PROCESS AND DEVICE FOR DOSING PHARMACEUTICAL AGENTS

• US 20070282276A1
• Filed: 06/02/2006
• Published: 12/06/2007
• Est. Priority Date: 06/02/2006
• Status: Active Grant

• Current Assignee: Boehringer Ingelheim Pharma GmbH & Company Kg (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim Pharma GmbH & Company Kg (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: GESER, Johannes, BOECK, Georg, HAUSMANN, Matthias, FEIERTAG, Christian, EICHER, Joachim, KOELBEL, Hans-Juergen
• Granted Patent: US 8,061,350 B2
• Time in Patent Office: Days
• US Class Current: 604/207
• CPC Class Codes: B05B 11/1001 Piston pumps B05B11/1087, B05B11/1088, B05B11/109 take precedence
• CPC Class Codes: B05B 9/0413 with reciprocating pumps, e.g. membrane pump, piston pump, bellow pump B05B9/0409 takes precedence
• CPC Class Codes: F04B 53/16 Casings; Cylinders; Cylinder liners or heads; Fluid connections

Abstract

A process and a device for dosing a pharmaceutical agent, preferably a liquid, are proposed. To achieve an enhanced dosing accuracy, a first component that is produced in batches, such as a shaped seal, is combined with a second component, such as a guide pipe selected from a suitable group guide pipes, wherein the suitable group of second components is selected based on at least one decisively significant value of the respective batch first components and is distinguished by an essential value of the second component which will optimize the sealing between the first and second components.

Claims

1. Process for producing a dosage of a pharmaceutical agent with enhanced accuracy, comprising the steps of:

producing a first component in batches,

determining at least one significant value of the first components of each batch on a random-sample basis and determining at least one decisively significant value for all first components of the respective batch therefrom,

providing a plurality of second components and dividing the second components into groups which are distinguished from each other by at least one essential value of the second component,

selecting a batch of first components based on a respective said at least one decisively significant value which is suitable for the purpose is selected,

combining each first component of the selected batch with a second component of a group that, based on the at least one decisively significant value of the selected batch, is suitable for the selected batch for purposes of optimizing production of a sealing action between the first and second components for improving the dosing accuracy by preventing air from passing therebetween, and

arranging at least the first and the second component so that tightly engage or adjoin one another in a manner enabling the first and second components to be movable relative to one another for production of a dose of the pharmaceutical agent.

2. Process according to claim 1, wherein the step of producing the first components is performed by injection molding.

3. Process according to claim 1, wherein the first components are ring-shaped seals.

4. Process according to claim 1, wherein said at least one significant value of the first components determined is at least one of a dimensional manufacturing tolerance, the volume of the first components, and the compressibility of the first components.

5. Process according to claim 1, wherein the mean and the standard deviation are determined to be significant values.

6. Process according to claim 11 wherein the second components have a recess for receiving the first component.

7. Process according to claim 6, wherein the recess comprises a shoulder or groove and forms a guide pipe for a piston.

8. Process according to claim 6, wherein at least one of the depth and width of the recess is used as said at least one essential value for division of the second components into groups.

9. Process according to claim 1, wherein the mean and the standard deviation are used as essential values for division of the second components into groups.

10. Process according to claim 1, wherein the second components are produced with different essential values, and wherein the difference of the essential values of different groups is greater than production tolerances.

11. Process according to claim 1, wherein the second components are produced in batches, wherein the at least one essential value of the second component of each batch is determined based on a random sample, and the essential value determined from the random sample is used for all second components of the respective batch for division into groups.

12. Process according to claim 1, wherein the device has at least one of an additional component which is sealed by the first component and a support ring for axial securing of the first component to the second component.

13. Process according to claim 12, wherein said additional component is a piston.

14. Process according to claim 13, wherein the piston is produced in batches, and at least one significant value thereof is determined only on a random-sample basis for each batch.

15. Process according to claim 14, wherein the piston at least one significant value of the piston is the diameter thereof.

16. Process according to claim 13, wherein at least one of the diameter of the piston and an axially active length of the support ring is determined, and is considered as an additional significant value in addition to the decisively significant value in selection of the suitable group.

17. Process according to claim 3, wherein the suitable group is selected such that the decisively significant value together with the at least one essential value results in a set fill level of the recess by the seal.

18. Device for administration of a pharmaceutical agent with improved dosing accuracy, comprising:

a guide pipe,

a piston,

a shaped seal for sealing between guide pipe and piston, and

a recess for receiving the shaped seal,

wherein the shaped seal has been selected from a specific batch of shaped seals based on at least one decisively significant value of the batch and is combined with a guide pipe of a suitable group of the guide pipes which has been selected from several groups of guide pipes such that the recess is fill up by the shaped seal to a set fill level to optimize sealing between the shaped seal and the guide pipe for enhancing the dosing accuracy by preventing leakage of air therebetween.

19. Device according to claim 18, wherein the recess is one of a groove and a shoulder.

20. Device according to claim 18, wherein the recess is formed together with the guide pipe.

21. Device according to claim 18, wherein the device has a support ring for axial securing of the shaped seal in the recess and/or limiting of the recess.

22. Device according to claim 18, wherein the shaped seal is ring-shaped.

23. Device according to claim 18, wherein the shaped seal in the recess is pressed and elastically deformed in the recess against the piston.

24. Device according to claim 18, wherein the diameter of the piston is 0.25 mm to 4 mm.

25. Device according to claim 18, wherein the diameter of the piston is 0.5 mm to 3 mm.

26. Device according to claim 18, wherein the diameter of the piston is 0.75 mm to 2.25 mm.

27. Device according to claim 18, wherein the device has pump volume of 1 μ

l to 1 ml per piston stroke.

28. Device according to claim 18, wherein the device has pump volume of 1 μ

l to 5 μ

l per piston stroke.

29. Device according to claim 18, wherein the device has pump volume of 5 μ

l to 100 μ

l per piston stroke.

30. Device according to claim 18, wherein the device has pump volume of 5 μ

l to 30 μ

l, per piston stroke.

31. Device according to claim 18, wherein the set fill level is at least 90% with a tolerance of at most 5%.

32. Device according to claim 18, wherein the set fill level is at least 95% with a tolerance of at most 4% or less.

33. Device according to claim 18, wherein the device is one of a sprayer, inhaler, injector, pressure generator and dosing pump for medical therapy.