WO2016100564A1 - Liquid dispensing device with electronic counting component - Google Patents

Abstract

A device for administering a predefined number of predefined volume unit doses of a solution is described. The device includes a system for counting each unit dose administered, recording the time of administration, and storing the information regarding each administered dose. The device may further include a locking mechanism which prevents dosing too frequently.

Description

LIQUID DISPENSING DEVICE WITH ELECTRONIC COUNTING COMPONENT

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. provisional application No. 62/092,487, filed December 16, 2014, which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

[0002] The subject matter described herein relates to self-sensing dispensing devices suitable for dispensing liquid substances, such as by activating a flow or a spray of droplets. The devices as disclosed herein have micro switches and an electronic control. A typical device further may have a locking mechanism, a clock and a timer. Electrical connections between the micro switches and the electronic control provide for the precise and correct administration of the liquid substance.

BACKGROUND

[0003] The present disclosure relates to a device for the controlled administration of a pharmaceutical solution such as but not limited to opioid analgesics for the relief and treatment of pain. Spray devices represent a convenient means for administering pharmaceutical solutions to, for example, mucous membranes and are prevalent in the pharmaceutical world, allowing self-administration of a wide variety of drugs.

[0004] The nasal route of opioid analgesic drug delivery can provide rapid onset of action such as pain relief, as well as convenience to patients or care givers. Nasal delivery allows for the rapid absorption of the drug molecule which can rapidly pass from the nasal passages into the systemic circulation. This rapid delivery, however, also results in the potential for extremely hazardous effects to the health of a patient.

[0005] Although such rapid treatment is advantageous when the analgesic is used properly, it can be extremely hazardous to the health of a patient if the analgesic is accidentally or deliberately misused. For example misuse could lead to life threatening side effects, in particular respiratory depression. As a consequence there are many legal and regulatory controls over the distribution, prescription and use of opioid analgesics.

[0006] For many therapeutic applications it is necessary to administer opioid analgesics several times throughout a day. Bearing in mind the consequences of administering the opioid analgesic incorrectly, it will be appreciated that it is highly desirable to provide for the administration of several predetermined doses of an opioid analgesic in a manner which can be done simply and safely by a patient or caregiver; in particular in a manner which minimizes the risk of administering too great a dose at any one time or too many doses in a predefined span of time. Disclosed below are devices which address this need.

[0007] The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the drawings.

BRIEF SUMMARY

[0008] The following aspects and embodiments thereof described and illustrated below are meant to be exemplary and illustrative, not limiting in scope.

[0009] In one aspect, a dose-monitoring device for administering a dose of a pharmaceutical solution is provided, wherein the dose-monitoring device comprises a dispenser comprising a container for a solution, and an electronic component which detects and/or records dose administration.

[0010] In one embodiment, the dispenser further comprises an actuator, a counter comprising a number display, and/or a spray head connected to a top portion of the container.

[0011] In one embodiment, the dose-monitoring device further comprises a counting sensor, a sleeve which encases the container, and a base which contains the electronic control component. In another embodiment, each time the spray head is depressed to release a dose of solution, the sensor sends a signal to the electronic component and a count is recorded in the electronic component.

[0012] In one embodiment, the spray head comprises a circular or oval flange. In another embodiment, the flange functions as a surface pushed upon by a user to administer a spray of the solution.

[0013] In one embodiment, the sleeve is comprised of a plastic material.

[0014] In one embodiment, the top edge of the sleeve is positioned below the flange. In another embodiment, the bottom edge of the sleeve is aligned with the bottom of the vial.

[0015] In one embodiment, the sensor is attached to the spray head.

[0016] In one embodiment, each time the spray head is depressed to release a dose of solution, the sensor sends a signal to the electronic component, and the date and time of the dose release is recorded in the electronic component. [0017] In one embodiment wherein the device comprises a base and a sleeve, the base comprises means to reversibly attach to the bottom portion of the sleeve. In another embodiment, the means to reversibly attach comprises a screw thread. In another embodiment, the base contains an electronic control unit. In yet another embodiment, the electronic control unit comprises a memory chip, a timer and/or a clock.

[0018] In one embodiment, the electronic control unit comprises a means for transferring data stored in the memory chip. In another embodiment, the means for transferring data is selected from a USB port and a Bluetooth connection.

[0019] In one embodiment, the device further comprises a locking mechanism.

[0020] In one embodiment, the locking mechanism is in a locked configuration when the spray head cannot be depressed. In another embodiment, the locking mechanism is in a locked configuration when the base is not attached to the sleeve. In still another embodiment, when the base is attached to the sleeve the locking mechanism is not in a locked configuration and the spray head can be depressed to deliver the dose of solution.

[0021] In one embodiment, the locking mechanism comprises a first locking member attached to the inner surface of the sleeve and a second locking member attached to the outer surface of the container. In another embodiment, the first locking member comprises one, two or more knobs attached to the inner surface of the sleeve and the second locking member comprises one, two or more knobs attached to the outer surface of the container. In yet another embodiment, the spray head cannot be depressed when the first and second locking members are in contact and/or form a locked configuration.

[0022] In one embodiment, the spray head can be depressed to deliver a dose of the solution when the first and second locking members are not in contact and/or are in an unlocked configuration.

[0023] In one embodiment, the counting sensor is attached to the spray head.

[0024] In one embodiment, the sleeve comprises a window which is aligned with the number display to allow the number display to be seen. In another embodiment, the window is a hole is the sleeve. In yet another embodiment, the window is comprised of a transparent sheet set in the hole in the sleeve.

[0025] In one embodiment, the device further comprises a strength sensor which detects the dosage strength of the pharmaceutical solution.

[0026] Additional embodiments of the present device and the like, will be apparent from the following description, drawings, examples, and claims. As can be appreciated from the foregoing and following description, each and every feature described herein, and each and every combination of two or more of such features, is included within the scope of the present disclosure provided that the features included in such a combination are not mutually inconsistent. In addition, any feature or combination of features may be specifically excluded from any embodiment of the present invention. Additional aspects and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying examples and drawings.

BRIEF DESCRIPTION OF DRAWINGS

[0027] FIG. 1 illustrates a spray device according to one embodiment.

[0028] FIG. 2 illustrates a spray device coupled with an electronic controller in accord with another embodiment.

DETAILED DESCRIPTION

[0029] Various aspects now will be described more fully hereinafter. Such aspects may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey its scope to those skilled in the art.

I. DEFINITIONS

[0030] As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a "polymer" includes a single polymer as well as two or more of the same or different polymers, reference to an "excipient" includes a single excipient as well as two or more of the same or different excipients, and the like.

[0031] Where a range of values is provided, it is intended that each intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the disclosure. For example, if a range of 1 μιτι to 8 μιτι is stated, it is intended that 2 μιτι, 3 μιτι, 4 μιτι, 5 μιτι, 6 μιτι, and 7 μιτι are also explicitly disclosed, as well as the range of values greater than or equal to 1 μιτι and the range of values less than or equal to 8 μιτι.

II. DEVICE DISPENSER FOR DELIVERY OF A SOLUTION

[0032] The device as disclosed herein is designed for spraying a predetermined amount of a solution to a surface. The device is designed to facilitate correct and precise dosing of a solution, which in one embodiment is a pharmaceutical solution, which can be contained in the device. The device is designed to prevent over-dosing of the solution. In one embodiment, the device contains a solution of a pharmaceutically active ingredient which is to be administered to a mucous membrane, such as that in the nasal cavity.

[0033] The device is, in one embodiment, intended for administration of a solution in the form of a spray such as in the intranasal, buccal or sublingual administration of drugs, or more particularly the intranasal administration of opioid analgesics.

[0034] Opioid analgesics are currently the most pharmacologically effective means of alleviating severe pain. Examples include but are not limited to alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, desomorphine, dextromoramide, dezocine, diampromide, diamorphine, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, etorphine, dihydroetorphine, fentanyl and derivatives, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levorphanol, levophenacylmorphan, lofentanil, meperidine, meptazinol, metazocine, methadone, metopon, morphine, myrophine, narceine, nicomorphine, norlevorphanol, normethadone, nalorphine, nalbuphene, normorphine, norpipanone, opium, oxycodone, oxymorphone, papaveretum, pentazocine, phenadoxone, phenomorphan, phenazocine, phenoperidine, piminodine, piritramide, propheptazine, promedol, properidine, propoxyphene, remifentanil, sufentanil, tapentadol, tilidine, tramadol, pharmaceutically acceptable salts, hydrates and solvates thereof, mixtures of any of the foregoing, and the like.

[0035] For purposes of the present disclosure, the term "opioid analgesic" includes single compounds and compositions of compounds selected from the group of opioids and which provide an analgesic effect such as one single opioid agonist or a combination of opioid agonists, one single mixed opioid agonist-antagonist or a combination of mixed opioid agonist-antagonists, or one single partial opioid agonist or a combination of partial opioid agonists and combinations of an opioid agonists, mixed opioid agonist-antagonists and partial opioid agonists with one or more opioid antagonists, stereoisomers, ether or ester, salts, hydrates and solvates thereof, compositions of any of the foregoing, and the like. The present disclosure is specifically meant to encompass the use of the opioid analgesic in form of any pharmaceutically acceptable salt thereof.

[0036] Intranasal administration of opioid analgesics is especially advantageous since it provides the potential for rapid treatment of pain since the drug molecule will rapidly pass from the nasal passages into the systemic circulation. In one embodiment, the solution contained in the device is intended for acute pain. In another embodiment, the solution contained in the device is intended for chronic pain. In other embodiments, the solution contained in the device is intended for treatment of opioid dependence.

[0037] Although such rapid treatment is advantageous when the analgesic is used properly, it can be extremely hazardous to the health of a patient if the analgesic is accidentally or deliberately misused. For example misuse could lead to life threatening side effects, in particular respiratory depression. As a consequence there are many legal and regulatory controls over the distribution, prescription and use of opioid analgesics.

[0038] For many therapeutic applications it is necessary to administer opioid analgesics several times throughout a day.

[0039] Bearing in mind the consequences of administering an opioid analgesic incorrectly, it will be appreciated that it is highly desirable to provide for the administration of several predetermined doses of an opioid analgesic (or combination of an opioid analgesic and a non-opioid analgesic) in a manner which can be done simply and safely by a patient or caregiver; in particular in a manner which minimizes the risk of administering too great a dose at any one time.

[0040] It is a general object of the present invention to provide a device for administration of an opioid analgesic in accordance with the aims set out above.

[0041] According to one aspect of the present disclosure there is provided a device for administering a predefined number of predefined volume unit doses of a pharmaceutical solution, such as an opioid analgesic solution, the device including a closed container that contains or is capable of containing a predetermined fill volume of the solution. A dispenser is connected to the container, the dispenser being operable to administer an individual one volume unit dose repeatedly for the predefined number of times. In one embodiment, both the dispenser and the concentration of the opioid analgesic in the solution are chosen such that the volume unit dose is in the range of about 0.05 mL to about 0.15 mL, alternatively about 0.01 mL to about 0.30 mL. In one embodiment, the volume unit dose is approximately 0.1 mL. When the solution contains an opioid analgesic in liquid form, typically, the concentration of the opioid analgesic is in the range of about 0.005 mg/mL to about 1000 mg/mL. In one embodiment, the solution is a solution of fentanyl, the concentration of the fentanyl in the solution being in the range of about 0.1 mg/mL to about 20 mg/mL. In one embodiment, the concentration of fentanyl citrate in the solution is in the range of about 0.16 mg/mL to about 31.4 mg/mL. [0042] The choice of the solution as defined above which is dispensed in a volume unit dose in the range of about 0.05 mL to about 0.15 mL enables the device to be used to administer one, two or more volume unit doses at any one time to provide effective treatment. This means that at any one treatment time, the patient will be administered with either one volume unit dose into one nostril, or one volume unit dose into both nostrils. This makes it easy for the patient or caregiver who is administering the drug from the device to understand and remember the number of volume unit doses administered at one treatment time. This makes it much more unlikely that more than the prescribed number of doses will be administered and so makes it much more likely that the drug will be administered safely at any one treatment time.

[0043] Preferably, the dispenser includes counting means operable to count the number of one volume unit doses administered. The device can further include a dispenser deactivating means which is operated by the counting means to prevent further administration of the drug by the dispenser when the counting means has counted said predefined number of times. This number is chosen (bearing in mind the fill volume of the solution contained in the container before any doses have been administered) in order to ensure that full doses are administered, i.e. the deactivating means operates to prevent further discharge of solution from the device before the tail off phenomenon is reached.

[0044] These features contribute to the safe use of the device as it gives to the patient or caregiver an indication as to the number of doses which have been administered and furthermore prevents administration of any solution remaining in the container after all the predefined number (N) of volume unit doses have been dispensed.

[0045] Referring initially to FIG. 1 there is shown a dispensing device 10 which includes a closed container 12 and a dispenser 14. A solution 15 is contained or may be contained within the container 12. The dispenser 14 can be a dispenser of the type disclosed in U. S. Patent No. 4,565,302 (the full disclosure being incorporated herein by reference).

[0046] The dispenser 14 includes a spray head 16 which is reciprocally mounted on a mounting body 18. The mounting body 18 is fixedly secured to the container 12 to prevent its removal; accordingly access to solution 15 is not permitted unless it is dispensed via the dispenser 14. Body 18 may be attached to container 12 by a crimp and snap fitting or a oneway screw fitting in which a ratchet on body 18 engages with lugs on the container such that the body can only be screwed in one direction only. An example of such a container can be purchased from Saint Gobain Desjonqueres, France. [0047] Dispenser 14 further includes a pump 20 mounted on body 18. Pump 20 has an inlet (not shown) communicating with a dip tube 22. The dip tube 22 extends from pump 20 towards the bottom of container 12 such that its terminal end is located beneath the surface of solution 15. Accordingly on operation of pump 20, solution is drawn along tube 22 into an inlet of pump 20. Pump 20 further includes an outlet (not shown) which communicates with a spray nozzle 26 formed on spray head 16. Accordingly on operation of the pump solution is discharged through spray nozzle 26 to form a spray b.

[0048] Pump 20 is preferably of the two stroke reciprocating type having a priming chamber in which a pump piston reciprocates; the reciprocal motion of the piston in one direction, i.e. a first stroke of the piston, causing solution contained in the priming chamber to be discharged through spray nozzle 26 and reciprocal motion of the piston in the opposite direction, i.e. a second stroke of the piston, causing solution to be drawn from container 12 and into the priming chamber in readiness for the next discharging first stroke.

[0049] With such a pump the volume of solution discharged through the nozzle is determined by the volume of the priming chamber. This volume is preferably chosen to be in the range about 0.05 mL to about 0.15 mL for the reasons previously mentioned and defines the volume unit dose (Vu) to be dispensed by device 10. In the embodiment shown in FIG. 1 the volume unit dose (Vu) is about 0.1 mL. Pump 20 is operably connected to spray head 16 such that downward depression of the spray head in the direction of arrows '0' in FIG. 1 causes the pump to discharge the volume unit dose of the solution in the form of spray 30.

[0050] The dispenser 14 includes a counting means which is operated each time the pump is operated to dispense a volume unit dose of solution. The counting means operates a visual display 34 which indicates to an operator (e.g., patient or caregiver) the number of volume unit doses which have been administered from the device.

[0051] Other examples of electronic and dose counters for pharmaceutical dispensing devices which can be used with the device of the present disclosure are described in U.S. Patent Nos. 7,347,200, 7,195,134, 6,769,601, 6,659,307, 6,651,844 and 6,446,627 (the disclosures thereof being incorporated herein by reference).

A. Electronic Control Unit (or Electronic Dose Monitor)

[0052] Use of a spray dispenser as described herein can be prone to user error— a user may forget how many times they sprayed the solution during a single administration or may lose track of the time passed since the last dose. Resultant accidental overdose of some pharmaceutical agents, such as fentanyl, can have serious effects. Accordingly, it is desirable to offer to a user a spray device which can track how many doses have been administered and how much time has lapsed between administration of each dose or since the last dose. This capability is also desirable to monitor abuse of the solution by either the patient, or a third party. To provide this feature, a spray device such as that described above may be modified to incorporate an electronic dose monitor. This electronic dose monitor counts each spray, records the time and date of the spray (dose), and prevents additional sprays (doses) from being released until an appropriate (medically pre-determined) time, thus preventing dosing which would lead to an overdose. A dose-monitoring spray device with electronic dose monitor is described below and illustrated in FIG. 2. The illustrative device comprises a spray dispenser as described above and illustrated in FIG. 1 and an electronic dose monitor, now to be described.

[0053] In one embodiment, the electronic dose monitor 50 comprises a cylindrical sleeve 30 and a base 70 which houses an electronic controller 110. In alternative embodiments, the electronic dose monitor further comprises a locking mechanism, a sensor and a dosage strength indicator. With reference to FIG. 2, cylindrical sleeve 30 is manufactured with dimensions that allow it to be fixed to the outer surface of a container 12. The dose- monitoring spray device with electronic dose monitor 50 is comprised of the spray device 10 as shown in FIG. 1 which comprises dispenser 14, spray nozzle 26, spray head 16, pump 20, and dip tube 22, The top edge of the sleeve is positioned below a flange 35 and the bottom of the sleeve approximately aligns with the bottom of container 12. In one embodiment, the bottom of the sleeve is modified to be able to reversibly attach to base 70. For example, the bottom of the sleeves can comprise screw threads to allow a user to screw the base onto the sleeve. As described in more detail below, a locking mechanism 80, 90 of the dose- monitoring device is activated and the device is unable to spray the solution when the base is not attached to the sleeve, however, the locking mechanism is inactivated and the solution can be sprayed when the base is attached to the sleeve, provided, for example, there is not a timed lockout in effect as described in more detail below.

[0054] The base comprises an electronic control 110. The electronic control comprises a clock, a timer, a battery, a USB interface, RFID components and/or a memory chip. The electronic control may also contain a digital display. The electronic control receives a signal each time the pump is depressed and records and stores this information in the memory chip according to means well known to the ordinarily skilled artisan. The clock allows the electronic control to record and store the time of each dose and the amount of each dose. In one embodiment, the device further comprises a sound component which can alert the user when the next dose is due to be administered. Because the base is reversibly attached to the sleeve, the base, with or without the remainder of the device, can be provided to the user's practitioner (e.g., doctor, nurse or other pertinent medical practitioner or caregiver) and the data from the electronic control can be transferred to computer system such as a database containing medical records. Data transfer can be according to any means readily available to the skilled artisan, such as through a USB port or a Bluetooth wireless connection. The data can also be transferred to the device user's personal computer. It is envisioned that such data can readily be made available for automated transmission to a healthcare-related database system, either locally or remotely.

[0055] In one embodiment, the electronic control detects and records when a dose is administered, prevents use of the device until the predetermined interval has elapsed following the previous use, provides feedback to the user and pharmacist or doctor as to the state of the device and accepts input from the user. Accordingly, the electronic control comprises an embedded microprocessor (microcontroller) capable of monitoring switches and sensors in the delivery device, interfacing with the user through input, buttons and output devices, monitoring elapsed real time and actuating the electro-mechanical systems.

[0056] The microprocessor can provide means for determining when user access to the drug to be administered shall be permitted and provides a user interface for the device. The microprocessor can detect and record when a dose is administered, prevent use of the device until the prescribed time has elapsed, provide information to the user and attending health professionals as to the state of the device, and accept input from the user and optionally, from the supervising health care professional who can enter the initial and/or changes to the protocol relating to the time lapse between doses. The microprocessor can perform the functions of monitoring the condition of switches and sensors in the device, interfacing with the user through buttons and output devices, monitoring elapsed real-time and actuating the electro-mechanical systems which permit the drug to be-administered.

[0057] In one embodiment, the device works regardless of whether the base is attached or not, but still takes a dose and time signature.

[0058] In one embodiment, the dose-monitoring device can be supplied to a user independent of the base. Accordingly, the base can be re-used with different spray dispensers. When the solution in a spray dispenser container has been exhausted, the user can replace the empty dispenser with a new dispenser, such as that prescribed by the physician and provided by the pharmacist, and simply attaches the new dispenser (the dose- monitoring device without the base) to the base that had been used with the previous dispenser.

[0059] The device can have a locking mechanism comprising a micro switch which is in communication with the electronic element according to methods and means known to the ordinarily skilled artisan. When the locking mechanism is activated, the spray head cannot be depressed to release a dose of spray. When the locking mechanism is inactivated, the spray head can be depressed to release a dose of spray. The purpose of the locking mechanism is to prevent dosing too frequently. Accordingly, the locking mechanism communicates with an electronic control which has a timer. Once a full dose is administered, the locking mechanism is activated and remains activated until the time of the next dose. In other words, if dosing is prescribed every 8 hours, the locking mechanism remains active for 8 hours after administration of a full dose.

[0060] The structural features of a locking mechanism are readily envisioned by the ordinarily skilled artisan. One non-limiting example is illustrated in FIG. 2 and comprises, for example, a first locking member 80 on the inner surface of the sleeve. In one embodiment, first locking member 80 is located near the top of the sleeve. In another embodiment, first locking member 80 protrudes from the inner surface of the sleeve. This locking mechanism further comprises a second locking member 90 which is fixed to the outer surface of the container and in a position such that it can form a connection with first locking member 80. When the locking mechanism is activated, the first and second locking members interact to prevent the spray head from being depressed. In one embodiment, the spray head is attached to a plunger 120 which is blocked by locking mechanism 80, 90 when locking mechanism 80, 90 is activated. When sufficient time has passed after a full dose of solution has been administered, the locking mechanism is inactivated, allowing the spray head to be depressed to administer the next dose.

[0061] In one embodiment, the electronic component will detect the dosage strength of the solution in the container. For example, the container as packaged by the manufacturer to contain a preset volume of a defined concentration of active ingredient would be coded to indicate the concentration (strength) of the pharmaceutical solution. In one embodiment, small protrusions on the external surface of the container near the bottom edge of the container would correlate with dosage strength. Then, as the base is attached to the sleeve (e.g. screwed to the bottom portion of the sleeve), the base would sense the number and/or partem of the protrusions, thereby receiving the information regarding the dosage strength. Communicating the dosage strength of the solution to the electronic component could occur through any number of means known to the skilled artisan. Such communication could be initiated via mechanical or simple electrical means, though more sophisticated approaches such as radiofrequency identification (RFID) could be used.

[0062] As discussed above, the device has a counter (e.g., counter 34 in FIGS. 1 and 2) which counts each spray based on action of the pump. This counter comprises a display to show the number of doses or sprays which have been administered from the container. In one embodiment, the device comprises a sensor which also counts the number of sprays and the number of doses that have been administered from a container containing a solution. The sensor is attached to the spray head and is connected to an electronic control in the base which also includes a timer, a clock and a memory chip. Accordingly, when the spray head is fully depressed, the sensor communicates with the electronic control in the base to mark the time of the spray. The time (time and date stamp) and number of sprays is recorded and stored in the memory chip. After a full dose is administered, the electronic control sends a signal to the locking mechanism to activate the locking mechanism, thus preventing any further sprays for the dosing period. Based on the dosage strength of the solution in the container and the number of sprays (pumps of the spray head), the electronic control is able to determine when a full and accurate dose has been administered and when the next dose is due to be administered.

[0063] As can be appreciated from the foregoing, in another aspect a method to monitor for drug misuse and/or abuse is provided. Providing a device as described herein to a user whereby dose and time signatures are obtained via the electronic dose monitor provides data related to administration of the pharmaceutical solution contained in the device. The data can be used to identify patterns of abuse or misuse.

[0064] While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.

Claims

WHAT IS CLAIMED IS:

1. A dose-monitoring device for administering a dose of a pharmaceutical solution, wherein the device comprises

a dispenser comprising a spray head and a sensor attached to the spray head, wherein each time the spray head is depressed to spray the solution, the sensor sends a signal to the memory chip and a count is recorded and saved in the memory chip,

a container which contains the solution,

an electronic control which detects and records dose administration, and

a locking mechanism and a micro switch, wherein the micro switch provides a connection between the locking mechanism and the electronic control.

2. The device according to claim 1, further comprising a sleeve encasing the container and a base containing the electronic control, wherein the sleeve and the base are reversibly attached.

3. The device according to claim 1 , wherein the electronic control comprises a clock, a timer, and a memory chip.

4. The device according to claim 1, wherein the locking mechanism prevents depression of the spray head when the locking mechanism is activated and wherein the locking mechanism allows depression of the spray head when the locking mechanism is inactivated.

5. The device according to claim 1 , wherein the locking mechanism comprises a first locking member attached to the inner surface of the sleeve and a second locking member attached to the outer surface of the container, and wherein the spray head cannot be depressed when the first and second locking members are in a locked configuration.

6. The device according to claim 2, wherein the sleeve comprises a window which is aligned with the number display to allow the number display to be seen.

7. The device according to any one of the preceding claims, further comprising a dosage strength sensor.

8. A method for administering a pharmaceutical solution, comprising providing a device according to claim 7.

9. A method to monitor for drug misuse and/or abuse, comprising: providing a device according to claim 7,

obtaining dose and time signatures upon administration of a pharmaceutical solution contained in the device; and

analyzing or transmitting the data to a party to analyze the data to identify patterns of abuse or misuse.