Pinna reflex assay

• US 7,115,399 B2
• Filed: 07/16/2002
• Issued: 10/03/2006
• Est. Priority Date: 07/31/2001
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Jenkins, Jennifer A.
• Primary Examiner(s): THOMPSON, JEWEL VERGIE
• Application Number:
  US10/197,009
• Publication Number:
  US 20030032891A1
• Time in Patent Office: 1,540 Days
• Field of Search: 514/14, 514/312, 514/183, 119/417, 119/103, 600/546, 800/18, 424/236.1, 424/93, 435/84, 435/4, 738/61
• US Class Current: 435/84
• CPC Class Codes: A61B 2503/40 Animals
• CPC Class Codes: A61B 2503/42 for laboratory research
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61B 5/6816 Ear lobe

Abstract

Method for measuring potency of a substance, the method including; administering the substance to a mammal; subjecting the mammal to a stimulus; and monitoring a pinna reflex response of the mammal.

Claims

1. A method for measuring potency of a Clostridial neurotoxin, said method comprising:

injecting a Clostridial neurotoxin into a muscle of a mammal;

subjecting said mammal to a stimulus; and

monitoring a pinna reflex response of said mammal to said stimulus to measure the potency of the Clostridial neurotoxin;

wherein said monitoring includes measuring a latency of the response.

2. The method of claim 1 which further comprises placing said mammal in a confined space prior to said subjecting.

3. The method of claim 1 which further comprises placing said mammal in a restraint prior to said subjecting.

4. The method of claim 2 which further comprises placing said mammal in a restraint in said confined space prior to said subjecting.

5. The method of claim 1 wherein said monitoring includes recording said pinna reflex response of said mammal to said stimulus.

6. The method of claim 1 wherein said mammal is a rat.

7. The method of claim 1 wherein the Clostridial neurotoxin is injected into a levator auris longus muscle of said mammal.

8. The method of claim 1 wherein the Clostridial neurotoxin is a toxin selected from the group consisting of botulinum toxin serotype A, botulinum serotype B, botulinum serotype C1, botulinum toxin serotype D, botulinum toxin serotype E, borulinum toxin serotype F, and combinations thereof.

9. The method of claim 2 wherein the Clostridial neurotoxin is botulinum toxin serotype A.

10. The method of claim 1 wherein said stimulus has an effect on a sense of said mammal.

11. The method of claim 1 wherein said stimulus is an acoustic stimulus or a visual stimulus.

12. The method claim 1 wherein said stimulus is an acoustic stimulus.

13. The method of claim 1 wherein said monitoring includes using a photocell device.

14. The method of claim 1 wherein said monitoring comprises measuring a flexion of an ear of said mammal.

15. The method of claim 14 wherein said measuring includes using a photocell device positioned in front of said ear of said mammal.

16. The method of claim 14 wherein said measuring includes recording said flexion of said ear of said manual.

17. The method of claim 1 which further comprises monitoring an activity of the muscle injected with the Clostridial neurotoxin.

18. The method of claim 17 wherein said muscle activity monitoring includes using an electromyograph.

19. The method of claim 17 wherein said muscle activity monitoring includes recording said activity of said muscle.

20. The method of claim 17 which further comprises repeating said subjecting and said activity monitoring after a time interval has elapsed.

21. The method of claim 17 which further comprises repeating said subjecting and said activity monitoring after a pre-determined time interval has elapsed.

22. The method of claim 17 further comprising correlating said activity to said potency of said Clostridial neurotoxin.

23. The method of claim 1 which further comprises monitoring an activity of the muscle injected with the Clostridial neurotoxin by appropriately positioning an electromyographical probe.

24. The method of claim 23 wherein said muscle activity monitoring includes recording information provided by said electromyographical probe.

25. The method of claim 1 which further comprises repeating said subjecting and said monitoring after a time interval has elapsed.

26. The method of claim 23 wherein said information is an amplitude of said response.

27. The method of claim 23 wherein said information is a frequency of said response.

28. The method of claim 23 wherein said information is a substance latency of said response.

29. The method of claim 1 which further comprises repeating said subjecting and said monitoring after a pre-determined time interval has elapsed.

30. The method of claim 1 which includes measuring a magnitude of said response.

31. The method of claim 1 further comprising correlating said response to said potency of said Clostridial neurotoxin.

32. The method of claim 31 wherein said correlating is done using a member selected from the group consisting of a latency, an EMG latency, a magnitude, an amplitude, a frequency and combinations thereof.

33. The method of claim 1 wherein more than one dose level of said Clostridial neurotoxin is administered to said mammal.

34. A method for measuring potency of a Clostridial neurotoxin, said method comprising:

injecting a Clostridial neurotoxin into a muscle of each of a plurality of mammals, each mammal being provided with a different dose level of Clostridial neurotoxin;

subjecting said mammals to a stimulus and;

monitoring a pinna reflex response of said mammals to said stimulus to measure the potency of the Clostridial neurotoxin;

wherein said monitoring includes measuring a latency of the response.

35. The method of claim 34 wherein said monitoring includes recording said pinna reflex response of said mammal to said stimulus.

36. The method of claim 34 wherein said mammal is a rat.

37. The method of claim 34 wherein the Clostridial neurotoxin is botulinum toxin serotype A.

38. The method claim 34 wherein said stimulus is an acoustic stimulus.

39. The method of claim 34 which further comprises monitoring an activity of the muscle injected with the Clostridial neurotoxin.

40. The method of claim 34 which further comprises repeating said subjecting and said monitoring after a time interval has elapsed.

41. The method of claim 34 which includes measuring a response magnitude.