Transdermal patch holder

• US 5,108,710 A
• Filed: 11/26/1990
• Issued: 04/28/1992
• Est. Priority Date: 11/26/1990
• Status: Expired due to Term

• Current Assignee: Varian Incorporated (Agilent Technologies, Inc.)
• Original Assignee: Amy C. Little, James E. Swon
• Inventors: Little, Amy C., Swon, James E.
• Primary Examiner(s): Kummert, Lynn
• Application Number:
  US07/617,560
• Time in Patent Office: 519 Days
• Field of Search: 422/104, 422/99, 422/58, 435/310, 128/157, 604/289, 604/304, 604/307, 604/308
• US Class Current: 422/562
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches

Abstract

In a preferred embodiment of the invention, a transdermal patch holder is provided for making possible an ascertaining of drug release rate of a transdermal patch mountable thereon. The holder includes upper and lower spaced-apart aligned annular adapter disc structures forming aligned through-spaces. An upper surface of the lower disc structure has a centrally positioned stepped indentation forming a recess space seatable of the transdermal patch. The lower surface of the upper disc structure has a centrally positioned stepped downwardly-extending projection of slightly lesser cross-section than the cross-section of the recess space and is adapted to downwardly press upon an upper surface of a seated transdermal patch when the upper disc structure is intermittently in a latched state of being latched to the lower disc structure. A latching mechanism provided by outer circumscribing upright edges at each of opposite sides of each of the upper and lower disc structures has spaced-apart cut-aways forming a radially outwardly extending lateral projection therebetween, and lateral projections of the upper and lower disc structures aligned and having elastic annular bands intermittently mounted thereon securable of the upper and lower disc structures in face to face relationship. A transdermal patch is mountable and may be thereby held therebetween, with a handle-tab of the patch being seatable in and extendable through a laterally extending channel to laterally exterior space.

Claims

1. A transdermal patch holder for making possible an ascertaining of release rate of drug carried by a transdermal patch during profiling of transdermal drug delivery systems, comprising in combination aligned separate upper and lower adapter disc structures each having opposite upper and lower surfaces, at least one of the upper and lower disc structures having a first through-space of predetermined first cross-sectional area extending between the upper and lower surfaces thereof, the lower surface of the upper disc structure having at-least some first outer portions thereof and the upper surface of the lower disc structure having at-least some second outer portions thereof with the first outer portions and the second outer portions in contact with one-another, at least one of the upper surface of the lower disc structure and the lower surface of the upper disc structure having a first stepped indentation of a first predetermined depth forming a first recess space in which outer edges of a transdermal patch having a second predetermined cross-sectional area greater than said first cross-sectional area are receivable and seatable, and latching means for intermittently latching-together said upper and lower adapter disc structures whereby a transdermal patch when seated within said first recess space is intermittently securely held in a supported state and position arranged for exposure to leaching liquid in contact with the transdermal patch through said first through-space by which drug is leachable from the transdermal patch, including substantially flattened through-channel structure constructed as part of said at-least one of the upper surface of the lower disc structure and the lower surface of the upper disc structure, the through-channel structure forming a through-channel space at at-least one of opposite sides of and in flow communication with said first recess space to sideward exterior space of which said through-channel structure is constructed and arranged to receive, mount and seat a radially-extending handle-tab of a transdermal patch when a transdermal patch is seated between the upper surface of the lower disc structure and the lower surface of the upper disc structure.

2. The transdermal patch holder of claim 1, in which each of said adapter disc structures has a substantially circular upright outer edge circumscribing and positioned between said upper and lower surfaces thereof and in which said first stepped indentation is of substantially circular shape.

3. The transdermal patch holder of claim 2, in which a remaining one of the lower surface of the upper disc structure and the upper surface of the lower disc structure has a stepped projection of increased disc structure-thickness of a predetermined thickness, said stepped projection having a substantially circular shape of a third predetermined cross-sectional area which is less in area than said second cross-sectional area such that said stepped projection is seatable within said first stepped indentation whereby said stepped projection is pressable on one surface of a transdermal patch sufficiently to restrain the transdermal patch when the transdermal patch is seated within said first stepped indentation.

4. The transdermal patch holder of claim 2, first through-space of predetermined major first cross-sectional area is of circular cross-section formed by an inside diameter of the first stepped indentation having an inside diameter ranging from about 0.125 inches to about 1.75 inches, and in which said first stepped indentation has an outside diameter ranging from about 0.1 inch to about 2.25 inches, wherein said inside diameter is selected to be smaller than said outside diameter, said first stepped indentation having a sufficiently small outside diameter as compared to an outside diameter of a drug reservoir such that a transdermal patch is supportable across said first through-space by support structure of the first stepped indentation.

5. The transdermal patch holder of claim 4, in which said inside diameter of the first stepped indentation ranges from about 0.75 inches to about 1.5 inches and in which said outside diameter of the first stepped indentation ranges from about 0.85 inches to about 2.0 inches, said first stepped indentation having support structure between said stepped indentation inside diameter and said stepped indentation outside diameter ranging from about 0.12 inch and 0.38 inch.

6. The transdermal patch holder of claim 5, in which said upper and lower adapter disc structures each have outside diameters ranging from about 1.7 inch to about 2.6 inch.

7. The transdermal patch holder of claim 6, in which said upper and lower adapter disc structures each have outside diameters ranging from about 1.0 inch to about 3 inches.

8. The transdermal patch holder of claim 6, in which each of said upper and lower adapter disc structures includes means defining said first through-space.

9. The transdermal patch holder of claim 8, said latching means including aligned upper and lower support-disc structures with the upper support-disc structure positioned above said upper adapter disc structure and with the lower support-disc structure positioned below said lower adapter disc structure, with the upper and lower adapter structures aligned with the upper and lower support-disc structures, each of the upper and lower support-disc structures having upper and lower faces, said upper and lower support-disc structures being intermittently securable with the upper support-disc having its lower face pressing downwardly on said upper surface of said upper adapter disc structure and with the lower support-disc having its upper face pressing upwardly on said lower surface of said lower adapter disc structure, at least one of said upper and lower support-disc structures having a centered through-space extending between said upper and lower faces.

10. The transdermal patch holder of claim 9, in which the lower face of the upper support-disc structure includes a second recess space of third predetermined cross-sectional area sufficiently large to receive and seat said upper disc structure, and in which the upper face of the lower support-disc structure includes a third recess space of fourth predetermined cross-sectional area sufficiently large to receive and seat said lower disc structure.

11. The transdermal patch holder of claim 10, in which each of said upper and lower support-disc structures includes said centered through-space.

12. The transdermal patch holder of claim 10, in which said latching means comprises at-least two opposite support-disc edges of each of said upper and lower support-disc structures, each of the opposite support disc edges including a lateral projection, and including at-least two elastic annular members each tightly mountable around each of aligned pairs of said lateral projections of the upper and lower support-disc structures whereby the upper and lower adapter disc structures are adapted to be intermittently held together.

13. The transdermal patch holder of claim 12, in which each said lateral projection is formed by spaced-apart cut-outs in said two opposite support-disc edges to define the lateral projection therebetween whereby distal portions of each lateral projection is substantially flush with its said upright outer edge.

14. A transdermal patch holder for making possible an ascertaining of release rate of drug carried by a transdermal patch during profiling of transdermal drug delivery systems, comprising in combination aligned separate upper and lower adapter disc structures each having opposite upper and lower surfaces, at least one of the upper and lower disc structures having a first through-space of predetermined first cross-sectional area extending between the upper and lower surfaces thereof, the lower surface of the upper disc structure having at-least some first outer portions thereof and the upper surface of the lower disc structure having at-least some second outer portions thereof with the first outer portions and the second outer portions in contact with one-another, at least one of the upper surface of the lower disc structure and the lower surface of the upper disc structure having a first stepped indentation of a first predetermined depth forming a first recess space in which outer edges of a transdermal patch having a second predetermined cross-sectional area greater than said first cross-sectional area are receivable and seatable, and latching means for intermittently latching-together said upper and lower adapter disc structures whereby a transdermal patch when seated within said first recess space is intermittently securely held in a supported state and position arranged for exposure to leaching liquid in contact with the transdermal patch through said first through-space by which drug is leachable from the transdermal patch, in which a remaining one of the lower surface of the upper disc structure and the upper surface of the lower disc structure has a stepped projection of increased disc structure-thickness of a predetermined thickness, said stepped projection having a substantially circular shape of a third predetermined cross-sectional area which is less in area than said second cross-sectional area such that said stepped projection is seatable within said first stepped indentation whereby said stepped projection is pressable on one surface of a transdermal patch sufficiently to restrain the transdermal patch when the transdermal patch is seated within said first stepped indentation.

15. The transdermal patch holder of claim 14, in which a remaining one of said aligned upper and lower adapter disc structures has a second through-space of predetermined major fourth cross-sectional area extending between the upper and lower surfaces thereof whereby each of opposite sides of a transdermal patch supported between the upper and lower aligned adapter disc structures is exposable to surrounding leaching liquid for the leaching of drug therefrom.

16. The transdermal patch holder of claim 15, in which said aligned upper and lower adapter disc structures are made of polytetrafluoroethylene.

17. The transdermal patch holder of claim 15, in which said aligned adapter disc structures are made of stainless steel.

18. The transdermal patch holder of claim 17, in which said upper and lower adapter disc structures each have a thickness ranging from about 0.045 inches to about 0.055 inches.

19. The transdermal patch holder of claim 17, in which said thickness ranges from about 0.025 inches to about 0.030 inches.

20. A transdermal patch holder for making possible an ascertaining of release rate of drug carried by a transdermal patch during profiling of transdermal drug delivery systems, comprising in combination aligned separate upper and lower adapter disc structures each having opposite upper and lower surfaces, at least one of the upper and lower disc structures having a first through-space of predetermined first cross-sectional area extending between the upper and lower surfaces thereof, the lower surface of the upper disc structure having at-least some first outer portions thereof and the upper surface of the lower disc structure having at-least some second outer portions thereof with the first outer portions and the second outer portions in contact with one-another, at least one of the upper surface of the lower disc structure and the lower surface of the upper disc structure having a first stepped indentation of a first predetermined depth forming a first recess space in which outer edges of a transdermal patch having a second predetermined cross-sectional area greater than said first cross-sectional area are receivable and seatable, and latching means for intermittently latching-together said upper and lower adapter disc structures whereby a transdermal patch when seated within said first recess space is intermittently securely held in a supported state and position arranged for exposure to leaching liquid in contact with the transdermal patch through said first through-space by which drug is leachable from the transdermal patch, said latching means comprising at-least two opposite edges of said upright outer edge of each of the aligned adapter disc structures, each of the opposite support edges including a lateral projection, and including at-least two elastic annular members each tightly mountable around aligned lateral projections of the upper and lower disc for each of the two opposite edges whereby the upper and lower adapter disc structures are intermittently held together.

21. The transdermal patch holder of claim 20, in which said lateral projection is formed by spaced-apart cut-outs in said upright outer edge defining the lateral projection therebetween whereby distal portions of each lateral projection are substantially flush with said upright outer edge.

22. A transdermal patch holder for making possible an ascertaining of release rate of drug carried by a transdermal patch during profiling of transdermal drug delivery systems, comprising in combination aligned separate upper and lower adapter disc structures each having opposite upper and lower surfaces, at least one of the upper and lower disc structures having a first through-space of predetermined first cross-sectional area extending between the upper and lower surfaces thereof, the lower surface of the upper disc structure having at-least some first outer portions thereof and the upper surface of the lower disc structure having at-least some second outer portions thereof with the first outer portions and the second outer portions in contact with one-another, at least one of the upper surface of the lower disc structure and the lower surface of the upper disc structure having a first stepped indentation of a first predetermined depth forming a first recess space in which outer edges of a transdermal patch having a second predetermined cross-sectional area greater than said first cross-sectional area are receivable and seatable, and latching means for intermittently latching-together said upper and lower adapter disc structures whereby a transdermal patch when seated within said first recess space is intermittently securely held in a supported state and position arranged for exposure to leaching liquid in contact with the transdermal patch through said first through-space by which drug is leachable from the transdermal patch, said latching means including aligned upper and lower support-disc structures with the upper support-disc structure positioned above said upper adapter disc structure and with the lower support-disc structure positioned below said lower adapter disc structure, with the upper and lower adapter structures aligned with the upper and lower support-disc structures, each of the upper and lower support-disc structures having upper and lower faces, said upper and lower support-disc structures being intermittently securable with the upper support-disc having its lower face pressing downwardly on said upper surface of said upper adapter disc structure and with the lower support-disc having its upper face pressing upwardly on said lower surface of said lower adapter disc structure.

23. The transdermal patch holder of claim 22, in which said upper and lower support-disc structures are stainless steel.

24. The transdermal patch holder of claim 22, in which the lower face of the upper support-disc structure includes a second recess space of third predetermined cross-sectional area sufficiently large to receive and seat said upper disc structure, and in which the upper face of the lower support-disc structure includes a third recess space of fourth cross-sectional area sufficiently large to receive and seat said lower disc structure.

25. The transdermal patch holder of claim 24, in which said latching means comprises at-least two opposite support-disc edges of each of said upper and lower support-disc structures includes a lateral projection, and including at-least two elastic annular members each tightly mountable around each of aligned pairs of said lateral projections of the upper and lower support-disc structures whereby the upper and lower adapter disc structures are adapted to be intermittently held together.

26. The transdermal patch holder of claim 25, in which each said lateral projection is formed by spaced-apart cut-outs in said two opposite support-disc edges to define the lateral projection therebetween whereby distal portions of each lateral projection is substantially flush with its said upright outer edge.

27. The transdermal patch holder of claim 26, in which said upper and lower support-disc structures each have outside diameters ranging from about 1.0 inch to about 3 inches.

28. The transdermal patch holder of claim 27, in which said upper and lower support-disc structures are stainless steel.