Method of mixing a pharmaceutical solution and mixing system

Patent metadata

Field	Value
Publication number	US-11524270-B2
Application number	US-201916392074-A
Country	US
Kind code	B2
Filing date	Apr 23, 2019
Priority date	Apr 27, 2018
Publication date	Dec 13, 2022
Grant date	Dec 13, 2022

Abstract

A method of mixing a pharmaceutical solution including adding a gas into an interior compartment of a mix bag to form a headspace. The interior compartment of the mix bag includes a top portion and a bottom portion. The headspace adjacent to the top portion contains gas. The method includes adding a solvent into the mix bag, and establishing a bubble column in the interior compartment by activating a recirculation assembly. The recirculation assembly includes a connecting pathway operably coupled to a recirculation pump. A first end of the connecting pathway is coupled to a top gas recirculation port and a second end is coupled to a bottom gas recirculation port of the mix bag such that the recirculation pump draws the gas from the headspace and delivers the gas to the interior compartment via the bottom gas recirculation port. The method includes adding a solute into the mix bag.

First claim

What is claimed:

1. A bubble agitation system for mixing a pharmaceutical solution, the system comprising:
a mix bag including one or more walls defining an interior chamber having a top portion and a bottom portion opposite the top portion;
a top gas recirculation port extending into the top portion of the interior chamber through the one or more walls of the mix bag;
a bottom gas recirculation port extending into the bottom portion of the interior chamber through the one or more walls of the mix bag;
a solvent pathway coupled to the interior chamber of the mix bag and configured to deliver a solvent into the mix bag;
a solute pathway coupled to the interior chamber of the mix bag and configured to deliver a solute into the mix bag; and
a recirculation assembly including a connecting pathway and a recirculation pump operably coupled to the connecting pathway, the connecting pathway having a first end coupled to the top gas recirculation port and a second end coupled to the bottom gas recirculation port;
wherein the recirculation pump engages the connecting pathway to pull gas from a headspace disposed adjacent to the top portion of the mix bag and deliver gas through the connecting pathway and into the bottom portion of the mix bag via the bottom gas recirculation port a solute port coupled to the solute pathway, the solute port extending into the top portion of the interior chamber and through the one or more walls of the mix bag;
wherein the solute port is in substantial axial alignment with the bottom gas recirculation port.

2. The system of claim 1 , wherein the connecting pathway is in fluid communication with the headspace via the top gas recirculation port, and at least one of the connecting pathway and the bottom gas recirculation port is configured to discharge gas drawn from the headspace into the bottom portion of the mix bag to form a bubble column.

3. The system of claim 1 , further comprising an air filter coupled to an ambient air pathway, the ambient air pathway coupled to the connecting pathway of the recirculation assembly.

4. The system of claim 1 , further comprising an auxiliary air pathway coupled to the connecting pathway of the recirculation assembly, the auxiliary air pathway coupled to a gas tank.

5. The system of claim 1 , further comprising:
a second recirculation assembly including a connecting pathway and a recirculation pump operably coupled to the connecting pathway of the second recirculation assembly; and
a second top recirculation port and a second bottom recirculation port;
wherein the connecting pathway of the second recirculation assembly is coupled to the second top recirculation port at a first end and coupled to the second bottom recirculation port at a second end.

6. The system of claim 1 , further comprising:
an excipient pathway coupled to the solvent pathway and configured to deliver an excipient into the solvent pathway; and
a pump operably coupled to at least one of the excipient pathway and the solvent pathway;
wherein the pump is configured to deliver the excipient and the solvent into the mix bag through the solvent pathway.

7. A bubble agitation system for mixing a pharmaceutical solution, the system comprising:
a mix bag including one or more walls defining an interior chamber having a top portion and a bottom portion opposite the top portion;
a top gas recirculation port extending into the top portion of the interior chamber through the one or more walls of the mix bag;
a bottom gas recirculation port extending into the bottom portion of the interior chamber through the one or more walls of the mix bag;
a solvent pathway coupled to the interior chamber of the mix bag and configured to deliver a solvent into the mix bag:
a solute pathway coupled to the interior chamber of the mix bag and configured to deliver a solute into the mix bag; and
a recirculation assembly including a connecting pathway and a recirculation pump operably coupled to the connecting pathway, the connecting pathway having a first end coupled to the top gas recirculation port and a second end coupled to the bottom gas recirculation port;
wherein the recirculation pump engages the connecting pathway to pull gas from a headspace disposed adjacent to the top portion of the mix bag and deliver gas through the connecting pathway and into the bottom portion of the mix bag via the bottom gas recirculation port
an excipient pathway coupled to the solvent pathway and configured to deliver an excipient into the solvent pathway; and
a pump operably coupled to at least one of the excipient pathway and the solvent pathway;
wherein the pump is configured to deliver the excipient and the solvent into the mix bag through the solvent pathway;
a valve operably coupled to the bottom gas recirculation port to control fluid flow through the bottom gas recirculation port, the valve operably coupled to the solvent pathway and the connecting pathway of the recirculation assembly;
wherein the pump is configured to deliver the excipient and the solvent into the mix bag through the bottom gas recirculation port.

8. The system of claim 6 , further comprising:
a solvent port coupled to the solvent pathway, the solvent port extending into the top portion of the interior chamber and through the one or more walls of the mix bag;
wherein the pump is configured to deliver the excipient and the solvent through the solvent port.

9. The system of claim 1 , further comprising a solute pump operably coupled to the solute pathway to deliver the solute to the top portion of the interior chamber of the mix bag.

10. A bubble agitation system for mixing a pharmaceutical solution, the system comprising:
a mix bag including one or more walls defining an interior chamber having a top portion and a bottom portion opposite the top portion;
a top gas recirculation port extending into the top portion of the interior chamber through the one or more walls of the mix bag;
a bottom gas recirculation port extending into the bottom portion of the interior chamber through the one or more walls of the mix bag;
a solvent pathway coupled to the interior chamber of the mix bag and configured to deliver a solvent into the mix bag;
a solute pathway coupled to the interior chamber of the mix bag and configured to deliver a solute into the mix bag; and
a recirculation assembly including a connecting pathway and a recirculation pump operably coupled to the connecting pathway, the connecting pathway having a first end coupled to the top gas recirculation port and a second end coupled to the bottom gas recirculation port;
wherein the recirculation pump engages the connecting pathway to pull gas from a headspace disposed adjacent to the top portion of the mix bag and deliver gas through the connecting pathway and into the bottom portion of the mix bag via the bottom gas recirculation port; and
a solute pump operably coupled to the solute pathway to deliver the solute to the top portion of the interior chamber of the mix bag;
wherein the solute pathway is coupled to the connecting pathway, the connecting pathway configured to deliver the solute into the mix bag via the top gas recirculation port.

11. The system of claim 10 , further comprising a valve operably coupled to the top gas recirculation port to control fluid flow through the top gas recirculation port, the valve configured to fluidly couple the solute pathway to the connecting pathway in a first position and fluidly decouple the solute pathway from the connecting pathway in a second position, such that when the valve is in the first position the solute pump is operable to cause the solute to reach the mix bag via the solute pathway, the conn

Assignees

• Baxter Int
• Baxter Healthcare Sa

Inventors

• Hurst William Spencer
• Williams Kent Alan
• Smith Donald A
• Wehrli Michael P
• Escobar Luis Ernesto Criales
• Tam Jessica
• Bigalke Joseph Edward
• Najdeni Gert
• Kerwell Karan
• Zhou Lushan
• Essien Michael Imeobong

Classifications

• B01F35/7176

  using pumps · CPC title

• A61J1/2003

  Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting · CPC title

• B01F23/451

  by injecting one liquid into another · CPC title

• B01F33/401

  Methods · CPC title

• B01F25/53

  in which the mixture is discharged from and reintroduced into a receptacle through a recirculation tube, into which an additional component is introduced · CPC title