WO2016064592A1

WO2016064592A1 - Pharmaceutical and biological agent desktop dispensing systems having biometric data acquisition and monitoring capabilities

Info

Publication number: WO2016064592A1
Application number: PCT/US2015/054767
Authority: WO
Inventors: Tony Hagen; Tim Hagen
Original assignee: Sumner Bluffs, Llc.
Priority date: 2014-10-25
Filing date: 2015-10-08
Publication date: 2016-04-28
Also published as: TW201618742A

Abstract

Embodiments of the present disclosure generally relate to devices, methods and systems for dispensing and monitoring solid forms of various pharmaceutical, biological and other agents to a subject. In certain embodiments, desktop dispensing devices and systems are provided having the capability to acquire and monitor biometric data before, during, and/or after dispensing solid dosage forms of various pharmaceutical, biological or other monitored agents to a subject. Other embodiments provide improvements to patient outcomes by giving patients more control over the delivery of their medication and by providing physicians with valuable compliance, biometric and diagnostic data during treatment in order to improve patient outcome.

Description

PHARMACEUTICAL AND BIOLOGICAL AGENT DESKTOP DISPENSING SYSTEMS HAVING BIOMETRIC DATA ACQUISITION AND MONITORING

CAPABILITIES

FIELD

[0001] Embodiments of the present disclosure generally relate to devices, methods and systems for dispensing solid dosage forms of various pharmaceutical and biological agents to a subject. In certain embodiments, the present disclosure provides desktop dispensing systems having the capability to acquire and monitor biometric data before, during, and/or after dispensing solid dosage forms of various pharmaceutical and biological agents to a subject.

BACKGROUND

[0002] The concept of personalized medicine is changing the healthcare landscape throughout the world. Personalized medicine is an emerging field that uses various diagnostic tools (e.g., genetic markers, biometric data) to help determine which medical treatments and procedures will be best for a given patient. By combining this personalized diagnostic information with a patient's medical records and individual needs, personalized medicine allows physicians and patients to develop targeted prevention and treatment plans. Certain goals of personalized medicine are to provide the right treatment in the right dose to the right patient at the right time.

[0003] Although great progress has been made, certain goals of personalized medicine have not yet been fully realized. For example, there is a paucity of currently available drug delivery devices with the capability to administer safely and effectively one or more pharmaceutical agents to a patient. Prescription medications and over-the-counter drugs are administered to patients in various forms, and this typically requires a different device for each mode of administration. Additionally, physicians typically not only rely on their patients to adhere to their medical instructions after leaving the clinical setting, they trust that their patients are accurately reporting information regarding their treatment. The ability for patients to have more control over the delivery of their medication, while at the same time providing physicians with meaningful and accurate biometric and diagnostic data during treatment would greatly augment the overall goals of personalized medicine and lead to better patient outcomes.

SUMMARY

[0004] Embodiments of the present disclosure include a pharmaceutical and biological agent desktop or tabletop dispensing device having biometric data acquisition and monitoring capabilities. The desktop or table top dispensing device includes a housing unit, a power source, a processor and memory, used in conjunction to dispense one or more solid dosage forms of various pharmaceutical and biological agents. Embodiments herein also include a loading cartridge having a plurality of rotatable storage chambers for storing and dispensing one or more solid dosage forms, and a prime mover operably coupled to the loading cartridge and a dispensing activator. In some aspects, activation of the dispensing activator actuates the prime mover to eject one or more solid dosage forms from the loading cartridge.

[0005] Some embodiments also include at least one scanner operatively coupled to the processor. The processor can, for example, verify the identity of a subject based upon information obtained by the at least one scanner. Other embodiments can include at least one biometric sensor for sensing biometric data of the subject. The biometric data can be sensed and acquired during at least one of prior to, during, and/or after dispensing the one or more solid dosage forms to the subject, and the biometric data is stored in memory. Other embodiments can also include at least one data transfer port.

[0006] In some embodiments, the device further includes a dispenser port and an image acquisition device centrally aligned with the dispenser port. In accordance with these embodiments, the image acquisition device comprises a lens, an image sensor and signal wires which operatively connect the image acquisition device to the processor. Embodiments disclosed herein also include a touchscreen or keypad or other communicating device that communicates at least one visual indicator to a subject. In certain embodiments, the touchscreen or keypad or other communicating device can be operatively coupled to the image acquisition device and facing the same direction as the lens.

[0007] In some embodiments, the device further includes at least one biometric sensor such as one or more of a temperature sensor, a galvanic skin response sensor, a pulse oximeter, a carbon dioxide sensor, an oxygen sensor, an optical sensor, an air flow velocity sensor, an air pressure sensor, a chemical sensor, and a global positioning system (GPS) sensor. In other embodiments, the desktop device further includes one or more peripheral module interfaces for coupling one or more peripheral modules to the device. The peripheral modules can include one or more of a blood pressure monitor, a blood glucose monitor, a CPAP machine, an electrocardiogram device, a battery, and a battery charger.

[0008] In some aspects, the scanner included in a device can be a fingerprint reader, a pressure sensor, and/or a radio-frequency identification (RFID) reader. In other aspects, the device can include Bluetooth™ hardware and software components. In certain embodiments, a scanner can cue a healthcare provider's handheld device when the scanner is accessed. In yet other aspects of the present disclosure, the processor included in the device can further include one or more software programs for operating a biometric sensor and for facilitating the acquisition of biometric data using a biometric sensor.

[0009] In other embodiments, the one or more solid dosage forms is one or more of a pill, capsule, gel capsule, gummy, timed-release capsule, slow-dissolving capsule, tablet, caplet, patch, strip, and thin-film strip.

[0010] Embodiments of the present disclosure also include a system for dispensing a solid dosage form to, and acquiring biometric data from, a subject. The system can include a housing unit, a power source, a processor and memory. Other embodiments also include a loading cartridge with a plurality of storage chambers for storing and dispensing one or more solid dosage forms, and a prime mover operably coupled to the loading cartridge and a dispensing activator. In some aspects, activation of the dispensing activator actuates the prime mover to eject one or more solid dosage forms from the loading cartridge. Embodiments also include at least one scanner operatively coupled to the processor. The processor is capable of verifying the identity of a subject based in part on information obtained by the scanner. Certain embodiments also include at least one biometric sensor for sensing biometric data of the subject. Biometric data can be sensed and acquired during at least one of prior to, during, and/or after dispensing the one or more solid dosage forms of a pharmaceutical or biological agent to the subject, and the biometric data can be stored in desktop device's memory. In addition, a sensor can be used for determining what and how many of an agent were dispensed. Other embodiments can also include at least one data transfer port. [001 1] Some embodiments of the present disclosure can also include a method for dispensing a solid dosage form to an authorized user. In accordance with these embodiments, the method can include scanning a biometric identifier of a user using the desktop dispensing device having biometric data acquisition and monitoring capabilities; determining, using the biometric identifier, whether the user is approved to take a pre-determined (e.g. , prescribed) dose of a solid dosage form; and dispensing the dosage of the solid dosage form from the desktop dispensing device having biometric data acquisition and monitoring capabilities, if the user is approved to take the dosage of the solid dosage form.

[0012] In some aspects, methods can include scanning a biometric identifier, including, but not limited to the following: a fingerprint pattern, an iris pattern, a retina pattern, a vocal pattern, a facial-feature pattern, a pore pattern, a thermal image pattern, or a blood vessel pattern.

[0013] In certain aspects of methods of the present disclosure, determining whether the user is approved to take a dosage of a solid dosage form can include matching the scanned biometric identifier to a stored biometric identifier, wherein the stored biometric identifier is an approved user's biometric identifier; identifying if the solid dosage form is included on a list of solid dosage forms that are eligible to be taken by the user; identifying a recent time that the biometric identifier was scanned and the solid dosage form was dispensed; and approving the dispensing of the solid dosage form if a present time during which the biometric identifier is scanned is within an approved time period for dispensing the solid dosage form, based on a recent time that the biometric identifier was scanned.

[0014] In some aspects, methods can include recording, on the desktop or tabletop dispensing device's memory, times that the solid dosage form is dispensed. In some aspects, method can include transmitting a time that a dose was dispensed, the dosage amount or number that was dispensed, and an identity of the solid dosage form that was dispensed to an auxiliary electronic device. In other aspects, methods can include taking an image of the user using an image acquisition device when dispensing a dosage of the solid dosage form, with the image acquisition device being coupled to the desktop dispensing device. In other embodiments, an image can be recorded during the dispensing. In certain embodiments, these processes can be overridden. [0015] In some aspects, methods disclosed herein can include providing sensory feedback to the user. Sensory feedback can include, but is not limited to, visual cues, haptic feedback, or auditory feedback. In other aspects, methods can include measuring a biometric response to the dosage of the solid dosage form. The biometric responses include, but are not limited to, a galvanic skin response, a blood oxygen level response, a body temperature response, a heartrate response, a perfusion index response, a blood pressure response, a retina response, an eye movement response, an inhalation velocity response, an inhalation pressure response, an inhalation volume response, an expiratory velocity response, an expiratory pressure response, an expiratory volume response, or an exhale chemical composition response.

[0016] In other aspects, methods can include transmitting the dosage of the solid dosage form and the measured biometric response to an auxiliary electronic device. In other aspects, methods include dispensing a revised dosage of the solid dosage form based on the measured biometric response.

Definitions and Terms

[0017] As used herein, the terms "subject," "user," and/or "patient" can include humans and other animals or mammals that are in need of treatment and capable of using or have assisted use of devices and systems as described herein. Additionally, the terms "subject," "user," and/or "patient" can include humans and other mammals treated in any type of environment such as a clinical setting, non-clinical setting, experimental setting, etc.

[0018] The term "solid dosage form," "solid pharmaceutical and biological agent dosage form" and derivatives thereof, as used herein, include but is not limited to, prescribed or otherwise regulated compounds in the form of pill, capsule, gel capsule, gummy, timed- release capsule, slow-dissolving capsule, tablet, caplet, patch, strip, and thin-film strip , mini- tablets, granules, beads, pellets, multiparticulates, spheroids, or combinations thereof. If the solid dosage form is a tablet, the tablet can be of any suitable shape such as round, spherical, or oval. A solid pharmaceutical dosage form may have a monolithic or a multilayered structure, and may contain active pharmaceutical ingredients, including prescription or nonprescription pharmaceutical agents, in both solid and liquid forms. [0019] As used herein the terms "pharmaceutical," "pharmaceutical agent," "biological agent," "biologic," "monitored agent," "agent" and "drug" can mean a pharmaceutically effective compound, and/or effective compound and/or the pharmaceutically acceptable salt of a pharmaceutically effective compound, used in the treatment of a disease or condition. For example, a pharmaceutical drug or agent contemplated herein can be used in the treatment of diseases such as asthma, bronchitis, emphysema, lung infection, cystic fibrosis, alpha- 1 antitrypsin (AAT) deficiency, chronic obstructive pulmonary disease (COPD), acute respiratory distress syndrome (ARDS), infant respiratory distress syndrome (IRDS), borderline personality disorder (BPD), and macrophage activation syndrome (MAS), among many other conditions. Useful pharmaceutical agents can be delivered via inhalation, injection, ingestion, by feeding tube, and/or sublingually, according to the present disclosure, but are not limited to only those listed in the present disclosure. Generally, the agents that can be delivered using the devices and systems of the present disclosure have been approved by the U.S. Food and Drug Administration. Other agents or drugs may be used in accordance with the devices and systems of the present disclosure; the agents listed in the present disclosure are not intended to be exhaustive.

[0020] The terms "determine," "calculate," and "compute," and variations thereof, as used herein, are used interchangeably and include any type of methodology, process, mathematical operation or technique.

[0021] It is to be noted that the term "a" or "an" entity refers to one or more of that entity. As such, the terms "a" (or "an"), "one or more" and "at least one" can be used interchangeably herein. It is also to be noted that the terms "comprising," "including," and "having" can be used interchangeably.

[0022] As used herein, "at least one," "one or more," and "and/or" are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions "at least one of A, B and C," "at least one of A, B, or C," "one or more of A, B, and C," "one or more of A, B, or C," and "A, B, and/or C" means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as Xi-X_n, Yi-Y_m, and Zi-Z₀, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., Xi and X₂) as well as a combination of elements selected from two or more classes (e.g., Y₁ and

[0023] The term "means" as used herein shall be given its broadest possible interpretation in accordance with 35 U.S.C. § 112(f). Accordingly, a claim incorporating the term "means" shall cover all structures, materials, or acts set forth herein, and all of the equivalents thereof. Further, the structures, materials or acts and the equivalents thereof shall include all those described in the summary, brief description of the drawings, detailed description, abstract, and claims themselves.

[0024] The term "computer-readable medium" as used herein refers to any storage and/or transmission medium that participate in providing instructions to a processor for execution. Such a medium is commonly tangible and non-transient and can take many forms, including but not limited to, non-volatile media, volatile media, and transmission media and includes without limitation random access memory ("RAM"), read only memory ("ROM"), and the like. Non-volatile media includes, for example, NVRAM, or magnetic or optical disks. Volatile media includes dynamic memory, such as main memory. Common forms of computer-readable media include, for example, a floppy disk (including without limitation a Bernoulli cartridge, ZIP drive, and JAZ drive), a flexible disk, hard disk, magnetic tape or cassettes, or any other magnetic medium, magneto-optical medium, a digital video disk (such as CD-ROM), any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, and EPROM, a FLASH-EPROM, a solid state medium like a memory card, any other memory chip or cartridge, a carrier wave as described hereinafter, or any other medium from which a computer can read. A digital file attachment to e-mail or other self-contained information archive or set of archives is considered a distribution medium equivalent to a tangible storage medium. When the computer-readable media is configured as a database, it is to be understood that the database may be any type of database, such as relational, hierarchical, object-oriented, and/or the like. Accordingly, the disclosure is considered to include a tangible storage medium or distribution medium and prior art-recognized equivalents and successor media, in which the software implementations of the present disclosure are stored. Computer-readable storage medium commonly excludes transient storage media, particularly electrical, magnetic, electromagnetic, optical, magneto- optical signals.

[0025] The term "module" as used herein refers to any known or later developed hardware, software, firmware, artificial intelligence, fuzzy logic, or combination of hardware and software that is capable of performing the functionality associated with that element. Also, while the disclosure is presented in terms of exemplary embodiments, it should be appreciated that individual aspects of the disclosure can be separately claimed.

[0026] "Radio-Frequency IDentification" (RFID) refers to the use of a wireless non- contact system that uses radio-frequency electromagnetic fields to transfer data from a tag attached to an object, for the purposes of automatic identification and/or tracking. Some tags require no battery and are powered and read at short ranges via magnetic fields (electromagnetic induction) (known as passive RFID tags). Others use a local power source and emit radio waves (electromagnetic radiation at radio frequencies) (known as active RFID tags). The tag contains electronically stored information which may be read from up to several meters away. Unlike a bar code, the tag does not need to be within line of sight of the reader and may be embedded in the tracked object.

[0027] It should be understood that every maximum numerical limitation given throughout this disclosure is deemed to include each and every lower numerical limitation as an alternative as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this disclosure is deemed to include each and every higher numerical limitation as an alternative, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this disclosure is deemed to include each and every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0028] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure.

[0030] FIG. 1 is a representative block diagram of a system incorporating a pharmaceutical and biological agent desktop dispensing device, according to one embodiment of the present disclosure.

[0031] FIG. 2 is a representative illustration of a top view of a pharmaceutical and biological agent desktop dispensing device according to one embodiment of the present disclosure.

[0032] FIG. 3 is a representative illustration of a perspective view of the inside of a pharmaceutical and biological agent desktop dispensing device, according to one embodiment of the present disclosure.

[0033] FIG. 4 is a representative illustration of a side view of a pharmaceutical and biological agent desktop dispensing device, according to one embodiment of the present disclosure.

[0034] FIG. 5A is a representative illustration of a perspective view of a pharmaceutical and biological agent desktop dispensing device, according to one embodiment of the present disclosure.

[0035] FIG. 5B is a representative illustration of a perspective view of a loading tray of a pharmaceutical and biological agent desktop dispensing device, according to one embodiment of the present disclosure. [0036] FIG. 6 is a representative flow diagram of a method for authenticating a user using a pharmaceutical and biological agent desktop dispensing device, according to one embodiment of the present disclosure.

[0037] FIG. 7 is a representative flow diagram illustrating a specific example of a method for authenticating a user using the pharmaceutical and biological agent desktop dispensing device described in FIG. 6.

DETAILED DESCRIPTION

[0038] Embodiments of the present disclosure generally relate to devices, methods and systems for dispensing solid dosage forms of various pharmaceutical and biological agents to a subject. In certain embodiments, the present disclosure provides desktop dispensing systems having the capability to acquire and monitor biometric data before, during, and/or after dispensing solid dosage forms of various pharmaceutical and biological agents to a subject.

[0039] Certain aspectss of the devices of the present disclosure can include three principal components: a scanner to verify, identify and/or authenticate a user (e.g., a fingerprint scanner), a biometric sensor to acquire user biometric data (e.g., a pulse oximeter), and a pharmaceutical delivery component (e.g., an inhalation canister) to deliver a pharmaceutical, biological or other monitored agent to the user. In accordance with these embodiments, the devices of the present disclosure allow an authenticated user or caregiver to deliver a pharmaceutical or biological agent while acquiring user biometric data before, during and/or after administration of the pharmaceutical or biological agent. In some embodiments, the devices and systems of the present disclosure can also facilitate transfer of user biometric data to an authorized caregiver, health professional or physician, which can be used by the caregiver, healthcare provider or physician to evaluate accurately the user's condition and provide more effective treatment options. In some embodiments, the devices and systems of the present disclosure can be used by subjects having limited physical capabilities and/or limited mental acuity, including, for example, the elderly, who often times require medical devices and systems having features that more directly address their particular needs, as described herein. [0040] FIG. 1 is a representative block diagram of a system 10 incorporating the pharmaceutical and biological agent desktop dispensing system having biometric data acquisition and monitoring capabilities, according to one embodiment of the present disclosure. The system 10 includes the pharmaceutical and biological agent desktop dispensing device 100, one or more accessory modules 200, one or more peripheral modules 250, a secondary electronic device 300, and a cloud computing device 400, all of which can be communicatively coupled, using either a wired or wireless connection. However, in some embodiments, the devices 100, 200, 250, 300, 400 illustrated in FIG. 1, are not required to be connected to one another and can be used to establish only intermittent connections. Furthermore, in some embodiments, the pharmaceutical and biological agent desktop dispensing device 100, may not connect to all the other devices 200, 250, 300, 400 illustrated in FIG. 1, but may only connect to one of the other devices 200, 250, 300, 400. For example, in some embodiments, the pharmaceutical and biological agent desktop dispensing device 100 may only connect to the secondary electronic device 300. In these embodiments, the secondary electronic device 300 may then connect to the cloud computing device 400, for example.

[0041] The pharmaceutical and biological agent desktop dispensing device 100, the accessory module(s) 200, and the peripheral modules(s) 250 are discussed in more detail below, with reference to FIGS. 2-4. In the illustrated example of FIG. 1, the secondary electronic device 300 is a smartphone. However, other exemplary secondary electronic device(s) 300 can include, but are not limited to, a telephone, a laptop computer, a tablet computer, a personal digital assistant (PDA), a digital camera, a gaming device, a desktop computer, a fitness tracking device, a digital display device, a docking station, or a security terminal or station. The cloud computing device 400 may be implemented, for example, as one or more servers which may be communicatively coupled to the Internet, and which may be co-located or geographically distributed.

[0042] As illustrated in FIG. 2, the pharmaceutical and biological agent desktop dispensing device 100 having biometric data acquisition and monitoring capabilities of the present disclosure includes a housing unit 105, which is configured to contain a battery, a real time clock, and a processing device for operating a plurality of biometric sensors. The structure of the housing unit 105 is generally configured to enable a user to operate the device without interfering with biometric data acquisition before, during, and/or after solid dosage forms of various pharmaceutical and biological agents are dispensed. For example, in certain embodiments, the desktop dispensing device 100 is generally oval-shaped, and configured to lie stably on a desktop or countertop surface, such that the device can be easily operated by the user without difficulty (see, e.g., FIG. 2). Other similar desktop shapes and configurations can readily be ascertained by one of ordinary skill in the art based on the present disclosure, including for example, the shape of the device 100 illustrated in FIGS 2-4.

[0043] In some embodiments, the pharmaceutical and biological agent desktop dispensing device 100 of the present disclosure is constructed of a top portion and a bottom portion, as illustrated in FIGS. 2 and 3, respectively. In some aspects, the top portion comprises a lid that connects to the bottom portion to form an enclosure that houses the internal dispensing mechanisms of the device 100, as illustrated in FIG. 3. The top portion or lid is detachable to enable access to the internal contents of the device 100 to refill the device 100 with pharmaceutical or biological agents and/or to service the device 100. The method or means for detachment and reattachment of the top portion of the device to the bottom portion of the device includes various methods known to one of ordinary skill in the art based on the present disclosure, for example, bolts, screws, screw threads, snap locks, quick release button, alignment of the portions by indicator, pins, and the like. In some aspects, the top and bottom portions are coupled together in a tamper-proof manner in order to restrict access to the internal contents of the device 100 {e.g., prevent access to the solid pharmaceutical agent dosage forms by unauthorized users). For example, the top and bottom portions can be sealed together with various tamper-proof adhesives and/or reinforced with tamper-proof screws or bolts.

[0044] Suitable materials that can be used to construct the housing unit 105 include, but are not limited to, various plastics and polymers materials, such as polystyrene (PS), polycarbonate (PC), acrylonitrile-butadiene-styrene (ABS), polybutylene terephthalate (PBTP), styrene acrylonitrile (SAN), polyamide (PA), polyoxymethylene (POM), polyphenylene oxide (PPO), PE, PP, PTFE and homopolymers and copolymers of these plastics. The plastics may also be used in a filled or fiber-reinforced form, carbon composites, carbon fibers, and/or coupled to portions of metals or metal alloys, such as aluminum, titanium, steel, stainless and combinations thereof. The materials used to construct the housing unit 105 can be surface-coated, for example with paints, varnishes or lacquers. The use of color plastics, for example colored with pigments, is also possible. In some embodiments, the housing unit 105 can be coated with substances that help to prevent contamination from microorganisms, bacteria, fungi, viruses, and the like. The coatings can be active solid pharmaceutical dosage forms that reduce the growth and/or survival of these harmful microorganisms (e.g., anti-bacterial substances), or the coatings can function passively to prevent contamination, for example, by preventing adherence of these microorganism to the housing unit 105 (e.g., wetting agents) or coated with agents to reduce moisture from penetrating the internal compartment.

[0045] In some embodiments, access to the internal contents of the device 100 is restricted to authorized users, for example, authorized caregivers, pharmacists, physicians, and the like. In some aspects, the top portion of the device 100 can be detached by an authorized user that has been identified and authenticated in order to obtain access to the internal contents of the bottom portion of the device (see FIG. 3) to, for example, refill various pharmaceutical and biological agents and/or to service or reprogram the device 100. The authorized user can be identified and authenticated using one or more biometric scanners, such as a fingerprint scanner, as described further below.

[0046] In some aspects, once an authorized user has been authenticated, he or she can perform various operations that other users are restricted from performing. For example, an authorized user can reprogram the list of solid dosage forms of various pharmaceutical and biological agents associated with a person's biometric identifier; an authorized user can add, subtract, or replace the number of solid dosage forms contained within the device (e.g., refill a prescription); an authorized user can alter the dose of a solid dosage form; and/or an authorized user can alter the dosing parameters (e.g., dispensing period) of a solid dosage form. Restricting access to or maintaining control over dispensing the solid dosage forms may be necessary if a user of the device 100 requires oversight, and/or to prevent misuse or abuse of the solid dosage forms. In such situations, the desktop dispensing devices 100 of the present disclosure provide increased safety and security, as compared to standard medication dispensing devices.

[0047] In some embodiments, once an authorized user has been authenticated and steps have been taken to fill or refill solid dosage forms of an agent in the device 100, a picture of the individual dosage form, or groups of dosage forms, to be dispensed can be presented to the user (e.g., via a touchscreen interface, or by audio indicator etc. as described below). In some cases, the authorized/authenticated user (e.g., pharmacist or other healthcare professional) may show one or more pictures of the solid dosage forms to the user who will be taking the dosage forms so that the user can verify if the correct types of dosage forms and the correct number of dosage forms have been dispensed. In some embodiments, the authorized/authenticated user can send one or more pictures of the dosage forms to the user's mobile/computing device and/or directly to the desktop dispensing device 100. In other embodiments, the pictures can be stored in the devices' respective memories so that when the corresponding dosage forms are dispensed, the user can view the picture to verify that the correct types and numbers of dosage forms have been dispensed prior to ingestion. If not, the user can provide feedback using the device and/or a mobile/computing device that indicates that types and/or numbers of dosage forms have not been accurately dispensed. This type of feedback can be accessed by an authenticated user and/or sent directly to an authenticated user for evaluation. This feature generally makes it easier for a user to determine if his or her medication has been accurately dispensed, without the need to memorize the types and quantities of the medication.

[0048] In some embodiments, the generally box-shaped design of the housing unit 105 can provide sufficient structure for allowing the user to interface with various biosensors included in the device while sitting at a desk or kitchen table, for example. In some embodiments, the device 100 can include one or more galvanic skin response (GSR) sensors 1 10, as illustrated in FIG. 2. The GSR sensors 1 10 of the present disclosure, also referred to as electrodermal response (EDR) sensors, psychogalvanic reflex (PGR) sensors, skin conductance response (SCR) sensors, or skin conductance level (SCL) sensors, generally measure electrical conductance of the skin, which varies depending, for example, on the state or condition of sweat in the skin. Sweating is generally considered to be controlled by the sympathetic nervous system; therefore, electrical skin conductance can provide psychological and/or physiologic biometric data about the user. In general, if the sympathetic branch of the autonomic nervous system is highly aroused, then sweat gland activity also increases, which in turn increases skin conductance. In this way, skin conductance can be used as a biometric measurement of emotional and sympathetic responses, which can be used to evaluate, for example, the efficacy and/or side effects caused by solid dosage forms of various pharmaceutical and biological agents administered to a subject.

[0049] In other embodiments, the housing unit 105 can provide sufficient structure for incorporating one or more temperature sensors, as illustrated in FIG. 2. For example, the device can include one or more fingertip temperature sensors 115 to enable the acquisition of the temperature of a user's skin before, during, or after dispensing a solid dosage form. Typically, the temperature at the surface of a subject's skin changes according to blood circulation through the body tissue. The small blood vessels crossing through the tissue are surrounded by fibers of smooth muscle, which are controlled by the sympathetic nervous system. In a state of increased exertion, excitement and stress, these muscle fibers contract, causing a stenosis of vasculature. This can lead to a reduction of skin temperature, because blood circulation through the tissue is reduced. In contrast, in a state of relaxation, the musculature is likely to relax, causing the vasculature to expand. Hence, skin temperature rises. Mental stress often leads to a lower peripheral perfusion and a decrease of skin temperature at the hands, caused by increased activity of the sympathetic nervous system. In this way, temperature of the skin at a user's fingertip can be used to as a biometric measurement for evaluating, for example, the efficacy and/or side effects caused by solid dosage forms of various pharmaceutical and biological agents administered to a subject.

[0050] In some embodiments, the housing unit 105 can provide sufficient structure for incorporating one or more ambient temperature sensors for measuring the air temperature immediately surrounding the device, thus reflecting changes in the environmental conditions. In some embodiments, an ambient temperature sensor can be integrated with the galvanic skin response sensors and/or the fingertip temperature sensors in order to account for alterations in the environmental conditions. The integration of the various temperature sensors can provide more accurate temperature measurements of the subject for evaluating, for example, the efficacy and/or side effects caused by solid dosage forms of various pharmaceutical and biological agents administered to a subject.

[0051] In some embodiments, a fingertip sensor can be included in the devices described herein to measure a user's heart rate (not illustrated). For example, a fingertip heart rate sensor unit can include, but is not limited to, an infrared light-emitting-diode (IR LED) and a photo diode, such that a user's fingertip can be placed over the sensor unit. The IR LED can transmit an infrared light into the fingertip, a part of which is reflected back from the blood inside the finger arteries. The photo diode then senses the portion of the light that is reflected back. The intensity of reflected light depends upon the blood volume inside the fingertip, which varies every time the heart beats in accordance with changes in the amount of reflected infrared light detected by the photo diode. Other similar methods of detecting heart rate using a fingertip sensor can readily be ascertained by one of ordinary skill in the art based on the present disclosure. Monitoring a user's heart rate can be an important biometric measurement for evaluating, the efficacy and/or side effects caused by solid dosage forms of various pharmaceutical and biological agents administered to a subject.

[0052] In some embodiments, the housing unit 105 can provide sufficient structure for incorporating one or more pulse oximeters 120, as illustrated in FIG. 2. For example, a pulse oximeter 120 can be used to measure the oxygen level (or oxygen saturation) in a subject's blood. Typically, the pulse oximeter 120 is placed on a thin part of a subject's body, usually a fingertip, and two wavelengths of light are passed through the fingertip to a photodetector. The photodetector measures the changing absorbance at each of the wavelengths, allowing it to determine the absorbance due to the pulsing arterial blood alone. The pulse oximeter 120 can be used to assess a user's blood oxygenation levels and determining the effectiveness of, or need for, supplemental oxygen. The pulse oximeter 120 can also be used as a biometric measurement for evaluating, for example, the efficacy and/or side effects caused by solid dosage forms of various pharmaceutical and biological agents administered to a subject. The pulse oximeter 120 can also be used to determine noninvasively a subject's hemoglobin level within 1-2 minutes without requiring any further equipment.

[0053] Other embodiments can include one or more scanners associated with the desktop device 100 which authenticate and/or verify the identity of a user or caregiver that will be dispensing solid dosage forms of various pharmaceutical and biological agents to a subject. In some embodiments, the top portion of the device 100 can include an image acquisition device 130, as illustrated in FIGS. 2 and 4. The image acquisition device 130 includes, but is not limited to, a lens, an image sensor, and signal wires which operatively connect the image acquisition device 130 to the processor in the device 100. In some embodiments, an image acquisition device can be a camera (e.g. a digital camera). Image acquisition device 130 can be centrally located on the top portion of the device 100, and be electrically coupled to the processor of the device 100.

[0054] In one manner of operation, the image acquisition device 130 can take a digital image and/or a series of digital images (e.g., a digital video) before, during, and/or after dispensing a solid dosage forms of various pharmaceutical and biological agents to a subject. In some cases, the image sensor can detect a user's pupils and capture one or more images of the user's pupils before, during, and/or after dispensing a solid dosage form from the desktop device 100 in order to assess the efficacy and/or side effects caused by the prescribed agent. In some embodiments, the image acquisition device 130 can be used to assess the color of a user's eye, including but not limited to, the color of a user's sclera. For example, certain conditions can cause a subject's eyes to appear yellow, which can indicate dysfunction in one or more bodily organs such as the liver, gallbladder, or pancreas. Yellowing of the sclera can be used to diagnose various conditions of a user, including, but not limited to, alcohol abuse, hepatitis (A, B, C, D, and E), liver cancer, liver infection, and non-alcoholic fatty liver disease.

[0055] In addition, an image acquisition device 130 can be configured to capture a digital image and/or a series of digital images that can be transferred to an auxiliary electronic device and viewed by a caregiver for diagnostic purposes. For example, the desktop dispensing device 100 can have an activation button functionally coupled to the image acquisition device 130 to enable a user to engage the activation button and capture a digital image or video of, for example, information pertaining to a pharmaceutical agent (e.g., dose, lot number, etc.) or a physical manifestation of a disease condition located on the subject (e.g., wound, laceration, allergic reaction, insect bite, swollen glands, and the like). [0056] In some embodiments, the image acquisition device 130 can be configured to take a picture of a subject's retina to evaluate the vascularization of the retina and/or whether the subject has a retinal vascular occlusion. A retinal vascular occlusion occurs when one of the veins or arteries carrying blood to or from the retina becomes blocked or contains a blood clot. The blockage could occur in the main vein or main artery. Blockages could also occur in the branch of veins and arteries throughout the retina. A blockage in the vein or artery of the retina can cause blood or other fluids to build up and inhibit the retina's ability to filter light properly. When light is blocked or fluids are present, sudden loss of vision can occur. The presence of a retinal vascular occlusion or blockage can be a predictor of an increased likelihood that the subject will experience a stroke.

[0057] The desktop dispensing device 100 can also be equipped with a microphone 132 that may or may not be functionally coupled to the image acquisition device 130 to facilitate real-time and/or recorded audio and/or video communication with a caregiver for diagnostic purposes (e.g., videoconferencing). In some embodiments, the image acquisition device 130 and the microphone 132 face the same direction as that of the centrally located dispenser port 125 (see FIGS. 2 and 4). The dispenser port 125 is the area of the device 100 where one or more solid dosage forms of various pharmaceutical and biological agents are dispensed from the device 100 and subsequently acquired by the user.

[0058] Other sensors can also be included in the devices of the present disclosure, as would be readily appreciated by one of ordinary skill in the art based on the present disclosure. For example, the devices of the present disclosure can include global positioning system (GPS) sensors, chemical sensors, thermal sensors, magnetic sensors, radiation sensors, proximity sensors, acoustic sensors, vibration sensors, acceleration sensors, moisture sensors, and the like. In some cases, the device can be equipped with a sensor or monitor capable of measuring a subject's blood glucose levels, as well as determining if the subject's blood glucose levels are within a certain range.

[0059] In other embodiments, a thermal imaging sensor can be included in the devices disclosed herein to facilitate user authentication and/or as a biometric sensor. A thermal imaging sensor can be integrated with the image acquisition device to facilitate the scanning and processing of a thermal image of one or more portions of a subject's face and/or the subject's entire body. In some cases, the thermal imaging sensor can be used to evaluate whether the subject has a medical condition (e.g., fever) that may require immediate attention. In such cases, the device can be configured to send an alert message to the subject to seek immediate medical attention.

[0060] In some embodiments, the desktop dispensing devices of the present disclosure include a touchscreen 135 as a user interface to facilitate communication between the user and the device 100, and/or third party authorized users such as physicians and caretakers who can access the device. The touchscreen 135 is adjustable and can be mounted such that it faces the centrally located dispenser port 125 to facilitate easy access by the user. The touchscreen 135 can be used to communicate different types of information to the user, including for example, emitting at least one visual indicator, such as a green, red, or white colored light signal, and/or word-based signals that conspicuously flash to convey instructions to the user. For example, the visual indicator can communicate to the user when the image acquisition device has been activated, deactivated, and/or is in the process of capturing images.

[0061] In some cases, the touchscreen 135 can request that the user take certain action, including but not limited to, requesting that the user record a dosage amount or a time a dosage was taken, request that the user upload one or more biometric measurements (e.g., images of the user's eyes) to a server or other computing device, requesting that the user download certain programing instructions for the device, requesting that the user respond to various questions pertaining to their physical and/or mental state (e.g., symptoms), and requesting that the user respond to one or more survey questions. These and other visual indicators that can be used to communicate instructions to the user via the touchscreen 135 include indicating whether the user has been authenticated, or when a solid dosage form has been dispensed.

[0062] In some embodiments, a user (e.g., authenticated user and/or health care provider) can set one or more alarms using the device, such as one or more medication alert alarms, which can present a stimulus to the user with or without an accompanying text-based message to, for example, take one or more doses of one or more solid pharmaceutical dosage forms of an agent. The alarm can be a visual (e.g., flashing light) and/or auditory (e.g., ringing bell sound) stimulus that is emitted from the device. The alarm can also be pushed to another device, such as a mobile phone or computing device. In some cases, the alarm can take the form of an email, text message, a message from a third party mobile phone application and the like. Similarly, a user can set one or more biometric alarms, which can present a similar stimulus to the user to, for example, obtain and record one or more biometrics using the device.

[0063] In some embodiments, visual indicators displayed to a user via the touchscreen 135 can also be used to facilitate the acquisition of biometric data from the user, such as emitting a flash of light to dilate a user's pupils. Changes in a user's pupil size or pupil dilation can be an important biometric measurement indicating, for example, the efficacy and/or side effects caused by solid dosage forms of various pharmaceutical and biological agents administered to a subject. In some cases, the touchscreen 135 can be used to send instructions to a user to activate an eye tracking program that uses visual stimulation, such as pulses of light, to assess various neurological problems, including brain diseases and brain injuries (e.g., concussions). Eye tracking technology and testing protocols are well established and can obtain hundreds of data points during, for example, a 30-second test facilitated by the video recording capability of the image acquisition device 130.

[0064] The touchscreen 135 can also be used as an interface to determine and/or adjust a user compliance rating. A user compliance rating can be determined using the delivery parameters of the dispensed solid pharmaceutical dosage form and/or at least one biometric response. For example, depending on the type of pharmaceutical agent, how relevant the time of day that the pharmaceutical agent is taken, the duration between doses, etc., compliance ratings can be determined and subsequently adjusted up or down, depending on whether the delivery parameters indicate that the pharmaceutical agent was or was not taken according to a predetermined treatment plan. If a higher or lower dosage of the pharmaceutical agent is prescribed, the compliance rating can be adjusted accordingly. The touchscreen 135 can be configured to display a user's compliance rating, which can be a tool for motivating a user to comply with a given treatment plan.

[0065] Other embodiments can include one or more scanners on the device which authenticate and/or verify the identity of a user or caregiver that will be dispensing a solid dosage form of various pharmaceutical and biological agents to a subject. In some embodiments, images captured using the image acquisition device 130 can be used for retinal scanning and/or facial recognition to, for example, prevent unauthorized users from dispensing a solid pharmaceutical dosage form and/or tampering with the device 100. In other embodiments, device 100 can include a fingerprint scanner 150 to prevent unauthorized users from dispensing a solid dosage form of a pharmaceutical or biological agent and/or tampering with desktop device 100.

[0066] In one exemplary device, desktop device 100 of the present disclosure can store in its memory a plurality of distinct user fingerprints (e.g., biometric identifiers), and device 100 can be programmed to correlate a particular fingerprint with certain device settings for a particular user. In this way, device 100 can be used by more than one user, for example, a family of users, without the need for multiple devices for each person or solid pharmaceutical or biological dosage form being dispensed. In other embodiments, device 100 can be configured to be accessed only by an authorized health provider such as a nurse, parent or other caregiver, and the nurse, parent or caregiver's fingerprint or other biometric identifier can be used to access the patient's settings on the device, as the patient may need to be restricted from using the device or the patient may not be capable of using the device without supervision (e.g., a child or elderly person). The fingerprint scanner 150 can also be used in conjunction with a lockout mechanism in which the device will be "locked out" or inactive for a given operation of a particular delivery program if the user's fingerprint is not recognized or the agent/drug is controlled for a programmed delivery, for example, when a dose is dispensed at predetermined times. In certain embodiments, if a dose is not removed by a user, patient or healthcare provider from a delivery compartment of a device, another dose will not be dispensed.

[0067] Desktop device 100 can include memory in electrical communication with the processor of the device and configured to facilitate the acquisition and storage of biometric data acquired using various biometric sensors from one or more users. Biometric data can include, but is not limited to, images, fingerprints, oxygen levels, carbon dioxide levels, skin electrical conductance measurements, time, temperature, heat, user identification, dosages, usage rates, medication batch numbers, bar codes, and any other biometric data that can be captured using the various biometric sensors of the present disclosure including, but not limited to, out of range, taken too soon, taken too late, misused or overridden and the like. User biometric data can be stored on the memory and u loaded/downloaded wirelessly to a variety of other memory storage and data processing devices, including but not limited to, cell phones, smart phones, watches, computers, laptops, tablets, servers, and the like. User biometric data can also be stored on the memory and uploaded/downloaded via a wire or cable to a variety of other memory storage and data processing devices, including but not limited to, cell phones, smart phones, watches, computers, laptops, tablets, servers, and the like. In accordance with these embodiments, devices can have one or more data transfer ports. The ability to acquire and store a subject's biometric data over time provides physicians with more accurate diagnostic and biometric data with which to evaluate the subject, and allows for more general patient trends to be analyzed with relation to, for example, a specific disease indication.

[0068] In some embodiments, desktop device 100 of the present disclosure can have various mechanisms for dispensing one or more solid dosage forms of various pharmaceutical and biological agents to a user. In embodiments illustrated in FIG. 3, the bottom portion of device 100 comprises one or more loading cartridges 155 that can be accessed by a user or caregiver, as described above, in order to load one or more solid dosage forms 165 into the device 100. The loading cartridge 155 can be comprised of a plurality of storage chambers 160 that are configured to house one or more solid dosage forms 165 prior to being dispensed to a user.

[0069] Embodiments of desktop device 100 illustrated in FIG. 3 include four loading cartridges 155, each loading cartridge 155 equipped with one storage chamber 160, which houses seven solid dosage forms. However, as one of skill in the art would recognize based on the present disclosure, desktop devices 100 can include a plurality of loading cartridges 155, equipped with a plurality of storage chambers 160, which can house a plurality of dosage forms 165, depending on the needs of the user(s). For example, a given loading cartridge 155 can be equipped with one or more storage chambers 160 that correspond to different types of solid dosage forms 165, or a given loading cartridge 155 can be equipped with only one storage chamber 160 that houses a single type of solid dosage form 165. Device 100 can include a single loading cartridge 155, or as many as ten individual loading cartridges 155. The precise number of loading cartridges 155, storage chambers 160, and types of dosage forms 165 will vary depending, for example, on the number of different users and the number of different types of solid dosage forms being administered to those users.

[0070] In some cases, the desktop device 100 contains a motion sensor (not illustrated) located adjacent to the dispenser port 125 of the device 100, which detects the release or ejection of one or more solid dosage forms 165 into the dispenser port 125. Motion sensors can be used to detect a change in the position of a solid dosage form as it exits the device 100. Motion detection can be achieved by mechanical and/or electronic methods, including but not limited to, infrared (passive and active sensors), optics (video and camera systems), radio frequency energy (radar, microwave and tomographic motion detection), sound (microphones and acoustic sensors), vibration (triboelectric, seismic, and inertia-switch sensors), and magnetism (magnetic sensors and magnetometers).

[0071] As part of one mechanism for dispensing solid dosage forms of various pharmaceutical and biological agents, the desktop device 100 includes, but is not limited to, a prime mover (e.g., actuator) operably coupled to the loading cartridge 155 and a dispensing activator. The dispensing activator can take a plurality of different forms, including but not limited to, an activation button located in the top portion of the device 100, a visual indicator used as part of the touchscreen 135, and/or a sensor mechanism coupled to one or more sensors in the device 100 (e.g., fingerprint scanner). Regardless of the form of the dispensing activator, the dispensing activator facilitates the convenient dispensing of a solid dosage form 165 from the desktop device 100. The user has convenient access to the dispensing activator while the device 100 rests on a flat surface, such as a desktop or a countertop.

[0072] For example, in one manner of operation, a user's engagement of the dispensing activator actuates the prime mover, such as the auger-like structure of the loading cartridge 155 illustrated in FIG. 3, which in turn facilitates the release or ejection of one or more solid dosage forms 165 from the loading cartridge 155. The release of one or more solid dosage forms 165 generally constitutes a single dose, and the time at which the one or more solid dosage forms 165 is dispensed to a user can be recorded and stored in the memory of the device 100, as explained further below. Other mechanisms to facilitate the release and/or ejection of one or more solid dosage forms of various pharmaceutical and biological agents can also be used with the device 100, as would be readily apparent to one of skill in the art based on the present disclosure.

[0073] In another exemplary manner of operation, as illustrated in FIGS. 5A-5B, a user's engagement with the dispensing activator can actuate a prime mover positioned at one end of a loading cartridge 155 (e.g., distal to the dispensing port 125). Actuation of the prime mover facilitates the release or ejection of one or more storage chambers 160 from the loading cartridge 155 and into the dispensing port 125. In some embodiments, actuation of the prime mover rotates the loading cartridge 155 such that a storage chamber 160 is brought into alignment with a ventrally located storage chamber ejection port. Alignment in this manner allows the storage chamber 160 to exit the loading cartridge 155 and be discharged into the dispensing port 125 so that the user can access the contents of the storage chamber 160 (e.g., solid pharmaceutical dosage forms).

[0074] In some embodiments, a plurality of loading cartridges 155 and loading chambers 160 can be contained within a loading tray 170, as illustrated in FIG. 5B. In accordance with these embodiments, in one example, four loading cartridges 155 can be constructed to house seven storage chambers 160, as illustrated in FIGS. 5A-5B, for a total of 28 different solid dosage form combinations (covering the timespan of about a month), all contained within a single loading tray 170. The loading tray 170, loading cartridges 160, and/or storage chambers 160 can be filled with various solid pharmaceutical dosage forms by an authenticated user, such as a pharmacist or healthcare provider. Other set-ups are contemplated, for example, a 5^th loading cartridge allowing up to 31 solid dosage form combination in accordance with a month having 30 or 31 days, for example. In some embodiments, to reduce cross- contamination and/or confusion among multiple users, only a single type of solid dosage form (a single dose or multiple doses) is contained within an individual storage chamber 160. In other cases, various different types of solid dosage forms can be contained within an individual storage chamber 160, and can be dispensed to a single user or multiple users.

[0075] In some embodiments, a user's engagement with the dispensing activator will not lead to the release of one or more solid dosage forms if the user's biometric identifier has not been authenticated (e.g., the user is not authorized to dispense that particular solid dosage form or is not authorized to use the device). In some embodiments, the dispensing activator can be coupled to a scanner, such as the fingerprint scanner 150, where the dispensing activator is in a "locked" position until a user has been authenticated, at which time the dispensing activator is in an "unlocked" position and can actuate the prime mover to release one or more solid dosage forms. In some embodiments, once the dispensing of one or more solid dosage forms is sensed by a motion sensor, the dispensing activator is placed in a "locked" position in order to prevent a user from dispensing more than one dose of a solid dosage form.

[0076] Embodiments disclosed herein can also include one or more accessory module interfaces on a device that facilitates the functional coupling of one or more accessory modules 200 to the desktop device 100. Examples of accessory modules 200 include, but are not limited to, an injectable syringe, an injectable needle, an inhaler, an inhaler canister, a syrup dispenser, a spray device, a nebulizer, a misting device, an inhalation mask, and the like. The accessory module interfaces allow for one or more accessory modules 200 to be coupled to the device. In other embodiments, devices can include a mechanism for monitoring amount or dosage of a solid dosage form dispensed to a subject. For example, the device can include a radio-frequency identification (RFID) reader, which can be used to assess the batch, date, amount and source of a particular solid pharmaceutical dosage form.

[0077] In some embodiments, peripheral accessory modules or peripheral modules can be functionally coupled to the device of the present disclosure via peripheral module interfaces rather than accessory module interfaces. Typically, a peripheral module requires its own power source separate from the device, which can preclude the peripheral module from being coupled to the device via an accessory module interface. The peripheral accessory interface can be a port, including any electronic data transfer port, such as a USB port, a firewire port, and the like. Peripheral modules can include, for example, blood pressure monitors, blood glucose monitors, CPAP machines, and/or electrocardiogram machines, as well as peripheral modules for providing additional power to the device, such as a battery or a battery charging device, and devices that enable the use of Bluetooth and WiFi compatibility. Just as with accessory modules, some peripheral modules can be functionally coupled to the processor of the device of the present disclosure to facilitate the dispensing of a solid pharmaceutical dosage form and/or the acquisition of biometric data from a user. [0078] In some embodiments, desktop device 100 can be coupled to a CPAP machine (Continuous Positive Airway Pressure) or a baby monitor (e.g., monitors used to assess Sudden Infant Death Syndrome, or SIDS), or other such medical monitoring peripheral devices. The device can be used to acquire other biometric data not possible using the medical monitoring peripheral device, and/or the device can be used to integrate the biometric data acquired using the medical monitoring peripheral device. In other cases, the device can be coupled to a motor vehicle, such that operation of the motor vehicle (e.g., starting a car) by the subject will only be allowed if certain biometric parameters are met. This feature can help prevent a subject who is taking various pharmaceutical and biological agents from operating a motor vehicle while impaired.

[0079] Solid dosage forms of various pharmaceutical and biological agents can be dispensed using the devices, systems, and methods of the present disclosure, including both prescription and non-prescription (e.g., "over the counter" or OTC) dosage forms. Solid dosage forms can include vitamins, minerals, nutraceuticals, supplements and various combinations of these. Solid dosage forms can include active pharmaceutical ingredients (APIs) that contain both solid and liquid components. A liquid component can be, for example, fish oil or other liquid form of a pharmaceutical or biological agent. Solid dosage forms can be one or more of pill, capsule, gel capsule, gummy, timed-release capsule, slow- dissolving capsule, tablet, caplet, patch, strip, dermal adhesion or aid, subdermal patch or the like, needle-free applicators and thin-film strip, mini-tablets, granules, beads, pellets, multiparticulates, spheroids, or combinations thereof.

[0080] In some cases, a solid dosage form can be in the form of a strip or a thin-film strip contained within and dispensed by the desktop dispensing device 100. Generally, thin- film strips are designed to deliver one or more doses of a solid pharmaceutical dosage form to a subject using a dissolving film or oral strip to administer a pharmaceutical agent via absorption in the mouth (buccally or sublingually) and/or via the small intestines (enterically). A film or thin-film strip can be prepared using hydrophilic polymers that rapidly dissolve on the tongue or buccal cavity, delivering the pharmaceutical agent to the systemic circulation via dissolution when contact with liquid is made. A film or thin-film strip can also include pH-sensitive microparticles and or mucoadhesive polymers that facilitate the release of the solid pharmaceutical dosage form in various portions of a subject's intestinal tract (e.g., small intestine, gastric cavity, etc.). In other embodiments, a film or thin-film strip comprising a solid pharmaceutical dosage form can also include a copolymer of methacrylic acid or acrylic acid, such as a Eudragit-style copolymer, a pluronic polymer, a chitosan, a chitosan derivative, a surfactant, a sugar, a buffering salt, or a combination thereof.

[0081] In some embodiments, a film or thin-film strip comprising a solid dosage form can be sealed in a sterile package with perforations demarcating each dose to facilitate the convenient removal of a dose from the desktop dispensing device 100 by a user. The removal of a dose from the device, such as by tearing along the perforation, can be sensed and recorded in the memory of the device in order to monitor the administration of the solid dosage form to the user.

[0082] In other embodiments, a solid dosage form can be in the form of a patch contained within, and dispensed by, the desktop dispensing device. For example, the desktop device 100 can include various patches that can be dispensed to an authorized user so that a pharmaceutical or biological agent can be delivered through the skin without the use of a needle or a syringe (e.g. needleless). In some embodiments, the patch can include protein- based pharmaceutical or biological agents that are between about 500 daltons (da) and about 150 kilodaltons (kDa), such as a vaccine or a biologic drug. The protein-based agents can be in the form of nanofibrils and/or nanofibers that adhere to a surface of the patch and are stable at room temperature, as well as lower temperatures (standard refrigerated temperatures), for 20 to about 30 weeks. The patch enhances the surface area in which the agents are in contact with a subject's skin, thus allowing for efficient delivery of an agent at much lower doses than the conventional injection of liquid-based formulations.

[0083] In addition to dispensing patches and/or strips comprising protein-based pharmaceutical and biological agents, the desktop dispensing device 100 can also be configured to dispense various other types of medication on patches and strips to an authorized user, such as small molecule drugs, and/or a combination of protein-based and small molecule agents, as would be readily recognized by one or ordinary skill based on the present disclosure. [0084] In certain embodiments, solid dosage forms of various pharmaceutical and biological agents that can be dispensed using the desktop devices, systems, and methods of the present disclosure include, but are not limited to, those dosage forms approved by the U.S. Food and Drug Administration, prescribed and non-prescription agents and biologies, such as, for example, albuterol, albuterol sulfate, atropine sulfate, beclomethasone dipropionate, bitolterol mesylate, budesonide, formoterol fumarate, cromolyn sodium, desflurane, dexamethasone sodium phosphate, dornase alfa, enflurane, epinephrine, ergotamine tartrate, flunisolide, fluticasone propionate, fomoterol fumarate, halothane, iloprost, insulin, ipratropium bromide, isoetharine hydrochloride, isoflurane, isoproterenol hydrochloride, levalbuterol hydrochloride, metaproterenol sulfate, methacholine chloride, mometasone furoate, nedocromil sodium, nicotine, nitric oxide, pentamidine isethionate, pentetate calcium trisodium, pentetate zinc trisodium, pirbuterol acetate, ribavirin, salmeterol xinafoate, sevoflurane, tetrahydrocannabinol, tiotropium bromide monohydrate, tobramycin, trimcinolone acetonide, zanamivir, and combinations and derivatives thereof.

[0085] Solid dosage forms of pharmaceutical and biological agents that can be dispensed using the desktop devices, systems, and methods of the present disclosure can include, but are not limited to, those dosage forms that have not yet been approved by the U.S. Food and Drug Administration where some agents are approved or in use in other jurisdictions, for example, 13-cis-retinoic acid, 2-pentenylpenicillin, L-alphaacetylmethadol, S-adenosylmethionine, acebutolol, aceclofenac, acetaminophen, acetaphenazine, acetophenazine, ademetionine, adinazolam, adrafmil, ahnotriptan, albuterol, albuterol, albuterol sulfate, alfentanil, alfentanil HC1, alizapride, allylprodine, alminoprofen, almotriptan, alperopride, alphaprodine, alpidem, alseroxion, amantadine, ambrisentan, amesergide, amfenac, aminopropylon, amiodarone HC1, amisulpride, amitriptyline, amixetrine, amlodipine, amoxapine, amoxicillin, amperozide, amphenidone, amphetamine, ampicillin, amylpenicillin, andropinirole, anileridine, apazone, apomorphine, apomorphinediacetate, atenolol, atropine sulfate, azacyclonol, azasetron, azatadine, azidocillin, bacille Calmette-Guerin, baclofen, beclomethasone dipropionate, benactyzine, benmoxine, benoxaprofen, benperidol, benserazide, benzpiperylon, benzquinamide, benztropine, benzydramine, benzylmorphine, benzylpenicillin, bezitramide, binedaline, biperiden, bitolterol, bitolterol mesylate, brofaromine, bromfenac, bromisovalum, bromocriptine, bromopride, bromperidol, brompheniramine, brucine, buclizine, budesonide, budesonide; formoterol fumarate, budipine, bufexamac, buprenorphine, bupropion, buramate, buspirone, butaclamol, butaperazine, butorphanol, butriptyline, cabergoline, caffeine, calcium-N-carboamoylaspartate, cannabinoids, Cannabis, Cannabis oil, captodiamine, capuride, carbamazepine, carbcloral, carbenicillin, carbidopa, carbiphene, carbromal, carfecillin, carindacillin, caroxazone, carphenazine, carpipramine, carprofen, cefazolin, cefinetazole, cefmetazole, cefoxitin, cephacetrile, cephalexin, cephaloglycin, cephaloridine, cephalosporin C, cephalosporins, cephalotin, cephamycin A, cephamycin B, cephamycin C, cephamycins, cepharin, cephradine, cericlamine, cetrizine, chloralbetaine, chlordiazepoxide, chlorobutinpenicillin, chlorpheniramine, chlorpromazine, chlorprothixene, choline, cialis, cilazaprol, cilostazol, cinchophen, cinmetacin, cinnarizine, cipramadol, citalopram, clebopride, clemastine, clobenzepam, clocapramine, clomacran, clometacin, clometocillin, clomipramine, clonidine, clonitazene, clonixin, clopenthixol, clopriac, clospirazine, clothiapine, clovoxamine, cloxacillin, clozapine, codeine, cotinine, cromolyn sodium, cyamemazine, cyclacillin, cyclizine, cyclobenzaprine, cyclosporin A, cyproheptadine, deprenyl, desflurane, desipramine, dexamethasone sodium phosphate, dexfenfluramine, dexmedetomidine, dextroamphetamine, dextromoramide, dextropropoxyphene, diamorphine, diazepam, diclofenac, dicloxacillin, dihydrocodeine, dihydroergokryptine, dihydroergotamine, diltiazem, diphenhydramine, diphenicillin, diphenidol, diphenoxylate, dipipanone, disulfiram, dolasetronmethanesulfonate, domeridone, dornase alfa, dosulepin, doxepin, doxorubicin, doxylamine, dronabinol, droperidol, droprenilamin HC1, duloxetine, eletriptan, eliprodil, enalapril, enciprazine, enflurane, entacapone, entonox, ephedrine, epinephrine, eptastigmine, ergolinepramipexole, ergotamine, ergotamine tartrate, etamiphyllin, etaqualone, ethambutol, ethoheptazine, etodolac, famotidine, fenfluramine, fentanyl, fexofenadine, fientanyl, flesinoxan, fluconazole, flunisolide, fluoxetine, flupenthixol, fluphenazine, flupirtine, flurazepam, fluspirilene, fluticasone propionate, fluvoxamine, formoterol fumarate, frovatriptan, gabapentin, galanthamine, gepirone, ghrelin, glutathione, granisetron, haloperidol, halothane, heliox, heptylpenicillin, hetacillin, hydromorphone, hydroxyzine, hyoscine, ibuprofen, idazoxan, iloprost, imipramine, indoprofen, insulin (recombinant human), ipratropium bromide, iproniazid, ipsapiraone, isocarboxazid, isoetharine hydrochloride, isoflurane, isometheptene, isoniazid, rifampin, pyrazinamide, ethambutol, isoproterenol, isoproterenol hydrochloride, isoproterenol bitartrate, isosorbide dinitrate, ketamine, ketoprofen, ketorolac, ketotifen, kitanserin, lazabemide, leptin, lesopitron, levalbuterol hydrochloride, levodopa, levorphanol, lidocaine, lisinopril, lisuride, lofentanil, lofepramine, lomustine, loprazolam, loratidine, lorazepam, loxapine, maprotoline, mazindol, mazipredone, meclofenamate, mecloqualone, medetomidine, medifoxamine, melperone, memantine, menthol, meperidine, meperidine HC1, meptazinol, mesoridazine, metampicillin, metaproterenol, metaproterenol sulfate, methacholine chloride, methadone, methaqualone, methicillin, methprylon, methsuximide, methyphenidate, methyprylon, methysergide, metoclopramide, metofenazate, metomidate, metopimazine, metopon, metoprolol, metralindole, mianserin, midazolam, milnacipran, minaprine, mirtazapine, moclobemide, mofegiline, molindrone, mometasone furoate, morphine, nabilone, nadolol, nafcillin, nalbuphine, nalmefene, nalorphine, naloxone, naltrexone, naratriptan, nedocromil, sodium, nefazodone, nefopam, nicergoline, nicotine, nicotine, nifedipine, nisoxetine, nitrous oxide, nitroglycerin, nomifensine, nortriptyline, obestatin, olanzapine, omoconazole, ondansetron, orphenadrine, oxprenolol, oxycodone, palonosetron, papaveretum, papaverine, paroxetine, pemoline, penfluridol, penicillin N, penicillin O, penicillin S, penicillin V, pentamidine isethionate, pentazocine, pentetate, calcium trisodium, pentetate, zinc trisodium, pentobarbital, peptides, pergolike, pericyazine, perphenazine, pethidine, phenazocine, phenelzine, phenobarbital, phentermine, phentolamine, phenyhydrazine, phosphodiesterase-5, pilocarpine, pimozide, pipamerone, piperacetazine, pipotiazine, pirbuterol acetate, pirbuterolnaloxone, piroxicam, pirprofen, pizotifen, pizotyline, polyeptides, polypeptide YY, pramipexole, prentoxapylline, procaine, procaterol HC1, prochlorperazine, procyclidine, promazine, promethazine, propacetamol, propanolol, propentofylline, propofol, propoxyphene, propranolol, proteins, protriptyline, quetiapine, quinine, rasagiline, reboxetine, remacemide, remifentanil, remoxipride, retinol, ribavirin, rimonabant, risperidone, ritanserin, ritodrine, rizatriptan, roxindole, salicylate, salmeterol xinafoate, salmetrol, scopolamine, selegiline, sertindole, sertraline, sevoflurane, sibutramine, sildenafil, spheramine, spiperone, sufentanil, sulpiride, sumatriptan, tandospirone, terbutaline, terguride, testosterone, testosterone acetate, estosterone enanthate, testosterone proprionate, tetrahydrocannabinol, thioridazine, thiothixene, tiagabine, tianeptine, timolol, tiotropium bromide monohydrate, tizanidine, tobramycin, tofenacin, tolcapone, tolfenamate, tolfenamicacid, topiramate, tramadol, tranylcypromine, trazadone, triamcinolone acetonide, triethylperazine, trifluoperazine, trifluperidol, triflupromazine, trihexyphenidyl, trimeprazine, trimethobenzamide, trimipramine, tropisetron, tryptophan, valproicacid, vardenafil, venlafaxine, verapamil, vigabatrin, viloxazine, yohimbine, zafirlukast, zalospirone, zanamivir, zileuton, ziprasidone, zolmitriptan, Zolpidem, zopiclone, zotepine, zuclopenthixol, and combinations and derivatives thereof.

[0086] In some embodiments, the pharmaceutical and biological agent desktop dispensing devices of the present disclosure can be used to administer unapproved drugs, pre- approved drugs, and/or drugs subject to clinical trials. For example, the devices can be used to assess the efficacy of various pharmaceutical and biological agents that are being evaluated in the context of a clinical trial. Test subjects can use the device in conjunction with clinical research being conducted to evaluate a drug's ability to attain or not attain certain clinical outcomes. The device can facilitate acquisition of biometric data from the test subjects, as well as aggregation and/or analysis of that data, in an effort to evaluate whether an experimental drug has therapeutic potential. In addition, test data can be acquired without the need for a test subject to go into a healthcare facility each time the subject needs to be evaluated for side effects of an agent or the like.

[0087] FIG. 6 is a flow diagram of an exemplary method 500 for dispensing solid dosage forms of various pharmaceutical and biological agents using the desktop dispensing devices of the present disclosure. The pharmaceutical and biological agent desktop dispensing device can also be referred to herein as the "biometric data acquisition device" or the "desktop dispensing device." In certain exemplary embodiments, desktop dispensing devices 500 can have some or all of the same characteristics as the pharmaceutical and biological agent desktop dispensing device 100 described above in FIGS. 1-4. For example, the pharmaceutical and biological agent desktop dispensing device can be turned on by holding a button (e.g., a fingerprint reader and/or pulse oximeter incorporated into the biometric data acquisition device). As another example, the pharmaceutical and biological agent desktop dispensing device can provide sensory feedback to a user at pre-determined times or intermittently as illustrated by method 500. Examples of sensory feedback include, but are not limited to, visual cues, haptic feedback, or auditory feedback. As another example, the pharmaceutical and biological agent desktop dispensing device can take an image of the user at predetermined times or intermittently during method 500. An example of sensory feedback is discussed in more detail in relation to FIG. 7 below. As another example, the pharmaceutical and biological agent desktop dispensing device can have wired and wireless connectivity. As another example, the pharmaceutical and biological agent desktop dispensing device can measure biometric responses of a user. This list, however, is not exhaustive and, therefore, not meant to be limiting.

[0088] Method 500 can commence by sensing a biometric identifier of a user using a pharmaceutical and biological agent desktop dispensing device (block 502). In certain exemplary methods, the biometric identifier includes, but is not limited to, the following: a fingerprint pattern, an iris pattern, a retina pattern, a vocal pattern, a facial-feature pattern, a pore pattern, a thermal image pattern, and a blood vessel pattern. The biometric data acquisition device can be equipped with various sensors and software to measure one or more of these biometric identifiers, as described above. In some exemplary methods, method 500 can begin when one or more audio sensors detects one or more audio signals from an authorized user, including the patient himself, or an authorized caregiver. In other embodiments, if a healthcare provider or caregiver must be present, a proximity reader can be used to verify presence of the healthcare provider or caregiver, such as an IR reader. In certain embodiments, a watch, ring, hospital band or other removable item having an IR or other identifier and further including a barcode, IR or other identifying feature.

[0089] At block 504, a determination can be made whether the scanned biometric identifier matches a stored biometric identifier. The stored biometric identifier can be an approved user's biometric identifier. In some exemplary embodiments, a stored biometric identifier can be securely stored in the pharmaceutical and biological agent desktop dispensing device's memory. In other exemplary embodiments, a stored biometric identifier can be concurrently securely stored on an auxiliary electronic device (e.g. , a smartphone or a cloud computing device) that the pharmaceutical and biological agent desktop dispensing device can connect by wired or wirelessly. Or, in some other exemplary embodiments, the stored biometric identifier is not stored in the pharmaceutical and biological agent desktop dispensing device's memory, but only stored on an auxiliary electronic device, where the device can connect to, by wire or wirelessly. In other exemplary embodiments, the stored biometric identifier can be included in a secure database of stored biometric identifiers. In exemplary embodiments, biometric identifiers for more than one user can be stored in the secure database of biometric identifiers and more than one biometric identifier for each user can be stored in the secure database of biometric identifiers.

[0090] In order to populate a list of stored biometric identifiers, an enrollment process can be undertaken. The enrollment process may include determining what biometric identifiers are to be used in method 500, enrolling each of those biometric identifiers using an iterative process, so that a fingerprint pattern, retina pattern, etc. can be recognized from various angles and under different conditions, and storing the enrollment data in the memory of the desktop dispensing device, or an auxiliary electronic device.

[0091] If the scanned biometric identifier matches a stored biometric identifier at block 504, then the method 500 continues to block 510. If the scanned biometric identifier does not match a stored biometric identifier, then method 500 can proceed back to scanning the biometric identifier at block 502 to try again. However, in some exemplary embodiments, if method 500 proceeds to scan a biometric identifier a predetermined number of times but is unable to match the scanned biometric identifier to a stored biometric identifier, then method 500 can proceed to locking the biometric data acquisition device at block 506. The predetermined number of times can be configurable when setting up the desktop dispensing device. In some exemplary embodiments, method 500 will try to match the scanned biometric identifier to a stored biometric identifier three times before locking the device. In some other exemplary embodiments, method 500 will attempt to match the scanned biometric identifier to a stored biometric identifier five times before locking device. In yet other exemplary embodiments, method 500 will attempt to match the scanned biometric identifier to a stored biometric identifier an unlimited number of times without locking the device. These parameters can be pre-set by a healthcare provider or set within a system when purchased.

[0092] In other embodiments, where method 500 proceeds to block 506 and locks the biometric data acquisition device, method 500 can proceed to block 508 and require either an alternate identifier or reauthorization to unlock the biometric data acquisition device. In some embodiments where method 500 requires an alternative identifier at block 508, a different biometric identifier than the one previously used may be required and matched to a stored biometric identifier in order to unlock the biometric data acquisition device. For example, if the biometric identifier initially used by the biometric data acquisition device was a fingerprint scanner, then a user's retina may be scanned and matched to a stored biometric identifier in order to unlock the biometric data acquisition device. Or, as another exemplary embodiment, a passcode may be entered into the biometric data acquisition device in order to unlock the biometric data acquisition device. In other embodiments, block 508 may require reauthorization of the biometric data acquisition device by the manufacturer of the device, a certified healthcare professional or other authorized third-party. It is contemplated herein that an override mechanism can be provided on the device in the event that a subject is on a solid dosage form agent where it is critical that the subject receive their medication in a timely manner or that missing the dose would put the subject's health at risk.

[0093] Once the biometric data acquisition device is unlocked, in some embodiments, method 500 can proceed back to block 502 or to block 510, depending on how the biometric data acquisition device was unlocked. For example, if a passcode was entered, method 500 may proceed back to 502 to identify a biometric identifier of a user because a biometric identifier was never matched to a stored biometric identifier. As another example, if a retina was scanned and the retina pattern is matched to a stored biometric identifier to unlock the biometric data acquisition device, method 500 may proceed to block 510 since a biometric identifier was matched to a stored biometric identifier. In yet another example, if the biometric data acquisition device was unlocked by the manufacturer, a healthcare professional or other third-party, the person or system that unlocked the biometric data acquisition device can determine whether method 500 proceeds to block 502 or to block 510.

[0094] In some embodiments, a scanned biometric identifier can match a stored biometric identifier at block 504, then method 500 determines, using the biometric identifier, whether the user is approved to take a pharmaceutical or biological agent of a list of approved pharmaceutical or biological agents for example, at block 510. In certain embodiments, determining whether the user is approved to take a pharmaceutical agent can include matching the scanned biometric identifier to a stored biometric identifier, wherein the stored biometric identifier is an approved user's biometric identifier. In other embodiments, each stored biometric identifier can be correlated to a specific user identifier of the user. For example, the user identifier can be the name of the user, the social security number of the user or rendition thereof, a username of the user, or a random number assigned to the user during configuration of the biometric data acquisition device. A random number or username can be used to protect the privacy of the user in addition to the biometric identifier being correlated to a user identifier.

[0095] In other embodiments, the user (e.g. subject or patient) information/identification can be linked to a database or list of pharmaceutical or biological agents that are eligible to be taken by the user based on for example, medical history of the user. In some embodiments, the database or list of pharmaceutical or biological agents may be limited to all the pharmaceutical agents currently and previously prescribed to the user of the user identifier. If the user has never taken an agent of interest, the list of prescribed pharmaceutical agents can be a null set and indicate that the subject or user is naive to agents under consideration. In some embodiments, the list or database of prescribed pharmaceutical agents can be uploaded to the device by a healthcare professional. This can be done either remotely when the biometric data acquisition device is either wired or wirelessly connected to a network or when the biometric data acquisition device is in the presence of a healthcare professional or data is stored on a portable auxiliary device (e.g. drive, chip, disk or the like). In other embodiments, pharmaceutical or biological agents may include over-the-counter agents, nutraceuticals, minerals, supplements, vitamins, and the like.

[0096] In addition to correlating a list of agents that are available for use by the user (e.g. prescribed, monitored and non-prescribed) for a particular purpose or in general, determining whether the user affiliated with the user identifier is approved to take a target pharmaceutical agent may include determining the present time (realtime) and date during which the biometric identifier is scanned, when the last time or any previous time a biometric identifier was scanned or when the pharmaceutical agent was administered to the user and based in part on this information, whether the instant time and/or date is within a time period that the pharmaceutical agent is allowed, safe or optimal to be taken. [0097] In certain embodiments, if a user (e.g. patient, subject) is approved to take a pharmaceutical agent, then the biometric data acquisition device can give sensory feedback (e.g., visual or audio signal) to the user (e.g. patient or subject) that the user is approved to take the pharmaceutical agent of interest. In some exemplary embodiments, to determine whether specific or families of pharmaceutical agents or monitored agents are approved to be taken by the user, agents may be associated with the biometric data acquisition device by an authenticated user or an approved caregiver or healthcare provider. Then, the biometric data acquisition device can assess whether the coupled pharmaceutical or monitored agent is approved to be taken by the user. The biometric data acquisition device can determine what pharmaceutical or biological or other agent is associated with the biometric data acquisition device. In accordance with these embodiments, this information can be determined in a variety of ways including, but not limited to, radio-frequency identification (RFID), resistance sensing, barcode scanning, etc. In some embodiments, to determine whether a specific pharmaceutical agent is approved to be taken by the user (e.g. patient or subject), the biometric data acquisition device can include an input and sensory feedback device for selecting a specific or family of pharmaceutical agents from a list of pharmaceutical agents. Similar to blocks 502-510, sensory feedback can be given to the user throughout the process of determining whether a user is approved to take a pharmaceutical agent.

[0098] In other embodiments, stored biometric information can be used to determine whether one or more of a subject's current biometrics is anomalous or abnormal and whether this observation can be connected to administration of a particular pharmaceutical, monitored or biological agent. For example, a subject's biometric data can be acquired and stored on the device or an auxiliary electronic device. If a subject's specific instantaneous biometric response is outside a certain usage range, which has been established by the subject's recent history of biometric responses aggregated together, an alarm may be triggered by the device, even if the biometric response has been determined to be within an acceptable, previously determined range (e.g., a clinical range determined from patient trials). In this way, the device can be customized to operate according to a user or subject's individualized biometric responses. [0099] At block 512, for example, if the user identifier is approved to take a pharmaceutical agent of interest to treat a disease or condition, method 500 proceeds to block 514 or block 516. On the other hand, if the user identifier is not approved to take the pharmaceutical agent of interest, then method 500 proceeds to block 502 or the method 500 ends. Similar to the blocks above, sensory feedback can be given to the user as to whether method 500 is proceeding to block 502, block 514, block 516, or ending. Depending on the feedback, a user where the pharmaceutical agent is not approved can receive feedback to contact their physician or seek alternative assistance through a healthcare provider or other third party.

[00100] In other exemplary embodiments, if a solid pharmaceutical or biological agent dosage form is approved at block 512 method 500 proceeds from block 512 to block 516. At block 516, a dosage of the solid pharmaceutical dosage form is dispensed. In some exemplary embodiments, dispensing a dosage of the solid pharmaceutical or biological dosage form includes, but is not limited to, identifying a solid dosage form associated with or found in the list or database of stored agents in the biometric data acquisition device; and determining whether a target solid pharmaceutical dosage form is the same as the approved solid pharmaceutical dosage form.

[00101] In another exemplary embodiment, dispensing a solid dosage form of agent can include identifying a solid dosage form of agent associated with the biometric data acquisition device; determining whether the agent matches an approved solid pharmaceutical dosage form; and if there is a match, dispensing the agent through the loading cartridge of the device. In some embodiments, methods can further include repeating this process for all subsequent dosages dispensed to a subject, including revised and unrevised dosages and frequency of taking the agents, as well as, if programmed to do so, recording the biometric data associated with the subsequent dosages to evaluate, for example, whether the user (e.g. patient or subject) is or is not complying with a certain treatment plan.

[00102] In some embodiments, method 500 can continue to block 518 and measure a biometric response in a user to one or more solid dose form dispensed to the user (e.g. subject or patient), before, during or after taking the solid dose for of one or more pharmaceutical or biological agents. In some embodiments, a biometric response of the user can be measured soon after the solid pharmaceutical dosage form has been dispensed, and/or after a predetermined period of time has lapsed after the solid pharmaceutical or biological dosage form has been dispensed and/or consumed by the user. In accordance with these embodiments, a biometric response of the user can be measured, immediately after dispensing, 5, 10, 15, 20, 30, 60, 90 or more minutes or more after dispensing. In some embodiments, a biometric response of the user can be performed periodically for a predetermined period. In other embodiments, a biometric response of the user can be performed before dispensing the agent and again sometime after dispensing the agent, for example, for comparison and diagnosis by a healthcare provider. In other embodiments, the biometric data acquisition device can be equipped with various sensors to measure one or more of the following biometric responses including, but not limited to, a galvanic skin response, a blood oxygen level response, a body temperature response, a heartrate response, a perfusion index, a blood pressure response, a retina response, an eye movement response, eye color (e.g., yellowing of the sclera), an inhalation velocity response, an inhalation pressure response, an inhalation volume response, an expiratory velocity response, an expiratory pressure response, an expiratory volume response, or an exhale chemical composition response.

[00103] In some embodiments where a biometric response is measured by a biometric data acquisition device, method 500 can proceed to block 520 where dosage and/or frequency can be updated to generate a revised dose (e.g. prescription) and/or frequency based on one or more measured biometric responses. In certain embodiments, dose and/or frequency can be revised by a healthcare professional after the information regarding one or more previous dosages, time of one or more previous dosages, frequency of one or more previous dosages and biological responses to one or more previous dosages has been transmitted to the healthcare professional.

[00104] In other embodiments, method 500 can continue to block 522 and record, on a biometric data acquisition device's memory or other recording device, time and date a dosage is dispensed and number of solid dose agents dispensed. In certain systems and methods, all dosages subsequent to a first dose, including revised and unrevised dosages and frequencies, can be recorded and used to evaluate a user or subject's cooperation (e.g. regimen) with respect to a pre-determined and prescribed treatment plan. In some embodiments, this information may be transmitted to an auxiliary electronic device or directly transmitted wirelessly to a storage device or for example directly to a health provider.

[00105] For each of blocks 516, 518, 522, amount of administered dosage, time of the dosage, frequency of the administered dosage, whether or not the dosage was revised, and any other information that may be pertinent in order to monitor treatment of the user can be transmitted to an auxiliary electronic device. Information can be transferred using a wired connection or a wireless connection if and when one becomes available. In some embodiments, until a network connection becomes available or portable storage is necessary, biometric information can be stored on the biometric data acquisition device's memory. Of note system 500 can proceed from block 516 to any or all of blocks 518, 522 and/or 524.

[00106] FIG. 7 is a flow diagram representing an exemplary method 600 illustrating one example of method 500. Method 600 serves as an example and is not meant to be limiting. In certain embodiments where a user is visually impaired, any visual cues (e.g. , presented using the touchscreen) in method 600 can be replaced with other sensory feedback (e.g., auditory or haptic feedback). Method 600 begins by turning on the biometric data acquisition device at block 601. In some embodiments, this function can be performed by holding down a fingerprint reader and pulse oximeter included in the biometric data acquisition device for a predetermined amount of time. For example, holding down on a fingerprint reader and pulse oximeter for 5 seconds or more can turn the biometric data acquisition device on. A power reserve can also be part of the system where, after a time of no further entry or use, the biometric data acquisition device turns off.

[00107] Once the biometric data acquisition device is powered up, method 600 can proceed to block 602 where a fingerprint of a user (patient, subject or healthcare provider or authorized caregiver) can be scanned by a fingerprint scanner or reader included in the biometric data acquisition device. At block 604, if the scanned fingerprint does not match a stored fingerprint, then method 600 proceeds to block 605, at which time an indicator, for example, a rapidly blinking visual indicator or alarm sounds, notifying the user that the scanned fingerprint did not match a stored fingerprint. Method 600 then proceeds back to block 602 to allow the user to scan their fingerprint again. If, the scanned fingerprint matches a stored fingerprint, then method 600 proceeds to 607, at which time a different indicator, for example, a solidly illuminated visual indicator or preset positive audio alarm notifies the user that their scanned fingerprint matches a stored fingerprint. It is also contemplated that the device can be powered up by scanning a subject or authorized user's eye to determine a match.

[00108] At block 610, method 600 proceeds by determining (e.g., by stored information) whether the user correlated to the scanned and matched fingerprint is approved to take a particular pharmaceutical, biological or other monitored agent. As detailed above, this may include determining the current time and date, when the last time an agent was dispensed to the user (e.g. patient or subject) and whether the current time and date is within an allowable or recommended time period for the user to receive another dose of the pharmaceutical, biological or other monitored agent.

[00109] At block 612, if a determination is made that the user is not approved to take a pharmaceutical agent, then method 600 proceeds to block 613, at which time an indicator, for example, a rapidly blinking visual indicator or an audio signal notifies the user that the a pharmaceutical agent has not been approved for the user or other authorized person to receive at the time of the fingerprint read. If method 600 does proceed to block 613 because the user is not approved to take a pharmaceutical agent, then method 600 can revert back to block 602 or method 600 can end. If, a determination is made that the user being assessed is approved to take a pharmaceutical or other monitored agent at block 612, then method proceeds to block 615, at which time an indicator, such as a solidly illuminated visual indicator or a different audio signal notifies the user that a pharmaceutical agent has been approved to be dispensed for consumption by the user.

[001 10] After block 615, method 600 proceeds to blocks 616, 617, and/or 619 which can occur concurrently or within a prescribed time period of one another. At block 616, a dosage of the solid pharmaceutical agent can be dispensed by the biometric data acquisition device. The dosage can be dispensed as describe above in method 500 and administered to the subject/user. While the pharmaceutical agent is being administered, and in some cases before, a visual or audio signal can slowly blink or sound-off to notify the user that the pharmaceutical agent is being dispensed or about to be dispensed at block 617. When the dispense of the pharmaceutical agent is completed, the visual indicator can stop blinking or the audio shuts off. Concurrently with dispensing and consumption of the pharmaceutical agent, the biometric data acquisition device can be configured to take a picture (e.g., for identification or assessment of after effects etc.) of the user at block 619. In some embodiments, a timestamp can be included with the picture, so that the time that the pharmaceutical agent was dispensed and/or administered can be recorded along with a record number and one or more user identifiers (e.g., user's picture).

[001 11 ] In another embodiment, method 600 can then proceed to block 622 where the data from administration can be recorded to the memory of the biometric data acquisition device. In some embodiments, the data recorded can be any of the data discussed above in method 500. Examples of data can include, but are not limited to, pharmaceutical, biological or monitored agent, dose of the agent, time and date of the administration of the pharmaceutical agent, and the biometric response to the administration of the biological agent. In other embodiments, other agents (e.g., over-the-counter agents, vitamins) taken or used by a user can also be documented and recorded by the user using a recorder on the device or other method for recordation in realtime or at a later time by the user. This information can provide additional insight into effects of the prescribed regimen of the monitored agent in a user/subject.

[001 12] Method 600 can proceed to block 624 where the recorded data can be transmitted to a secondary electronic device, to a healthcare provider data port, a cloud computing device or an application stored therein while backed-up by the device. Various user identifiers can be associated with a user's biometric data stored on an electronic record, such that the user can access the biometric data using his/her user identifier. In other embodiments, the user's biometric data can be uploaded and stored in a cloud computing device that can be accessed using one or more user identifiers linked to the user/subject or other authorized personnel.

[001 13] A number of variations and modifications of the disclosure can be used, as would be readily appreciated by one or ordinary skill in the art based on the present disclosure. It would be possible to provide for some features of the disclosure without providing others.

[001 14] For example, the systems and methods of this disclosure can be implemented in conjunction with a special purpose computer, a programmed microprocessor or microcontroller and peripheral integrated circuit element(s), an ASIC or other integrated circuit, a digital signal processor, a hard-wired electronic or logic circuit such as discrete element circuit, a programmable logic device or gate array such as PLD, PL A, FPGA, PAL, special purpose computer, any comparable means, or the like. In general, any device(s) or means capable of implementing the methodology illustrated herein can be used to implement the various aspects of this disclosure. Exemplary hardware that can be used for the disclosed embodiments, configurations and aspects includes computers, handheld devices, telephones (e.g., cellular, Internet enabled, digital, analog, hybrids, and others), and other hardware known in the art. Some of these devices include processors (e.g., a single or multiple microprocessors), memory, nonvolatile storage, input devices, and output devices. Furthermore, alternative software implementations including, but not limited to, distributed processing or component/object distributed processing, parallel processing, or virtual machine processing can also be constructed to implement the methods described herein.

[001 15] In yet another embodiment, the disclosed methods may be readily implemented in conjunction with software using object or object-oriented software development environments that provide portable source code that can be used on a variety of computer or workstation platforms. Alternatively, the disclosed system may be implemented partially or fully in hardware using standard logic circuits or VLSI design. Whether software or hardware is used to implement the systems in accordance with this disclosure is dependent on the speed and/or efficiency requirements of the system, the particular function, and the particular software or hardware systems or microprocessor or microcomputer systems being utilized.

[001 16] In yet another embodiment, the disclosed methods may be partially implemented in software that can be stored on a storage medium, executed on programmed general-purpose computer with the cooperation of a controller and memory, a special purpose computer, a microprocessor, or the like. In these instances, the systems and methods of this disclosure can be implemented as program embedded on personal computer such as an applet, JAVA® or CGI script, as a resource residing on a server or computer workstation, as a routine embedded in a dedicated measurement system, system component, or the like. The system can also be implemented by physically incorporating the system and/or method into a software and/or hardware system. [00117] The present disclosure, in various aspects, embodiments, and configurations, includes components, methods, processes, systems and/or apparatus substantially as depicted and described herein, including various aspects, embodiments, configurations, sub combinations, and subsets thereof. Those of skill in the art will understand how to make and use the various aspects, aspects, embodiments, and configurations, after understanding the present disclosure. The present disclosure, in various aspects, embodiments, and configurations, includes providing devices and processes in the absence of items not depicted and/or described herein or in various aspects, embodiments, and configurations hereof, including in the absence of such items as may have been used in previous devices or processes, e.g., for improving performance, achieving ease and\or reducing cost of implementation.

[00118] The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more, aspects, embodiments, and configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and configurations of the disclosure may be combined in alternate aspects, embodiments, and configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspects, embodiments, and configurations. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[00119] Moreover, though the description of the disclosure has included description of one or more aspects, embodiments, or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

Claims

What is claimed is:

1. A pharmaceutical, biological or other monitored agent desktop or tabletop dispensing device having biometric data acquisition and monitoring capabilities, the device comprising:

a housing unit;

a power source;

a processor and memory;

a loading cartridge comprising a plurality of storage chambers for storing and dispensing one or more solid forms of the pharmaceutical, biological or other monitored agent;

a prime mover operably coupled to the loading cartridge and a dispensing activator, wherein activation of the dispensing activator actuates the prime mover to eject the one or more solid forms of the pharmaceutical, biological or other monitored agent from the loading cartridge;

at least one scanner operatively coupled to a processor, wherein the processor verifies identity of a subject based upon information obtained by the at least one scanner; and at least one biometric sensor for sensing biometric data of the subject, wherein the biometric data is sensed and acquired during at least one of prior to, during, and after dispensing the one or more solid dosage forms to the subject.

2. The device according to claim 1, wherein the biometric data is stored in memory in the device.

3. The device according to either claim 1 or 2, further comprising at least one data transfer port.

4. The device according to claim 3, wherein the at least one data transfer port comprises a USB port.

5. The device according to any of claims 1-4, wherein the device further comprises a dispenser port and an image acquisition device centrally aligned with the dispenser port, the image acquisition device comprising a lens, an image sensor and signal wires which operatively connect the image acquisition device to the processor; and

a touchscreen or keypad that communicates at least one visual indicator to the subject, operatively coupled to the image acquisition device and facing the same direction as the lens.

6. The device according to any of claims 1-5, wherein the at least one biometric sensor includes one or more of a temperature sensor, a thermal imaging sensor, a galvanic skin response sensor, a pulse oximeter, a carbon dioxide sensor, an oxygen sensor, an optical sensor, an air flow velocity sensor, an air pressure sensor, a chemical sensor, and a global positioning system (GPS) sensor.

7. The device according to any of claims 1-6, wherein the device further comprises one or more peripheral module interfaces for coupling one or more peripheral modules to the device.

8. The device according to claim 7, wherein the one or more peripheral modules comprises one or more of a blood pressure monitor, a blood glucose monitor, a CPAP machine, an electrocardiogram device, a battery, and a battery charger.

9. The device according to any of claims 1-8, wherein the at least one scanner comprises a fingerprint reader.

10. The device according to any of claims 1-9, wherein the at least one biometric sensor comprises a pressure sensor.

11. The device according to any of claims 1-10, wherein the device further comprises a radio-frequency identification (RFID) reader.

12. The device according to any of claims 1-11, wherein the device further comprises a device locator.

13. The device according to any of claims 1-12, wherein the device further comprises Bluetooth hardware and software components.

14. The device according to any of claims 1-13, wherein the processor further comprises one or more software programs for operating the at least one biometric sensor and for facilitating the acquisition of biometric data using the at least one biometric sensor.

15. The device according to any of claims 1-14, wherein the one or more solid forms of the pharmaceutical, biological or other monitored agent is one or more of a pill, gel capsule, microparticle capsule, tablet, caplet, patch, strip, and thin-film strip.

16. A system for dispensing solid forms of the pharmaceutical, biological or other monitored agent to and acquiring biometric data from a subject, the system comprising:

a housing unit;

a power source;

a processor and memory;

a loading cartridge comprising a plurality of rotatable storage chambers for storing and dispensing one or more solid forms of the pharmaceutical, biological or other monitored agent;

at least one scanner operatively coupled to the processor, wherein the processor verifies an identify of a subject based upon information obtained by the at least one scanner;

at least one biometric sensor for sensing biometric data of the subject, wherein the biometric data is sensed and acquired during at least one of prior to, during, and after dispensing the one or more solid dosage forms to the subject, wherein the biometric data is stored in memory; and

at least one data transfer port;

wherein the system facilitates the dispensing of the one or more solid forms of the pharmaceutical, biological or other monitored agent to the subject and the acquisition of the biometric data from the subject.

17. The system according to claim 16, wherein the device further comprises a dispenser port and an image acquisition device centrally aligned with the dispenser port, the image acquisition device comprising a lens, an image sensor and signal wires that operatively connect the image acquisition device to the processor; and

18. The system according to either claim 16 or 17, wherein the at least one biometric sensor comprises one or more of a temperature sensor, a thermal imaging sensor, a galvanic skin response sensor, a pulse oximeter, a carbon dioxide sensor, an oxygen sensor, an optical sensor, an air flow velocity sensor, an air pressure sensor, a chemical sensor, and a global positioning system (GPS) sensor.

19. The system according to any of claims 16-18, wherein the system further comprises one or more peripheral module interfaces for coupling one or more peripheral modules to the device.

20. The system according to claim 19, wherein the one or more peripheral modules includes one or more of a blood pressure monitor, a glucose monitor, a CPAP machine, an electrocardiogram device, a battery, and a battery charger.

21. The system according to any of claims 16-20, wherein the at least one scanner comprises a fingerprint reader.

22. The system according to any of claims 16-21, wherein the at least one at least one biometric sensor comprises a pressure sensor.

23. The system according to any of claims 16-22, wherein the system further comprises a radio-frequency identification (RFID) reader.

24. The system according to any of claims 16-23, wherein the system further comprises Bluetooth hardware and software components.

25. The system according to any of claims 16-24, wherein the processor further comprises one or more software programs for operating the at least one biometric sensor and for facilitating the acquisition of biometric data using the at least one biometric sensor.

26. The system according to any of claims 16-25, wherein the one or more solid forms of the pharmaceutical, biological or other monitored agent is one or more of a pill, capsule, gel capsule, gummy, timed-release capsule, slow-dissolving capsule, tablet, caplet, patch, strip, and thin-film strip , mini-tablets, granules, beads, pellets, multiparticulates, spheroids, or combinations thereof.

27. A method for dispensing a solid form of a pharmaceutical, biological or other monitored agent to an authorized subject, the method comprising:

scanning a biometric identifier of the subject using a desktop dispensing device having biometric data acquisition and monitoring capabilities;

determining, using the biometric identifier, whether the subject is approved to take a dose of one or more solid forms of the pharmaceutical, biological or other monitored agent; and dispensing to the subject, the solid form of the pharmaceutical, biological or other monitored agent from the desktop dispensing device having biometric data acquisition and monitoring capabilities if the subject is approved to take the dosage of the solid dosage form.

28. The method according to claim 27, wherein the biometric identifier comprises at least one of a fingerprint pattern, an iris pattern, a retina pattern, a vocal pattern, a facial- feature pattern, a pore pattern, a thermal image pattern, or a blood vessel pattern.

29. The method according to either claim 27 or 28, wherein determining whether the user is approved to take the one or more solid forms of the pharmaceutical, biological or other monitored agent comprises:

matching the scanned biometric identifier to a stored biometric identifier, wherein the stored biometric identifier is an approved user's biometric identifier;

identifying if the one or more solid forms of the pharmaceutical, biological or other monitored agent is included on a list of solid dosage forms that are eligible to be taken by the user;

optionally, identifying a recent time that the biometric identifier was scanned and the one or more solid forms of the pharmaceutical, biological or other monitored agent was dispensed; and

approving the dispensing of the one or more solid forms of the pharmaceutical, biological or other monitored agent if a present time during which the biometric identifier is scanned is within an approved time period for dispensing the solid dosage form.

30. The method according to any of claims 27-29, further comprising recording, on the desktop dispensing device's memory, times that the one or more solid forms of the pharmaceutical, biological or other monitored agent is dispensed.

31. The method according to any of claims 27-30, further comprising transmitting to an auxiliary electronic device a time that the dosage of the one or more solid forms of the pharmaceutical, biological or other monitored agent was dispensed, the amount that was dispensed, and an identity of the one or more solid forms of the pharmaceutical, biological or other monitored agent that was dispensed.

32. The method according to any of claims 27-31 , further comprising taking an image of the user, using an image acquisition device, when dispensing a dosage of the solid dosage form, wherein the image acquisition device is part of or removably coupled to the desktop dispensing device.

33. The method according to any of claims 27-32, further comprising providing sensory feedback to the subject.

34. The method according to claim 33, wherein the sensory feedback comprises at least one of visual cues, haptic feedback, or auditory feedback.

35. The method according to any of claims 27-34, further comprising measuring a biometric response of the subject to the dosage of the one or more solid forms of the pharmaceutical, biological or other monitored agent.

36. The method according to claim 35, wherein the biometric response comprises at least one of a galvanic skin response, a blood oxygen level response, a body temperature response, a heartrate response, a perfusion index response, a blood pressure response, a retina response, an eye movement response, an inhalation velocity response, an inhalation pressure response, an inhalation volume response, an expiratory velocity response, an expiratory pressure response, an expiratory volume response and an exhale chemical composition response.

37. The method according to either claim 35 or 36, further comprising transmitting the dosage of the one or more solid forms of the pharmaceutical, biological or other monitored agent and the measured biometric response to an auxiliary electronic device.

38. The method according to any of claims 35-37, wherein the biometric response data of the subject is analyzed by a healthcare provider or other personnel.

39. The method according to claim 38, further comprising dispensing a revised dosage of the one or more solid forms of the pharmaceutical, biological or other monitored agent based on the analysis by the healthcare provider or other personnel.