel.

2 . The adapter of claim 1 , wherein the mixing channel is a microfluidic channel.

3 . The adapter of claim 1 , wherein the dimples surround the pathway.

4 . The adapter of claim 1 , wherein the dimples are arranged in sets that extend along the longitudinal axis.

5 . The adapter of claim 4 , wherein each set of the sets comprises two circumferential rows of the dimples that are angularly offset relative to each other about the longitudinal axis of the adapter.

6 . The adapter of claim 1 , wherein the mixing channel has an inner dimension of between 200 μm and 800 μm.

7 . The adapter of claim 1 , further defining:

a first transit channel that connects the first port with the mixing channel; and

a second transit channel that connects the second port with the mixing channel.

8 . The adapter of claim 7 , wherein:

the mixing channel is one of a plurality of mixing channels, and

each of the plurality of mixing channels connects the first transit channel and the second transit channel to the third port.

9 . The adapter of claim 1 , further comprising a one-way valve connected to the second port.

10 . The adapter of claim 1 , wherein the third port is configured to be in bidirectional fluid communication with the third container.

11 . A system comprising:

the adapter of claim 8 ;

the first container containing lyophilized RNA;

the second container; and

a syringe.

12 . The system of claim 11 , wherein the second container contains an alcohol-dissolved lipid component.

13 . The system of claim 11 , wherein the syringe contains a buffer.

14 . A method of mixing two constituents of a pharmaceutical complex via an adapter, the adapter comprising:

a first port connected to a first container holding a first constituent of the two constituents;

a second port connected to a second container holding a second constituent of the two constituents;

a third port configured to connect to a syringe;

wherein the adapter defines a mixing channel extending from a first end in fluid communication with the third port to a second end;

a first transit channel that connects the first port with the mixing channel;

a second transit channel that connects the second port with the mixing channel,

wherein the mixing channel comprises a tortuous path along a longitudinal axis of the adapter,

the method comprising:

connecting the syringe comprising a plunger to the third port; and

withdrawing the plunger, wherein withdrawing the plunger draws the first constituent from the first container into the first transit channel and the second constituent from the second container into the second transit channel, wherein withdrawing the plunger further draws the first and second constituent into the syringe via the mixing channel.

15 . The method of claim 14 , wherein the first constituent is an organic compound in at least 25% alcohol solution and the second constituent is a dehydrated pharmaceutical composition.

16 . The method of claim 14 , the syringe initially holding an aqueous buffer, the method further comprising, prior to withdrawing the plunger, depressing the plunger, wherein depressing the plunger transfers at least a portion of the aqueous buffer into the second container.

17 . The method of claim 14 , the method further comprising, prior to connecting the syringe to the third port, connecting the first container to the first port, and connecting the second container to the second port.

18 . A method of manufacturing an adapter, the method comprising:

forming a first depression in a first polymer piece, the first depression comprising a first discontinuous depression;

forming a second depression in a second polymer piece, the second depression comprising a second discontinuous depression; and

fusing the first polymer piece to the second polymer piece,

wherein fusing the first polymer piece to the second polymer piece comprises offsetting the first discontinuous depression and the second discontinuous depression to define a mixing channel from a first end to a second end, the mixing channel comprises a tortuous path along a longitudinal axis of the adapter.

19 . The method of manufacturing of claim 18 , wherein the offsetting comprises offsetting the first polymer piece and the second polymer piece by an amount between about 100 μm and about 200 μm.

20 . The method of manufacturing of claim 18 , wherein:

forming the first discontinuous depression comprises injection molding or compression molding the first discontinuous depression, and

forming the second discontinuous depression comprises injection molding or compression molding the second discontinuous depression.

Assignments (1)

Continuity (2)

References Cited (13)