Unit dose drug delivery platform

• US 8,579,856 B2
• Filed: 08/05/2010
• Issued: 11/12/2013
• Est. Priority Date: 05/16/2007
• Status: Active Grant

• Current Assignee: Mystic Pharmaceuticals Inc.
• Original Assignee: Mystic Pharmaceuticals Inc.
• Inventors: Sullivan, Timothy R., Nelson, Jeffrey
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US12/851,524
• Publication Number:
  US 20100331765A1
• Time in Patent Office: 1,195 Days
• Field of Search: 128/200.14, 604294-298, 604300-301
• US Class Current: 604/118
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/0003 with means for dispensing more than one drug
• CPC Class Codes: A61M 15/0025 with caps
• CPC Class Codes: A61M 15/0031 by bursting or breaking the package, i.e. without cutting or piercing
• CPC Class Codes: A61M 15/0036 hollow piercing means
• CPC Class Codes: A61M 15/004 with fixed piercing or cutting means
• CPC Class Codes: A61M 15/0048 the dosages being arranged in a plane, e.g. on diskettes
• CPC Class Codes: A61M 15/0051 the dosages being arranged on a tape, e.g. strips
• CPC Class Codes: A61M 15/0055 the used dosages being coiled
• CPC Class Codes: A61M 15/0056 the used dosages being crushed
• CPC Class Codes: A61M 15/0058 the used dosages being cut from the carrier
• CPC Class Codes: A61M 15/006 the used dosages being discarded out of the inhaler's housing
• CPC Class Codes: A61M 15/0073 on a ring
• CPC Class Codes: A61M 15/0078 on a strip
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 15/06 Inhaling appliances shaped like cigars, cigarettes or pipes
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2202/0468 : non-physiological
• CPC Class Codes: A61M 2202/064 : Powder
• CPC Class Codes: A61M 2205/073 : Syringe, piston type
• CPC Class Codes: A61M 2205/273 : preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/582 : by tactile feedback
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/584 : having a color code
• CPC Class Codes: A61M 2205/6054 : Magnetic identification systems
• CPC Class Codes: A61M 2205/6081 : Colour codes
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2206/16 : Rotating swirling helical flow, e.g. by tangential inflows
• CPC Class Codes: A61M 2210/0612 : Eyes
• CPC Class Codes: A61M 5/2425 : by compression of deformable ampoule or carpule wall
• CPC Class Codes: B05B 11/0035 : Pen-like sprayers
• CPC Class Codes: B05B 11/0083 : one of the components being in powder form
• CPC Class Codes: B05B 11/02 : Membranes or pistons acting on the contents inside the container, e.g. follower pistons
• CPC Class Codes: B05B 11/048 : characterised by the container, e.g. this latter being surrounded by an enclosure, or the means for deforming it B05B11/041, B05B11/046 take precedence
• CPC Class Codes: B05B 11/062 : designed for spraying particulate material
• CPC Class Codes: B05B 11/1056 : comprising rotatable or articulated levers B05B11/1053 takes precedence; lever actuated piston pumps B05B11/1009; lever actuated pumps with deformable chamber B05B11/1029
• CPC Class Codes: B05B 11/1057 : Triggers, i.e. actuation means consisting of a single lever having one end rotating or pivoting around an axis or a hinge fixedly attached to the container, and another end directly actuated by the user

Abstract

The delivery systems of the present disclosure are configurable to administer either single-dose or multiple-doses of one or more substances to a user, for example to the eye, nose, mouth, ear or rectum of the user. The precise and repeatable dosing features of the presently disclosed delivery systems overcome many of the disadvantages associated with known methods for dispensing substances to, for example, the eye of a user. The delivery systems administer precise doses of a substance to a precise location from unit dosage forms that may be single-dose or multiple-dose unit dosage forms, which may be externally or internally pierced.

Claims

1. A drug delivery system comprising:

a housing configured to contain one or more crushable unit dosage forms;

a user activation mechanism, effective when activated, to engage a drug delivery mechanism comprising a piston drivable into at least one dosage form contained in the housing, wherein the activation mechanism provides a mechanical advantage, a mechanical disadvantage or a combination of mechanical advantage and disadvantage to the activation mechanism; and

a discharge port formed in or contiguous with the housing and configured to release the contents of a dosage form upon activation of the activation mechanism.

2. The drug delivery system of claim 1, wherein the dosage forms are blisters comprising a piercable region and an internal piercing mechanism, wherein, the piercing mechanism comprises an internal channel positioned to release the content of the blister through the piercing mechanism in a spray, stream, or mist pattern and out the discharge port when the blister is crushed and the piercing mechanism pierces the piercable region.

3. The drug delivery system of claim 1, wherein the housing is configured to contain multiple dosage forms, and wherein the drug delivery system further comprises a mechanism to sequentially position a dosage form adjacent the dispensing channel and optionally to simultaneously advance a spent dosage form away from the dispensing channel.

4. The drug delivery system of claim 3, wherein the housing is configured to accept a cartridge containing one or more blister dosage forms and to position the dosage forms in dispensing position.

5. The drug delivery system of claim 4, wherein the housing is configured to accept a cartridge containing a single dosage form.

6. The drug delivery system of claim 4, wherein the housing is configured to accept a cartridge containing a plurality of dosage forms contained on a disc, a ring or a strip.

7. The drug delivery system of claim 6, comprising an indexing wheel knob connected to an indexing lever configured such that activating the indexing knob advances a unit dosage form into dispensing position.

8. The drug delivery system of claim 6, wherein the housing comprises a winding take-up wheel/torsion spring in engagement with an indexing sprocket attachable to a strip of blister dosage forms.

9. The drug delivery system of claim 4, wherein the housing is configured to accept a rotatable disc or ring containing a plurality of blister dosage forms.

10. The drug delivery system of claim 1, wherein the activation mechanism provides a mechanical disadvantage such that a pre-defined minimum threshold force must be applied to the activation mechanism in order to active a drug delivery mechanism.

11. The drug delivery system of claim 1, wherein the activation mechanism provides a mechanical advantage such that, when activated the force driving the piston into the dosage form is greater than the simultaneous force applied to the activating mechanism.

12. The drug delivery system of claim 1, wherein the activation mechanism comprises a hinge, spring, cam, or motorized drive.

13. The drug delivery system of claim 1, wherein the mechanically advantaged or disadvantaged mechanism comprises a lever, cam or an inclined plane.

14. The drug delivery system of claim 13, wherein a mechanical advantage or disadvantage is provided by an interaction of an angled face on an activation button and an angled face on a piston.

15. The drug delivery system of claim 13, wherein a mechanical advantage or disadvantage is provided by an interaction of an arcuate face on an activation button and an arcuate face on a piston.

16. The drug delivery system of claim 13, wherein the activation mechanism provides for a mechanical disadvantage during first stage of activation until a minimum threshold force is exerted and a mechanical advantage during a second stage of activation during which a piston is driven into a dosage form.

17. The drug delivery system of claim 2, wherein the dosage form contains a substance comprising an active pharmaceutical ingredient or biologic.

18. The drug delivery system of claim 17, wherein the substance is preservative-free.

19. The drug delivery system of claim 17, wherein the substance is dispensed as a drop, droplet, stream or spray upon release from the unit dosage form.

20. The drug delivery system of claim 17, wherein the substance is sterile until released from the unit dosage form.

21. The drug delivery system of claim 17, wherein the unit dosage forms further comprises a head space of gas or air.

22. The drug delivery system of claim 1, further comprising a delivery device configured to deliver the contents of a dosage form to a selected body part of a drug recipient.

23. The drug delivery system of claim 22, wherein the delivery system is designed to deliver a dosage of drug into to the eye, nose, mouth, ear, or rectum of a recipient.

24. The drug delivery system of claim 22, wherein the delivery device is an eyecup.

25. The drug delivery system of claim 22, wherein the delivery device further comprises a detachable cap.

26. The drug delivery system of claim 25, wherein the cap is configured as a storage device for dosage form containing cartridges.

27. The drug delivery system of claim 1, wherein the delivery system further comprises a programmable microprocessor.

28. The drug delivery system of claim 27, wherein the programmable microprocessor is a Printed Circuit Board or an Application Specific Integrated Circuit coupled to visual display interface and audible notification system.

29. The drug delivery system of claim 27, wherein the visual display interface is a Liquid Crystal Display or Light Emitting Diodes.

30. An ophthalmic drug delivery system comprising:

a housing configured to contain one or more crushable unit dosage forms;

a user activation mechanism, effective when activated, to engage a drug delivery mechanism comprising a piston drivable into at least one dosage form contained in the housing, wherein the activation mechanism provides a mechanical advantage, a mechanical disadvantage or a combination of mechanical advantage and disadvantage to the activation mechanism;

a discharge port formed in or contiguous with the housing and configured to release the contents of a dosage form upon activation of the activation mechanism; and

an eye cup attached to the housing disposed to direct the contents of the dosage form into the eye of a recipient.

31. The ophthalmic drug delivery system of claim 30, further comprising one or more unit dosage forms contained in the housing, wherein the dosage forms are blisters comprising a piercable region and an internal piercing mechanism, wherein, the piercing mechanism comprises an internal channel positioned to release the content of the blister through the piercing mechanism in a spray, stream, or mist pattern and out the discharge port when the blister is crushed and the piercing mechanism pierces the piercable region.

32. The ophthalmic drug delivery system of claim 31, wherein the dosage forms are contained in a cartridge.

33. The ophthalmic drug delivery system of claim 32, wherein the cartridge contains a plurality of unit dosage blisters configured on a strip, disk or ring, and further wherein the housing contains an indexing wheel connected to an indexing lever configured such that activating the indexing knob advances a unit dosage form into dispensing position.

34. The drug delivery system of claim 30, wherein the activation mechanism provides a mechanical disadvantage such that a pre-defined minimum threshold force must be applied to the activation mechanism in order to active a drug delivery mechanism.

35. The drug delivery system of claim 30, wherein the activation mechanism provides a mechanical advantage such that, when activated the force driving the piston into the dosage form is greater than the simultaneous force applied to the activating mechanism.

36. The drug delivery system of claim 30, wherein the activation mechanism comprises a hinge, spring, cam, or motorized drive.

37. The drug delivery system of claim 30, wherein the mechanically advantaged or disadvantaged mechanism comprises a lever, cam or an inclined plane.

38. The drug delivery system of claim 37, wherein a mechanical advantage or disadvantage is provided by an interaction of an angled face on an activation button and an angled face on a piston.

39. The drug delivery system of claim 37, wherein a mechanical advantage or disadvantage is provided by an interaction of an arcuate face on an activation button and an arcuate face on a piston.

40. The drug delivery system of claim 37, wherein the activation mechanism provides for a mechanical disadvantage during first stage of activation until a minimum threshold force is exerted and a mechanical advantage during a second stage of activation during which a piston is driven into a dosage form.

41. The drug delivery system of claim 32, wherein the unit dosage form cartridge comprises one or more aids for administering the unit dosage forms to a user selected from the group consisting of numbering, color coding, icon system coding, Braille, bar coding, and Radio Frequency Identification Device.

42. A drug delivery system comprising:

a housing;

a button on a surface of the housing and pivotable indexing lever that acts as a cover and an indexing lever from a closed position to a dispense position;

a firing mechanism comprising a piston connected to a link contained in the housing and in contact with the button through the link;

a discharge port attached to the housing and in fluid communication with a unit dosage form dispensing position in the housing; and

a feed mechanism for a blister strip contained in the housing, and comprising a feed wheel, an indexing wheel, and a take-up wheel, effective to sequentially move unit dosage forms contained on the blister strip into dispensing position in front of the discharge port by turning the indexing wheel;

wherein when the dispensing button is in the raised position, depressing the button forces the piston into an unit dosage form in the dispensing position, thereby forcing the contents of the unit dosage form through the discharge port into the eye, and wherein the link provides a mechanical advantage to the piston.

43. The drug delivery system of claim 42, wherein the link comprises an inclined plane cam or a lever.

44. The drug delivery system of claim 42, wherein the blister strip comprises a plurality of internally pierced unit dosage forms.

45. The drug delivery system of claim 42, comprising an indicator connected to the indexing wheel and visible from outside the housing, wherein the indicator comprises symbols to indicate the number of unused unit dosage forms on a blister strip.

46. The drug delivery system of claim 42, wherein the symbols are numbers, letters, colors, or a combination thereof.

47. The drug delivery system of claim 42, wherein the indexing mechanism comprises a rotating lever.

48. The drug delivery system of claim 42, wherein the indexing mechanism comprises a rotating lever that also acts as a cover to the drug discharge area.

49. The drug delivery system of claim 42, comprising an indicator port adjacent to the discharge port positioned to reveal dosage counter indicators on the delivery system when viewed from the exterior of the housing.