WO2023022665A2 - A dispersion releaser - Google Patents

A dispersion releaser Download PDF

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Publication number
WO2023022665A2
WO2023022665A2 PCT/SG2022/050594 SG2022050594W WO2023022665A2 WO 2023022665 A2 WO2023022665 A2 WO 2023022665A2 SG 2022050594 W SG2022050594 W SG 2022050594W WO 2023022665 A2 WO2023022665 A2 WO 2023022665A2
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WO
WIPO (PCT)
Prior art keywords
dispersion
releaser
base member
dialysis membrane
members
Prior art date
Application number
PCT/SG2022/050594
Other languages
French (fr)
Other versions
WO2023022665A3 (en
Inventor
Matthias Gerhard WACKER
Björn FÄHLER
Original Assignee
National University Of Singapore
Pharma Test Apparatebau AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by National University Of Singapore, Pharma Test Apparatebau AG filed Critical National University Of Singapore
Publication of WO2023022665A2 publication Critical patent/WO2023022665A2/en
Publication of WO2023022665A3 publication Critical patent/WO2023022665A3/en

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N13/00—Investigating surface or boundary effects, e.g. wetting power; Investigating diffusion effects; Analysing materials by determining surface, boundary, or diffusion effects
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N13/00—Investigating surface or boundary effects, e.g. wetting power; Investigating diffusion effects; Analysing materials by determining surface, boundary, or diffusion effects
    • G01N2013/006—Dissolution of tablets or the like

Definitions

  • the present invention relates broadly, but not exclusively, to devices and methods for testing drug release, including a dispersion releaser.
  • a dispersion releaser is a device for testing drug release from dispersed dosage forms and works as an adapter for a conventional United States Pharmacopoeia (USP) Apparatus l/ll system.
  • USP United States Pharmacopoeia
  • An aspect of the present disclosure provides a dispersion releaser comprising: a first base member; a second base member; and a cage disposed between the first and second base members, wherein the first base member, cage and second base member define a unitary construction having a tubular shape, and wherein the cage comprises a honeycomb structure.
  • the honeycomb structure may comprise a plurality of interconnected members, the interconnected members forming an alternating pattern of hexagonal openings.
  • the first base member, interconnected members and second base member may be made of a single, substantially rigid material.
  • the material may comprise a three-dimensional (3D)-printable material.
  • the interconnected members may extend substantially orthogonally from at least one of the first and second base members.
  • the dispersion releaser may further comprise a dialysis membrane configured to enclose the first base member, cage and second base member, wherein the dialysis membrane is permeable to selected molecules.
  • the first and second base members may comprise first and second grooves respectively.
  • the dialysis membrane may be configured to extend over the first and second grooves, and the first and second grooves may be configured to receive respective O-rings for sealingly retaining the dialysis membrane.
  • the dialysis membrane may be configured to be attached to the interconnected members of the honeycomb structure.
  • the dialysis membrane may be permanently attached to the interconnected members of the honeycomb structure.
  • test apparatus comprising the dispersion releaser as described.
  • the test apparatus may further comprise a support member, and one of the first and base second members may comprise threads for mounting the dispersion releaser to the support member.
  • the test apparatus may further comprise a rotatable mechanical stirrer supported by the support member, and the threads may have an orientation opposite to a stirring direction of the mechanical stirrer.
  • Another aspect of the present disclosure provides a testing method comprising disposing a first fluid in the dispersion releaser as described; immersing the dispersion releaser in a chamber, the chamber containing a second fluid; and monitoring migration of the selected molecules between the first and second fluids.
  • the method may further comprise disposing the dispersion releaser after completing monitoring.
  • Figure 1 shows a perspective view of a dispersion releaser according to an example embodiment.
  • Figure 2 shows a schematic side view of the dispersion releaser of Figure 1 with a dialysis membrane attached thereto.
  • Figure 3 shows an enlarged view of a portion of the dispersion releaser of Figure 1.
  • Figure 4 shows a side view of the dispersion releaser of Figure 1 mounted to an external support according to an example embodiment.
  • Figure 5A shows a test apparatus comprising the dispersion releaser of Figure 1.
  • Figure 5B shows an enlarged view of a portion of the test apparatus of Figure 5A.
  • Figure 6 shows a flow chart illustrating a testing method according to an example embodiment.
  • the present disclosure provides a dispersion releaser that includes a cage having a honeycomb design.
  • the dispersion releaser can be three-dimensional (3D) printed, thereby having lower manufacturing cost and allowing single-use applications.
  • the dispersion releaser can also be light weight, thereby allowing easy transportation.
  • the dispersion releaser 100 includes a first base member 102, a second base member 104 and a cage 106 having a honeycomb structure disposed between the first base member 102 and second base member 104.
  • the first base member 102, cage 106 and second base member 104 define a unitary construction having a generally tubular shape.
  • the first cage member 102 includes threads 108 for mounting the dispersion releaser 100 to an external support member (not shown in Figures 1 -3). It will be appreciated that the threads can be alternatively formed on the second support member 104.
  • the honeycomb structure of the cage 104 includes a plurality of interconnected members 110 which form an alternating pattern of hexagonal openings 112.
  • the honeycomb structure with hexagonal openings 112 can provide rigidity to resist bending, vibrational and torsional forces that may be experienced by the dispersion releaser 100 during use, and is preferably light-weight.
  • the thickness of the interconnected members 110 and the size of the openings 112 can be selected based on practical requirements.
  • the interconnected members 110 extend substantially orthogonally from at least one of the first and second base members 102, 104.
  • the interconnected members 110 extend substantially orthogonally from the first base member 102, while in the example shown in Figure 3, the interconnected members 110 extend substantially orthogonally from the second base member 104.
  • the configuration as shown in Figure 3 can reduce accumulation of residue at the bottom of the dispersion releaser 100.
  • the first base member 102, interconnected members 110 and second base member 104 are made of a single, substantially rigid material.
  • the rigid material is a three-dimensional (3D)-printable material.
  • 3D-printable material include, but are not limited to metal, Polyether ether ketone (PEEK), resins.
  • PEEK Polyether ether ketone
  • the dispersion releaser 100 further includes a dialysis membrane 114 which encloses the first base member 102, cage 106 and second base member 104.
  • the dialysis membrane 114 is permeable to selected molecules (i.e. selectively permeable) such that during operation, the rate of dispersion or release of such molecules, but not others, into a medium can be accurately determined. It will be appreciated that the material of the dialysis membrane 114 and its associated permeability can be selected based on practical requirements, for example, the molecules being tested.
  • the first base member 102 includes a first groove 116 while the second base member 104 includes a second groove 118.
  • the dialysis membrane 114 extends over the first and second grooves 116, 118.
  • the first and second grooves 116, 118 can receive respective O-rings 120, 122 for sealingly retaining the dialysis membrane 114.
  • the first groove 116 is sufficiently spaced from the threads 108 such that deformation of the dialysis membrane 114 is avoided, or the excess membrane material does not interfere with the mounting of the dispersion releaser 100 using the threads 108, when the dispersion releaser 100 is mounted in a testing apparatus.
  • the dialysis membrane 114 is supported by the interconnected members 110 of the honeycomb structure against fluidic forces acting on the dialysis membrane 114 during operation.
  • the dialysis membrane 114 is permanently attached to the interconnected members 110 using an adhesive.
  • the interconnected members 110 provide a relatively larger surface area for adhering the dialysis membrane 114 compared to other configurations, for example, parallel pillars.
  • the whole dispersion releaser 100 including the dialysis membrane 114 can be disposed of (i.e. single-use), thereby avoiding the need to remove and replace the dialysis membrane as is being done in conventional devices.
  • Figure 4 shows a side view of the dispersion releaser 100 of Figure 1 mounted to an external support 400 according to an example embodiment.
  • the threads 108 ( Figures 1 -2) can mate with corresponding threads of the external support 400.
  • a rotatable mechanical stirrer 402 extends through the dispersion releaser 100 and is supported by the external support 400.
  • the threads 108 have an orientation opposite to a stirring direction of the mechanical stirrer 402 such that rotation of the mechanical stirrer 402 during operation does not inadvertently cause the dispersion to become loose or to detach from the external support 400.
  • the external support 400 is made of a metallic material, e.g. stainless steel, and is compatible with existing devices. In other words, the dispersion releaser 100 can fit into existing set-up without requiring modification. However, it will be appreciated that in other embodiments, the external support 400 can be made of a different material, e.g. a 3D-printable material, that may allow the external support 400 to be manufactured at a lower cost.
  • a metallic material e.g. stainless steel
  • the external support 400 can be made of a different material, e.g. a 3D-printable material, that may allow the external support 400 to be manufactured at a lower cost.
  • Figure 5A shows a test apparatus 500, also known as a dissolution tester, that includes the dispersion releaser 100 of Figure 1 , for performing an in-vitro test of a certain molecule, e.g. a pharmaceutical composition.
  • Figure 5B shows an enlarged view of a portion of the test apparatus 500 of Figure 5A.
  • the dispersion releaser 100 together with the external support 400 and mechanical stirrer 402 as described above with reference to Figure 4, is suspended in a chamber or container 502.
  • a fluid, gel or cream containing the molecule is disposed in the dispersion releaser 100, while another fluid 54, such as one simulating a bodily fluid (e.g.
  • the chamber 502 blood, intestinal juice or gastric juice
  • the migration or dissolution of the relevant molecule between the fluid in the dispersion releaser 100 and the fluid in the chamber 502 is then monitored. After the test is completed, the used dispersion releaser 100 is disposed of in accordance with the required safety protocols.
  • Figure 6 shows a flow chart 600 illustrating a testing method according to an example embodiment.
  • a first fluid is disposed in the dispersion releaser as described above.
  • the dispersion releaser is immersed in a chamber which contains a second fluid.
  • migration of the selected molecules between the first and second fluids is monitored.
  • the 3D-printed dispersion releaser in example embodiments includes a honeycomb design and other improvements.
  • a honeycomb design can be manufactured by 3D printing much more easily and cost-effectively without the use of significant “support structure”. This can lead to fewer irregularities on the surface of the device and, consequently, reduced friction between the dialysis membrane and the stirrer parts.
  • the honeycomb design enables the manufacture of a single-use device because of the larger contact area with the dialysis membrane.

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  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • External Artificial Organs (AREA)

Abstract

A dispersion releaser includes a first base member, a second base member, and a cage. The cage is disposed between the first and second base members. The first base member, cage and second base member define a unitary construction having a tubular shape. The cage has a honeycomb structure.

Description

A DISPERSION RELEASER
TECHNICAL FIELD
[0001] The present invention relates broadly, but not exclusively, to devices and methods for testing drug release, including a dispersion releaser.
BACKGROUND
[0002] A dispersion releaser (DR) is a device for testing drug release from dispersed dosage forms and works as an adapter for a conventional United States Pharmacopoeia (USP) Apparatus l/ll system. In the past, such devices have been applied to evaluate drug release from liposomes, nanoparticles, creams and gels, for example.
[0003] Main disadvantages of a conventional dispersion releaser are the high manufacturing cost due to serval customized metal parts and the long preparation time of the cell to make it ready for operation.
[0004] A need therefore exists to provide a dispersion releaser that can address at least some of the above problems.
SUMMARY
[0005] An aspect of the present disclosure provides a dispersion releaser comprising: a first base member; a second base member; and a cage disposed between the first and second base members, wherein the first base member, cage and second base member define a unitary construction having a tubular shape, and wherein the cage comprises a honeycomb structure.
[0006] The honeycomb structure may comprise a plurality of interconnected members, the interconnected members forming an alternating pattern of hexagonal openings.
[0007] The first base member, interconnected members and second base member may be made of a single, substantially rigid material. The material may comprise a three-dimensional (3D)-printable material. [0008] The interconnected members may extend substantially orthogonally from at least one of the first and second base members.
[0009] The dispersion releaser may further comprise a dialysis membrane configured to enclose the first base member, cage and second base member, wherein the dialysis membrane is permeable to selected molecules.
[0010] The first and second base members may comprise first and second grooves respectively. The dialysis membrane may be configured to extend over the first and second grooves, and the first and second grooves may be configured to receive respective O-rings for sealingly retaining the dialysis membrane.
[0011] The dialysis membrane may be configured to be attached to the interconnected members of the honeycomb structure. The dialysis membrane may be permanently attached to the interconnected members of the honeycomb structure.
[0012] There is also disclosed a test apparatus comprising the dispersion releaser as described. The test apparatus may further comprise a support member, and one of the first and base second members may comprise threads for mounting the dispersion releaser to the support member. The test apparatus may further comprise a rotatable mechanical stirrer supported by the support member, and the threads may have an orientation opposite to a stirring direction of the mechanical stirrer.
[0013] There is also disclosed a method of manufacturing the dispersion releaser as described, the method comprising 3D-printing the unitary construction having the first base member, cage and second base member.
[0014] Another aspect of the present disclosure provides a testing method comprising disposing a first fluid in the dispersion releaser as described; immersing the dispersion releaser in a chamber, the chamber containing a second fluid; and monitoring migration of the selected molecules between the first and second fluids.
[0015] The method may further comprise disposing the dispersion releaser after completing monitoring. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Embodiments of the invention will be better understood and readily apparent to one of ordinary skill in the art from the following written description, by way of example only, and in conjunction with the drawings, in which:
[0017] Figure 1 shows a perspective view of a dispersion releaser according to an example embodiment.
[0018] Figure 2 shows a schematic side view of the dispersion releaser of Figure 1 with a dialysis membrane attached thereto.
[0019] Figure 3 shows an enlarged view of a portion of the dispersion releaser of Figure 1.
[0020] Figure 4 shows a side view of the dispersion releaser of Figure 1 mounted to an external support according to an example embodiment.
[0021] Figure 5A shows a test apparatus comprising the dispersion releaser of Figure 1.
[0022] Figure 5B shows an enlarged view of a portion of the test apparatus of Figure 5A.
[0023] Figure 6 shows a flow chart illustrating a testing method according to an example embodiment.
DETAILED DESCRIPTION
[0024] The present disclosure provides a dispersion releaser that includes a cage having a honeycomb design. The dispersion releaser can be three-dimensional (3D) printed, thereby having lower manufacturing cost and allowing single-use applications. The dispersion releaser can also be light weight, thereby allowing easy transportation.
[0025] With reference to Figures 1 -3, a dispersion releaser 100 according to an example embodiment is now described. The dispersion releaser 100 includes a first base member 102, a second base member 104 and a cage 106 having a honeycomb structure disposed between the first base member 102 and second base member 104. The first base member 102, cage 106 and second base member 104 define a unitary construction having a generally tubular shape. In one implementation, the first cage member 102 includes threads 108 for mounting the dispersion releaser 100 to an external support member (not shown in Figures 1 -3). It will be appreciated that the threads can be alternatively formed on the second support member 104.
[0026] The honeycomb structure of the cage 104 includes a plurality of interconnected members 110 which form an alternating pattern of hexagonal openings 112. The honeycomb structure with hexagonal openings 112 according to example embodiments can provide rigidity to resist bending, vibrational and torsional forces that may be experienced by the dispersion releaser 100 during use, and is preferably light-weight. The thickness of the interconnected members 110 and the size of the openings 112 can be selected based on practical requirements.
[0027] In a non-limiting implementation, the interconnected members 110 extend substantially orthogonally from at least one of the first and second base members 102, 104. For example, in the example shown in Figure 2, the interconnected members 110 extend substantially orthogonally from the first base member 102, while in the example shown in Figure 3, the interconnected members 110 extend substantially orthogonally from the second base member 104. In use, with the dispersion releaser 100 being upright, the configuration as shown in Figure 3 can reduce accumulation of residue at the bottom of the dispersion releaser 100.
[0028] The first base member 102, interconnected members 110 and second base member 104 are made of a single, substantially rigid material. In a preferred embodiment, the rigid material is a three-dimensional (3D)-printable material. Examples of such a 3D-printable material include, but are not limited to metal, Polyether ether ketone (PEEK), resins. The use of a single material and 3D-printing can provide quick and cost-effective fabrication of the relatively intricate geometry of the cage 106.
[0029] With particular reference to Figure 2, the dispersion releaser 100 according to example embodiments further includes a dialysis membrane 114 which encloses the first base member 102, cage 106 and second base member 104. The dialysis membrane 114 is permeable to selected molecules (i.e. selectively permeable) such that during operation, the rate of dispersion or release of such molecules, but not others, into a medium can be accurately determined. It will be appreciated that the material of the dialysis membrane 114 and its associated permeability can be selected based on practical requirements, for example, the molecules being tested.
[0030] The first base member 102 includes a first groove 116 while the second base member 104 includes a second groove 118. When assembled, the dialysis membrane 114 extends over the first and second grooves 116, 118. Further, the first and second grooves 116, 118 can receive respective O-rings 120, 122 for sealingly retaining the dialysis membrane 114. In some implementations, the first groove 116 is sufficiently spaced from the threads 108 such that deformation of the dialysis membrane 114 is avoided, or the excess membrane material does not interfere with the mounting of the dispersion releaser 100 using the threads 108, when the dispersion releaser 100 is mounted in a testing apparatus.
[0031 ] The dialysis membrane 114 is supported by the interconnected members 110 of the honeycomb structure against fluidic forces acting on the dialysis membrane 114 during operation. For example, during the preparation stage, the dialysis membrane 114 is permanently attached to the interconnected members 110 using an adhesive. The interconnected members 110 provide a relatively larger surface area for adhering the dialysis membrane 114 compared to other configurations, for example, parallel pillars. After use, the whole dispersion releaser 100 including the dialysis membrane 114 can be disposed of (i.e. single-use), thereby avoiding the need to remove and replace the dialysis membrane as is being done in conventional devices.
[0032] Figure 4 shows a side view of the dispersion releaser 100 of Figure 1 mounted to an external support 400 according to an example embodiment. For example, the threads 108 (Figures 1 -2) can mate with corresponding threads of the external support 400. A rotatable mechanical stirrer 402 extends through the dispersion releaser 100 and is supported by the external support 400. The threads 108 have an orientation opposite to a stirring direction of the mechanical stirrer 402 such that rotation of the mechanical stirrer 402 during operation does not inadvertently cause the dispersion to become loose or to detach from the external support 400.
[0033] Here, the external support 400 is made of a metallic material, e.g. stainless steel, and is compatible with existing devices. In other words, the dispersion releaser 100 can fit into existing set-up without requiring modification. However, it will be appreciated that in other embodiments, the external support 400 can be made of a different material, e.g. a 3D-printable material, that may allow the external support 400 to be manufactured at a lower cost.
[0034] Figure 5A shows a test apparatus 500, also known as a dissolution tester, that includes the dispersion releaser 100 of Figure 1 , for performing an in-vitro test of a certain molecule, e.g. a pharmaceutical composition. Figure 5B shows an enlarged view of a portion of the test apparatus 500 of Figure 5A. The dispersion releaser 100, together with the external support 400 and mechanical stirrer 402 as described above with reference to Figure 4, is suspended in a chamber or container 502. A fluid, gel or cream containing the molecule is disposed in the dispersion releaser 100, while another fluid 54, such as one simulating a bodily fluid (e.g. blood, intestinal juice or gastric juice), is disposed in the chamber 502 to a level that totally covers the dispersion releaser 100. The migration or dissolution of the relevant molecule between the fluid in the dispersion releaser 100 and the fluid in the chamber 502 is then monitored. After the test is completed, the used dispersion releaser 100 is disposed of in accordance with the required safety protocols.
[0035] Figure 6 shows a flow chart 600 illustrating a testing method according to an example embodiment. At step 602, a first fluid is disposed in the dispersion releaser as described above. At step 604, the dispersion releaser is immersed in a chamber which contains a second fluid. At step 606, migration of the selected molecules between the first and second fluids is monitored.
[0036] As described, the 3D-printed dispersion releaser in example embodiments includes a honeycomb design and other improvements. Such a structure can be manufactured by 3D printing much more easily and cost-effectively without the use of significant “support structure”. This can lead to fewer irregularities on the surface of the device and, consequently, reduced friction between the dialysis membrane and the stirrer parts. Also, the honeycomb design enables the manufacture of a single-use device because of the larger contact area with the dialysis membrane.
[0037] It will be appreciated by a person skilled in the art that numerous variations and/or modifications may be made to the present invention as shown in the specific embodiments without departing from the scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects to be illustrative and not restrictive.

Claims

7 CLAIMS
1 . A dispersion releaser comprising: a first base member; a second base member; and a cage disposed between the first and second base members, wherein the first base member, cage and second base member define a unitary construction having a tubular shape, and wherein the cage comprises a honeycomb structure.
2. The dispersion releaser according to claim 1 , wherein the honeycomb structure comprises a plurality of interconnected members, the interconnected members forming an alternating pattern of hexagonal openings.
3. The dispersion releaser according to claim 2, wherein the first base member, interconnected members and second base member are made of a single, substantially rigid material.
4. The dispersion releaser according to claim 3, wherein the material comprises a three-dimensional (3D)-printable material.
5. The dispersion releaser according to any one of claims 2 to 4, wherein the interconnected members extend substantially orthogonally from at least one of the first and second base members.
6. The dispersion releaser according to any one of claims 2 to 5, further comprising a dialysis membrane configured to enclose the first base member, cage and second base member, wherein the dialysis membrane is permeable to selected molecules.
7. The dispersion releaser according to claim 6, wherein the first and second base members comprise first and second grooves respectively, wherein the dialysis membrane is configured to extend over the first and second grooves, and wherein the first and second grooves are configured to receive respective O-rings for sealingly retaining the dialysis membrane. 8
8. The dispersion releaser according to claim 6 or 7, wherein the dialysis membrane is configured to be attached to the interconnected members of the honeycomb structure.
9. The dispersion releaser according to claim 8, wherein the dialysis membrane is permanently attached to the interconnected members of the honeycomb structure.
10. A test apparatus comprising the dispersion releaser according to any one of the preceding claims.
11. The test apparatus according to claim 10, further comprising a support member, wherein one of the first and base second members comprises threads for mounting the dispersion releaser to the support member.
12. The test apparatus according to claim 11 , further comprising a rotatable mechanical stirrer supported by the support member, wherein the threads have an orientation opposite to a stirring direction of the mechanical stirrer.
13. A method of manufacturing the dispersion releaser according to any one of claims 1 to 9, the method comprising 3D-printing the unitary construction having the first base member, cage and second base member.
14. A testing method comprising: disposing a first fluid in the dispersion releaser according to claim 6; immersing the dispersion releaser in a chamber, the chamber containing a second fluid; and monitoring migration of the selected molecules between the first and second fluids.
15. The method according to claim 14, further comprising disposing the dispersion releaser after completing monitoring.
PCT/SG2022/050594 2021-08-19 2022-08-19 A dispersion releaser WO2023022665A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SG10202109083W 2021-08-19
SG10202109083W 2021-08-19

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WO2023022665A3 WO2023022665A3 (en) 2023-03-23

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Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19839398B4 (en) * 1998-08-29 2006-02-16 Sanofi-Aventis Deutschland Gmbh Mini-Basket for investigating drug release from a dosage form
WO2010099519A1 (en) * 2009-02-27 2010-09-02 University Of Connecticut Dialysis adapter cell and method of use
WO2011081857A1 (en) * 2009-12-14 2011-07-07 Cephalon, Inc. Container and device for dissolution testing
DE102013015522B4 (en) * 2013-09-18 2023-04-13 Pharma Test Apparatebau AG Dialysis cell for in vitro dissolution test apparatus, Use of the dialysis cell and in vitro dissolution test apparatus

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