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EP-4306803-B1 - DEVICE AND METHOD FOR COATING SURFACES

EP4306803B1EP 4306803 B1EP4306803 B1EP 4306803B1EP-4306803-B1

Inventors

  • WANG, XI
  • JUNGER, MICHAEL CARL
  • KANDASAMY, Sasikaran
  • HARRIS, NEIL
  • FLAIM, CHRISTOPHER

Dates

Publication Date
20260506
Application Date
20180329

Claims (15)

  1. A device for coating one or more microprojections on a microprojection array, the device comprising: a) a pumping chamber (106) wherein a sterile biological fluid is contained; b) a nozzle plate (109) attached to the pumping chamber (106) wherein the nozzle plate comprises a plurality of nozzles for dispensing the sterile biological fluid; c) a descender plate (108) attached to the nozzle plate (109) comprising a plurality of holes aligned with the nozzles of the nozzle plate (109); d) a membrane plate (104); and, e) a piezoelectric actuator (102) wherein the piezoelectric actuator (102) pushes against the membrane plate (104) such that the sterile biological fluid is dispensed through the nozzles as drops and deposited onto the microprojections.
  2. The device of claim 1, wherein the piezoelectric actuator is at least one of: a) a piezoelectric stack actuator (102); and, b) a piezoelectric unimorph actuator (302).
  3. The device of any of claims 1 to 2, further comprising a device (4582) for mixing the fluid.
  4. The device of any of claims 1 to 3, further comprising one or more fluid ports (107) by which the sterile biological fluid flows into the pumping chamber (106).
  5. The device of claim 4, comprising two fluid ports (107).
  6. The device of any one of claims 1 to 5, wherein the nozzles are made of at least one of: a) etched silicon; and, b) electroformed nickel.
  7. The device of any of claims 1 to 6, wherein the nozzles are made in a two-dimensional array.
  8. The device of claim 7, wherein the number of nozzles in each of the two-dimensional directions of the two-dimensional array is between 10 and 100, preferably between 30 and 50.
  9. The device of any of claims 1 to 8, wherein the nozzle diameter is from 30 to 200 micrometers.
  10. The device of any of claims 1 to 9, wherein the nozzles are coated to increase at least one of: a) durability; and, b) hydrophobicity.
  11. The device of any of claims 1 to 10, wherein the sterile biological fluid is a vaccine.
  12. The device of any of claims 1 to 11, wherein the nozzle plate (109) and descender plate (108) geometry has a continuous internal profile having no singular points.
  13. The device of any of claims 1 to 12, wherein the holes in the descender plate (108) are larger than the nozzles of the nozzle plate (109).
  14. The device of any of claims 1 to 13, wherein the holes in the descender plate (108) are from 100 to 250 micrometers in size and the nozzles in the nozzle plate (109) are from 20 to 200 micrometers in size.
  15. The device of claim 14, wherein the size of the drop deposited on to the microprojection is between 20 and 3000 picoliters, preferably between 30 and 500 picoliters.

Description

Background of the Invention The present invention relates to devices for coating microprojections on microprojection arrays. Description of the Prior Art The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that the prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates. In recent years, attempts have been made to devise new methods of delivering drugs and other bioactive materials, for vaccination and other purposes, which provide alternatives that are more convenient and/or enhanced in performance to the customary routes of administration such as intramuscular and intradermal injection. Limitations of intradermal injection include: cross-contamination through needle-stick injuries in health workers; injection phobia from a needle and syringe; and most importantly, as a result of its comparatively large scale and method of administration, the needle and syringe cannot target key cells in the outer skin layers. This is a serious limitation to many existing and emerging strategies for the prevention, treatment and monitoring of a range of untreatable diseases. There is also a need to reduce the amount of material delivered due to toxicity of the material or due to the need to conserve the material because it is difficult or expensive to produce. In an effort to solve some of the issues referenced above microprojection arrays or microneedle arrays have been utilized to deliver various materials through the skin. For example, WO 2005/072630 describes devices for delivering bioactive materials and other stimuli to living cells. The devices comprise a plurality of projections which can penetrate the skin so as to deliver a bioactive material or stimulus to a predetermined site. The projections can be solid and the delivery end of the projection is designed such that it can be inserted into targeted cells or specific sites on the skin. Other devices utilizing microprojections and/or microneedles either solid or biodegradable are described in One of the challenges of using devices that contain microneedles and/or microprojections is the need to coat the projections. Various coating techniques such as dipping the array into a coating solution or spraying the coating onto the projections have been described. For example, Gill and Prausnitz, J. Controlled Release (2007), 117: 227-237 describe coating microprojections by dipping the microprojections into a coating solution reservoir through dip holes that are spaced in accordance with the microprojection array. Cormier et al., J. Controlled Release (2004), 97: 503-511 describe coating microneedle arrays by partial immersion in an aqueous solution containing active compounds and polysorbate. WO 2009/079712 describes methods for coating microprojection arrays by spray coating the microprojections and drying the sprayed solution with gas. Inkjet printing has been used to deposit pharmaceutical compositions on a variety of devices and media. For example Wu et al., (1996) J. Control. Release 40: 77-87 described the use of inkjets to creating devices containing model drugs; Radulescu et al. (2003) Proc. Winter Symposium and 11th International Symposium on Recent Advance ins Drug Delivery Systems described the preparation of small diameter poly(lactic-co-glycolic acid) nanoparticles containing paclitaxel using a piezoelectric inkjet printer; Melendez et al. (2008) J. Pharm. Sci. 97: 2619-2636 utilized inkjet printers to produce solid dosage forms of prednisolone; Desai et al. (2010) Mater. Sci. Eng. B 168: 127-131 used a piezoelectric inkjet printer to deposit sodium alginate aqueous solutions containing rhodamine R6G dye onto calcium chloride surfaces; Sandler et al. (2011) J. Pharm. Sci. 100: 3386-3395 used inkjet printing to deposit various pharmaceutical compounds on porous paper substrates; Scoutaris et al. (2012) J. Mater. Sci. Mater. Med. 23: 385-391 described the use of inkjet printing to create a dot array containing two pharmacological agents and two polymers. Inkjet printing has also been used to deposit various pharmaceutical compositions on stents (Tarcha, et al. (2007) Ann. Biomed. Eng. 35: 1791-1799). Recently, piezoelectric inkjet printers have been used to coat microneedles. Boehm et al. (2014) Materials Today 17(5): 247-252 has described the use of inkjet printers to coat microneedles prepared from a biodegradable acid anhydride compolymer which contains alternating methyl vinyl ether and maleic anhydride groups with miconazole. US 2009/053402 A1 describes methods of manufacturing a piezoelectric actuator for ink-jet printers for printing on paper. US 2005/172956 A1 discloses a medicament dispenser for medicament inhaler comprising ejector, valve in fluid communication with flui