DEVICE FOR DELIVERY OF A FOAMABLE COMPOSITION

• US 20090068118A1
• Filed: 09/04/2008
• Published: 03/12/2009
• Est. Priority Date: 09/04/2007
• Status: Active Grant

• Current Assignee: VYNE Therapeutics, Inc.
• Original Assignee: Foamix Ltd. (VYNE Therapeutics, Inc.)
• Inventors: SHIFRIN, Helen, TAMARKIN, Dov, EINI, Meir, SCHUZ, David, HAZOT, Yohan
• Granted Patent: US 8,617,100 B2
• Time in Patent Office: Days
• US Class Current: 424/45
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

A device for delivery of a foamable composition to a body cavity includes a pressurized composition reservoir; a hollow body having a longitudinally extending wall and having at least one aperture provided through a wall of said body, the proximal end in fluid communication with the reservoir for receiving a foamable composition from said composition reservoir; and an actuator operatively connected to the composition reservoir for effecting release of a foamable composition from said composition reservoir into a body cavity through said hollow body; wherein said body has a length less than about 125 mm and internal diameter in the range of about 1.5 mm to about 3.5 mm, wherein said length and internal diameter are selected to provide a delivery of at least about 70% of the foamable composition during operation. The foam delivery device can have multiple apertures.

Claims

1. A device for delivery of a foamable composition to a body cavity, the device comprising:

a pressurized composition reservoir capable of receiving a foamable composition;

a hollow body having distal and proximate ends and a longitudinally extending wall and having at least one aperture provided through a wall of said body, the proximal end in fluid communication with the reservoir for receiving a foamable composition from said composition reservoir, said hollow body being shaped and adapted for insertion within the body cavity; and

an actuator operatively connected to the composition reservoir for effecting release of a foamable composition from said composition reservoir into a body cavity through said hollow body,

wherein said body has a length less than about 125 mm and internal diameter in the range of about 1.5 mm to about 3.5 mm, wherein said length and internal diameter are selected to provide a delivery of at least about 70% of the foamable composition during operation.

2. The device of claim 1, wherein the said length and internal diameter are selected to provide a delivery of at least about 90% of the foamable composition during operation.

3. The device of claim 1, wherein an internal diameter of said hollow body is in the range of from about 2.0 mm to about 3.1 mm.

4. The device of claim 1, wherein a ratio of said internal diameter of said proximal end to said internal diameter of said distal end is in the range of from about 1:

1 to about 1;

4.

5. The device of claim 4, wherein said ratio is about 1:

2.

6. The device of claim 4, wherein said internal diameter increases gradually along the length of said tubular wall.

7. The device of claim 4, wherein said internal diameter increases stepwise.

8. The device of claim 1, wherein the hollow body has a tip at the distal end having a shape selected from the group consisting of bulbous, rounded and triangular.

9. The device of claim 1, wherein the device further comprises a guard surrounding the hollow body at a location along its length.

10. The device of claim 9, wherein the guard is movable between stops located above and below the guard at locations along its length.

11. The device of claim 1, wherein the composition reservoir is pressurized with a low pressure propellant gas.

12. The device of claim 1, wherein said at least one aperture is provided through said distal end of said body.

13. The device of claim 12, wherein said at least one aperture is provided through at least a portion of said tubular wall.

14. The device of claim 13, wherein said at least one aperture comprises a plurality of apertures.

15. The device of claim 1, wherein said pressurized composition reservoir contains a foamable composition and a propellant.

16. The device of claim 1, further comprising a metering chamber.

43. The device of claim 1, further provided with a flexible insertion tube.

17. A device for delivery of a foamable composition to a body cavity, the device comprising:

a pressurized composition reservoir capable of receiving a foamable composition;

a hollow body having distal and proximate ends and a longitudinally extending wall and having at least one aperture provided through a wall of said body, the proximal end in fluid communication with the reservoir for receiving a foamable composition from said composition reservoir, said hollow body being shaped and adapted for insertion within the body cavity; and

an actuator operatively connected to the composition reservoir for effecting release of a foamable composition from said composition reservoir into a body cavity through said hollow body,

wherein said body has a length of about 55-65 mm and an internal diameter and the ratio of the body length to the internal diameter is about 1;

40 to 1;

16.

18. The device of claim 17, wherein the ratio of the body length to the internal diameter is about 2:

65-2;

50.

19. The device of claim 17, wherein ratio of the body length to the internal diameter is about 2:

65-1;

21.

20. A device for delivery of a foamable composition to a body cavity, the device comprising:

a pressurized composition reservoir capable of receiving a foamable composition;

a hollow body having distal and proximate ends and a longitudinally extending wall and having at least one aperture provided through a wall of said body, the proximal end in fluid communication with the reservoir for receiving a foamable composition from said composition reservoir, said hollow body being shaped and adapted for insertion within the body cavity; and

an actuator operatively connected to the composition reservoir for effecting release of a foamable composition from said composition reservoir into a body cavity through said hollow body,

wherein said body has a length of about 95-105 mm and an internal diameter and the ratio of the body length to the internal diameter is about 1;

60-1;

15.

21. The device of claim 20, wherein the ratio of the body length to the internal diameter is about 1:

50-1;

19.

22. The device of claim 20, wherein the ratio of the body length to the internal diameter is about 1:

50-1;

32.

23. A device for delivery of a foamable composition to a body cavity, the device comprising:

a pressurized composition reservoir capable of receiving a foamable composition;

a hollow body having distal and proximate ends and a longitudinally extending wall and having at least one aperture provided through a wall of said body, the proximal end in fluid communication with the reservoir for receiving a foamable composition from said composition reservoir, said hollow body being shaped and adapted for insertion within the body cavity; and

an actuator operatively connected to the composition reservoir for effecting release of a foamable composition from said composition reservoir into a body cavity through said hollow body,

wherein said body has a length of about 120-125 mm and an internal diameter and the ratio of the body length to the internal diameter is about 2;

150-1;

19.

24. The device of claim 23, wherein the ratio of the body length to the internal diameter is about 2:

125-1;

24.

25. The device of claim 23, wherein the ratio of the body length to the internal diameter is about 2:

125-1;

40.

26. A device for delivery of a foamable composition to a body cavity, the device comprising:

a pressurized composition reservoir capable of receiving a foamable composition;

a hollow tube having distal and proximate ends and a longitudinally extending wall and having a plurality of apertures provided through a wall of said tube, the proximal end in fluid communication with the reservoir for receiving a foamable composition from said composition reservoir, said hollow tube being shaped and adapted for insertion within the body cavity; and

an actuator operatively connected to the composition reservoir for effecting release of a foamable composition from said composition reservoir into a body cavity through said hollow tube,

wherein at least one aperture is located at the distal end of the hollow tube and at least one aperture is located along a side wall of the hollow tube, where the location and relative size of the apertures are selected to provide delivery of the foam in a preselected proportion from each aperture.

27. The device of claim 26, wherein said plurality of apertures comprises at least two sidewall apertures, wherein each of a first and a second of said plurality of apertures is located at a distance from said proximal end of from about 1% to about 100% of the length of said tube.

28. The device of claim 26, wherein said plurality of apertures comprises at least two side wall apertures, wherein a first of said plurality of apertures is located at a distance from said proximal end of 90-100% the length of the tube, and said second of said plurality of apertures is located at a distance of from about 90% to about 40% of the length of said tube.

29. The device of claim 26, wherein said plurality of apertures comprises at least two side wall apertures, and wherein the ratio of the diameter of a first of said at least two apertures to the diameter of a second of said at least two apertures is in the range of from about 1:

1 to about 4;

1.

30. The device of claim 29, wherein said ratio is about 2:

1.

31. The device of claim 29, wherein said ratio is selected to provide uniform delivery from said first aperture and said second aperture.

32. The device of claim 29, wherein said ratio is selected to provide uniform pressure at said first and said second aperture.

33. The device of claim 26, wherein said plurality of apertures comprises a first aperture in the distal end of said tube, and a second aperture in a side wall of the wherein the aperture diameters are selected to provide greater release from said second aperture than from said first aperture.

34. The device of claim 33, wherein a first of said plurality of apertures has a diameter of about 1 mm and a second of said plurality of apertures has a diameter of about 2 mm.

35. The device of claim 26, wherein the device has a distance ratio (DR) in the range of from about 1:

2 to about 1;

10, wherein DR is defined as the distance of a first of two side wall apertures to the tip (D1) to the distance between the two side wall apertures (D2).

36. The device of claim 26, wherein DR is in the range of about 1.3 to about 1:

7.

37. The device of claim 26, wherein the side wall aperture diameter is in the range of about 0.5 mm to about 10 mm.

38. The device of claim 26, wherein the side wall aperture diameter is in the range of about 0.9 mm to about 3.2 mm.

39. The device of claim 26, wherein the ratio of the side wall aperture diameters is in the range of about 1:

1 to about 4;

1.

40. The device of claim 26, wherein the ratio of the side wall aperture diameters is in the range of about 2:

1 to about 4;

1.

41. The device of claim 26, wherein the device comprises an aperture ratio (AR) ranging from 1 to 5, where AR is defined as the ratio of a first side wall aperture closest to the tip to a second side wall aperture located further from the tip.

42. The device of claim 26, wherein said tube has a length less than about 125 mm and internal diameter in the range of about 1.5 mm to about 3.5 mm, wherein said length and internal diameter are selected to provide a delivery of at least about 70% of the foamable composition during operation.

44. The device of claim 35, adapted for use with a camera.

45. A device for delivery of a foamable composition to a body cavity, the device comprising:

a pressurized composition reservoir capable of receiving a foamable composition;

a hollow tube having distal and proximate ends and a longitudinally extending wall and having at least one apertures provided through a wall of said tube, the proximal end in fluid communication with the reservoir for receiving a foamable composition from said composition reservoir, said hollow tube being shaped and adapted for insertion within the body cavity; and

an actuator operatively connected to the composition reservoir for effecting release of a foamable composition from said composition reservoir into a body cavity through said hollow tube,

wherein the device has a success parameter (SP) score ranging from 1 to 4 in the following relationship;

SP=J+N+T+C+(RM/DT),

where SP=Success Parameters;

J=Jets;

N=Noise;

T=Tailing;

C=Continuity;

DT=Dispensing Time (measured in seconds); and

RM=Residual Mass (measured in %); and

J, N, T and C can range from 0 to 3.

46. The device of claim 45, wherein the device is selected to provide a preferred delivery mass, minimal residual mass, minimal jetting and minimal tailing.

48. The device of claim 46, wherein the SR score ranges between 1.4 and 7.0.

49. The device of claim 46, wherein the SR score ranges between 2.0 and 6.0.

51. The kit of claim 49, wherein said body cavity is selected from the group consisting of the vagina, the rectum, the colon and the small intestine.

52. The kit of claim 49, wherein the body cavity is the vagina.

53. The kit of claim 49, wherein said active ingredient is selected from the group consisting of an estradiol, pregn-4-ene-3,20-dione, also known as progesterone;

19-nor-pregn-4-en3,20-dione;

17-hydroxy-19-nor-17α

-pregn-5(10)-3-en-20-yn-3-one;

di-β

-ethyl-17α

-ethynyl-17-β

hydroxypregn-4-en-3-one;

17α

-ethynyl-17-hydroxy5(10)-estren-3-one;

17-α

-ethynyl-19-norestosterone;

6-chloro-17-hydroxypregn-4,6-diene-3,20-dione;

17-α

-hydroxy-6.-α

-methyl-17-(1-propynyl)androst4-en-3-one;

9-β

-10-α

-pregna-4,6-diene-3,20-dione;

17-hydroxy-17-α

-pregn-4-en-20-yn-3-one;

19-nor-17-α

-regn-4-en-20yne-3-β

-17-diol;

17-hydroxypregn-4-en-3,20-dione;

17-α

-hydroxy-progesterone;

17-hydroxy-6-α

-methylpregn-4-ene-3,10-dione;

an oxytocic agent, an ergot alkaloid, quinine, quinidine, histamine;

sparteine;

a prostaglandin;

an antimicrobial agent;

tetracycline, chlortetracycline, oxytetracycline, democlocycline, doxycycline, lymecycline, mecolcycline, rolitetracycline and minocycline.

54. A method for treatment of a subject in need thereof, the method comprising placing in a body cavity of the subject the kit of claim 49, and wherein the device when positioned in the body cavity releases the agent in the body cavity.

55. The method of claim 54, wherein the body cavity is the vagina.

56. The method of claim 54, wherein said treatment is selected from the group consisting of controlling fertility and treating a microbial infection of the vagina.

57. A method for treatment of a subject in need thereof, the method comprising placing in a deep body cavity of the subject the device of claim 49, and wherein the device when positioned in the deep body cavity releases the agent in the deep body cavity.

58. The method of claim 57, wherein said deep body cavity is selected from the group consisting of the stomach, the bladder, the uterus, and the intestine.

47. A device for delivery of a foamable composition to a body cavity, the device comprising:

a pressurized composition reservoir capable of receiving a foamable composition;

a hollow tube having distal and proximate ends and a longitudinally extending wall and having at least one apertures provided through a wall of said tube, the proximal end in fluid communication with the reservoir for receiving a foamable composition from said composition reservoir, said hollow tube being shaped and adapted for insertion within the body cavity; and

an actuator operatively connected to the composition reservoir for effecting release of a foamable composition from said composition reservoir into a body cavity through said hollow tube,

wherein the device has a success range (SR) score ranging from 1.2 to 7.4 in the following relationship;

SR=SP+(AR/K)

where SP is a defined above;

AR is aperture ratio and K is ideal internal diameter.

50. A kit for delivery of a foamable composition comprising:

a pressurized canister comprising a foamable composition comprising an active ingredient;

a hollow body for receiving the foamable composition from said composition reservoir, said hollow body being shaped and adapted for insertion within the body cavity and having at least one aperture provided through a wall of said body;

an actuator for effecting release of said foamable composition from said composition reservoir into the body cavity through said hollow body; and

a port for providing fluid communication between said hollow body and said actuator,

wherein said body has a length and internal diameter selected for optimal delivery of the foamable composition to the body cavity.

59. A method of designing an applicator tube, comprising:

identifying the site of the delivery (e.g., local or systemic);

determining an aperture length and diameter to provide minimal mass residue and jetting for the selected medicament; and

locating the apertures to maximize delivery at the desired site.

60. A method of designing an applicator tube, comprising:

identifying the site of the delivery (e.g., local or systemic);

determining an aperture length and diameter to provide minimal mass residue a jetting and tailing for the selected medicament; and

locating each apertures to maximize delivery at the desired site; and

calibrating the aperture size for each aperture to optimize foam release at each aperture.

61. An actuator which connects to a pressurized canister comprising:

a foamable composition;

a connecting means that connects the actuator to a catheter means, which when connected provides a first pressure sensitive seal so that foam released from the canister through the actuator and seal does not escape from the seal and passes into and through the catheter means;

a catheter means suitable for insertion into a deep body cavity which could include the stomach, the bladder, the uterus, the intestine and deliver foam to a target area within the body cavity and having a first and second catheter end;

a first catheter means end suitable for receiving the connecting means;

a second catheter means end suitable for discharging foam or for receiving a foam applicator, which is adapted to discharge foam into the body cavity or onto a particular target, and which when connected provides a second pressure sensitive seal so that foam released from the canister through the actuator and seal through the catheter does not escape from the second seal and passes into and through the foam applicator; and

is then released into the body cavity.

62. A device for delivery of a foamable composition to a body cavity, the device comprising:

a hollow tube having distal and proximate ends and a longitudinally extending wall defining an inner diameter, the proximal end in fluid communication with the reservoir for receiving a foamable composition, said hollow tube being shaped and adapted for insertion within the body cavity; and

a plunger of substantially the same diameter as the inner diameter of the hollow tube, capable of moving from a first position at the proximal end to a second position at the distal end for effecting release of a foamable composition from said hollow tube;

wherein the hollow tube comprises at least first and second apertures along the wall of the hollow tube, wherein first wall aperture is located closest to the distal end of the tube and wherein the aperture size of the first wall aperture is smaller than the aperture size of the second wall aperture.

63. A device for delivery of a foamable composition to a body cavity, the device comprising:

a pressurized composition reservoir capable of receiving a foamable composition;

a hollow tube having distal and proximate ends and a longitudinally extending wall and having a plurality of apertures provided through a wall of said tube, the proximal end in fluid communication with the reservoir for receiving a foamable composition from said composition reservoir, said hollow tube being shaped and adapted for insertion within the body cavity; and

an actuator operatively connected to the composition reservoir for effecting release of a foamable composition from said composition reservoir into a body cavity through said hollow tube,

wherein the hollow tube comprises at least first and second apertures along the wall of the hollow tube, wherein first wall aperture is located closest to the distal end of the tube and wherein the aperture size of the first wall aperture is larger than the aperture size of the second wall aperture.

64. A device for delivery of a foamable composition to a body cavity, the device comprising:

a hollow tube having distal and proximate ends and a longitudinally extending wall defining an inner diameter, the proximal end in fluid communication with the reservoir for receiving a foamable composition, said hollow tube being shaped and adapted for insertion within the body cavity; and

an actuator operatively connected to the hollow tube for effecting release of a foamable composition from said hollow tube,

the location and relative size of the apertures are selected to provide delivery of the foam in a preselected proportion from each aperture so as to provide the maximal coverage of a body coverage with the minimal amount of foamable composition.