(12) INTERNATIONALAPPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 18 February 2010 (18.02.2010) WO 2010/017586 Al

(51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61M 15/00 (2006.01) A61M 11/00 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (21) Number: International Application CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, PCT/AU2009/001029 DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 11 August 2009 ( 11.08.2009) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (25) Filing Language: English NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (26) Publication Language: English SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 2008904085 11 August 2008 ( 11.08.2008) AU (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): SIL- GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, PHION PTY LIMITED [AU/AU]; Suite 102, 93-95 Pa ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, cific Highway, North Sydney, New South Wales 2060 TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, (AU). ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, SM, (72) Inventor; and TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, (75) Inventor/Applicant (for US only): KELLY, Alexander ML, MR, NE, SN, TD, TG). James [AU/AU]; 14 Potter Street, Russell Lea, New South Wales 2046 (AU). Published: (74) Agent: CULLENS; Level 32, 239 George Street, Bris — with international search report (Art. 21(3)) bane, Queensland 4000 (AU).

(54) Title: INHALER WITH PIERCABLE VIAL AND DRUG IN LIQUID FORM

Figure 7

(57) Abstract: The invention provides a device for facilitating inhalation of an inhalable drug in liquid form comprising a barrel for holding a vial of the drug, a piercing means substantially in the barrel, and a mouthpiece attached to an end of the barrel, and a method of providing an inhalable drug in liquid form using the device of the invention. INHALER WITH PIERCABLE VIAL AND DRUG IN LIQUID FORM

TECHNICAL FIELD

The invention described herein relates generally to a device and method for the administration of volatile drugs in liquid form. In particular, the invention is directed to a device and method for inhalation administration of volatile drugs in liquid form, although the scope of the invention is not necessarily limited thereto.

BACKGROUND ART

In many medical circumstances, there is a need for rapid onset of analgesia. This is generally achieved by intravenous administration of -based analgesics. There are many disadvantages associated both with the drugs used and with the method of administration.

Opioid analgesics are known to have the potential to cause dependency, and are therefore not always the drug of choice for these medical circumstances.

Intravenous administration is a difficult mode of administration under many conditions, including for example emergency roadside incidents, non-compliant patients, or non-sterile environments.

The use of inhalation has been contemplated for use in analgesia. There are devices which administer for example and for inhalation, but these suffer from several disadvantages.

The device disclosed in PCT/US02/33190 administers the drug using compressed air/oxygen is cumbersome, expensive and not easily portable.

A further device which is a hand-held device, currently available in at least Australia, suffers from the severe drawback that the drug has to be poured into the barrel of the device for administration. This pouring action easily results in spillage on the skin of the medical carer or patient, and release of the drug into the air space around these people, which is dangerous and inefficient as the actual dosage is then unknown. Therefore, there would be an advantage if it were possible to provide a device for administration of inhalable drugs which may overcome at least some of the above- mentioned disadvantages or provide a useful or commercial choice.

SUMMARY OF THE INVENTION

In a first embodiment, the invention provides a device for facilitating inhalation of an inhalable drug in liquid form, the device comprising a barrel for holding a vial of the inhalable drug in liquid form, a piercing means substantially in the barrel, and a mouthpiece attached to an end of the barrel.

In a second embodiment, the invention provides a method of providing an inhalable drug in liquid form comprising inserting a vial of the drug into the barrel of the device of the first embodiment, piercing the seal of the vial with the piercing means, applying the mouthpiece to a subject wherein the subject inhales through the mouthpiece the drug released upon piercing of the seal.

With regard to the first and second embodiments as defined above, the drug can be any inhalable drug in liquid form that is sufficiently volatile to be available for inhalation upon release from the vial. The device is particularly suited to drugs such as analgesics, including but not limited to inhalable fiuorocarbon-based analgesics such as sevoflurane, methoxyflurane, , , enfiurane, diethyl , methoxypropane, , and .

The barrel of the device can be any configuration which will accommodate a vial of inhalable drug in liquid form. Preferably the barrel is a substantially straight tube, or a tube including a substantially right angled bend towards the mouthpiece. The vial can be a standard commercially available vial, or a vial made specifically for the device of the invention. Preferably the vial is a standard 1-5OmL vial.

The device of the invention can be a disposable, single-use device, or can be configured for repeated use. To this end, the barrel can be configured such that the vial is sealed inside the barrel upon manufacture of the device, or the barrel can be configured to reversibly open at one end to receive a vial when needed. The latter option can include any practicable reversible opening means, including a screw-type device, clip device or snap-lock device. The piercing means can be any means capable of piercing the seal of a drug vial. Preferably the piercing means is a plastic needle-type device, attached near to the vial end inside the barrel. The piercing means preferably is an integral part of the barrel moulding itself.

When the vial is moved towards the piercing means, this can be effected in any practicable manner. Preferably the barrel has a rotatable actuator mechanism in contact with the base of the vial which, when twisted, forces the vial along the barrel until the piercing means pierces the seal of the vial.

Alternatively, the piercing means can be moved towards the seal of the vial. In this embodiment, the barrel can have any practicable mechanism for activation to move the needle towards the piercing means, such as a depressable actuator or more than one depressable actuators on the exterior of the device which, when depressed, moves the needle towards the seal of the vial and forces the needle to pierce that seal.

The device of the invention can also include a wick of any practicable material inside the barrel. Upon piercing of the seal of the vial, the contents of the vial run or disperse onto the wick, increasing the available surface area for active evaporation. This assists vaporization and retention of the drug for inhalation.

The mouthpiece is attached to an end of the barrel by any means, and can be fixed or movable. If the mouthpiece is movable, which is generally when the barrel is a straight tube, preferably that mouthpiece is movable through approximately 180°, allowing the subject to access the mouthpiece and thereby the drug from any body position or recline. The mouthpiece can also be fitted into a standard medical mask to assist with administration of the drug to an incapacitated patient.

The device can also include a filter in communication with the mouthpiece. The filter can be located in any practicable position on the device but is preferably located in an exhalation port on the barrel of the device. The filter can be made any material capable of absorbing vapours of the inhalable drug in liquid form. The filter is preferably made of activated carbon matrix or another equivalent solvent-retaining medium.

The device of the invention can be made of any practicable material but is preferably made from solvent-resistant plastic. The device can be any colour, including different colours to indicate the nature of the inhalable drug in liquid form in the vial in the barrel of the device. The device can also be colourless or coloured translucent plastic so that the level of drug in the vial in the barrel of the device is visible. The material of manufacture can also have an additive to render the device able to glow in the dark. This would assist patients and care providers in emergency situations where lighting is not available.

The device of the invention can also include a strap reversibly or irreversibly attached to any practicable position on the barrel. The strap can be intended for use around the wrist or neck of a patient. The strap is preferably attached to the end of the barrel furthest from the mouthpiece. The strap is preferably attached by one or more snap- tag to prevent trapping or strangulation of the patient. The snap-tag can be easily removed with a sharp pull to release the strap from the barrel.

The device can also include a nozzle or port on the barrel for attachment of a medical standard oxygen hose if required.

In order that the invention may be more readily understood and put into practice, one or more preferred embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a representation of a first embodiment of the device showing internal and external features.

Figure 2 is a perspective view of the external features of a first embodiment of the device.

Figure 3 is a top view of the external features of a first embodiment of the device.

Figure 4 is a side view of the external features of a first embodiment of the device.

Figure 5 is a top view of the external features of a second embodiment of the device.

Figure 6 is a side view of the external features of a second embodiment of the device.

Figure 7 is an exploded view of a second embodiment of the device. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Figures 1 to 4 refer to a first embodiment of the invention.

Referring firstly to Figure 1, which shows internal and external features of the device (1), the vial (2) containing the inhalable drug in liquid form is loaded in the barrel (3) of the device. By loading the sealed vial into the barrel, any wastage or potentially harmful spillage of the drug is avoided. This also ensures that the patient dose is accurately known.

The actuator (4) is turned, forcing the seal of the vial (2) onto a piercing means (5). The piercing means (5) pierces the seal of the vial (2) and releases the drug in the barrel (3) and onto a wick (not shown).

The patient places the mouth around the mouthpiece (6), which can be swiveled around an axis (7). This function of the mouthpiece allows for administration of the drug to a patient in any physical position.

Referring also to Figures 2 and 4, the patient then inhales through the mouthpiece (6), inhalation made possible by inlet air vents included in the actuator section (8).

Upon exhalation, any remaining drug is absorbed by the filter (not shown) in the outlet vents (9), thereby preventing escape of any drug into the environment of the patient and caregiver.

The snap-tags (10) for attachment of a strap are shown in the Figures, as is the optional nozzle ( 11) for attachment of an oxygen hose.

Figures 5 to 7 refer to a second embodiment of the invention.

Referring to the exploded view of the second embodiment, Figure 7, which shows internal and external features of the device, the vial (12) containing the inhalable drug in liquid form is loaded in the barrel (13) of the device. By loading the sealed vial into the barrel, any wastage or potentially harmful spillage of the drug is avoided. This also ensures that the patient dose is accurately known.

The depressable actuators (14) are depressed and the piercing means (15) pierces the seal of the vial (12) and releases the drug in the barrel (13). Figure 7 represents the piercing means (15) after piercing the vial seal. Referring also to Figures 5 and 6, the patient places the mouth around the mouthpiece (16), which is at the end of a substantially right angle in the barrel, furthest from the depressable actuators. This position of the mouthpiece allows for administration of the drug to a patient in any physical position.

The patient then inhales through the mouthpiece (16), inhalation made possible by inlet air vents included in the actuator portion (17).

Upon exhalation, any remaining drug is absorbed by the filter (18) in the outlet vents (not shown) in the actuator portion (17), thereby preventing escape of any drug into the environment of the patient and caregiver.

Attachment of a strap (not shown in the Figures) is preferably on the side of the mouthpiece (20), opposite the air inlet (see Figure 6). The optional nozzle (19) for attachment of an oxygen hose is also shown in the Figures.

The many advantages of the device of the invention will be clear from the above discussion and from the Figures. The invention therefore provides a novel and efficient way of administering an inhalable drug in liquid form to a patient, without wastage or spillage of the drug, contamination of the surroundings, or discomfort to the patient. The device also provides a portable administration unit which is easy to operate, allowing a patient to self-administer should the need arise. The device can be disposable which improves the safety and reproducibility of administration of the drug.

The foregoing embodiments are illustrative only of the principles of the invention, and various modifications and changes will readily occur to those skilled in the art. The invention is capable of being practiced and carried out in various ways and in other embodiments. It is also to be understood that the terminology employed herein is for the purpose of description and should not be regarded as limiting.

The term "comprise" and variants of the term such as "comprises" or "comprising" are used herein to denote the inclusion of a stated integer or stated integers but not to exclude any other integer or any other integers, unless in the context or usage an exclusive interpretation of the term is required.

Any reference to publications cited in this specification is not an admission that the disclosures constitute common general knowledge in Australia. The claims defining the invention are as follows:

I. A device for facilitating inhalation of an inhalable drug in liquid form, the device comprising a barrel for holding a vial of the inhalable drug in liquid form, a piercing means substantially in the barrel, and a mouthpiece attached to an end of the barrel.

2. The device of claim 1 including a filter in communication with the mouthpiece.

3. The device of claim 1 wherein the drug is a volatile analgesic.

4. The device of claim 3 wherein the drug is a fluorocarbon-based analgesic.

5. The device of claim 1 wherein the barrel is a substantially straight tube.

6. The device of claim 1 wherein the barrel is a tube including a substantially right angled bend towards the mouthpiece.

7. The device of claim 1 wherein the device is disposable.

8. The device of claim 1 wherein the piercing means is a needle.

9. The device of claim 1 additionally including a means external of the barrel for moving the vial towards the piercing means or the piercing means towards the vial.

10. A method of providing an inhalable drug in liquid form comprising inserting a vial of the drug into the barrel of the device of claim 1, piercing the seal of the vial with the piercing means enabling release of the drug, applying the mouthpiece to a subject wherein the subject inhales through the mouthpiece the released drug.

I 1. The method of claim 10 wherein the drug is a volatile analgesic.

12. The method of claim 10 wherein the piercing means is a needle.

13. The method of claim 10 wherein the seal of the vial is moved towards the piercing means.

14. The method of claim 10 wherein the piercing means is moved towards the seal of the vial.

15. The method of claim 14 wherein the piercing means is moved towards the seal of the vial by activation of at least one depressable actuator external to the barrel.

INTERNATIONAL SEARCH REPORT International application No.

PCT/AU2009/00 1029

A CLASSIFICATION O F SUBJECT MATTER Int Cl

A61M /5/(90 (2006 0 1) A61M 11/00 (2006 0 1)

According to International Patent Classification (IPC) or to both national classification and IPC

B FIELDS SEARCHED

Minimum documentation searched (classification system followed by classification symbols)

Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched

Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)

WPI, EPODOC A61M 15/00, A61M 11/00 , VOLATILE, LIQUID, FL[U,OU]ROCARBON, FLUID, VAP[O1OU]R, MIST OR SPRAY OR FOG OR NEBUL1+, CAPSULE, VIAL, PHIAL AMP[U OU]LE, CARPULE ,CAKNISTER, CARTRIDGE, CONTAINER, PIERC+, PUNCTUR+, PERFORAT+, SPIKE, LANCET, CUT+ , OPEN+ C DOCUMENTS CONSIDERED TO BE RELEVANT

Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim N o

U S 2007/01 19450 A l (WHARTON et al) 3 1 May 2007 X Paragraph 0007, 0008, 0079, 0 13 1 ,0 146, , 0 177, Claim 1, 33, Figure 42, 45E 1- 15

Y Paragraph 0079, 0 13 1, 1-7, 10, 11 U S 2002/0092520 A l (CASPER et al) 18 July 2002 X Paragraph 0008 ,00 10, 0007, 0036, 0037, 0043 1-1 5

Y Paragraph 004 1, 0043 2 W O 2006/1 25577 A2 (BOEHRINGER INGELHEIM INTERNATIONAL) 30 November 2006 X Paragraph 0007, 0008, 001 3, 0058, 0069, 0073, 0074, 0092, Figure 1, 12 1, 3-1 5

Y Paragraph 0058 2

U S 356507 1 A (COBB et al) 23 February 197 1 Column 1 lines 1-33, column 2 lines 39-44, column 3 lines 29-30, Figure 2 1-7, 10, 11

X Further documents are listed in the continuation of Box C X See patent family annex

Special categories of cited documents "A" document defining the general state of the art which is "T" later document published after the international filing date or priority date and not in not considered to be of particular relevance conflict with the application but cited to understand the principle or theory underlying the invention "E" earlier application or patent but published on or after the "X" document of particular relevance, the claimed invention cannot be considered novel international filing date or cannot be considered to involve an inventive step when the document is taken alone "L' document which may throw doubts on priority claim(s) "Y" document of particular relevance the claimed invention cannot be considered to or which is cited to establish the publication date of involve an inventive step when the document is combined with one or more other another citation or other special reason (as specified) such documents, such combination being obvious to a person skilled in the art "O" document referring to an oral disclosure, use, exhibition or other means "&" document member of the same patent family "P" document published prior to the international filing date but later than the priority date claimed Date of the actual completion of the international search Date of mailing of the international search report

02 September 2009 1 5 SEP 2009 Name and mailing address of the ISA/AU Authorized officer John Schweitzer AUSTRALIAN PATENT OFFICE PO BOX 200, WODEN ACT 2606, AUSTRALIA AUSTRALIAN PATENT OFFICE E-mail address pct@ιpaustralia gov au (ISO 9001 Quality Certified Service) Facsimile No +61 2 6283 7999 Telephone No +61 2 6283 2400

Form PCT/ISA/2 10 (second sheet) (July 2009) INTERNATIONAL SEARCH REPORT International application No. PCT/AU2009/001029

C (Continuation). DOCUMENTS CONSIDERED TO BE RELEVANT

Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. ' WO 2007/020073 Al (PARI GMBH) 22 February 2007 Paragraphs 0009, 0015, 0016, 0057 1, 5, 8-10, 12- 15

US 2003/0034033 Al (BINI et al) 20 February 2003 Paragraph 0002, 0008, 0024, 0026, 0044, Figures 1, 3-7, 9-1 13-15 INTERNATIONAL SEARCH REPORT International application No. Information on patent family members PCT/AU2009/001029

This Annex lists the known "A." publi.cation level patent family members relating to the patent documents cited in the above-mentioned international search report. The Australian Patent Office is in no way liable for these particulars which are merely given for the purpose of information.

Patent Document Cited in Patent Family Member Search Report

US 2007/0119450 AU 2004/273547 AU 2006/225241 CA 2540179 EP 1675636 EP 2076304 NZ 546730 WO 2005/028006 WO 2008/040062 US 2002/0092520 AU 2002/235318 AU 2002/246961 AU 2003/228967 AU 2004/24505 1 EP 1349598 EP 1349599 EP 1351724 EP 1351735 EP 1506030 EP 1631345 US 6443152 US 6644309 US 6722364 US 6782887 us 6929005 us 7040316 US 7051734 us 7270127 us 7540285 us 2002/0092521 us 2002/0092523 us 2002/0092524 us 2003/0047184 us 2004/001 1356 us 2004/0079363 us 2004/0163645 us 2005/0000514 us 2005/0188985 us ' 2006/0150969 us '2006/0276755 us 2008/0006269 WO 2002/055133 WO 2002/055142 WO 2002/056950 WO 2002/0605 17 WO 2003/09501 1 W O 2004/108205 WO 2006/125577 AR 057031 AU 2006/251377 CA 2608568 CN 101203259 DE 102005024439 EA 2007/002388 EP 1883439 KR 20080031194 MX 2007013951 NO 2007/005168 U S 2007/0107720 ZA 2007/008463- us 3565071 DE 1815796 GB 1237223 IL 31003 WO 2007/020073 AU 2006/281561 CA 2619605 CN 101291699 DE 102005038619 EP 1919542 us 2003/0034033 AU 70955/01 EP 1294415 US 6457471 US 6691704 W O 2002/002160

Due to data integration issues this family listing may not include 10 digit Australian applications tiled since May /UOl.

END OF ANNEX