Devices, systems and methods for optimized, personalized administration of oral dosage forms

Abstract

This invention provides methods, systems and devices for personal, secure authenticated provision of oral solid dosage forms, administered as a dosage regimen which may be altered over time. The methods and systems rely on providing a device for personal secure administration of oral solid dosage forms to a subject, where the device comprises a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of the plurality contained therein differs from that of at least a second oral dosage form of the plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said solid oral dosage form, or any combination thereof and wherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following a personal authentication protocol and wherein the device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program and wherein the device comprises a user interface and optionally at least one sensor and wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in the programming; and_whereby the programming controls adjusting, altering or overwriting the first distribution program via a secure protocol to a second distribution program, as a function of the collected subject response data, sensor collected data, or testing result data or any combination thereof and completing an authentication protocol for dispensing the oral dosage form to the subject and dispensing the first oral dosage form within an oral cavity of the subject and following secure communication with an authorized provider,enabling adjustment, alteration or overwriting of the programming to activate the second oral dosage form distribution program in the device; and_dispensing the oral dosage forms of the second oral dosage form distribution program to the subject, whereby an oral dosage form regimen is adjusted, altered or overwritten in the device resulting in altering dispensing of the oral dosage form, by means of a secure authenticated protocol.

Description

DEVICES, SYSTEMS AND METHODS FOR OPTIMIZED, PERSONALIZED ADMINISTRATION OF ORAL DOSAGE FORMSBACKGROUND OF THE INVENTION

[0001] There is a clearly understood need in the medical community for the ability to safely administer single or multiple oral dosage forms over a length of time, where the dosage and / or medication active ingredient(s) can be altered or modified over time. Currently, the patient obtains the medication via prescription filling at a pharmacy, and any subsequent changes in the treatment protocol require repeat visits by the patient to a pharmacy, and patient ability to follow changing instructions as applicable, relying on active involvement therefore not only of the pharmacy to dispense multiple regimens, but importantly relying on patient compliance in filling the additional prescriptions and correctly following the instructions for changing medications.

[0002] The medical community has also long known of the need to be able to titrate the amount of active agent(s) taken by the patient, in order to achieve the optimal benefit of the agent(s) in an individual patient, and at the same time to prevent any undesirable side effects that taking too much of the agent(s) could produce. A continuous balance between taking enough of the agent(s) in order to gain the benefits from that agent(s), and at the same time not taking so much agent(s) as to elicit a toxic event and this balance should ideally be adjusted on an individual patient level.

[0003] An important consideration in achieving this balance derives from the interindividual variability in patient biological interactions and / or the patient pharmacodynamic and pharmacokinetic interactions of the active ingredients. Current dosage guidelines are based epidemiologic evidence and / or regulatory guidelines, which cannot account for interindividual variability, let alone, changes over time even in individual patients.

[0004] Algorithms have been developed to arrive at dosage recommendations, which have limited utility and typically relate to specific classes of drugs.

[0005] Ideally, dosage and therapeutic agent administration on an individual level, that can be adjusted dynamically, in a secure manner, which does not require constant trips to the pharmacy or in any way interfere with the direct communication between the prescribing physician and patient is desirable, yet this ideal remains elusive.SUMMARY OF THE INVENTION

[0006] This invention provides for various aspects and embodiments of a system including an apparatus or device for dispensing one or more solid oral dosage forms containing one or more desired active ingredients. The features described in this summary may be combined with any of the aspects and embodiments of the invention described herein insofar as they are suitable therefor. As will be appreciated, all of the systems, apparatuses and devices described herein operate on similar principles.

[0007] In one aspect, this invention provides a device for personal secure administration of oral solid dosage forms, comprising a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of at least a second oral dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form, or any combination thereof; o wherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following a personal authentication protocol; and o wherein said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program; o wherein said device comprises a user interface and optionally at least one sensor; and o wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof.

[0008] In another aspect, this invention provides a method for personal, secure authenticated provision of oral solid dosage forms, administered as a dosage regimen which may be altered over time, the method comprising the steps of:• providing a device for personal secure administration of oral solid dosage forms to a subject, said device comprising: o a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained thereindiffers from that of at least a second oral dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said solid oral dosage form, or any combination thereof; o wherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following a personal authentication protocol; and o wherein said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program; o wherein said device comprises a user interface and optionally at least one sensor; and o wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and o whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof;• completing an authentication protocol for dispensing said oral dosage form to said subject and dispensing said first oral dosage form within an oral cavity of said subject;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral dosage form distribution program in said device; and• dispensing said oral dosage forms of said second oral dosage form distribution program to said subject; whereby an oral dosage form regimen is adjusted, altered or overwritten in said device resulting in altering dispensing of said oral dosage form, by means of a secure authenticated protocol.

[0009] In another aspect, this invention provides a method for secure authenticated provision of an oral cancer therapeutic, administered in a dosage regimen which may be altered over time, the method comprising the steps of:• providing a device for personal secure administration of the oral cancer therapeutic to a subject, said device comprising:o a plurality of individually addressable oral cancer therapeutics contained therein, wherein a first oral cancer therapeutic of said plurality contained therein differs from that of at least a second oral cancer therapeutic of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral cancer therapeutics, or any combination thereof; o wherein the device provides for dispensing at least one individually addressable oral cancer therapeutic contained therein following a personal authentication protocol; and o wherein said device is subject to programming, which programming controls distribution of said oral cancer therapeutics contained therein according to a first secure distribution program; o wherein said device comprises a user interface and optionally at least one sensor; and o wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and o whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof;• completing an authentication protocol for dispensing said oral cancer therapeutics to said subject and dispensing said first oral cancer therapeutic to said subject;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral cancer therapeutic distribution program in said device; and• dispensing said oral cancer therapeutic of said second oral cancer therapeutic distribution program to said subject; whereby an oral cancer therapeutic regimen is adjusted, altered or overwritten in said device resulting in altering dispensing of said oral cancer therapeutic, by means of a secure authenticated protocol.

[0010] In another aspect this invention provides a method for optimization of secure authenticated provision of oral solid dosage forms to a subject in need thereof, the method comprising the steps of:• providing a device for personal secure administration of the oral solid dosage forms to a subject, said device comprising: o a plurality of individually addressable oral solid dosage forms contained therein, wherein a first oral solid dosage form of said plurality contained therein differs from that of at least a second oral solid dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral solid dosage form, or any combination thereof; o wherein the device provides for dispensing at least one individually addressable oral solid dosage form contained therein following a personal authentication protocol; and o wherein said device is subject to programming, which programming controls distribution of said oral solid dosage form contained therein according to a first secure distribution program; o wherein said device comprises a user interface and optionally at least one sensor; o wherein subject compliance with said first secure distribution program is collected and incorporated in said programming; o wherein subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof is collected and incorporated in said programming; and o whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof;• completing an authentication protocol for dispensing said oral solid dosage forms to said subject and dispensing said first oral solid dosage form to said subject;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral solid dosage form distribution program in said device; and• dispensing said oral solid dosage form of said second oral solid dosage form distribution program to said subject; whereby an oral solid dosage form regimen is adjusted, altered or overwritten in said device as a consequence of said collected subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof, resulting in optimized dispensing of said oral solid dosage forms, by means of a secure authenticated protocol.

[0011] In another aspect, this invention provides a system for personal secure administration of oral solid dosage forms to a subject, said system comprising:• a secured personal oral solid dosage form delivery device dispensing a solid oral dosage form to a subject, said device comprising: o a first non -transitory computer-readable storage medium having computer executable instructions stored thereon, which when executed by a processor, causes the processor to perform the oral solid dosage form distribution to a subject, which medium is enabled for remote secure communication in real time and which computer executable instructions facilitate distribution of said oral dosage form according to an at least a first distribution program, a second distribution program or a combination thereof; o a subj ect user interface; o optionally at least one sensor; o a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality differs from that of at least a second oral dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form, or any combination thereof; and■ wherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following at least a personal authentication protocol; and■ wherein operation of dispensing in said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program; ando a second secure non-transitory computer-readable storage medium, which medium is enabled for remote secure communication in real-time and which medium has computer executable instructions stored thereon, which when executed by a processor, promotes collection, input or a combination thereof of subject response data, sensor collected data, or testing result data or any combination thereof to determine whether a first distribution protocol promotes a desired clinical endpoint being reached,■ wherein the desired clinical endpoint comprises a therapeutic effect, a lack of adverse event of pre-determined scale, or a combination thereof,■ which reaching of the desired clinical endpoint reflects collected subject response data, sensor collected data, or testing result data or any combination thereof meeting established values;■ wherein reaching said desired clinical endpoint results in maintenance of said first distribution program; and■ wherein lack of a therapeutic effect, presence of an adverse event of predetermined scale, or a combination thereof results in performing a second distribution program.DESCRIPTION OF THE DRAWINGS

[0012] The drawings provided herein represent non-limiting examples of certain embodied aspects of the devices, systems and use of certain components in the methods of this invention, and are for illustrative purposes and to aid in understanding this invention, but not to unduly limit the scope of the invention.

[0013] Figure 1 provides a schematic depiction of a non-limiting example of certain aspects of embodied system components of the embodied systems for personal secure administration of oral solid dosage forms to a subject.

[0014] Figures 2 A - 2H provides a schematic depiction of a non-limiting example of certain aspects of embodied hand-held oral dosage form distribution devices, highlighting certain aspects of the user interface and screen-relayed instructions and / or secure authentication protocols, etc.

[0015] Figures 3 A - 3F provides a schematic depiction of a similar example of the handheld oral dosage form distribution device of Figures 2A-2H, further relating to potential means to alter a first distribution program by pausing therapy.

[0016] Figures 4A - 4E provides a schematic depiction of a similar example of the handheld oral dosage form distribution device of Figures 2A-2H, and Figures 3A-3F, further relating to potential means to continue therapy. . . .

[0017] Figures 5 A - 5E provides a schematic depiction of a similar example of the handheld oral dosage form distribution device of Figures 2A-2H, and Figures 3A-3F, further relating to potential means to alter a first distribution program by concluding therapy.

[0018] Figure 6 provides a non-limiting schematic depiction of an example of different on- device means to alter the distribution regimen by physical device manipulation, for example, rotating a carousel in a different direction or skipping certain chambers to effect the change in the distribution program as described.

[0019] Figure 7A-7B provides a non-limiting schematic depiction of an example of a user interface relating to a particular patient record and functionalities in the interface to relate to same.

[0020] Figures 8A-8B provide flow charts for embodied aspects of decision-making steps that may result in the alternation of a drug distribution program.

[0021] Figures 9A-9C provide flow charts for other embodied aspects of decision-making steps that may result in the alternation of a drug distribution program.

[0022] Figure 10 provides a flow chart for other embodied aspects of decision-making steps that may result in the alternation of a drug distribution program.

[0023] Figures 11A-11D provide flow charts for other embodied aspects of decisionmaking steps that may result in the alternation of a drug distribution program.

[0024] Figures 12A - 12F provide flow charts for other embodied aspects of decisionmaking steps that may result in the alternation of a drug distribution program.DETAILED DESCRIPTION OF THE INVENTION

[0025] This invention provides a device for secure administration of oral solid dosage forms, comprising a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of at least a second oral dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form, or any combination thereof; o wherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following an authentication protocol; ando wherein said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program; o wherein said device comprises a user interface and optionally at least one sensor; and o wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof.

[0026] This invention provides in some aspects therefore, a device for secure administration of oral solid dosage forms.

[0027] According to this aspect and representing some embodiments of the invention, the reference to “secure administration” refers, to the ability to ensure that the device is provided to a subject for whom the oral dosage form contained therein is intended. In some aspects, this may be at the level of providing the device to an individual for whom such oral dosage form has been prescribed, subject to verification of the subject identity at some level, e.g. through the subject presenting a prescription or appropriate identification.

[0028] In some embodiments, the secure administration may involve additional security measures, such as, for example, password-controlled access to the user interface of the device, preventing unauthorized use / access to the solid dosage forms contained therein.

[0029] In still other embodiments, the secure administration may involve an RFID tag provided to the user granting access to the user interface, and similar to password protection, thereby controlling access of a subject to the dosage forms contained therein.

[0030] In still other embodiments, the secure administration may involve additional personal identification measures, for example, relying on facial or partial facial recognition, or in some aspects, relying on e.g. fingerprint or other known scans, to ensure authenticated use by the subject for whom the distribution of the oral dosage forms contained in the device / system is intended.

[0031] It is to be understood that any means by which administration of the oral dosage forms in the device can be ensured to be provided to the intended subject only for use is to beconsidered as part of this invention, in regard to the secure administration element of any device, system and method of this invention.

[0032] In some embodiments, the oral solid dosage form administration devices, systems making use of same and methods of use of same, will comprise a plurality of individually addressable oral dosage forms contained therein. In some embodied aspects of the invention, reference to the plurality of individually addressable oral dosage forms relates to compartmentalization or localization of oral solid dosage forms for administration that can be separately accessed, so that, for example, a first oral solid dosage form and a second oral solid dosage form may be maintained in the device, yet administration of the first versus the second, or second versus the first oral dosage form may be individually accessed and dispensed, and thus is “individually addressable”.

[0033] It will be appreciated by the skilled artisan that any means of separately maintaining the plurality of oral dosage forms, while ensuring that individual dosage forms may be separately addressable is envisaged for incorporation in the devices / systems / methods of this invention.

[0034] For example, and representing certain embodiments of the invention, the plurality of individually addressable oral dosage forms are maintained in compartments wherein each compartment may maintain a plurality of oral dosage forms with the same active pharmaceutical ingredient (API) at the same dosage, in the same composition, or in some embodiments, each compartment may maintain a plurality of oral dosage forms constituting a particular dosage regimen, for example, comprising the same active pharmaceutical ingredient (API) at different dosages, or including a desired combination therapy and therefore comprising two different APIs, etc.

[0035] According to this aspect and in some embodiments, the devices / systems / methods of the invention which dispense oral dosage forms from a plurality of oral dosage forms, may include in the plurality of oral dosage forms, those which differ in terms of an active ingredient type, an active ingredient dosage, or a composition component of the oral dosage form, which are sorted into separate individually addressable compartments in the device / system.

[0036] In some embodiments of the devices / systems / methods of the invention a single oral dosage form is dispensed at a time. In other embodiments, multiple oral dosage forms may be dispensed at a time.

[0037] In some embodiments, a defined plurality of dosage forms may be dispensed according to and as controlled by programming as described herein. In some embodiments, for example, the programming promotes increasing the number of oral dosage forms dispensedto a subject and in other embodiments, the programming promotes decreasing the number of oral dosage forms dispensed to a subject.

[0038] Further according to this aspect and in some embodiments, the individually addressable oral dosage forms may be maintained in compartments, configured, for example, as a rotating carousel, or in some embodiments, as a rotating cartridge, within which individually accessible compartments containing the plurality of oral dosage forms are separately maintained.

[0039] In some embodiments of the devices / systems / methods of the invention, the oral solid dosage form device is a hand-held device, having a plurality of individually contained, individually addressable oral dosage forms contained therein. According to this aspect and in some embodiments, the hand-held oral solid dosage form secure distribution device contains a tamper proof casing within which the solid dosage form holder is contained, and in some embodiments, the tamper-proof container prevents access to the oral dosage forms housed therein and only through authorized use can specific oral dosage forms be dispensed to a specific user.

[0040] In other embodiments, the tamper-proof container will encase a multi-chamber holder, which multi-chamber holder is individually addressable so that the multiple chambers in which the oral dosage forms are contained each comprise access portals sized to accommodate pass-through of the oral solid dosage forms contained therein; whereby upon regulated and authenticated alignment of the chamber access portal with an appropriate dispensing structure in the device, can the oral solid dosage forms for a single dosage regimen be dispensed. In some embodiments, the regulated and authenticated alignment is subject to security protocols built into the programming of the device / system that regulate movement of the multi-chamber holder within the tamper-proof container. In some embodiments, only upon authentication of the user following specific security protocols, can the user access the dispensing program, whereby the device / system will allow for dispensing a prescribed dosage regimen to a subject, for example, and representing certain embodied aspects, whereby only following insertion of the dispensing outlet or mouthpiece of the device / sy stems of the invention into the oral cavity of the user will a prescribed dosage regimen be released into the oral cavity of the user.

[0041] In other embodiments, the solid dosage form holder may be a rotatable or advanceable carousel structure containing multiple compartments, each compartment containing one or more oral dosage forms for dispensing for a single dosage regimen, wherein in some embodiments, the programming oromotes skipping a compartment, to align thedesired compartment so that dispensing of the solid dosage forms located therein can be specifically addressed, or in other embodiments, the programming promotes rotation of the container in an opposing direction, to align the desired compartment so that dispensing of the solid dosage forms located therein can be specifically addressed.

[0042] In some embodiments, the devices / systems / methods of the invention may make use of blister pack encased solid dosage forms, where the device / system is further equipped to comprise a blister-pack releasing element to specifically and addressably release the oral dosage forms for dispensing for a single dosage regimen located in a given blister pack, contained in the holder compartment, for programmed release of the dosage form / s.

[0043] In some embodiments, the individually addressable oral dosage forms may be maintained in compartments, configured, for example, to be individually released or released in a specified plurality within a bulk device, with compartments separately maintained for different e.g. oral dosages than the one being instantly dispensed and therefore are individually addressable, as well.

[0044] In some embodiments, the devices / systems / methods of this invention wherein a bulk device is in use, will further comprise a solid dosage form dispensing port with a tamper proof locking mechanism to prevent access to the solid dosage forms contained within the device / sy stems of this invention in the absence of appropriate user identification as described herein.

[0045] In still other embodiments, the bulk device may further comprise a secure handheld device, which can be loaded through programming for same in the bulk device.

[0046] In other embodiments of the bulk device or bulk device containing systems or uses of same, the device comprises multiple individually addressable oral dosage form reservoirs, so that the multiple reservoirs in which the oral dosage forms are contained each comprise access portals sized to accommodate pass-through of the oral solid dosage forms contained therein; whereby upon regulated and authenticated alignment of the chamber access portal with an appropriate dispensing structure in the device, can the oral solid dosage forms for a single dosage regimen be dispensed.

[0047] According to this aspect and in some embodiments, the regulated and authenticated alignment is subject to security protocols built into the device that regulate movement of the oral dosage forms within the bulk device to the dispensing channels.

[0048] In other embodiments of the devices / systems / methods described herein, for any authenticated user, a dispensing program for dispensing the oral dosage forms contained in the device has been established.

[0049] In other embodiments of the devices / systems / methods described herein, the device is equipped with communication means whereby authorized medical personnel may introduce said second dispensing program, which is distinguished from the first dispensing program, so that the oral dosage forms dispensed to the subject differ from that which would have been dispensed to the subject, by means of the first dispensing program.

[0050] In a further aspect, the first oral dosage form of said plurality contained therein differs from that of at least a second oral dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form, or any combination thereof, as is explained further hereinunder.

[0051] The skilled artisan will appreciate that the devices / systems / methods of the invention enable administration of oral dosage forms that differ in terms of the API, or dosage of the API or composition comprising the API, or combination of APIs being administered, or any combination thereof, whereby a particular administration protocol can be altered, changed or concluded, wherein the device / system / method of this invention enables certain criteria to be established to alter, change or conclude a particular administration program, which can be effected at the level of the personal oral dosage administration device, or bulk access device, via feedback provided by the patient, sensors included, test results, and other criteria as herein described.

[0052] In some embodied aspects of the invention, the device provides for dispensing at least one individually addressable oral dosage form contained therein following an authentication protocol wherein said device is subject to programming, which programming controls distribution of the oral dosage forms contained therein according to a first secure distribution program.

[0053] By reference, in some aspects to the programming of the device controlling distribution of the oral dosage forms contained therein according to a first secure distribution program, this can refer to, e.g. dispensing an oral dosage form containing an active ingredient type, an active ingredient dosage, or a composition component of the oral dosage form, or any combination thereof, as a treatment regimen being provided to a subject, whereby such “first” or original, or initially intended treatment regimen can be altered, through controlled access to the device / system programming so that a second distribution program is activated / utilized / entered, so that an oral dosage form that differs from the “first” or original, or initially intended dosage form to be provided to the subject is now changed.

[0054] In some embodiments, the devices / systems / methods of this device comprise a user interface and optionally at least one sensor, or in some embodiments, data collected from asensor is coordinately integrated within the device / system programming so that such data is incorporated in the programming to further control, adjust, alter or overwrite a first oral dosage distribution program to a second distribution program.

[0055] In some embodiments, the devices / systems / methods of this invention comprise a sensor, for example, measuring pH of the environment, capacitance, humidity, carbon dioxide concentration, temperature, or presence of particular enzymes, or presence of certain secreted proteins or other indicators, as will be appreciated by the skilled artisan.

[0056] In some embodiments, the programming provided as part of the devices / systems / methods of this device comprise a databank or provide databank access to established value ranges for data collected from sensors integrated within the devices / systems / methods of this invention so that when collected values are outside the established ranges under established conditions, the programming will implement a change in the oral dosage form distribution program from a first to a second distribution program, which will result in distribution of a different oral dosage form than what would have otherwise been distributed, or stopping distribution of an oral dosage form that would have otherwise been distributed.

[0057] In other embodiments, the programming provided as part of the devices / systems / methods of this device comprise a databank or provide databank access to established value ranges for data collected from patient input data, such as, for example, vital signs as determined by a healthcare provider and / or collected from integrated sensors, or in some embodiments, patient input data taken from responses collected from the patient, for example, as collected through the user interface in the systems / devices of the invention or in some embodiments, input via remote communication through an application on a mobile device, or input via web access, or any other means, as will be known to the skilled artisan.

[0058] According to this aspect and in other embodiments, the patient input data will be assessed against a databank of reference values for a range of replies that would result in maintaining the existing oral distribution program, whereby if input data is not consistent with the established response range of replies, then the programming provided as part of the devices / systems / methods of this device will implement a change in the oral dosage form distribution program from a first to a second distribution program, which will result in distribution of a different oral dosage form than what would have otherwise been distributed, or stopping distribution of an oral dosage form that would have otherwise been distributed.

[0059] According to this aspect and in some embodiments, patient input data may also be by means of established responses to a questionnaire posed to the patient via the user interface,with questions related to symptoms, severity, pain, or any combination thereof, as well as other questions related to the patient well being or for example, indicating responsiveness to medication for a particular treatment regimen, as will be appreciated by the skilled artisan.

[0060] For example, and in some embodiments, questions related to gastrointestinal distress and related symptoms may be a part of the patient interface questionnaire for protocols regarding cancer therapy, antibiotics, and others as will be known to the skilled artisan. In other embodiments, questions related to headaches, nausea and related symptoms may be a part of the patient interface questionnaire for protocols regarding neurological treatment regimens, for example ADHD and other related conditions.

[0061] It will be clear that there are any number of useful questions that can be posed to the patient making use of the devices / systems / methods of the invention, whereby patient feedback from such questionnaire provides additional insight into patient well being, which in turn can correlate with patient compliance, prognosis and other important aspects of a given treatment, and any appropriate questions and valuation of response can be incorporated within the user interface as part of the devices / systems / methods of the invention, and represents an envisioned embodiment thereof.

[0062] In some embodiments, the devices / systems / methods of the invention allow for introduction of test result data, such as, for example, blood test result or imaging result or biopsy result or other histopathologic result or sequencing or marker assessment result or any appropriate testing result that relates to a patient’s disease or condition or pathogenesis or responsiveness related to same, wherein such testing data may be collected and incorporated in the programming, whereby the programming can then allow for controlling, adjusting, altering or overwriting the first distribution program to a second distribution program.

[0063] In some embodiments, the programming ensures that subject response data is first reviewed by medical personnel prior to implementing any changes to the oral dosage form distribution program. In some embodiments, the programming enables generation of a recommendation to the medical care personnel to review subject response data and / or provide recommendations regarding changes to the oral dosage form distribution program and in some embodiments, medical care personnel can independently receive, review and incorporate patient response data into the programming, including recommendations regarding changes to the oral dosage form distribution program, in consideration of the responses being input into the device / system of the invention.

[0064] In some embodiments, this invention provides devices / systems / methods for specific oral dosage form delivery according to a given distribution program that can bedynamically altered, changed or otherwise adjusted over time, wherein the oral dosage forms being dispensed are for a particular subject, matching the distribution program to a specific subject, so that the devices / systems / methods represent personal point of care devices / systems / methods.

[0065] In some embodiments, this invention provides devices / systems / methods for specific oral dosage form delivery according to a given distribution program that can be dynamically altered, changed or otherwise adjusted over time, whereby the change in distribution program can be a result of patient response data, patient test result data, medical personnel assessment of test result data, as described, and in some embodiments, patient behavior and compliance, as well, may be factored into either the medical personnel recommendations, device / system programming or a combination thereof.

[0066] For example, and in some embodiments, if a patient routinely delays taking a scheduled dosage, the programming may be adjusted to include additional aspects in the questionnaire to elicit from the patient certain potential reasons that the behavioral observation, for example, delayed access of the dosage form, is occurring. In some embodiments, such behavioral modification may be a result of negative symptomatology or distress in the patient in taking the prescribed oral dosage form and may serve as a rationale to alter or change the distribution program, as described herein.

[0067] It will be apparent to the skilled artisan that any behavioral aspects related to patient access and / or responses e.g. to questionnaires posed to the patient may provide invaluable information that can be incorporated into the programming in the devices / sy stems of this invention to improve dosing regimens, patient assessment, pathogenesis of a disease, compliance tendencies of a patient, overall well being of a patient, pain threshold of a patient, support group or support environment for the patient, and many other factors that cumulatively improve the accuracy and optimize treatment for the patient.

[0068] In some embodiments, the devices / systems / methods allow for dispending oral solid dosage forms only after a personal / subject verification has occurred, which verification may be at the level of providing a prescription to obtain a device or system of the invention to the subject, whereby the pharmacist or vendor transferring the device or system of the invention to the subject verifies the subject identity, and in some embodiments, additional or alternate personal verification may occur, for example, by incorporating RFID or other security tags, password-protection, cameras verifying identification, or other methods, as will be appreciated by the skilled artisan.

[0069] In some embodiments the devices / systems / methods of this invention will incorporate the features of devices / systems / methods described in PCT International Patent Application Publication Number W02017064709A1, fully incorporated herein by reference. According to this aspect, and in some embodiments, the devices / systems / methods of this invention may further comprise a personal authentication protocol comprising authentication of a user through at least partial facial recognition, electronic key or tag authentication; or any combination thereof.

[0070] The instant systems, devices and methods of this invention as described herein and as defined in the subsequent listing of the application claims recite elements that are integrated into a practical application and are therefore not directed to an abstract idea.

[0071] The instant systems, devices and methods of this invention as described herein and as defined in the subsequent listing of the application claims relate to numerous practical applications, including those aspects imparting technical advantages unique to the device elements herein described, the components of the system and methods of application of same.

[0072] For example and representing one embodiment of the invention, there is provided a system, adapted to implement a cloud based architecture that allows device and / or system programming elements controlling distribution of dosage forms contained therein to be processed remotely as cloud services. For example, a device may send distribution program objects to a cloud-based distribution object processing system to offload the resources used for processing the distribution objects. In this example, the device is able to receive processed distribution objects from the cloud-based distribution object processing system without having to consume the device’s processing resources. The cloud-based distribution object processing system allows devices to utilize the benefits of distribution objects (e.g. information security) while offloading the computing resources. In some embodiments, uniquely, the real-time connection and coupling between on-device and cloud-based programming and integration of the two promotes off-loading of resource-draining elements of the programming while allowing real time distribution and altering of medication dispensing programs to most ideally suit the patient, while taking into consideration the complete patient experience and health, including in view of patient subjective responses to questionnaires, sensor collected data, other test result and imaging data, vital signs and patient care giver assessment, for the most optimal, personalized medication dispensing program.

[0073] In still other embodiments, uniquely the system also enables analysis of patient behavior over time, which elements are further incorporated into the programming, for example, including cloud-based storage and statistical analysis of behavior-related collecteddata, such as timing of patient taking medication, including for example, any changes beyond a pre-set norm of responsiveness of patient medication ingestion following, for example, a device-based prompt sent to the patient (e.g. by cell phone or on the display of the device) to take a given dosage, and statistical analysis of patient compliance and accuracy in following the receipt of the prompt with taking the medication timely (e.g. within 5 minutes of receipt of the prompt) and other additional data that may reflect on changes in patient compliance in terms of timing, such as, for example, increased heart rate or decreased heart rate and how same may correlate with prompt or delayed timing on behalf of the patient. In some embodiments, cloud-based storage allows for greater data storage volume and thereby greater analytic complexity to track patient behavior, including in real-time.

[0074] This invention provides, in one embodiment, an oral solid dosage form secure distribution device, having a plurality of individually contained, individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of a subsequent oral dosage form of said plurality, in terms of an active ingredient type, dosage, or composition component of said oral dosage form, or a combination thereof; wherein the device provides for dispensing an oral dosage form contained therein following an authentication protocol; and• wherein said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program;• wherein said programming may be adjusted, altered or overwritten to alter said first distributing program via said secure protocol to a second distribution program; or• wherein said programming may be adjusted, altered or overwritten to further prevent distributing any of the oral dosage forms contained in said device.

[0075] This invention provides, in other embodiments, a method for secure provision of oral solid dosage forms, administered as a dosage regimen which may be altered over time, the method comprising the steps of:• providing a device for secure administration of oral solid dosage forms to a subject, said device comprising: o a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of at least a second oral dosage form of said plurality, interms of an active ingredient type, an active ingredient dosage, or a composition component of said solid oral dosage form, or any combination thereof; o wherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following a personal authentication protocol; and o wherein said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program; o wherein said device comprises a user interface and optionally at least one sensor; and o wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and o whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof;• dispensing said first oral dosage form to said subject;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral dosage form distribution program in said device; and• dispensing said oral dosage form of said second oral dosage form distribution program to said subject; whereby an oral dosage form regimen is adjusted, altered or overwritten in said device resulting in altering dispensing of said oral dosage form, by means of a secure protocol.

[0076] According to this aspect and in some embodiments, the device for use in accordance with the method may include any device in any embodiment of same as described herein.

[0077] In some embodiments, the method will include wherein uptake of the oral dosage form by the subject following administration of the oral dosage form is verified, for example, making use of a camera or sensor or any appropriate mechanism as will be understood by the artisan and including any embodiment as described herein.

[0078] In some embodiments, the devices / systems / methods of the invention are particularly suitable in cases wherein the subject has a condition, whereby a treatment regimen provides for increasing the dosage of the treatment over time.

[0079] In some embodiments, according to this aspect, the device / system programming incorporates subject response data, sensor collected data, or testing result data or any combination thereof collected from the subject and promotes altering the first secure distribution program, such that the second distribution program may commence or may be itself further altered if the collected subject response data, sensor collected data, or testing result data or any combination thereof differs from established values for the collected subject response data, sensor collected data, or testing result data or any combination thereof.

[0080] In some embodiments, according to this aspect, the device / system programming can promote the second dispensing program to increase a solid oral form dosage rapidly if the subject does not display significant negative symptomatology as the dosage is increased, as determined by subject response data, sensor collected data, or testing result data or any combination thereof as collected from the subject.

[0081] In some embodiments, according to this aspect, the device / system programming can promote the second dispensing program to increase a solid oral form dosage rapidly if the subject does not display significant negative symptomatology as the dosage is increased, as determined by data input by a medical caregiver of the subject.

[0082] In some embodiments, according to this aspect, the device / system programming can promote said second dispensing program to increase a solid oral form dosage rapidly if the subject displays therapeutic effects as a result of increasing the dosage. According to this aspect and in some embodiments, the second dispensing program increases the dosage or the frequency of distribution of the oral dosage form, or a combination thereof. According to this aspect and in some embodiments, the subject has cancer and the first oral dosage form or second oral dosage form or any combination thereof is a chemotherapy agent.

[0083] In other embodiments, the device / system comprises at least a third solid oral dosage form, which treats or alleviates a side effect in a subject dispensed the first oral dosage or the at least a second oral dosage form or any combination thereof, whereby the programming controls adjusting, altering or overwriting the first distribution program via a secure protocol to a second distribution program, as a function of collected subject response data, sensor collected data, or testing result data or any combination thereof to further provide the third solid oral dosage form to the subject, as well.

[0084] In some embodiments, such third oral dosage form is an analgesic, an antiemetic, an anti-diarrheal, a steroid, an immunosuppressant, a growth factor, or any combination thereof.

[0085] In some embodiments, according to this aspect, the device / system programming can promote the second dispensing program to decrease a solid oral form dosage if the subject displays significant negative symptomatology, as determined by subject response data, sensor collected data, or testing result data or any combination thereof as collected from the subject.

[0086] In some embodiments, the device / system programming can promote the second dispensing program to decrease a solid oral form dosage, which may find application in use in a subject that has a condition, whereby a treatment regimen providing for decreasing the dosage of the treatment over time is desirable.

[0087] In some embodiments of the devices / systems / methods of this invention, according to this aspect, the programming incorporates subject response data, sensor collected data, or testing result data or any combination thereof collected from said subject wherein altering a first secure distribution program, such that a second distribution program may commence or may be itself further altered may occur if the collected subject response data, sensor collected data, or testing result data or any combination thereof differs from established values for the collected subject response data, sensor collected data, or testing result data or any combination thereof.

[0088] In some embodiments of the devices / systems / methods of this invention, according to this aspect, the programming can promote the second dispensing program to decrease a solid oral form dosage rapidly if the subject displays significant negative symptomatology following the first dispensing program, as determined by said sensor collected data, subject response data, or testing result data or a combination thereof as collected from said subject. In some embodiments, the second dispensing program decreases the dosage or the frequency of distribution of the oral dosage form, or a combination thereof.

[0089] In some embodiments of the devices / systems / methods of this invention, the subject has cancer and the first oral dosage form or second oral dosage form or any combination thereof is a chemotherapy agent.

[0090] In some embodiments of the devices / systems / methods of this invention, the subject response data comprises responses input by said subject to questions posed in a questionnaire. In some embodiments of the devices / systems / methods of this invention, the responses relate to symptomatology, pain existence, pain severity, or any combination thereof and in someembodiments, the symptomatology comprises gastrointestinal symptoms, fatigue, respiratory function.

[0091] In some embodiments of the devices / systems / methods of this invention, the sensor collected data comprises vital signs, body temperature, oxygenation, circulating glucose levels or any combination thereof.

[0092] In some embodiments of the devices / systems / methods of this invention, the testing result data may comprise blood test results, imaging results, or a combination thereof.

[0093] . In some embodiments of the devices / systems / methods of this invention, the sensor data may be collected from sensors located externally to said device, but in communication with said device, said authorized medical personnel or a combination thereof.

[0094] In some embodiments, the invention provides a method for secure provision of an oral cancer therapeutic, administered in a dosage regimen which may be altered over time, the method comprising the steps of:• providing a device for personal secure administration of the oral cancer therapeutic to a subject, said device comprising: o a plurality of individually addressable oral cancer therapeutics contained therein, wherein a first oral cancer therapeutic of said plurality contained therein differs from that of at least a second oral cancer therapeutic of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral cancer therapeutics, or any combination thereof; o wherein the device provides for dispensing at least one individually addressable oral cancer therapeutic contained therein following a personal authentication protocol; and o wherein said device is subject to programming, which programming controls distribution of said oral cancer therapeutics contained therein according to a first secure distribution program; o wherein said device comprises a user interface and optionally at least one sensor; and o wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and o whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to at least a seconddistribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof;• dispensing said first oral cancer therapeutic to said subject;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral cancer therapeutic distribution program in said device; and• dispensing said oral cancer therapeutic of said second oral cancer therapeutic distribution program to said subject; whereby an oral cancer therapeutic regimen is adjusted, altered or overwritten in said device resulting in altering dispensing of said oral cancer therapeutic, by means of a secure protocol.

[0095] In still other embodiments, this invention provides a method for optimization of secure provision of oral solid dosage forms to a subject in need thereof, the method comprising the steps of:• providing a device for secure administration of the oral solid dosage forms to a subject, said device comprising: o a plurality of individually addressable oral solid dosage forms contained therein, wherein a first oral solid dosage form of said plurality contained therein differs from that of at least a second oral solid dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral solid dosage form, or any combination thereof; o wherein the device provides for dispensing at least one individually addressable oral solid dosage form contained therein following a personal authentication protocol; and o wherein said device is subject to programming, which programming controls distribution of said oral solid dosage form contained therein according to a first secure distribution program; o wherein said device comprises a user interface and optionally at least one sensor; o wherein subject compliance with said first secure distribution program is collected and incorporated in said programming;o wherein subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof is collected and incorporated in said programming; and o whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof;• dispensing said first oral solid dosage form to said subject;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral solid dosage form distribution program in said device; and• dispensing said oral solid dosage form of said at least a second oral solid dosage form distribution program to said subject; whereby an oral solid dosage form regimen is adjusted, altered or overwritten in said device as a consequence of said collected subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof resulting in optimized dispensing of said oral solid dosage forms, by means of a secure authenticated protocol.

[0096] This invention provides, in one embodiment, a hand-held oral solid dosage form secure distribution device, having a plurality of individually contained, individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of a subsequent oral dosage form of said plurality, in terms of an active ingredient type, dosage, or composition component of said oral dosage form, or a combination thereof; wherein the device provides for dispensing an oral dosage form contained therein following an authentication protocol; and• wherein said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first distribution program;• wherein said programming may be adjusted, altered or overwritten to alter said first distributing program via a secure protocol to a second distribution program; or• wherein said programming may be adjusted, altered or overwritten to further prevent distributing any of the oral dosage forms contained in said device.

[0097] This invention provides, in some aspects, a device for personal secure administration of oral solid dosage forms, comprising a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of at least a second oral dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form, or any combination thereof; o wherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following a personal authentication protocol; and o wherein said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program; o wherein said device comprises a user interface and optionally at least one sensor; and o wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof.

[0098] Further according to this aspect, and in some embodiments, the personal authentication protocol comprises authentication of a user through at least partial facial recognition, electronic key or tag authentication; or a combination thereof.

[0099] Further according to this aspect, and in some embodiments, the hand-held oral solid dosage form secure distribution device contains a tamper proof casing within which the solid dosage form holder is contained. According to this aspect, and in some embodiments, the solid dosage form holder may be a rotatable or advanceable carousel structure containing multiple compartments, each compartment containing one or more oral dosage forms for dispensing for a single dosage regimen. According to this aspect, and in another embodiment, the solid dosage form holder may accommodate blister pack encased solid dosage forms and be further equipped with a blister-pack releasing element to specifically and addressablyrelease the oral dosage forms for dispensing for a single dosage regimen located in a given blister pack, contained in the holder compartment, for programmed release.

[0100] In one embodiment, the hand-held oral solid dosage form secure distribution device ensures secure dispensing of the oral solid dosage forms contained therein through components in the device in coordination with secure protocols enabling operation of the device to dispense the oral solid dosage form only to the subject for which such dispensing is intended.

[0101] According to this aspect, and in some embodiments, the hand-held oral solid dosage form secure distribution device comprises a tamper-proof container housing a plurality of individually contained, individually addressable oral dosage forms.

[0102] According to this aspect, and in some embodiments, the tamper-proof container prevents access to the oral dosage forms housed therein and only through coordinated, authorized use with the hand-held oral solid dosage form secure distribution device can specific oral dosage forms be dispensed to a specific user.

[0103] Still further according to this aspect, the tamper-proof container will encase a multi-chamber holder, which multi-chamber holder is individually addressable so that the multiple chambers in which the oral dosage forms are contained each comprise access portals sized to accommodate pass-through of the oral solid dosage forms contained therein; whereby upon regulated and authenticated alignment of the chamber access portal with an appropriate egress / dispensing structure in the device, can the oral solid dosage forms for a single dosage regimen be dispensed.

[0104] In some aspects, the regulated and authenticated alignment is subject to security protocols built into the device that regulate movement of the multi -chamber holder within the tamper-proof container.

[0105] According to this aspect and in some embodiments, only upon authentication of the user following specific security protocols, can the user access the dispensing program, whereby the device, when inserted into the oral cavity of the user will dispense a prescribed dosage regimen into the oral cavity of the user.

[0106] According to this aspect and in some embodiments, for any authenticated user, a dispensing program for dispensing the oral dosage forms contained in the device has been established. In some embodiments, the device is equipped with communication means whereby authorized medical personnel may introduce a second dispensing program, which is distinguished from the first dispensing program, so that the oral dosage forms dispensed to the subject differ from that which would have been dispensed to the subject, by means of the first dispensing program.

[0107] For example, and representing an embodiment of this invention, the subject has a condition, whereby a treatment regimen for the subject should ideally provide for increasing the dosage over time, subject to certain responsiveness indicators from the subject.

[0108] For example, and representing an embodiment of this invention, the dosage can be increased rapidly if the subject does not display significant negative symptomatology as the dosage is increased, or if the subject displays rapid therapeutic effects as a result of increasing the dosage, or others, as will be appreciated by the skilled artisan. In accordance with this example, and representing some embodiments, the tamper-proof container housing a plurality of individually contained, individually addressable oral dosage forms, will contain a plurality of chambers, which chambers may contain incrementally increasing doses of a single oral solid medication.

[0109] In some embodiments the reference to being “individually addressable” refers to an ability to incorporate programming that alters a distribution pattern or order for the device to accommodate, e.g. skipping a compartment, or going in an opposing direction to align the desired compartment so that dispensing of the solid dosage forms located therein can be specifically addressed, or releasing more than a single dosage form from a given compartment, such that the chambers and, in some embodiments, individual dosage forms located in each compartment are individually addressable in that same are individually accessible and performance of the dispensing of the content of an individual chamber or an individual dosage form in a chamber is attainable uniquely in this invention.

[0110] In some embodiments the reference to being “individually addressable” refers to an ability to incorporate programming that alters a distribution pattern or order for the device to accommodate, e.g. skipping a compartment, or going in an opposing direction to align the desired compartment so that dispensing of the solid dosage forms located therein can be specifically addressed, or releasing more than a single dosage form from a given compartment, such that the chambers and, in some embodiments, individual dosage forms located in each compartment are individually addressable in that same are individually accessible and performance of the dispensing of the content of an individual chamber or an individual dosage form in a chamber is attainable uniquely in this invention.

[0111] In some embodiments, the hand-held oral solid dosage form secure distribution device, has a plurality of individually addressable compartments comprising a plurality of oral dosage forms contained therein.

[0112] In some embodiments, the plurality of oral dosage forms may include one or more pills in each compartment, wherein a first oral dosage form of said plurality contained thereindiffers from that of another oral dosage form of said plurality, in terms of an active ingredient type, dosage, or composition component of said oral dosage form, or a combination thereof.

[0113] According to this aspect and in some embodiments, the plurality of oral dosage forms may include one or more oral dosage forms in each compartment, wherein the oral dosage forms are combined for a desired purpose. For example, and representing one embodiment, the plurality of oral dosage forms in a single compartment are of the identical composition and identical dosage, and in some embodiments, same provides for an increased dosage to the subject, by providing more than one oral dosage form in a “next compartment” so that when accessed the dosage is increased. Of course, in some embodiments, this same goal is accomplished by containing increasing dosages in different chambers in the device. In another embodiment, the plurality of oral dosage forms in a single compartment are of the identical composition and differing dosage, and each dosage form located within the compartment, in some embodiments, can be individually dispensed, so as to provide for an increased dosage to the subject. In another embodiment, the plurality of oral dosage forms in a single compartment are of different compositions, for example, to provide for a combination therapy to the subject.

[0114] It will be appreciated that any combination of oral dosage forms may be provided in the compartments of the hand-held oral solid dosage form secure distribution devices of this invention, as appropriate, and the invention is not to be limited in any way in terms of the types of oral dosage forms that may be dispensed thereby.

[0115] In one embodiment, representing a non-limiting example, the tamper-proof container houses a substantially circular carousel structure with individual chambers. In one aspect, the carousel may comprise 18 chambers, whereby every 3 chambers contains a single oral medication, with incrementally increasing dosages. In one aspect, a typical subject may make use of only the first 9 chambers, each chamber accessed daily, and in some aspects, an authorized personnel may decide to alter the dosage to increase the dosage, for example, accessing chambers 9-12 after chambers 1-3 have been accessed, thereby altering the original dispensing program.

[0116] Referring for example to Figure 6 herein, where oral dosage forms that differ in drug composition, formulation components, dosage, or any combination thereof are positioned in different chambers of the device (e.g. 6-50, versus 6-100, versus 6-150, versus 6-200), where for example, a first distribution program would administer the dosage form sequentially rotating the carousel for example in the clockwise direction as depicted by the red arrow. In some embodiments, a second dosage form could be placed within the regimen, for example asdepicted at 6-50, wherein the first distribution program may include administering the 6-50 dosage form, or in some embodiments, skipping the chamber in which the 6-50 dosage form is located. Alteration of this distribution program to either skip the 6-50 dosage form, or in some embodiments, administering the dosage form in the chamber in which the 6-50 dosage form is located, respectively, in contrast to the first distribution program would represent the described change to a second distribution program, in some aspects of the invention. In a further aspect of the invention, in addition to skipping chambers, the rotation of the carousel for example may be altered, for example, from the clockwise orientation depicted by the red arrow to follow a counter clockwise orientation marked by the blue arrow. Such change in rotation would reflect a change to follow a second distribution program, as described herein. In still other aspects, for example, as opposed to dosage form 6-50 being followed by administration of dosage 6-100, when a clockwise orientation is followed, the shift to a distribution program altering rotation may instead deliver a different dosage form, for example, delivering the 6-200 dosage form following the 6-150 dosage form, or other combinations, as will be appreciated by the skilled artisan.

[0117] According to this aspect, and in some embodiments, such alteration of the dispensing program may, for example, arise as a consequence of visual inspection / examination of the subject or following verbal or written exchanges with the subject by the health care provider, or in some aspects based on replies to a questionnaire which is accessed by the subject on the device, and in some aspects, the replies to which are graded based on programming on the device and / or reviewed by a care giver, who in turn may execute additional changes to the dosage regimen administration protocol enabled on the device, including altering the dosage and / or the drug and / or providing additional agents to the subject, depending on the circumstances as further described hereinbelow.

[0118] In other embodiments, such alteration of the dispensing program may, for example, arise as a consequence of medical test results obtained for the subject by the health care provider, by the patient, or a combination thereof.

[0119] According to this aspect and in some embodiments, the device may be further equipped with sensors and the like to independently assess parameters of the subject, that, as well, may serve as indicators to adjust or otherwise alter a dosage regimen. In some embodiments, the combination of patient reported data and questionnaire responses, inspection of results and / or patient appearance by medical personnel, sensor obtained data and test results or any combination thereof may in turn result in programming to adjust or otherwise alter a dosage regimen as herein described.

[0120] According to this aspect, and in some embodiments, the hand-held oral solid dosage form secure distribution device will contain a plurality of chambers, which chambers may contain incrementally decreasing doses of a single oral solid medication comprises a plurality of compartments, which compartments are individually addressable and securely contain one or more oral dosage forms in each compartment.

[0121] For example, and representing an embodiment of this invention, the subject has a condition, whereby a treatment regimen for the subject for a particular dosage was employed, however, following assessment of the subject, for example, in a case where the subject displayed significant negative symptomatology, or if the subject displayed no therapeutic effects, or others clinical indications that may arise to decrease the dosage, as will be appreciated by the skilled artisan, the programming in the device provides for altering the first distribution program (of a given drug at a given dosage) to a second distribution program, whereby the dosage is reduced and even altogether stopped. I accordance with this example, and representing some embodiments, the tamper-proof container housing a plurality of individually contained, individually addressable oral dosage forms, will contain a plurality of chambers, which chambers may contain incrementally decreasing doses of a single oral solid medication.

[0122] It will be appreciated that there are many additional means through the devices, systems and methods of the invention to alter the treatment dosage regimen, for example, by introducing / loading additional agents to be e.g. co-administered or subsequently administered to the subject, for example to provide relief for a symptom, that does not interfere with the effective treatment by the drug, yet can offer comfort or reduced symptomatology to the subject.

[0123] The present invention broadly relates to devices, systems and methods, which, inter alia, monitor symptoms of diseases, disorders, and injuries, and / or correlate same with a need to adjust, alter or otherwise change a treatment regimen, using unique personal oral administration dosage form devices and systems.

[0124] In some aspects, the present invention relates to such devices, systems and methods for monitoring symptoms of diseases, disorders, and injuries and also for providing possible treatment methods including titrations, changes and recommendations for those diseases, disorders, and injuries and their symptoms and side effects of treatment, including combining treatments for the diseases, disorders and injuries and adjusting same on a personal regimen level, along with the opportunity and option to treat the side-effects of the medication, with additional agents uniquely suitable for same.

[0125] The present invention further relates to a device, system and method of providing possible treatment methods for diseases, disorders, and injuries, their symptoms, and side effects of treatment based on correlating subject response data, sensor collected data, or testing result data collected or any combination thereof with a database of similar data and incorporating same into the programming in the devices / sy stems, so that the invention represents a personally customized and adaptive treatment system, which can dynamically alter the oral solid dosage treatment regimen of a subject in real time, to most ideally address treating the patients’ diseases, disorders, and injuries, including optimizing treatment for any side-effects or new symptomatology arising as a result of the treatment regimen.

[0126] The present invention provides for a device, system and method that can customize treatments on an individual patient level, using the drug delivery devices / sy stems of this invention.

[0127] The present invention provides for a device, system and method that may incorporate, in some aspects, a database, or in some embodiments, a system of databases, of patient and treatment histories to correlate current subject information and data with historical data, and in some embodiments, the subject response data, sensor collected data, or testing result data collected or any combination thereof, can also be extrapolated to describe patient behavioral aspects such as compliance with prompt medication dispensing at the advocated time, patient feedback regarding symptomatology or pain threshold, and others, and such “behavioral information” collected may also be correlated with historical data from the same subject.

[0128] In other embodiments, the invention may comprise movement data related to the patient's external body motion. According to this aspect, and in some embodiments, the device / system of this invention and method may incorporate a processor adapted for processing movement data of the patient and further comprise a quantification algorithm adapted to quantify symptom severity and / or solid dosage form ingestion / compliance with regimen as a behavioral indicator, as well, in other embodiments, to arrive at a score for therapy or symptomatology, as appropriate, based at least in part on the movement data; which score may be incorporated in the programming as described herein, and weighted as appropriate in the evaluation of a treatment regimen being provided to a subject and / or in terms of serving as an indicator for altering a treatment regimen for a subject, as described herein.

[0129] In some embodiments, according to this aspect, the algorithm may be adapted to address the timing or number of times that a drug or medication should be administered, or insome embodiments, the timing of, or whether a dosage of a given medication should be increased, or in some embodiments, reduced, or in some embodiments, should be provided in combination with another agent to address symptomatology in the patient, which in some embodiments, will promote preventing symptoms and / or reducing symptom severity in the subject, based in part on early detection of changes in the presence of symptoms and / or symptom severity, which may in some aspects further consider the historical data of the subject, or age- or other population- matched subjects and / or an appropriate representative pool of subjects, and to provide a recommended alteration in the drug or medication regimen comprising recommendations regarding the drug, drug dosage, and / or instructions for administration of the drug and / or the drug dosage, the recommended drug or medication regimen based at least in part on the calculated score, described hereinabove.

[0130] In some embodiments, such quantification and / or treatment algorithms may be trained at least in part on reference data of the subject and / or further improved, for example, over time, by considering reference data from other subjects, the reference data comprising: historical movement data collected using at least one historical movement sensor or a historical physiological sensor corresponding to historical movement of the subject and / or comprising data from a bank of other subjects, similarly collected, and in some embodiments, further incorporating at least one type of data from the group consisting of: clinician scores or sensor-based symptom quantification scores corresponding to historical movement data, and treatment parameters for the subject and / or in some aspects comprising scores similarly obtained from other subjects and further wherein a recommended drug or medication regimen is adapted to provide a desired drug profile in a bloodstream of the subject, and in some embodiments, the system is further adapted to recommend or provide a new or additional drug dose based on the quantified symptom severity in order to prevent an onset or recurrence of the at least one symptom.

[0131] The devices, systems and methods in some preferred embodiments, dynamically and uniquely provide for drug titrations, in terms of dosage and timing, in a personal, secure framework, and same may enable continuous improvement of the treatment protocols for use with subjects in the future.

[0132] The present invention provides for devices, systems and methods that can accurately measure, monitor, and incorporate symptoms of disorders, diseases, and injuries, as well as side effects of treatment, into the device / system programming and method steps, so as to optimize treatment regimens, including altering same i.e. by changing a first distribution program from the device / system to a second distribution program, altered, adjusted, etc., inconsideration of the values obtained, which in some embodiments, is reflective of the symptoms of disorders, diseases, and injuries, as well as side effects of treatment.

[0133] The devices, systems and methods accurately quantify symptoms and side effects utilizing, in some aspects, sensor data, where the sensors or devices comprising the sensors can be worn continuously to provide continuous information to be analyzed as needed by system and / or a clinician, physician, or technician.

[0134] The devices, systems and methods of this invention, can operate in real-time, including all measurement / sensing and analysis functions, which allows, inter alia, for remote monitoring of symptoms and side effects in subjects to capture the complex fluctuation patterns of the disease, disorder, or injury over the course of days, weeks or months in a manner that maximizes subject safety and efficacy of treatment, and that provides remote access to the clinician, physician, or technician.

[0135] The present invention relates to methods for semi-automatically and automatically adjusting, or tuning, oral dosage treatment regimens in the described devices and systems herein, and in some embodiments, remotely and intelligently adjusting or tuning such devices and systems.

[0136] According to this aspect and in some embodiments, reference to “semi-automatic adjustment” may include providing the clinician, physician or technician with collected data or measurements related to a subject's disorder, including symptoms, response to therapy, patient complaints, or any patient feedback from any collected source, determining desired parameters, including, in some embodiments, by comparison to database stored ranges of norms or in some embodiments, historic data for the subject, and then remotely entering changes into the oral dosage distribution regimen of a subject, to the devices / sy stems for use by the subject. In other embodiments, reference to “semi-automatic adjustment” may include providing the clinician, physician or technician with collected data or measurements related to a subject's disorder, including symptoms, response to therapy, patient complaints, or any patient feedback from any collected source, determining desired parameters, including, in some embodiments, by comparison to database stored ranges of norms or in some embodiments, historic data for the subject, and then remotely entering feedback to maintain the oral dosage distribution regimen of a subject currently in use, to the devices / sy stems for use by the subject, until and unless a change is subsequently entered by a health care personnel, or other authorized user.

[0137] Semi-automatic or automatic adjustment (including but not limited to remote adjustment by clinicians) includes for example, providing collected data as described herein,including, but not limited to, objective, quantitative or semi -quantitative data and / or measurements related to a subject's disorder or symptoms to an algorithm, using the data or measurements for determining desired parameters using the algorithm, and then entering those parameters either semi-automatically (i.e., allowing clinician, physician or technician to review and / or approve / adjust) or to automatically into the subject's therapy device.

[0138] Alternatively or in addition, semi-automatic or automatic adjustment may not require sensors to provide data and / or measurements related to a subject's disorder or symptoms, but rather may use qualitative or quantitative information such as, for example, traditional telemedicine techniques or remote observation by a clinician, physician or technician via video connection.

[0139] In some embodiments, the clinician, physician or technician may rely wholly or in part on scoring of the subject's symptoms, including considering but not necessarily relying on quantified data and / or measurements collected, e.g. from sensors or for example by using video links between the clinician and the patient or subject.

[0140] In other embodiments, reference to “remote adjustment” or “tuning” includes the control and / or decision regarding the therapy parameters to be programmed into the system or subject's therapy device, whereby such controlling can be effected by a caregiver located remotely from the subject. For example, remote adjustment or tuning may be controlled by a clinician, physician or technician or an automated or semi -automated system using data transmitted from the subject and / or his or her therapy device without the subject having to travel to the clinical site to for such data to be obtained or transferred.

[0141] The present invention further relates to a system for screening patients to determine if they respond well to certain therapy modalities. According to this aspect and in some embodiments, the first distribution program is provided to the patient, whereafter collected subject response data, sensor collected data, or testing result data or any combination thereof is incorporated into the programming to determine if the patient displays therapeutic effects. Further according to this aspect and in some embodiments, the collected subject response data, sensor collected data, or testing result data or any combination thereof may also advise if any side effects or complications arise as a result of such first distribution program. Further according to this aspect and in some embodiments, the first distribution program may be altered to administer a second distribution program, for example, to increase the dosage of the oral dosage form, if same seems to produce a therapeutic effect. In another embodiment, the first distribution program may be altered to administer a second distribution program, forexample, to treat symptoms or side-effects that do not impair the therapeutic effect in the subject but, for example, may impact patient compliance with continuing the treatment course.

[0142] The present invention yet further relates to methods of automatically and intelligently tuning a therapy device using the collected subject response data, sensor collected data, or testing result data or any combination thereof, to further adjust the oral dosage form distribution programs, as a function of same.

[0143] In some embodiments of the invention, and including the aspect described immediately hereinabove, but equally applicable to any embodied device, system or method of this invention as described herein, the collected subject response data, sensor collected data, or testing result data or any combination thereof, provides a measurement that can be performed by measuring a single metric, various metrics, or a combination of a number of metrics.

[0144] In some aspects, the sensors used to collect subject response data in any embodied device / system / method of this invention may comprise sensors for measuring body movement or motion, such as gyroscopes and accelerometers, and the like. In other embodiments, the sensors for measuring physiological signals such as electromyogram (EMG), electrooculogram (EOG), electroencephalogram (EEG), electrocardiogram (EKG), or other physiological signals which can directly or indirectly measure movement metrics in the subject may be included. In other embodiments, the devices / systems / methods of the invention may incorporate motion capture systems, machine vision systems, sonic or laser Doppler velocity transducers, infrared systems, GPS, or any other similar device known to those skilled in the art.

[0145] In some embodiments, the devices / systems of the invention will comprise at least one electronic component that further may contain internal or onboard memory for storage of data, in particular subject response data, sensor collected data, or testing result data or any combination thereof, such that the data may be transferred at a later time.

[0146] In some embodiments, the devices / systems of the invention will comprise communications electronics, which transmit the data to an external device for storage and / or analysis. The communication electronics may be wireless, and in some aspects, comprise radio frequency wireless.

[0147] In some embodiments, the devices / systems of the invention will comprise a centralized storage database, parallel databases, a cloud-based database, a computer, tablet, cell phone including for example smartphone, personal data assistant (PDA) or similar device, or a combination of database and computer or communication devices.

[0148] In some embodiments, subject response data, sensor collected data, or testing result data or any combination thereof is transmitted substantially in real-time between different databases, as described herein.

[0149] In some embodiments, by reference to the term “real-time”, it is meant that preferably, data is transmitted within 30 minutes of being acquired, measured, or calculated. In some embodiments, data is transmitted within 20 minutes of being acquired, measured, or calculated. In some embodiments, data is transmitted within 10 minutes of being acquired, measured, or calculated. In some embodiments, data is transmitted within 5 minutes of being acquired, measured, or calculated. In some embodiments, data is transmitted within 4 minutes of being acquired, measured, or calculated. In some embodiments, data is transmitted within 3 minutes of being acquired, measured, or calculated. In some embodiments, data is transmitted within 60 seconds of being acquired, measured, or calculated. In some embodiments, data is transmitted within 45 seconds of being acquired, measured, or calculated. In some embodiments, data is transmitted within 30 seconds of being acquired, measured, or calculated. In some embodiments, data is transmitted within 15 seconds of being acquired, measured, or calculated. In some embodiments, data is transmitted within 5 seconds of being acquired, measured, or calculated. In some embodiments, data is transmitted within 1 second of being acquired, measured, or calculated. In some embodiments, data is transmitted substantially simultaneously within milliseconds of being acquired, measured, or calculated.

[0150] In some embodiments, following collection of subject response data, sensor collected data, or testing result data or any combination thereof collected from said subject, assessment and / or quantification of any discrepancy from collected values versus established values is conducted via data processing. This processing may take place during or following data acquisition and may occur within a subject personal device or within a remote processing device, such as a personal computer, PDA, smart phone, tablet computer, touch screen interface, or the like, with which the acquisition device interfaces, either through a cable connection or by wireless transmission.

[0151] In some embodiments, subject response data, sensor collected data, or testing result data or any combination thereof collected from said subject, may be subjected to statistical analysis to ensure that any discrepancies between collected data and established values is not due to chance alone.

[0152] In some embodiments, the analysis may comprise a simple or multiple linear regression analysis, or any appropriate analysis as will be appreciated by the skilled artisan.

[0153] In other embodiments, the device / system parameter settings changes may be input into the algorithm by a software user interface (integrated tuning) or may be automatically sensed and input by communicating with the device, to regulate oral dosage administration, or may be known because the therapy or treatment parameter settings have been preset to some known baseline settings or restored to a previously saved settings preset. The existing parameter settings might also be predicted or derived based, for example, on observed or measured therapy effectiveness. Suggested therapy system parameter settings changes are then input into the device / system, and their effectiveness is measured using the above-described method of symptom quantification.

[0154] In some embodiments, the device / system parameter settings may be iterative, while in some aspects, the devices / systems / methods of the invention may reduce the time and expertise required to arrive at optimized therapeutic dosage regimen settings, wherein the added value of including subject response data, sensor collected data, or testing result data or any combination thereof collected from said subject, and assessing same against established values enables clinicians, technicians or physicians with lesser training or experience to adjust parameter settings and to do so in less time than is currently required. In some embodiments, the present invention increases access to geographically disparate populations by putting the expertise into the system and reducing or eliminating the need for an expert or trained clinician to be present with each subject.

[0155] In some embodiments of the present invention, the devices / sy stems of this invention and uses thereof provide for a remote tuning or adjustment system. In such embodiments, at least one electronic component for transmitting and receiving signals is required. In such embodiments, subject response data, sensor data, or testing result data or any combination thereof is collected as described herein and transmitted using the at least one electronic component for transmitting signals to a remote location or remote locations. The data may be transmitted to a clinical center or location where a clinician, physician or technician can view the data. In such embodiments, the clinician, physician or technician can then make a decision and determination regarding whether adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program is warranted and should be applied to the subject's therapy device / system.

[0156] In other embodiments, an algorithm may be used to provide the determination as to whether adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program is warranted, based on the subject response data, sensor data, or testing result data or any combination thereof collected as described herein. Still further according to this aspect, a clinician, physician or technician may optionally review the data underlying the basis of the determination by the algorithm.

[0157] In some embodiments of the remote tuning or adjustment functions, once a determination that adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program is warranted is made, this is then transmitted back to the subject's device / system where it is received by at least one electronic component for receiving signals. In still other remote embodiments, the determination that adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program is warranted may be transmitted to storage or other remote locations as described, which in some embodiments is additionally transmitted to a central server, cloud-based server, or other such database for storage and backup purposes.

[0158] In some embodiments, the devices / systems / methods / uses of the invention provide for optimization or tuning algorithm(s) which are used to determine or recommend optimum therapy settings or parameters, by means of adjusting, altering or overwriting a first oral dosage form distribution program via a secure protocol to a second distribution program. Such optimization algorithms may include, but are not limited to simplex algorithms, extensions of the simplex algorithm designed for quadratic and / or linear function programming, combinatorial algorithms, and other multi-variant optimization algorithms known to those in the art.

[0159] In order to determine what a desired or optimal level of therapy parameters might be, the subject's symptoms or side effects must first be measured and quantified. The measurement and quantification take into account the collected subject response data, sensor collected data, or testing result data or any combination thereof. In some embodiments, once the initial measurement and quantification has been obtained, a clinician, physician or technician programs the second distribution program into the subject's device or system, and in some embodiments, an iterative process may ensue, such that, in some embodiments, the subject response data, sensor collected data, or testing result data or any combination thereof is similarly repeatedly collected and assessed over time, while the symptoms or side effects or therapeutic effect, or any combination thereof,are again measured and quantified, and in some embodiments, a further, e.g. third distribution program may be enacted.

[0160] According to this aspect, and in some embodiments, this process is repeated until the desired result(s), goals or constraints are achieved. Various embodied aspects of the processes and steps are described in greater detail herein, representing non-limiting examples of this invention.

[0161] In some embodiments, the devices / sy stems and / or methods of the invention include acquiring subject information, be it in terms of first drug distribution program information such as medication type, dosage or timing, or patient response data to same, or patient symptomatology associated with ingestion of same or patient behavioral metrics in taking same or any combination thereof and determining a consequence factor for same.

[0162] In some embodiments, the “consequence factor” may refer to a metric associated with a disease or disorder in terms or pathogenesis of the disease or disorder, or symptom of the disease or disorder, where reducing pathogenesis or any metric or symptom associated with the disease or disorder, or increasing pathogenesis or any metric or symptom associated with increased pathogenesis of the disease or disorder is to be considered a consequence factor.

[0163] According to these aspects and in some embodiments, the consequence factor will in turn be considered as part of the device / system / method programming for incorporation in the drug distribution program, and in some aspects, as part of the considerations included in the programming, for changing or altering the first drug distribution program to a second distribution program as herein described. In some aspects, iterative processing of output information if performed such that same is used for evaluating drug recommendation information output, in terms of any potential recommendation to change or alter a drug distribution program.

[0164] According to this aspect and in some embodiments, the programming may further comprise obtaining medical record information of the patient and obtaining an evaluation result of the drug recommendation information for the patient based on the subject response data, sensor collected data, or testing result data or any combination thereof, wherein the evaluation result indicates whether there is incompatibility in the drug recommendation information for the patient, for example, as obtained from the medical record information.

[0165] According to this aspect and in some embodiments, the devices / sy stems and / or methods contemplate performing iterative processing of the output information forevaluating drug recommendations and in particular, for evaluating whether to proceed with any change and / or alteration of a drug distribution program for the subject.

[0166] According to this aspect and in some embodiments, the devices / sy stems and / or methods of this invention comprise that such iterative processing is performed on a non- transitory computer-readable storage medium for storing computer instructions, wherein the computer instructions, when executed by a computer, cause the computer to acquire the information as described to perform the iterative processing and including arriving at the output decisions / instructions regarding evaluating whether to proceed and proceeding with performing any change and / or alteration of a drug distribution program for the subject

[0167] According to this aspect and in some embodiments, the devices / systems / methods of the invention may be considered to comprise an information acquisition module, configured to acquire information regarding a patient / subject, which information in turn is to be factored into additional modules for use with the devices / systems / methods of the invention, such as, for example, a drug recommendation module, configured to determine drug recommendation information for the subject based on the related information collected from initial health care provider treatment related information, and as refined / further in consideration of subject response data, sensor collected data, or testing result data or any combination thereof, as herein described, as part of the iterative processing herein described, which in turn will reflect on drug recommendations in accordance with the invention devices / systems / methods. In some aspects, according to this embodiments, the drug recommendation information may relate to information regarding at least one drug, and in some embodiments, may relate to, inter alia, timing of drug administration, dosage of drug, combinations of drugs for administration, as herein described including in any embodiment described herein, whereby the iterative processing, will comprise consideration of any of the evaluation results obtained, for example, and including those obtained in any of the flow chart decision points described herein, or any recommended course of action described herein, given a patient responsiveness in terms of achieving a desired clinical endpoint and in view of overall patient symptomatology in the context of same, as described herein.

[0168] In some embodiments the devices / systems / methods of the invention will comprise at least one processor and a memory communicatively connected to the at least one processor, wherein the memory stores instructions executable by the at least one processor, the instructions are executed by the at least one processor to enable the at least one processor to perform the aforementioned method.

[0169] According to some aspects of the present application, a non-transitory computer-readable storage medium for storing computer instructions is provided. The computer instructions, when executed by a computer, cause the computer to perform the aforementioned method.

[0170] By applying embodiments of the present application, a drug recommendation is provided by a first model according to related information of a target object. In addition, the first model is obtained by performing iterative processing on output information of a second model, and the role of the second model is to evaluate drug recommendation information. In this way, since the evaluation of drug recommendation information is introduced in training of the first model, so that finally recommended drugs may be more accurate.

[0171] It should be understood that the content described herein is not intended to denote key or critical elements of embodiments of the present application nor to limit the scope of the present application. Further features of the present application may be readily understood from the following description.

[0172] In other embodiments, the

[0173] In some aspects of the invention, the devices / systems / methods of this invention provide oral dosage forms in a regimen intended to treat a disease or disorder, whereby in some aspects, there is a reduction in the occurrence and / or severity of the subject's disorders and / or symptoms while the subject is receiving therapy or is under the effects of recently received therapy.

[0174] Optimization of therapy or treatment parameters or settings, or recommended drug regimens or protocols, can be described in reference to various constraints or desired results. In some embodiments, optimization of the recommended treatment or therapy based at least in part on collected subject response data, sensor collected data, or testing result data or any combination thereof which in turn points to a reduction or minimization of symptom occurrence and / or severity in the subject, achieving a desired outcome, be it therapeutic or palliative, or any other desired outcome, as will be appreciated by the skilled artisan.

[0175] In some embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least a 10% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least a 10% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently receivedtherapy. In some embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least a 20% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least a 20% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently received therapy. In other embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least a 30% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least a 30% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently received therapy. In other embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least a 40% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least a 40% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently received therapy. In other embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least a 50% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least a 50% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently received therapy. In other embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least a 60% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least a 60% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently received therapy. In other embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least a 70% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least a 70% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently received therapy. In other embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least a 75% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least a 75% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently receivedtherapy. In other embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least an 80% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least a 80% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently received therapy. In other embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least an 85% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least an 85% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently received therapy. In other embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least a 90% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least a 90% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently received therapy. In other embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to at least a 95% reduction in the occurrence and / or severity of the subject's disorders and / or symptoms or at least a 95% reduction in reduction in the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently received therapy. In other embodiments, an optimized or second level of therapy parameters or settings, or recommended drug regimens or protocols, corresponds to substantially eliminating the occurrence and / or severity of the subject's disorders and / or symptoms or at least substantially eliminating the occurrence and / or severity of the subject's side effects while the subject is receiving therapy or is under the effects of recently received therapy.

[0176] In some embodiments, the devices / systems / methods of this invention may include a general optimization strategy in which optimized settings may reflect selective combinations of the above desired results or constraints being incorporated in the programming relating to the oral dosage distribution program. For example, such embodiments may optimize based on reducing or minimizing both symptoms and side effects. Any combination of type and / or number of desired results or constraints may be used to optimize the system. In some embodiments, at least two different desired results or constraints are considered when determining an optimized group of therapy settings or parameters. In some embodiments, at least three different desired results or constraints are considered when determining anoptimized group of therapy settings or parameters. In some embodiments, at least four different desired results or constraints are considered when determining an optimized group of therapy settings or parameters. In some embodiments, at least five different desired results or constraints are considered when determining an optimized group of therapy settings or parameters. In some embodiments, at least six different desired results or constraints are considered when determining an optimized group of therapy settings or parameters. In some embodiments, more than seven different desired results or constraints are considered when determining an optimized group of therapy settings or parameters.

[0177] In some embodiments, therefore, this invention provides a method for personal, secure authenticated provision of oral solid dosage forms, administered as a dosage regimen which may be altered over time, the method comprising the steps of:• providing a device for personal secure administration of oral solid dosage forms to a subject, said device comprising: o a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of at least a second oral dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said solid oral dosage form, or any combination thereof; o wherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following a personal authentication protocol; and o wherein said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program; o wherein said device comprises a user interface and optionally at least one sensor; and o wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and o whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof;• completing an authentication protocol for dispensing said oral dosage form to said subject and dispensing said first oral dosage form within an oral cavity of said subject;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral dosage form distribution program in said device; and• dispensing said oral dosage forms of said second oral dosage form distribution program to said subject; whereby an oral dosage form regimen is adjusted, altered or overwritten in said device resulting in altering dispensing of said oral dosage form, by means of a secure authenticated protocol.

[0178] According to this aspect and in some embodiments, such method may employ use of a device of this invention in accordance with any embodiment for same as described herein, including certain aspects of the device and system as depicted in the provided figures and as elaborated in part in the non-limiting examples described further herein.

[0179] According to this aspect, and in some embodiments, the device or system for use with the afore-mentioned method, or with any method as described herein, as well, representing other embodiments, such device or system component that dispenses the oral dosage forms may be equipped with communications infrastructure whereby authorized medical personnel may introduce a second dispensing program, which is distinguished from the first dispensing program, so that oral dosage forms dispensed to the subject differ from that which would have been dispensed to the subject, by means of the first dispensing program, as described herein and in accordance with any embodied change to the first dispensing program contemplated herein.

[0180] According to these aspects and representing certain embodiments, the devices, system and methods of the invention contemplate a situation where the subject has a condition, whereby a treatment regimen providing for increasing the dosage of the treatment over time is desired and in some embodiments, the subject response data, sensor collected data, or testing result data or any combination thereof collected from said subject may have been subject to the device / system programming such that same will promote altering the first secure distribution program, such that the second distribution program may commence or may be itself further altered if the collected subject response data, sensor collected data, or testing result data or any combination thereof differs from established values for the collected subject response data, sensor collected data, or testing result data or any combination thereof, so that some change inthe distribution program is now desired. According to this aspect and in some embodiments, such change may a priori be included in the programming, as a function of the straightforward nature of the collected subject response data, sensor collected data, or testing result data or any combination thereof, and in some embodiments, such change may be following a recommendation being sent via the communications infrastructure in the method / system and device use enabling same, to a care giver for the subject advising of a recommended review of the first dispensing program to consider altering same to a second dispensing program that, if authorized by the care giver is then programmed into the device / system so that the dispensing program is changed.

[0181] It will be appreciated that indeed, the subject following commencing the first treatment regimen, in turn yields subject response data, sensor collected data, or testing result data or any combination thereof collected from the subject whereby same indicates no need to alter the first secure distribution program, in that the collected subject response data, sensor collected data, or testing result data or any combination thereof conforms to that of established values for the collected subject response data, sensor collected data, or testing result data or any combination thereof, so that no change in the distribution program is desired and such option is also, in some embodiments, part of the existing device / system programming, including, in some aspects, the ability to result in a recommendation being sent via the communications infrastructure in the method / system and device use enabling same, to a care giver for the subject advising of the collected subject response data, sensor collected data, or testing result data or any combination thereof conformity with the established values for same so that there is no recommendation to consider altering the first dispensing program.

[0182] It will be appreciated that where the device / system / methods result in a desired alteration of the first distribution regimen to a second distribution regimen that the programming included in the devices / systems / methods of this invention can promote increase of a solid oral form dosage rapidly if the subject does not display significant negative symptomatology as the dosage is increased, as determined by the subject response data, sensor collected data, or testing result data or any combination thereof as collected from the subject.

[0183] In some embodiments of the invention the devices / systems / methods of this invention can promote the second dispensing program to increase the solid oral form dosage rapidly if the subject does not display significant negative symptomatology as the dosage is increased, as determined by data input by a medical caregiver of the subject, or as the data is made available through any of the means described herein.

[0184] In some embodiments of the invention the devices / systems / methods of this invention can promote the second dispensing program to increase the solid oral form dosage rapidly if the subject displays therapeutic effects as a result of increasing the dosage, as determined by data input by a medical caregiver of the subject, or as the data is made available through any of the means described herein.

[0185] In some embodiments of the invention the devices / systems / methods of this invention can promote the second dispensing program increasing the dosage or the frequency of distribution of the oral dosage form, or a combination thereof.

[0186] In some embodiments of the invention the devices / systems / methods of this invention, according to these aspects, and others as described herein, the subject has cancer and the first oral dosage form or second oral dosage form or any combination thereof may comprise a chemotherapy agent, or a cancer therapeutic.

[0187] In still other aspects of the devices / systems / methods of this invention, the device comprises at least a third solid oral dosage form, which treats or alleviates a side effect in a subject dispensed the first oral dosage from the first dispensing regimen or the second or any subsequent oral dosage from a second or subsequent dispensing regimen or any combination thereof, whereby the programming controls adjusting, altering or overwriting the first distribution program via a secure protocol to a second or subsequent distribution program, as a function of the collected subject response data, sensor collected data, or testing result data or any combination thereof to further provide the third solid oral dosage form to said subject, as well.

[0188] According to this aspect, and representing some non-limiting embodied aspects, the third oral dosage form comprises an analgesic, an antiemetic, an anti -diarrheal, a steroid, an immunosuppressant, a growth factor, a vaccine, an antibiotic, an antimycotic, or any combination thereof.

[0189] It will be appreciated that the third oral dosage form, as described herein, representing a dosage form , which treats or alleviates a side effect in a subject dispensed the first oral dosage from the first dispensing regimen or the second or any subsequent oral dosage from a second or subsequent dispensing regimen or any combination thereof, is envisioned for use in accordance with the devices / systems / methods of this invention and should not be limited in any way to the examples provided herein, but can reflect a choice of any appropriate agent to improve, treat, alleviate, abrogate or otherwise positively impact a side-effect or negative consequence of the patient having taken a different oral dosage form as part of the dispensing program provided by the devices / systems / methods of this invention.

[0190] In some embodiments of the invention the devices / systems / methods of this invention can promote the second dispensing program to decrease the dosage of the treatment over time.

[0191] In some embodiments of the invention the devices / systems / methods of this invention can promote the programming to refer to subject response data, sensor collected data, or testing result data or any combination thereof collected from the subject and promoting altering the first secure distribution program, such that said second distribution program may commence or may be itself further altered if said collected subject response data, sensor collected data, or testing result data or any combination thereof differs from established values for said collected subject response data, sensor collected data, or testing result data or any combination thereof.

[0192] In some embodiments of the invention the devices / systems / methods of this invention, the programming can promote a dispensing program to decrease a solid oral form dosage rapidly if the subject displays significant negative symptomatology following the first dispensing program, as determined by said sensor collected data, subject response data, or testing result data or a combination thereof as collected from said subject.

[0193] In some embodiments of the invention the devices / systems / methods of this invention can promote the programming to ensure second dispensing program decreases the dosage or the frequency of distribution of the oral dosage form, or a combination thereof.

[0194] According to this aspect and in some embodiments, the subject has cancer and the first oral dosage form or second oral dosage form or any combination thereof is a chemotherapy agent. In some embodiments, the subject response data comprises responses input by the subject to questions posed in a questionnaire and in some embodiments, the responses relate to symptomatology, pain existence, pain severity, or any combination thereof. According to this aspect and in some embodiments, the symptomatology comprises gastrointestinal symptoms, fatigue, respiratory function. In some embodiments, the sensor collected data comprises vital signs, body temperature, oxygenation, circulating glucose levels or any combination thereof. In some embodiments, the testing result data may comprise blood test results, imaging results, or a combination thereof. In some embodiments, the sensor data may be collected from sensors located externally to the device, but in communication with the device, the authorized medical personnel or a combination thereof.

[0195] In some embodiments the reference to being “individually addressable” refers to an ability to incorporate programming that alters a distribution pattern or order for the device to accommodate, e.g. skipping a compartment, or going in an opposing direction toalign the desired compartment so that dispensing of the solid dosage forms located therein can be specifically addressed, or releasing more than a single dosage form from a given compartment, such that the chambers and, in some embodiments, individual dosage forms located in each compartment are individually addressable in that same are individually accessible and performance of the dispensing of the content of an individual chamber or an individual dosage form in a chamber is attainable uniquely in this invention.

[0196] In some embodiments, the hand-held oral solid dosage form secure distribution device, has a plurality of individually addressable compartments comprising a plurality of oral dosage forms contained therein.

[0197] In some embodiments, the plurality of oral dosage forms may include one or more pills in each compartment, wherein a first oral dosage form of said plurality contained therein differs from that of another oral dosage form of said plurality, in terms of an active ingredient type, dosage, or composition component of said oral dosage form, or a combination thereof.

[0198] According to this aspect and in some embodiments, the plurality of oral dosage forms may include one or more oral dosage forms in each compartment, wherein the oral dosage forms are combined for a desired purpose. For example, and representing one embodiment, the plurality of oral dosage forms in a single compartment are of the identical composition and identical dosage, and in some embodiments, same provides for an increased dosage to the subject, by providing more than one oral dosage form in a “next compartment” so that when accessed the dosage is increased. Of course, in some embodiments, this same goal is accomplished by containing increasing dosages in different chambers in the device. In another embodiment, the plurality of oral dosage forms in a single compartment are of the identical composition and differing dosage, and each dosage form located within the compartment, in some embodiments, can be individually dispensed, so as to provide for an increased dosage to the subject. In another embodiment, the plurality of oral dosage forms in a single compartment are of different compositions, for example, to provide for a combination therapy to the subject.

[0199] It will be appreciated that any combination of oral dosage forms may be provided in the compartments of the hand-held oral solid dosage form secure distribution devices of this invention, as appropriate, and the invention is not to be limited in any way in terms of the types of oral dosage forms that may be dispensed thereby.

[0200] It will be further appreciated that as used herein the term “oral dosage forms” may be interchangeably referred to with known oral dosage forms such as the terms “pills”,“capsules”, “tablets” and the like and any reference to any of these terms herein is to be understood to encompass any and all oral dosage forms, in any embodiment of same.

[0201] In some embodiments, the hand-held oral solid dosage form secure distribution device, has a plurality of individually addressable compartments comprising a single oral dosage form contained in each compartment.

[0202] The drugs may be referred to as an oral dosage form and may be a unit dose and / or a solid oral dosage form. It is envisaged that the oral dosage form could in some cases comprise a hard, solid (or semi-solid, e.g., gelatin or cellulose) outer shell and a softer core, such as a gel or even a liquid core.

[0203] In some aspects, this invention provides a handheld device for dispensing one or solid oral dosage forms contained in a blister pack. Such a device may be an advancement on the types of apparatus used for dispensing oral solid dosage forms, especially when combined with the features that allow the apparatus to safely and securely dispense such blister-pack encased solid oral dosage forms.

[0204] Further according to this aspect, and in some embodiments, the hand-held oral solid dosage form secure distribution device contains a tamper proof casing within which the solid dosage form holder is contained. According to this aspect, and in some embodiments, the solid dosage form holder may be a rotatable or advanceable carousel structure containing multiple compartments, each compartment containing one or more oral dosage forms for dispensing for a single dosage regimen. According to this aspect, and in another embodiment, the solid dosage form holder may accommodate blister pack encased solid dosage forms and be further equipped with a blister-pack releasing element to specifically and addressably release the oral dosage forms for dispensing for a single dosage regimen located in a given blister pack, contained in the holder compartment, for programmed release.

[0205] In some embodiments, the device provides for dispensing the oral dosage form(s) contained therein only following the completion of a secure authentication protocol.

[0206] Secure authentication protocols are well known in the art, and for example, may comprise password protection along with two-step verification procedures commonly in use. Such authentication protocols may specifically be in use for patient engagement with the device, as well as for access of any health care provider to in any way access the device or the device programming, or the stored data relating to the device and / or its operation and / or entering data that will be accessed by the device and / or programming.

[0207] It will be appreciated that any secure identification / authentication means, including scanners such as fingerprint, retinal, facial recognition based, or any other protocol, alone or incombination with any known secure verification protocol is to be considered an embodied, contemplated aspect of the invention for inclusion with the operation of the device and / or its programming / methods of use.

[0208] In some embodiments, the device is subject to programming, which controls distribution of the oral dosage forms contained within the device, wherein the device when activated, may for example, be programmed to dispense the solid oral dosage forms contained therein according to a first distribution program and in some embodiments, the programming may be adjusted, altered or overwritten to alter the first distributing program via a secure protocol to a second distribution program. In other embodiments, the programming may be adjusted, altered or overwritten to further prevent distributing any of the oral dosage forms contained in said device. In still other embodiments, there may be a safety override on the device itself to alter or halt drug dispensing, for example, if a security authentication protocol fails, or for example, the patient exhibits symptoms and a medical provider sees need / sees fit to activate the failsafe / override.

[0209] In other embodiments, the hand-held oral solid dosage form secure distribution device securely contains and dispenses the solid oral dosage forms directly into the mouth of the user, wherein the oral solid dosage forms are stored in an individually addressable chamber operationally connected to an outlet sized to be comfortably inserted between the lips of a user, the outlet being further provided with a displaceable sealing closure having a normally closed position, wherein displacement of the closure from the closed position to an open position, to enable the dispensing of at least one oral dosage form from within the chamber, is actuated only by the oral cavity, in particular the mouth of the user interacting with the outlet; which actuation is subject to secure controls following an authentication protocol of the device.

[0210] According to this aspect and in some embodiments, the hand-held oral solid dosage form secure distribution device securely contains and dispenses the solid oral dosage forms in specialized chambers, which chambers comprise access portals sized to accommodate pass- through of the oral solid dosage forms contained therein; whereby upon regulated and authenticated alignment of the chamber access portal with an appropriate egress / dispensing structure, upon further displacement of the device sealing closure, the solid oral dosage form is dispensed directly into the mouth of the user.|U021 1 ] In still further aspects of the invention the hand-held oral solid dosage form secure distribution device is subject to image recognition-driven dispensing, which image recognition

[0212] According to this aspect and in some embodiments, the hand-held oral solid dosage form secure distribution device securely contains and dispenses the solid oral dosage forms directly into the mouth of the user, wherein the oral solid dosage forms are stored in an individually addressable chamber operationally connected to an outlet sized to be comfortably inserted between the lips of a user, the outlet being further provided with a displaceable sealing closure having a normally closed position, wherein displacement of the closure from the closed position to an open position, to enable the dispensing of at least one oral dosage form from within the chamber, is actuated only by the oral cavity, in particular the mouth of the user interacting with the outlet; which actuation is subject to secure controls following an authentication protocol of the device.

[0213] According to this aspect and in some embodiments, the hand-held oral solid dosage form secure distribution device securely contains and dispenses the solid oral dosage forms in specialized chambers, which chambers comprise access portals sized to accommodate pass- through of the oral solid dosage forms contained therein; whereby upon regulated and authenticated alignment of the chamber access portal with an appropriate egress / dispensing structure, upon further displacement of the device sealing closure, the solid oral dosage form is dispensed directly into the mouth of the user.[00214 [ In still further aspects of the invention the hand-held oral solid dosage form secure distribution device is subject to image recognition-driven dispensing, which image recognition

[0215] The apparatus and / or device may be a handheld and / or portable apparatus and / or device. In other words, the device may be held and transported using one hand and / or operable using one hand.

[0216] This invention provides, in some embodiments, a system for secure administration of oral solid dosage forms to a subject, said system comprising:• a secured oral solid dosage form delivery device dispensing a solid oral dosage form to a subject, said device comprising: o a first non -transitory computer-readable storage medium having computer executable instructions stored thereon, which when executed by a processor, causes the processor to perform the oral solid dosage form distribution to a subject, which medium is enabled for remote secure communication in real time and which computer executable instructions facilitate distribution of said oral dosage form according to an at least a first distribution program, a second distribution program or a combination thereof; o a subj ect user interface; o optionally at least one sensor; o a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality differs from that of at least a second oral dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form, or any combination thereof; and■ wherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following at least an authentication protocol; and■ wherein operation of dispensing in said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program; and o a second secure non-transitory computer-readable storage medium, which medium is enabled for remote secure communication in real-time and which medium has computer executable instructions stored thereon, which when executed by a processor, promotes collection, input or a combination thereof of subject response data, sensor collected data, or testing result data or any combination thereof to determine whether a first distribution protocol promotes a desired clinical endpoint being reached,■ wherein the desired clinical endpoint comprises a therapeutic effect, a lack of adverse event of pre-determined scale, or a combination thereof,■ which reaching of the desired clinical endpoint reflects collected subject response data, sensor collected data, or testing result data or any combination thereof meeting established values;■ wherein reaching said desired clinical endpoint results in maintenance of said first distribution program; and■ wherein lack of a therapeutic effect, presence of an adverse event of predetermined scale, or a combination thereof results in performing a second distribution program.

[0217] In some embodiments, the devices of the invention, in particular the hand-held device as herein described or the bulk distribution device as herein described, if fully independently functional and may proceed with a programmed administration protocol even in the absence of communications functionality for the device with any remote communication site.

[0218] According to this aspect, and in some embodiments, the device programming may require communication with remotely located non-transitory computer-readable storage media, which in turn may provide instructions regarding the dispensing program as described herein and / or influence or affect the choice to change a distribution program or not to alter an existing distribution program.

[0219] It will be appreciated that the device may comprise, fully contained therein, a set of executable instructions that alter the distribution program if certain circumstances are met, including instructions to prevent further oral dosage form distribution.

[0220] In still other aspects, the remotely stored instructions may comprise a cloud or cloud farm, and both the device and cloud may further comprise a shadow, for rapid transfer of information between the device and cloud. In some aspects, communication with the device is initiated by commands from the device, for example, at certain time intervals, or following certain pre-programmed prompts in the device programming, to specifically enable remote communication and access.

[0221] In still other embodiments, the “shadow” will fulfill a storage function for instructions and data collected, and shadow transfers between device and cloud can be via known means, as will be appreciated by the skilled artisan.

[0222] In some embodiments, the first non-transitory computer-readable storage medium has computer executable instructions stored thereon, which when executed by a processor, causes the processor to perform a personal authentication protocol comprising authenticationof a user through at least partial facial recognition, electronic key or tag authentication; or a combination thereof.

[0223] According to this aspect and in some embodiments, any embodiment as herein described regarding the devices of this invention are equally applicable to the systems of this invention, as will be clear to the skilled artisan. For example, and in a non-limiting embodiment of the systems of the invention, the plurality of oral dosage forms which differ in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form are sorted into separate individually addressable compartments in the device. In some embodiments, the device dispenses a single oral dosage form at a time or in some embodiments, the device dispenses a defined plurality of said dosage forms, controlled by said programming and in some embodiments, the programming promotes increasing the number of oral dosage forms dispensed to a subject as expanded upon hereinabove, and in some embodiments, the programming promotes decreasing the number of oral dosage forms dispensed to a subject, as expanded upon hereinabove. In some embodiments, the oral solid dosage form secure distribution device is a hand-held device, having a plurality of individually contained, individually addressable oral dosage forms contained therein, which in some embodiments, contains a tamper proof casing within which the solid dosage form holder is contained and any and all embodied aspects of the tamper-proof container is envisioned for use with the devices or systems or in the methods of this invention and represent contemplated embodiments of the invention.

[0224] In other embodiments of the systems of this invention and methods making use of same, for any authenticated user, a dispensing program for dispensing the oral dosage forms contained in the device has been established. In some embodiments, authorized medical personnel may securely access the first or second non-transitory computer-readable storage mediums or a combination thereof in order to introduce or modify the second (or subsequent) dispensing program (s), which is distinguished from the first dispensing program, so that the oral dosage forms dispensed to the subject differ from that which would have been dispensed to the subject, by means of the first dispensing program.

[0225] According to some aspects, the systems and methods making use of same of this invention provide for the solid dosage form holder to accommodate blister pack encased solid dosage forms and be further equipped with a blister-pack releasing element to specifically and addressably release the oral dosage forms for dispensing for a single dosage regimen located in a given blister pack, contained in the holder compartment, for programmed release.

[0226] In other embodiments, the systems and / or methods making use of same will provide for the oral solid dosage form secure distribution device being a bulk device, having a plurality of individually contained, individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of a subsequent oral dosage form of said plurality, in terms of an active ingredient type, dosage, or composition component of said oral dosage form, or a combination thereof, and any embodiment described herein regarding bulk devices is equally applicable for use in the systems of this invention and / or methods of use of same and is to be considered an embodied aspect of the invention.

[0227] In other embodied aspects of the systems of this invention, the user interface provides for input of information directly from said user, or in some embodiments, the user interface provides for input of information from an authorized caregiver through a secure protocol. In some embodiments, the user interface includes input of medical information by both the user and said authorized caregiver through a secure protocol.

[0228] In other embodied aspects of the systems of this invention, the sensors collect information from the subject during use of the device, and depending on the sensor data obtained, the programming provides for adjusting, altering or overwriting the programming to alter the first distribution program. In other embodied aspects of the systems of this invention, the programming further provides for adjusting, altering or overwriting the programming to alter the first distribution program as a function of results obtained from the subject response data, or testing result data or a combination thereof.

[0229] In other embodied aspects of the systems of this invention, the programming provides for adjusting, altering or overwriting said programming to alter said first distribution program as a function of results obtained from said subject response data, or testing result data or a combination thereof.[002301 In other embodied aspects of the systems of this invention, the oral solid dosage form secure distribution device is subject to image recognition-driven dispensing, based on a

[0231] In other embodied aspects of the systems of this invention, the device comprises at least a third solid oral dosage form, which treats or alleviates a side effect in a subject dispensed the first oral dosage or the at least a second oral dosage form or any combination thereof.

[0232] In other embodied aspects of the systems of this invention, the system is used as part of a method for secure authenticated provision of oral solid dosage forms, administered as a dosage regimen which may be altered over time, the method comprising the steps of:• providing the device for personal secure administration of oral solid dosage forms to the subject;• completing an authentication protocol for dispensing said oral dosage form to said subject and dispensing said first oral dosage form within an oral cavity of said subject;• wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and• whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral dosage form distribution program in said device; and• dispensing said oral dosage forms of said second oral dosage form distribution program to said subject; whereby an oral dosage form regimen is adjusted, altered or overwritten in said device resulting in altering dispensing of said oral dosage form, by means of a secure authenticated protocol.

[0233] In other embodied aspects of the systems of this invention, the subject has a condition, whereby a treatment regimen provides for increasing the dosage of the treatment over time.

[0234] In other embodied aspects of the systems of this invention, the subject has a condition, whereby a treatment regimen provides for decreasing the dosage of the treatment over time.

[0235] In other embodied aspects of the systems of this invention, the system is used as part of a method for secure authenticated provision of an oral cancer therapeutic, the method comprising the steps of:• providing the device for personal secure administration of oral cancer therapeutics to the subject;• completing an authentication protocol for dispensing said cancer therapeutic to said subject and dispensing a first cancer therapeutic within an oral cavity of said subject;• wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and• whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second cancer therapeutic distribution program in said device; and• dispensing said oral cancer therapeutic of said second oral cancer therapeutic distribution program to said subject;• whereby an oral cancer therapeutic regimen is adjusted, altered or overwritten in said device resulting in altering dispensing of said oral dosage form, by means of a secure authenticated protocol.

[0236] In other embodied aspects of the systems of this invention, the subject has a condition, whereby a treatment regimen provides for increasing the dosage of the treatment over time.

[0237] In other embodied aspects of the systems of this invention, the subject has a condition, whereby a treatment regimen provides for decreasing the dosage of the treatment over time.

[0238] In other embodied aspects of the systems of this invention, the system is used as part of a method for optimization of secure authenticated provision of oral solid dosage forms to a subject in need thereof, the method comprising the steps of:• providing the device for personal secure administration of oral cancer therapeutics to the subject;• completing an authentication protocol for dispensing said oral solid dosage forms to said subject and dispensing said first oral solid dosage form to said subject; o wherein subject compliance with said first secure distribution program is collected and incorporated in said programming;o wherein subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof is collected and incorporated in said programming; and o whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral solid dosage form distribution program in said device; and• dispensing said oral solid dosage form of said second oral solid dosage form distribution program to said subject;• whereby an oral solid dosage form regimen is adjusted, altered or overwritten in said device as a consequence of said collected subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof, resulting in optimized dispensing of said oral solid dosage forms, by means of a secure authenticated protocol.

[0239] In some aspects, the devices / systems / methods of the present invention utilize a smartphone and in further embodiments, may utilize an associated application (“app”) for the processing and interface components, such app will preferably be available for use with any type of capable phone and operating system (e.g., Apple or Android operating systems). The app preferably includes a simple user-interface and several key features (e.g., monitoring via sensors, GPS, data transfer). The software may, in some embodiments, take advantage of the smartphone's internal Bluetooth to collect kinematic data from the motion sensors, other sensors related to physiological characteristics affected by a disease or disorder in a subject, GPS, and mobile broadband / Wi-Fi. In some embodiments, the data is encrypted. In some embodiments, the software and app versions adhere to recently published FDA guidance on mobile medical applications.

[0240] In some embodiments, the software app takes advantage of the smartphone's internal GPS to track how often and where the patient travels throughout the day, wherein, in some aspects, the more active a patient is, serving as a sign of, in some aspects, less suffering from a given disease or disorder, when such disease or disorder more typically impacts patient mobility.

[0241] Monitoring the GPS signals of the system, whether in a subject's smartphone or in a separate monitoring and / or diagnostic device, can allow for identification of wandering movements that indicate, for example, confusion or disorientation, or sedentary or low-activity lifestyles that may indicate difficulty in moving or performing activities of daily living. The app tabulates how often the patient is at home, traveling, and at various locations. In addition to location, the app stores kinematic data from the motion sensors and other sensors related to physiological characteristics affected by the disease or disorder, or pain, which will be analyzed to extract features related to physical activity. The activity monitoring feature may be designed to continuously run in the background unless disabled by the patient. The frequency of GPS tracking and communication with motion sensors and the other sensors related to physiological characteristics affected by the disease or disorder, or pain, (e.g., once every two minutes) are optimized, in some embodiments, to ensure that the smartphone battery lasts for at least 18 hours.

[0242] In some aspects, the collected subject data comprises subject response data input by the subject to questions posed in a questionnaire. According to this aspect and in some embodiments, the questionnaire may elicit patient responses to their experiences regarding taking the oral solid dosage regimen at the first versus the second, or second versus the first distribution program. In some embodiments, the questionnaire may elicit patient responses to sleep habits, travel / activities, and self-rated disability / activity limitations (e.g., symptom occurrence, subjective reports on subject status).

[0243] In some embodiments, the questionnaire may elicit patient responses to any impact of the taking of the prescribed medication on patient functioning relating to the type of day (e.g., work, school, day off), Periods of sleep and waking, including periods of being awake at night, consumption of coffee or alcohol, and other similar or related activity or status inputs. In some embodiments, the questionnaire may elicit patient responses to an Epworth Sleepiness Scale (ESS) or utilize other assessment methods or devices once per day to rate sleepiness.

[0244] In some embodiments, the questionnaire may elicit patient responses to self-rated pain, for example, as entered using an 11 -point numerical pain rating scale (NPRS), similar to the current gold standard for clinical trials and pain management, which includes asking subjects to record ratings several times per day to monitor treatment efficacy.

[0245] In some embodiments, the questionnaire may elicit patient responses to non- clinically-known numerical scales that are based on independently researched and developed algorithms. Disability and activity limitations may be logged via subject questionnaires to be completed in the smartphone app once per day. These subject-centered manual entries ofsymptom intensity, disability, and community mobility are used to assess the accuracy of the automatic tracking that the app performs in the background using GPS motion sensors, and other sensors related to physiological characteristics affected by the disease or disorder, or pain.

[0246] In some embodiments, the questionnaire may elicit patient responses to a secondary outcome measure, for example, involving speech analysis integrated into the methods, systems or devices and associated software.

[0247] In some embodiments, in order to minimize the data stored on subjects' phones or other processing or data acquisition device, data may be encrypted and uploaded to a secure cloud server for storage and processing. According to this aspect, and in some embodiments, the system may store data on an external server that provides the physical safeguards required for HIPAA compliance.

[0248] In some embodiments, the devices / systems / methods / uses of the invention may be used by a physician, technician or clinician for treatment and further diagnosis of a subject's diseases, disorder, or injuries; for clinical research regarding the diseases, disorders, injuries, or treatments for such; or for delivery of treatment for such disorders, diseases, or injuries in clinical settings or for subjects outside the clinical setting such as at home or away from home while performing activities of daily living. Other elements of this system may include, but are not limited to, receivers, routers, communication devices, processors, displays, electrical stimulators, databases, algorithms, and the like, some of which are described further in various embodiments described in more detail below.

[0249] In some embodiments, the devices / systems / methods / uses of the invention perform measurement, analysis and quantification steps including measuring the particular metric(s) related to pain and dynamically altering an oral dosage regimen tailored to the subject's disease, disorder, injury, pain, or symptomatology in rapid turn-around time, which in some embodiments, is in real-time.

[0250] In some embodiments, the devices / systems / methods / uses of the invention perform measurement, analysis and quantification steps including measuring the particular metric(s) related to pain and dynamically altering or adjusting an oral dosage regimen in less than 2 minutes, or in some embodiments, in less than 1 minute, or in some embodiments, in less than 30 seconds, or in some embodiments in less than 1 second. In some embodiments, the devices / systems / methods / uses of the invention perform measurement, analysis and quantification steps including measuring the particular metric(s) related to pain and dynamically altering an oral dosage regimen in less than 500 milliseconds, or in someembodiments, in less than 100 milliseconds, or in some embodiments in less than 50 milliseconds, or in some embodiments, in less than 1 millisecond, or in some embodiments, essentially simultaneously.

[0251] In some embodiments, the devices / systems / methods / uses of the invention provide for significant improvements over devices / systems / methods / uses known to those of skill in the art based on the enhanced and improved hardware and software of the present invention.

[0252] According to this aspect and in some embodiments, the devices / systems / methods / uses of the invention are uniquely suited to highly personalized adjustment of an oral dosage regimen from a first dosage regimen to a second (and third, fourth, etc.), that incorporates collected subject response data, sensor collected data, or testing result data or any combination thereof and considers same as part of the programming of the devices / systems / methods / uses of the invention to dynamically adjust, in real time, the dosage regimen being administered to the patient. In some embodiments, uniquely this provides the real-time advantage of remotely addressing patient responsiveness to therapy in a highly controlled, personalized protocol, and in some embodiments, providing the added value of addressing any side effects or symptomatology that would, for example, warrant administering a different agent along with a prior administered dosage regimen, or in some embodiments, warranting administering a different agent along with the administered dosage regimen adjusted to increase the dosage, if therapeutic indices are evident, or in some aspects, administering a different agent along with the administered dosage regimen adjusted to decrease the dosage, if patient responsiveness, symptoms or side effects are not in accordance with accepted norms.

[0253] In some embodiments, the devices / systems / methods / uses of the invention provide for greater sensitivity and accuracy in treatment regimens provided to a subject, allowing for personal titration of medication, combinations of medication, which is far more responsive in terms of rapidity and efficiency and accuracy, than current devices / sy stems known in the art, further decreasing the time required to analyze the measured data, quantify the subject's disorders and / or symptoms, and administer or adjust treatment or therapy for such disorders and / or symptoms.

[0254] In some embodiments, the devices / systems / methods / uses of the invention provide for temporary storage of the collected subject response data, sensor collected data, or testing result data or any combination thereof in onboard memory, and in some embodiments such data may be transmitted to an external device and in some embodiments, some data may be stored in onboard memory concurrent with some data being transmitted to an external device.

[0255] According to further aspects and in some embodiments, the data may be exported to a centralized database, to multiple databases at the same or multiple locations, or to a cloudbased database where the data can be stored and accessed essentially immediately by authorized users who can in some embodiments, analyze and / or further process the data, use it to diagnose or assess the subject's symptoms or disorders, and establish or contribute to established guidelines for adjusting, altering or overwriting the first oral dosage form distribution program to a second distribution program. According to this aspect and in some embodiments, the data may be accessed by authorized personal on any connected computer or processor device, which in some embodiments, is understood to be any type of device known to those skilled in the art usable for the intended purpose(s) or function(s), including, but not limited to, desktop computers, laptop computers, tablet computers, personal digital assistants (PDAs, “smart” cellular telephones, and the like).

[0256] The computer or processor device may be provided as part of the present invention's device or system. In some embodiments, such devices / systems / methods / uses may make use of specialized software providing the user interface, symptom severity scale determination capabilities, diagnostic and analysis tools, and the like, which in some embodiments, may be provided as software or an application (or “app”), or the interaction with the user(s) can be web based through a web portal.

[0257] In some embodiments, the devices / systems / methods / uses may make use of a central database system, which in some embodiments, may consist of one or many databases specialized to certain forms of patient and / or test result data, such as patient demographics, treatment history, disorder details, test result data, imaging (ultrasound scans, pet scans, MRI scans, CT scans, etc.), current treatment protocols, symptom severity scores, and the like. Symptom severity scores may be a rescaling of a measured quantity. Alternatively, symptom severity scores may be representative of a score that a skilled clinician might give to the subject during a diagnostic exam in the clinician's office using a standardized scale. The central database or databases, in some embodiments, may be located locally or remotely with respect to a single patient or clinician. In other embodiments, the database may be part of another computer system, which in some embodiments, may be run by a dedicated processor or group of processors. In other embodiments, all databases are located remotely, which in some embodiments, maximizes access by clinicians and patients, increasing an algorithm's ability to correlate data and determine a most customized treatment. In other embodiments, all databases are adaptive to new patient information, and grow in size as their use increases, thereby increasing the effectiveness of correlation algorithms as they have more information tocompare and contrast with. The database system, in some embodiments, may be of any framework readily known to those skilled in the art, such as SQL, XML, or the like, so as to allow for relational queries between the databases and correlations with outside data.

[0258] In some embodiments, the system includes a GUI allowing a user to interact with the measurement / quantification and / or treatment devices. In some embodiments, the GUI is adapted to display information to the user as well as for the user to input information to the system, and in some embodiments to communicate with a remote system and / or clinician, physician, or technician.

[0259] In some embodiments, the GUI may be used to display raw measured data from the sensors of the system (e.g., electrophysiological or physiological signals, raw or preprocessed signals from sensors). In some embodiments, the GUI is adapted to at least display any calculated indices, such as symptom severity indices or scores for the subject or integrated score derived based on other collected data, for example, for a medical care giver to readily see and be able to ascertain the objective quantified severity of their disorder(s) and / or symptom(s).

[0260] In some embodiments, the score or index may be represented purely as a numerical value, and in some embodiments, the numerical value may be further indicative of the relative severity based on predetermined or adaptive thresholds. For example, if the severity is within normal ranges that are not particularly strong or troublesome to the subject, the index or score may be depicted as the numerical value in green or white, but if the index or score is indicative of a high, painful, or particularly strong level of severity, then the index or score may be presented in red, as a flashing numerical value, or other such indication that the value is above the preferred threshold.

[0261] According to this aspect, and in some embodiments, this representation of the index will reflect and / or be incorporated in the programming controls adjusting, altering or overwriting the first distribution program to the second distribution program.

[0262] In some embodiments, the different disorders and / or symptoms may use different thresholds, and the thresholds may be adaptive in that the threshold value may be changed to better suit the subject's particular activity, surroundings, environment, or condition.

[0263] For example, if the subject is going to sleep, he or she may input to the system that he or she is doing so, and the threshold might be lowered so that if the disorder and / or severity index approaches the lower threshold the system can notify the subject to take medication so that the symptoms do not become too severe and thus interrupt or otherwise perturb the subject's sleep. However, if the subject is relaxing at home or out performing activities of dailyliving (e.g., eating, shopping, exercising, and the like), and he or she is able to tolerate a higher level or severity of disorder and / or symptoms, then the threshold may be raised in order to only provide instructions for therapy if the disorder and / or symptoms approach or exceed the higher threshold.

[0264] In other embodiments, the threshold levels may be set by the subject, or in some embodiments, by a physician, clinician, or health care provider, or the system may automatically determine the qualitative threshold values using an Al algorithm and calculating the optimal threshold value based on a database of historical data comprising such threshold values for other subjects and / or the instant subject's past thresholds.

[0265] In other embodiments, the GUI may further be adapted to output additional signals, such as an audible alarm or notification or visual message or indicator (e.g., flashing screen or icon, color changes) in order to obtain the subject's attention when the index or score changes in a manner requiring attention by the subject and / or the care giver or provider.

[0266] In some embodiments, the GUI is part of the device / system software, including in an app, which in some embodiments, incorporates the subject input.

[0267] In some embodiments, the GUI inputs measured status values (e.g., blood pressure, temperature, other physiological measurements taken by sensors from those associated with the devices and systems or measured by a clinician, physician, or technician), and the like. When such data is input, the devices / systems and through the methods of the present invention such data is incorporated in calculations used therein.

[0268] In some embodiments, the subject response data, sensor collected data, or testing result data or any combinations thereof is further related to the oral dosage form distribution programming, in order to provide a recommended treatment or therapy to the subject, by means of the dispensing of the oral dosage regimen, or, in some aspects, adjusting, altering or overwriting a first distribution program (in some aspects, via a secure protocol) to a second distribution program.

[0269] In some embodiments, the adjusting, altering or overwriting of a first distribution program is output via the GUI to the subject, thereby instructing the subject on any changes implemented in terms of the oral dosage form distribution program, for example, and representing some embodiments, in terms of the dosage form dispensed, dosage being administered, changes in timing of oral dosage form dispensing, or any combination thereof, or any related parameter for same.

[0270] In some embodiments, the devices / systems / methods / uses of the invention promote a unique ability to self-administer medication or drug treatment or therapy, that can bemonitored and / or altered or changed or overwritten in real time, which in some embodiments, uniquely takes into account the subject’s pathogenesis, for example, by determining if there is a change in the level or severity of the subject's disorder and / or symptoms, which in some aspects, can then be incorporated, in real-time, into a rapid address of this change, including altering the subject’s initial drug distribution regimen to a new regimen.

[0271] In some embodiments, according to this aspect, uniquely, the devices / systems / methods / uses of the invention ability to influence the drug distribution program in real time may be preventative in order to maintain a level or severity of the disorder or symptoms before a prior dose of medication or other treatment begins to wear off, or otherwise as the worsening disorder or symptom severity approaches or crosses the threshold, or, in other circumstances, where patient response is optimal and continued administration of one or more drugs in a regimen may best be discontinued.

[0272] In some embodiments, according to this aspect, uniquely, the devices / systems / methods / uses of the invention ability to influence the drug distribution program in real time, such that the subject takes the medication only when the disorder and / or symptom severity crosses the threshold and the worsening disorder and / or symptoms start to become disruptive to the subject.

[0273] In some embodiments, the devices / systems / methods / uses of the invention provide for monitoring the dispensing of the administered oral dosage form, and in some embodiments, monitors emptying of the containment chamber of the oral dosage form to be dispensed, or in some embodiments, monitors depositing the dosage form in an oral cavity of a subject, or a combination thereof.

[0274] In some embodiments, according to this aspect, the monitoring of the dispensing and uptake of the dispensed dosage form is further recorded, and in some aspects, serves as additional collected data that in some aspects is further incorporated in the device / system / methods programming, providing important information about the behavioral and compliance related activity of a subject.

[0275] In some embodiments, according to this aspect, the monitoring of the dispensing and uptake of the dispensed dosage form is further incorporated within a report function provided e.g. via the device(s) / system / methods of the invention to monitor the use of the subject's medication, which in other embodiments, provides a level of oversight of the drug or medication use.

[0276] In some embodiments of the device / system / methods of the invention, there is an ability to provide a real-time prompt for medication refills when needed or expected, which, insome embodiments, may enable transmission of refill requests, such as providing same to an authorized clinician, physician, or health care provider for review and notification purposes so that the clinician, physician, or health care provider can address same.

[0277] In some embodiments, the database or database system of the present invention should comply with the Health Insurance Portability and Accountability Act (HIPAA) of 1996, an in some embodiments, in particular, Title II of the act, which covers the privacy of protected patient and subject health care information. Protected information may be any part of the subject's medical record or payment history which may be linked to the individual. Such information related to this invention may include patient demographics, health history, recorded sensor data, past and current treatment protocols, clinician notes, patient questionnaire responses, patient imaging results, patient blood test results, patient histopathology results, and the like.

[0278] In some embodiments, compliance with the Security Rule of Title II for electronic protected health information, administrative, physical, and technical safeguards promotes protecting sensitive health information. In some embodiments, the systems / devices / methods / uses of the invention ensure administrative safeguards, for example, providing privacy procedures and oversight, describing access permissions in place for protected information. In some embodiments, safeguards govern hardware of the database system, access to the equipment and software of the system, and policies regarding same. In still other embodiments, technical safeguards such as encryption techniques for the transfer of data, authentication techniques, records of all network settings, and risk management programs may be used. In other embodiments, encrypted passwords may be used for accessing any of the devices / systems / databases as herein described, cookies and IP address tracking may be used to monitor remote access, a firewall may be installed on the database system, to limit inbound and outbound traffic.

[0279] It will be appreciated that the described implementations regarding HIPAA compliance are not meant to be limiting or all inclusive.

[0280] In some embodiments, the devices / systems / methods / uses of the invention are provided to the subject, and in some embodiments, the subject receives training, instruction or assistance to familiarize the subject with the device / system of the invention and its use. Such training may occur, in some embodiments, in the clinical setting where a physician, clinician, therapist or technician guides the subject in the use of the devices / sy stems of the invention, and the particular, providing training for various embodiments of the devices / systems of the invention that the particular subject mav utilize.

[0281] In some embodiments, video, audio or telecommunication instruction may be made available to the subject such that the subject may become acquainted with, or reacquainted with, the instructions for use of the device / system of the invention outside of the clinical setting, and thus not requiring a special, separate clinical appointment for retraining or recollection on the use of the device.

[0282] According to this aspect, and in some embodiments, such non-clinical instruction may be provided through video medium (e.g., DVD, video file provided through a smartphone or tablet application) provided with the device, audio recording (e.g., .mp3 format sent to subject for remote access, on the portable device itself, provided through a smartphone or tablet application), or through teleconference or video conference whereby the subject interacts directly with the physician, clinician, therapist or technician and is walked through the use and operation of the device. Such initial and ongoing training, instruction or assistance ensures that the subject is always able to safely, properly and effectively use the devices / sy stems of the invention.

[0283] In other embodiments, once the device / sy stems of the invention have been provided to the subject and the subject is comfortable and knowledgeable as to the use of same, the subject may then utilize the device / system in the manner best fitting his or her particular needs.

[0284] In some embodiments, the various components of the devices / sy stems of the invention must be able to communicate with each other in order to transmit signals, data, commands, and the like between and amongst each other. Wireless communication is preferred for all communication of data to and from the device. Therefore, a radio or electronic component for communication is included in many embodiments of the present invention. The radio of the device controls and carries out communications between the device components, and between the portable diagnostic / measurement and therapy systems or devices and external devices. The radio may be a Bluetooth® communications device to provide wireless communications with external components such as displays, computers or processors, data acquisition circuitry, internet or cloud-based memory banks or databases, and the like, as well as internal components such as the internal portable diagnostic / measurement and therapy systems or devices memory, microprocessor, and the like. Both internal (between electrical components of the portable device(s)) and external (between the portable device(s) and external components or devices) communications may also be transmitted through wireless, wired, or a combination of both systems and methods. In some embodiments, a processor or micro-controller comprises algorithms and protocols for coordinating the operation of at leastthese internal electrical components, and in some embodiments also for preprocessing or processing sensor data.

[0285] Many embodiments of the present invention include the step of collecting subject response data, sensor collected data, or testing result data or any combination thereof from the subject and / or the subject use of the devices / sy stems of the invention / and in accordance with the methods / uses of the invention. In some embodied aspects, the data collected is a function of the particular embodiment, and thus the particular needs of the subject. Measurements, or data acquisition, may be performed a single time or multiple times, iteratively over an extended period of time, or may even be performed substantially continuously for the entire time the subject uses the device / system of the invention.

[0286] In some embodiments, according to this aspect, data collection is at least during described time periods for measurement (real-time measurement and quantification), treatment or therapy delivery time, and measurement-to-treatment time.

[0287] In some aspects, the circuitry of the one or more electronic components of the devices / sy stems of the invention are appropriately modified so as to function with any suitable miniature DC power source, which in some embodiments, is a battery.

[0288] In some embodiments, the battery may comprise lithium powered batteries. Lithium ion batteries offer high specific energy (the number of given hours for a specific weight), which are readily available and inexpensive. In other embodiments, batteries include but are not limited to primary and secondary batteries, such as, for example, lithium primary batteries (e.g., lithium / thionyl chloride, lithium / manganese dioxide, lithium / carbon monofluoride, lithium / copper oxide, lithium / iodine, lithium / silver vanadium oxide and others), alkaline primary batteries, zinc-carbon, zinc chloride, magnesium / manganese dioxide, alkaline-manganese dioxide, mercuric oxide, silver oxide as well as zinc / air and others. Rechargeable (secondary) batteries may include nickel-cadmium, nickel-zinc, nickel-metal hydride, rechargeable zinc / alkaline / manganese dioxide, lithium / polymer, lithium-ion and others.

[0289] In some embodiments, the circuitry of the one or more electronic components of the devices / systems / system components of the invention comprises data acquisition circuitry, which in some aspects, may further comprise an amplifier that amplifies the sensor signals. The data acquisition circuitry is designed with the goal of reducing size, lowering (or filtering) the noise, increasing the DC offset rejection and reducing the system's offset voltages. The data acquisition circuitry may be constrained by the requirements for extremely high input impedance, very low noise and rejection of very large DC offset and common-mode voltages,while measuring a very small signal of interest. In some embodiments, the parameters of the design, such as input impedance, gain and passband, can be adjusted at the time of manufacture to suit a specific application via a table of component values to achieve a specific full-scale range and passband.

[0290] In some embodiments, a low-noise, lower power instrumentation amplifier is used. In some embodiments, the acquired analog signals are converted to a digital form, which in some embodiments, can be achieved with an electronic component or processing chip through the use of an ADC.

[0291] In some embodiments, the circuitry of any sensor board of the present invention comprises a digital section, for example, comprising a Texas Instruments MSP430-169 microcontroller, or any other microcontroller with similar characteristics and capabilities, or more advanced characteristics and capabilities. In still other embodiments, the circuitry of any transceiver module of the present invention also comprises a digital section, for example, comprising an Analog Devices ADVC7020 microcontroller, or another microcontroller with similar characteristics and capabilities, or more advanced characteristics and capabilities.

[0292] In still other embodiments, the circuitry for the one or more electronic components of the devices / systems of the invention or in the methods / uses of the invention comprises nonvolatile, rewriteable memory, or in other embodiments, allows for reprogramming of the final parameters such as radio channelization and data acquisition and scaling in the devices / systems of the invention.

[0293] In some embodiments, the circuitry of the one or more electronic components includes an RF transmitter which may be a Bluetooth radio as described herein. Another feature of the circuitry of the one or more electronic components may include, in some embodiments, an antenna, which in some embodiments, is integrated in the rest of the circuitry.

[0294] In some embodiments, the antenna can be configured in a number of ways, for example as a single loop, dipole, dipole with termination impedance, logarithmic-periodic, dielectric, strip conduction or reflector antenna. In some aspects, the antenna is designed to include but not be limited to the best combination of usable range, production efficiency and end-system usability. In some aspects, the antenna consists of one or more conductive wires or strips, which are arranged in a pattern to maximize surface area. In some aspects, the large surface area will allow for lower transmission outputs for the data transmission. In some aspects, the large surface area will also be helpful in receiving high frequency energy from an external power source for storage. Optionally, the radio transmissions of the present inventionmay use frequency-selective antennas for separating the transmission and receiving bands, if a RF transmitter and receiver are used on the electrode patch, and polarization-sensitive antennas in connection with directional transmission. Polarization-sensitive antennas consist of, for example, thin metal strips arranged in parallel on an insulating carrier material.

[0295] In some aspects, it is possible to integrate the antenna into the frame of a processing chip or into one or more of the other electronic components, whereby the antenna is preferably realized by means of thin film technology. The antenna can serve to just transfer data or for both transferring data to and for receiving control data received from a remote communication station which can include but is not limited to a wireless relay, a computer or a processor system. Optionally, the antenna can also serve to receive high-frequency energy (for energy supply or supplement).

[0296] In some embodiments, the devices / systems / methods / uses of the invention uniquely enable for tailored and targeted treatment or therapy based on objective, quantitative collected subject response data, sensor collected data, or testing result data or any combination thereof, in addition to an ability to incorporate observation of the subject by a caregiver and / or further incorporating the subject's self-reported level or severity of symptoms for a given dosage regimen, or stage of disease, or both. As part of this advantage, and in further embodiments, the devices / systems / methods / uses of the invention uniquely enable determining whether and when the treatment or therapy dispensing regimen needs to be changed, adjusted, or altered in any way, and in a controlled, fully personalized manner, adjusting same in real time, so that the end-user may benefit from such changes onboarded to the device / system in use by the subject.

[0297] In some embodiments, the devices / systems / methods / uses of the invention uniquely enable meaningful iterative measurement and quantification of collected subject response data, sensor collected data, or testing result data or any combination thereof, to derive the subject's response to various forms and variables of treatment or therapy. According to this aspect, and in some embodiments, this provides the clinician or system with a desired or optimal or most effective treatment or therapy plan and in some aspects, the ability to increase or in some embodiments, decrease a dosage of a particular agent in a treatment regimen, adjusted in real time, as part of this optimization.

[0298] In other embodiments, uniquely, when the subject is receiving a prescribed treatment or therapy and the system measures and quantifies an increased level or intensity of disorders and / or symptoms, or a quantified level or intensity of disorders and / or symptoms that is not expected based on the applied treatment or therapy occurs, the system or a clinician canthen determine that the treatment or therapy needs to be changed, adjusted, or otherwise altered, and same can be addressed in a regulated, personal manner, at the level of the personalized machine provided to the subject and / or through a bulk device requiring personal verification to modify a distribution program from a first program to a second program, which second program in some embodiments, can be prescribed / effected in real-time.

[0299] In some embodiments, this ability to adjust the distribution program in real time in a highly personalized manner may provide the benefit of significantly reducing the amount of time the subject likely has to suffer from the increased or altered disorders and / or symptoms and allows the system to rapidly adapt to the subject's changed disorder and / or symptom conditions.

[0300] In another embodiment, a primary benefit of the present invention involves the ability to provide precision dosing of medication or drug treatments or therapies to the subject. By precision dosing it is mean that the devices / systems and methods / uses of the present invention can recommend and provide, in some embodiments, smaller doses of drugs or medications at precise and specific times to most accurately and effectively treat the subject's disorders and / or symptoms. In other embodiments, by precision dosing it is mean that the devices / sy stems and methods / uses of the present invention can recommend and provide, in some embodiments, larger doses of drugs or medications at precise and specific times to most accurately and effectively treat the subject's disorders and / or symptoms.

[0301] Precision dosing allows the system to provide the drug or medication, or to instruct the clinician or the subject to administer or take the drug or medication, precisely when needed to prevent the onset or return of disorders and / or symptoms, or to treat such disorders and / or symptoms at the optimal time in order to mitigate the effects thereof and or the intensity or severity thereof.

[0302] In some embodiments, the ability to administer smaller doses of drugs and medication may be useful in preventing overdose, dependency, and tolerance to the drug or medication. The precision dosing function of the present invention in some embodiments, provides an opportunity to administer a smaller dose to a subject, precisely when needed based on the various metrics or measurements of the system, and thus the drugs or medications are only provided when needed, and in smaller amounts thereby increasing the effectiveness of the treatment while minimizing the cost of the treatment by potentially reducing the cost of the medication and number of refills, while also optimizing the efficacy of the drug in the subject's system as it relates to treating his or her disorders and / or symptoms, and reducing negative symptoms or side effects that may be associated with the drug, as well.

[0303] According to these aspects and in some embodiments, providing precision dosing creates a desired or optimal drug or medication profile in the subject's bloodstream in order to provide the maximum effect and benefit to the subject in treating their disorders and / or symptoms while reducing the chance of building a tolerance or overdosing.

[0304] In some embodiments, the personalized administration dosage distribution devices / systems / methods / uses afforded by the instant invention enable tailoring the dosage administration regimen to different subjects, in a singular, personal manner. According to this aspect, it is known that different subjects metabolize drugs differently and it is therefore preferable that a subject's desired or optimal drug profile takes into account the particular subject's propensity with respect to metabolism of the drug, which can be assessed in real time during the treatment window, in part through the collection of subject response data, sensor collected data, or testing result data or any combination thereof, in real time, adjusting the oral dosage dispensing regimen as a consequence of the obtaining of these results.

[0305] In some aspects the devices / systems / methods / uses of the invention specifically allow for tracking of the subject's symptoms and treatments over time, and in some embodiments, correlating same with the specific drug, drug dose, timing of dosages, symptoms, symptom severity, and timing of symptoms as appearing, tracking and / or otherwise recording same for the specific subject, and relating this information through the programming as described herein to adjust, alter or overwrite a first distribution program to a second distribution program, when the collected data warrants such a chang e / adjustm ent, and taking into consideration certain factors, including recommendations of health care providers, as herein described.

[0306] In other embodiments, additional information that may be recorded may include the subject's activities, habits, environment, and other such conditions which were present and thus might affect the drug's efficacy and metabolization, which in turn may also comprise this information through the programming as described herein to adjust, alter or overwrite a first distribution program to a second distribution program, when the collected data warrants such a change / adjustment, and taking into consideration certain factors, including recommendations of health care providers, as herein described.

[0307] In some embodiments, such information may also be saved, digitized, and stored for later reference, for example, by storage in a central or cloud database as described herein. In some aspects, the collected and / or stored information may be used to predict the particular subject's metabolization of the drug under given circumstances, and a subject-based profile of the drug's activity can be formulated which predicts when the drug will take effect, how long itwill last, when the subject's symptoms might be expected to begin to recur, how severe the symptoms will be during off times (times when the drug is having diminishing effect or is out of the subject's system), and the like.

[0308] Thus, according to these aspects and representing certain embodiments of the invention, the device / system / method / use of the invention can provide a customized, precision prediction within the drug's intended uses and indications of use to provide a desired or optimal drug profile in the subject's bloodstream based on the predicted activity of the drug in the subject's system and altering same in real time, as needed, when the subject’s condition changes from that at first dosage regimen distribution at first treatment time.

[0309] In other embodiments, the devices / systems / methods / uses of the invention in any embodiment as described herein, may be adapted to provide for automated or semi-automated notification to a clinician, physician, or technician, for example if the first drug distribution regimen or protocol fails to result in the desired outcome.

[0310] In some embodiments, such determination would be made based at least in part on the quantified severity of the subject's disorder's and / or symptoms and / or side effects. If the drug regimen or protocol is administered, and the subject's disorders, symptoms, and / or side effects are too severe compared to what would be expected from the regiment or protocol, then the system may transmit a message to the clinician, physician, or technician of the discrepancy, and the clinician, physician, or technician can then take appropriate measures to alter the subject's recommended drug regimen or protocol, by adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as described herein.

[0311] In some embodiments, according to this aspect, such alterations may include prescribing a new drug, altering the dose of a drug, suggesting combinations of drugs and / or action recommendations, and providing proper instructions to the subject and / or into a device for administration of the new regimen or protocol.

[0312] The subject and / or the system may then provide notification to the clinician, physician, or technician when the new regimen or protocol has begun to be administered so that the new regimen or protocol can be similarly monitored and assessed over time.

[0313] The following examples describe certain embodiments of the invention and should not be construed as limiting the scope of what is encompassed by the invention in any way.EXAMPLES EXAMPLE 1:SYSTEMS FOR PERSONAL SECURE ADMINISTRATION OF ORAL SOLID DOSAGE FORMS

[0314] Figure 1 provides a non-limiting example of an embodied system of the invention.

[0315] In this embodied aspect, a secured personal oral solid dosage form delivery device 1-20, 1-30, 1-40 capable of dispensing a solid oral dosage form to a subject 1-5 is depicted.

[0316] The system will further comprise a first non-transitory computer-readable storage medium having computer executable instructions stored thereon, which when executed by a processor, causes the processor to perform the oral solid dosage form distribution to the subject. The non-transitory computer-readable storage medium is enabled for remote secure communication in real time 1-35 and which computer executable instructions facilitate distribution of said oral dosage form according to an at least first distribution program, second distribution program or a combination thereof.

[0317] The non-transitory computer-readable storage medium may be located within the dispensing device itself (1-20, 1-30, 1-40), or alternatively, the non-transitory computer-readable storage medium 1-50 may be located external to the device, but in communication with the device 1-35, through any known means, or the system may comprise both non-transitory computer-readable storage mediums, located on the dispensing device and / or connected thereto remotely.

[0318] The system further comprises a subject user interface 1-15 and optionally at least one sensor 1-25, which both may provide information incorporated within and stored in the non-transitory computer-readable storage medium having computer executable instructions stored thereon, ultimately being, in some embodiments, incorporated within the programming that controls distribution of the oral dosage forms contained in the device.

[0319] The system further comprises within the personal oral solid dosage form delivery device 1-20, 1-30, 1-40, a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form differs from that of at least a second oral dosage form of the plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form, or any combination thereof.

[0320] Still further, the device provides for dispensing at least one individually addressable oral dosage form contained therein following at least a personal authentication protocol, either at the level of purchase of the device, or in use in the personal oral solid dosage form delivery device 1-20, 1-30, 1-40.

[0321] As noted herein, the operation of dispensing an oral dosage form stored in the device is subject to programming, which programming controls distribution of the oral dosage forms contained in the personal oral solid dosage form delivery device 1-20, 1-30, 1-40 in accordance with a first secure distribution program.

[0322] For example, and in some embodiments, the first secure distribution program may result in dispensing a first drug, at a first dosage, twice a day, where, for example, the device for personal secure administration of oral solid dosage forms is a hand-held oral solid dosage form secure distribution device containing a tamper proof casing within which a solid dosage form holder is contained. In one embodied example, the solid dosage form holder is a carousel dispenser, for example as described in WO2017077529A1, fully incorporated by reference herein, whereby a multi-oral solid dosage form holder is present in the device, with each section containing one or more solid oral dosage forms for administration at a given time to a subject in need. In some embodiments, as a nonlimiting example, a first distribution program controls that each successive compartment is advanced and accessed, dispensing the oral dosage form located therein in a sequential manner, to a subject in need thereof.

[0323] Further according to this aspect and representing some embodiments of the invention, a secure non-transitory computer-readable storage medium is enabled for remote secure communication in real-time and has computer executable instructions stored thereon, which when executed by a processor, promotes collection, input or a combination thereof of subject response data, sensor collected data, or testing result data or any combination thereof to determine whether a first distribution protocol promotes a desired clinical endpoint being reached, when the desired clinical endpoint comprises a therapeutic effect, a lack of adverse event of pre-determined scale, or a combination thereof, wherein reaching of the desired clinical endpoint reflects collected subject response data, sensor collected data, or testing result data or any combination thereof meeting established values and therefore reaching the desired clinical endpoint results in maintenance of the first distribution program, or in some embodiments, determining completion of a therapy and establishing that the subject was successfully treated.

[0324] In another embodiment, the collection, input or a combination thereof of subject response data, sensor collected data, or testing result data or any combination thereof to determine whether a desired clinical endpoint was reached, indicates a lack of a therapeutic effect, a presence of an adverse event of pre-determined scale, or a combination thereof, in for example, comparison to established values and therefore the r desired clinical endpointwas not reached, which in turn will result in the switching to a second distribution program in the device.

[0325] According to this aspect and representing one embodiment, referring to the carousel holder for dispensing oral dosage forms, wherein the first distribution program may reflect advancing in a single direction a carousel compartment containing a solid oral dosage form to align with the drug egress port / outlet, by a single compartment. In some embodiments, when the second distribution program is activated, according to this aspect, the carousel, for example, may advance a single compartment in the reverse direction, to result in a different solid oral dosage form to align with the drug egress port / outlet, or in some embodiments, the carousel may advance a multiplicity of compartments in the original direction, skipping interim compartments in order to allow for the different solid oral dosage form to align with the drug egress port / outlet and other various means that a given distribution program, having a particular sequence to access first program chambers, may be altered to result in access of different chambers, thereby altering the previously established dosage regimen.

[0326] In some embodiments, the sensors 1-25 located on the device 1-20, 1-30, 1-40 and / or patient responses to questionnaires provided through the User Interface 1-15 contribute to the determination as to whether a distribution protocol promotes a desired clinical endpoint being reached as described herein. In other embodiments, health care providers / care team members 1-60 input data through a user interface 1-65, which in turn contribute to the determination as to whether a distribution protocol promotes a desired clinical endpoint being reached as described herein. In some embodiments, the system / device / methods include programming such that combined input from User interface(s), for example as described by 1- 15 and 1-65 in Figure 1, or any User interface or plurality of user interfaces that could be incorporated within the devices / sy stems and in the methods of this invention, as will be appreciated by the skilled artisan.

[0327] According to this aspect, and in some embodiments, transmission of the relevant information may be effected from a collection point, for example, through sensors incorporated in the devices or in the systems as herein described, or in some embodiments, input through a user interface by a patient, or in some embodiments, by a medical care giver or health care provider, or any combination thereof, and such relevant information may be relayed to a remote device / system, through any appropriate means, such as WIFI, or internet communication or cellular communication or Bluetooth or via RFID, or through a LAN, or any means known in the art. According to this aspect and in some embodiments, the remote / device / system receiving the transmitted information is a secure non-transitorycomputer-readable storage medium, which medium is enabled for remote secure communication in real-time and which medium has computer executable instructions stored thereon, which when executed by a processor, promotes collection, input or a combination thereof of subject response data, sensor collected data, or testing result data or any combination thereof to determine whether the first distribution protocol promotes a desired clinical endpoint being reached, as described. In some aspects, a secure non-transitory computer-readable storage medium, which medium has computer executable instructions stored thereon, which when executed by a processor, promotes collection, input or a combination thereof of subject response data, sensor collected data, or testing result data or any combination thereof to determine whether the first distribution protocol promotes a desired clinical endpoint being reached, as described may also be referred to herein as a “treatment manager”, which in some aspects, contributes to the determination of the desired clinical endpoint being reached through analysis of the collected subject response data, sensor collected data, or testing result data or any combination thereof and the results of same meeting established values; whereby reaching said desired clinical endpoint results in maintenance of said first distribution program; and lack of a therapeutic effect, presence of an adverse event of pre-determined scale, or a combination thereof results in performing a second distribution program, as described herein, instead of maintaining the first distribution program.EXAMPLE 2:HANDHELD PERSONAL DEVICE FOR SECURE ADMINISTRATION OF ORAL SOLID DOSAGE FORMS ADJUSTED IN USE

[0328] As described herein, the devices / systems / methods of this invention may make use of a personal hand-held oral solid dosage form distributing device, for example as depicted in 1-20 of Figure 1, illustrating a non-limiting example of an embodied device of the invention.

[0329] In this embodied aspect, a secured personal oral solid dosage form delivery device 1-20, 1-30, 1-40 capable of dispensing a solid oral dosage form to a subject 1-5 is depicted.

[0330] Referring now to a non-limiting example of an embodied hand-held dispenser depicted by 1-20 in Figure 1, and as also further depicted in Figure 2, the device 2-20 will comprise a User interface, which comprises a display screen on the device 2-70. The display screen may include a touch screen, in some embodiments, enabling user interaction, by responding to prompts by touching a “button” as appearing on the screen 2-75, or entering more complex feedback through the touch screen, for example, a security code, as seen in Figure 2E.

[0331] The skilled artisan will appreciate that the personal secure device does not a priori require use of a touch screen and a simple hand-held device comprising a mini-keyboard for patient access as part of the user interface is another envisioned aspect of the invention and the device is not to be limited in any way by the choice of user interface components.

[0332] Referring to Figure 2A, the personal devices of the invention, according to some aspects, will contain user profiles, wherein the User name will appear, as exemplified in Figure 2A by the term “USER 1”, which in use would list the name of the patient to which the device and oral dosage regimen is being provided, for example, by specific authorized filling of a prescription. In some embodiments, the device 2-20 comprises the oral dosage distribution apparatus to dispense a solid oral dosage form from the outlet, which is initially covered by the device cap, 2-80.

[0333] In some embodiments, the drug being dispensed according to a first secure distribution program is listed on the screen, for example, as exemplified by the appearance of the term “DRUG Y” on the screen 2-70, and in some embodied aspects, the dosage regimen may also be displayed, for example, as exemplified by the appearance of the term “ZZ mg” and “twice a day” to indicate the regimen on the screen 2-70. In some embodiments, a first personal security check can be effected by the patient to ensure that the display provides a drug dosage regimen that the patient knows is appropriate. According to this aspect, as part of the User interface, the patient can interactively press a button or touch the screen, for example, as depicted by “Start my therapy” 2-75.

[0334] According to this aspect, and in some embodiments, Figure 2C depicts a nonlimiting example of the activation of the first distribution program, according to the personalized administration protocol, specific for a particular patient. In some embodiments, additional security measures may be implemented, as desired or needed, for example, there being a prompt to provide a password / code, as depicted, as well, for example, in a non-limiting way in Figure 2E, which in turn enables administration of the oral dosage form to the subject.

[0335] In some aspects, such secure administration methods may provide for a failure to advance a drug internally in the device to be released from a drug containment element to the outlet, and in some embodiments, may provide for a failure to release a locking mechanism maintaining the cap securely covering the outlet and in some embodiments both operations are prevented in the absence of a prior security requirement / measure being met.

[0336] In still a further embodiment, as depicted, the date and time of administration of the dosage form is recorded, and in some aspects, projected on the display.

[0337] In some embodiments the user interface enables the subject to dynamically update the device if any discomfort is experienced, or in some embodiments, if an existing aspect of a distribution regimen is unsatisfactory to the subject.

[0338] In other embodiments, a member of a care team may similarly interface to dynamically update the device if any warranting symptoms are discerned, for example through assessment of collected sensor data, or in some embodiments, if any collected results such as blood or imaging or ultrasound test results or other medical results are received. It will be appreciated that any subject response data, sensor collected data, or testing result data or any combination thereof as collected may be incorporated dynamically through the user interface to impact the oral dosage form distribution program of the dispensing device.

[0339] In some embodiments, the patient may communicate a request to a care team member to adjust the solid dosage distribution program, and in some embodiments, such communication may be via any means, including specific communication through the device, or in other embodiments, independently for example, by calling the treating physician.

[0340] According to this aspect and in some embodiments, the physician or any authorized health care personnel can in turn, through the user interface, adjust or alter or halt the distribution program, as necessary, and the patient will be alerted to same. In some embodiments, the alert in turn may be displayed through the device.

[0341] In some embodiments, one means of alerting the health care personnel of a patient distress / dissatisfaction or need to adjust a treatment regimen may be through patient non- compliance in taking the dosage form at the prescribed time, for example, effectively skipping a dose. According to this aspect and in some embodiments, such activity of a failure to administer a dosage at a specified time results in a system alert. In some embodiments, such a system alert may result in a prompt to the patient to collect questionnaire data to ascertain the reasoning behind the non-compliance / failure to administer the dosage. In other embodiments, such a system alert may result in a check by a health care provider to assess patient wellbeing. In other embodiments, such a system alert may result in a physician call and / or physician issuance for further testing. In some embodiments any combination of system alert results as described herein may be pursued. In still other embodiments, such a system alert may result in a formal entry of a dosage form distribution program adjustment.

[0342] Further according to this aspect, and in some embodiments, through any embodied method / rationale as described herein to adjust a first distribution program in said device, may result in a display prompt for the user on the device, confirming an adjustment / change to the distribution program. For example, a non-limiting illustration of such a prompt is depicted inFigure 2D, wherein instructions, for example, were introduced through a user interface into the programming in the device, and in some embodiments, user confirmation may in some aspects be a required step to complete adjustment or change to the distribution program. According to this aspect, the touch display, or any other means, for example, a keyboard button, or other input means is provided on the device, so that the user can confirm same.

[0343] It will be appreciated that user confirmation of an adjustment is not required, and instead health care provider / physician confirmation of any adjustment to the distribution program is absolutely required for any adjusting, altering or overwriting of a first distribution program to a second distribution program to occur, and this confirmation is via user interface comprising, in some aspects, specific security protocols.

[0344] In some embodiments, the system may relay a preference by the user for an adjustment to the distribution program, in terms of dosage, timing, or requesting a change in medication entirely, and the user is advised that an alert will be sent accordingly to a health care provider through the user interface, and Figure 2E illustrates in a non-limiting example, how the display may elicit patient agreement to send such an alert.

[0345] According to this aspect and in some embodiments, to ensure the patient authorizes this measure being taken, same may include secure protocols, for example by entering a password code, which for example, can be entered into the device display, as depicted in a non-limiting example shown in Figure 2F.

[0346] It will be appreciated that any means of relaying the information between patient and caregiver is envisioned, including, for example, via an electronic transmission means, which as well can employ use of a code. In some embodiments, even if the secure code is entered in the device, additional security protocols, including patient contact information authentication, such as, for example, issuance of a temporary code transmitted to the patient’s cell phone, may then be entered into the device, as an additional security measure, if same is desired.

[0347] In still further embodiments, when the dose distribution program is adjusted, altered or overwritten, and the device is appropriately updated in terms of its programming to ensure same, in some aspects, an alert is further sent as confirmation to the subject. For example, and as illustrated in a non-limiting example in Figure 2G, the display may issue an alert to the adjustment and confirm that the health care management team has been duly apprised. According to this aspect, modifications in the drug distribution are then effected, such that the switch from the first distribution program to the second distribution program occurs.

[0348] According to this aspect, and in some embodiments, for example, when using a hand-held device, such a change from the first distribution program to the second distribution program may result in a change in orientation in terms of alignment of a drug containment compartment with the outlet, such that a different oral dosage form in terms of its active ingredient type, active ingredient dosage, or a composition component of the oral dosage form, or any combination thereof is then accessed and dispensed to the subject. Still according to this aspect and in another embodiment, such a change from a first distribution program to the second distribution program may result in, for example, a rotating carousel that ordinarily advances by a single compartment in the device, in a first direction (for example, clockwise) to advance instead by multiple compartments, for example, skipping the next 5 or 6 or 8 compartments in the first direction, to dispense an oral dosage form contained in a compartment, that would ordinarily not be accessed next unless a change has been effected to the distribution program.

[0349] In another embodiment, such a change from a first distribution program to the second distribution program may result in, for example, a rotating carousel that ordinarily advances in a first direction (for example, clockwise) to advance instead in a second direction (for example, counter clockwise), to dispense an oral dosage form contained in a compartment, that would ordinarily not be accessed next unless a change has been effected to the distribution program.

[0350] In some embodiments, the display may specifically include information to advise of the new drug, dosage or timing changes that have been enacted as part of the change from the first distribution program to the second distribution program, for example, as depicted in Figure 2H, and in some embodiments, patient feedback may as well be incorporated, such that a patient request to further adjust the therapy can be enacted through the device, as well, while obviously the same goal of patient feedback can be accomplished through any other means by direct communication between the patient and the care giver or health care personnel contact means.

[0351] In still other embodiments, the invention provides devices / systems / methods / uses for dispensing at least one individually addressable oral dosage form subject to programming, which programming controls distribution of the oral dosage forms according to a first distribution program, wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in the programming whereby the programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution urogram, as a function of said collected subjectresponse data, sensor collected data, or testing result data or any combination thereof, wherein included in the adjusting, altering or overwriting of the first distribution program is the possibility of pausing therapy altogether, so that the second distribution program does not in fact dispense an oral dosage form at a previous time or according to a prior dosage regimen.

[0352] For example, and as schematically depicted in the non-limiting example of Figure 3, when a personal device is used, the program accessed by the patient, when including an option to pause therapy, will in some aspects, include a screen display advising that the therapy is in fact paused, and Figure 3B, for example, denotes that health care personnel are to be involved in the changing of the protocol to pause therapy. In some embodiments, the patient may submit a request for pausing therapy through the device, which in some embodiments may include secure transmission, for example, via password protected control as depicted in Figure 2 in a non-limiting example of how such communication can be achieved. According to this aspect and in some embodiments, the health care team will be notified of the request, which if granted will then be displayed on a screen, for example, as depicted in a nonlimiting example in Figure 3E-3F, wherein the pausing of therapy is communicated through the display, as is the option for the patient to further use the device built-in communications system if desired to further request adjustment of the therapy regimen.

[0353] In still other embodiments, such pausing of therapy may be temporary, or in some embodiments, may be resumed following further consultation with health care providers following evaluation of collected subject response data, sensor collected data, or testing result data or any combination thereof, which both provider and patient agree would warrant, in some embodiments, restarting therapy. According to this aspect, for example, as depicted in the non-limiting example of Figure 4, when a personal device is used, the program accessed by the patient, when including an option to resume therapy, will in some aspects, include a screen display advising that the therapy is in fact resumed, and Figure 4A-4B, for example, provides the patient the opportunity to reinitiate the therapy, including providing same instructions securely by password protection as depicted in Figure 4C. According to this aspect, similar to embodiments related to with regard to Figure 3, in a non -limiting example as depicted herein in Figures 4D-4E, the health care team will be notified of the request, which if granted will then be displayed on a screen, for example, as depicted in the figures, wherein the resumption of therapy is communicated through the display, as is the option for the patient to further use the device built-in communications system if desired to further request adjustment of the therapy regimen.

[0354] In still further embodiments, the invention provides devices / systems / methods / uses for dispensing at least one individually addressable oral dosage form subject to programming, which programming controls distribution of the oral dosage forms according to a first distribution program, wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in the programming whereby the programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof, wherein included in the adjusting, altering or overwriting of the first distribution program is the possibility of ending the therapy altogether, so that the second distribution program does not in fact dispense any oral dosage form to the subject.

[0355] For example, and as schematically depicted in the non-limiting example of Figure 5, when a personal device is used, the program accessed by the patient, when including an option to end therapy, will in some aspects, include a screen display advising that the therapy is in fact concluding, and Figures 5A-5B, for example, describe that health care personnel are to be involved in the changing of the protocol to pause therapy.

[0356] In some embodiments, the patient may submit a request for halting therapy through the device, which in some embodiments may include secure transmission, for example, via password protected control as depicted in Figure 5C in a non-limiting example of how such communication can be achieved. According to this aspect and in some embodiments, the health care team will be notified of the request, which if granted will then be displayed on a screen, for example, as depicted in a non-limiting example in Figure 5D-5E, wherein the halting of therapy is communicated through the display. According to this aspect and in some embodiments, the health care team will be notified of the request, as depicted in a non-limiting exemplified aspect in Figure 5D, which in turn may as part of internal recording of cessation of a treatment program, for example as depicted in Figure 5E, may in fact include logging the patient out of the administration program and result in loading / commencement of a new user profile and requiring, in some embodiments, new authorization and / or a new password, etc., to ensure that a new or different program is dispensed, if authorization to commence same has been provided by the appropriate health care provider.

[0357] Figure 6 as described herein illustrates in a non-limiting example, oral dosage forms that differ in drug composition, formulation components, dosage, or any combination thereof positioned in different chambers of the device (e.g. 6-50, versus 6-100, versus 6-150, versus 6-200), where the first distribution urogram for example, being one of sequentiallyrotating the carousel in the clockwise direction as depicted by the red arrow, dispenses the depicted dosage forms in a particular order, while in some embodiments, skipping the chamber in which the 6-50 dosage form is located can then result in a shift to the second distribution program. Also depicted as described herein, is the ability to rotate the carousel for example from the clockwise orientation depicted by the red arrow to follow a counter clockwise orientation marked by the blue arrow, which in turn would change the order of administration e.g. of a dosage form 6-50 being followed by administration of dosage 6-100, when a clockwise orientation is followed, to instead deliver the 6-200 dosage form following the 6- 150 dosage form, for example, as will be appreciated by the skilled artisan.

[0358] Figure 7A-7B illustrates a non-limiting example of an interface for a health care provider, for authorized medical personnel to for example, modify the dispensing program to e.g. continue a first dispensing program, shift the treatment program to encompass a second dispensing program, or in other embodiments, halt the dispensing program altogether.

[0359] In some embodiments, the health care provider interface may allow for selection of a particular patient, introducing program instructions regarding the dispensing programs and in some aspects, forwarding a message to the patient, as seen on the right hand side of the figure, to alert the patient to a dose adjustment, pausing of therapy, ending therapy, or for example, altering the therapy composition, which according to this exemplified aspect, could be summarized using the “free text” option in the drop down menu depicted.

[0360] It will be readily apparent to the skilled artisan that the various permutations and display instructions are mere non-limiting examples of potential communication messages incorporated on a display of a personal drug delivery device for use in accordance with the devices / systems / methods / uses of the invention, for illustrative purposes, but that any number of means and changes to the personal device can be envisioned as described herein.

[0361] As exemplified and described herein, the devices / systems / methods of this invention comprise a databank or provide databank access to established value ranges for data collected from patient input data, such as, for example, vital signs as determined by a healthcare provider and / or collected from integrated sensors, or in some embodiments, patient input data taken from responses collected from the patient, for example, as collected through the user interface in the systems / devices of the invention or in some embodiments, input via remote communication through an application on a mobile device, or input via web access, or any other means.

[0362] According to this aspect and in other embodiments, the devices / systems / methods of this invention lend themselves to semi-automatically and automatically adjusting, or tuning,oral dosage treatment regimens in the described devices and systems herein, and in some embodiments, remotely and intelligently adjusting or tuning such devices and systems. According to this aspect and in some embodiments, reference to “semi-automatic adjustment” may include providing the clinician, physician or technician with collected data or measurements related to a subject's disorder, including symptoms, response to therapy, patient complaints, or any patient feedback from any collected source, determining desired parameters, including, in some embodiments, by comparison to database stored ranges of norms or in some embodiments, historic data for the subject, and then remotely entering changes into the oral dosage distribution regimen of a subject, to the devices / sy stems for use by the subject. In other embodiments, reference to “semi-automatic adjustment” may include providing the clinician, physician or technician with collected data or measurements related to a subject's disorder, including symptoms, response to therapy, patient complaints, or any patient feedback from any collected source, determining desired parameters, including, in some embodiments, by comparison to database stored ranges of norms or in some embodiments, historic data for the subject, and then remotely entering feedback to maintain the oral dosage distribution regimen of a subject currently in use, to the devices / systems for use by the subject, until and unless a change is subsequently entered by a health care personnel, or other authorized user.

[0363] Alternatively or in addition, semi-automatic or automatic adjustment may not require sensors to provide data and / or measurements related to a subject's disorder or symptoms, but rather may use qualitative or quantitative information such as, for example, traditional telemedicine techniques or remote observation by a clinician, physician or technician via video connection.

[0364] In other embodiments, reference to “remote adjustment” or “tuning” includes the control and / or decision regarding the therapy parameters to be programmed into the system or subject's therapy device, whereby such controlling can be effected by a caregiver located remotely from the subject. For example, remote adjustment or tuning may be controlled by a clinician, physician or technician or an automated or semi -automated system using data transmitted from the subject and / or his or her therapy device without the subject having to travel to the clinical site to for such data to be obtained or transferred.

[0365] According to these aspects, and in some embodiments, any and all means of availing analysis of the collected response data, sensor collected data, or testing result data or any combination thereof and / or inputting relevant information by any clinician, physician or technician or health care provider can be accomplished directly on the device / system by theprovider, or in some embodiments, such information may be input remotely, and in some embodiments, through an specific interface for use by the health care provider.

[0366] According to this aspect and in some embodiments, such devices / systems / methods / uses may make use of a secure non-transitory computer-readable storage medium, which medium is enabled for direct or remote secure communication in realtime and which medium has computer executable instructions stored thereon, which when executed by a processor, promotes collection, input or a combination thereof of subject response data, sensor collected data, or testing result data or any combination thereof to determine whether a first distribution protocol promotes a desired clinical endpoint being reached and optionally further enables communication with the device / sy stems of the invention which controls the programming related to the dispensing of the drug according to an oral dosage form distribution program in the device / sy stem, which may be located on a separate secure non-transitory computer-readable storage medium, or within the same secure non-transitory computer-readable storage medium.

[0367] In some embodiments, the secure non-transitory computer-readable storage medium accessed by a health care provider may be referred to herein as a “treatment manager” or “therapy manager” 7-300 and in some embodiments same relates to programmed instructions in the devices / sy stems of this invention that relate to, inter alia, controlling the oral dosage form distribution program.

[0368] According to this aspect and in some embodiments, the non-transitory computer- readable storage medium will comprise computer executable instructions to adjust a solid oral dosage from in terms of its active ingredient type, active ingredient dosage, or composition component of the oral dosage form, or any combination thereof by adjusting a distribution program as described herein. In another embodiment, the computer executable instructions may comprise instructions to pause or halt distribution as well.

[0369] For example, and referring to Figure 7, an embodied display of an interface for use by a health care provider in conjunction with the devices / systems / methods / uses of the invention may comprise a navigation panel, for example as depicted at 7-300, which in turn displays various menus, such as patient information containing pages that list the therapy regimen, which can include the first oral dosage form distribution program, and optional second, third, fourth, etc. distribution programs, that can be accessed from a device to which the patient is assigned / can access. In accordance with this embodied non-limiting example, a dashboard is provided as part of the interface, where additional access pages may includetherapy templates 7-330, which may list different distribution programs and optionally correlating suggestion choices of a particular program assuming certain results are obtained.

[0370] In another aspect, there is provided a guide library 7-340, which in turn may comprise guidance regarding the correlation between results collected from the patient and proposed distribution programs, and other reference information for the care giver. Standard questions that the doctors will ask patients, for example, may comprise assessing patient temperature, providing a scored response of their subjective feelings at the time, experiencing nausea, etc., as will be understood by the skilled artisan, and in some embodiments, these questions can be continuously updated and tailored to the concerns about for example side effects for particular drugs administered or signs of disease progression or both, or any other appropriate medical concern that a physician will wish to follow over time.

[0371] In another aspect, there is provided a care team page 7-350, which in turn may provide information as to which care team members may access the patient file in question. In another aspect, there is provided an account settings page 7-350, which in turn may provide a description of the system defaults, or settings specific for the care giver accessing the account in question.

[0372] The device enables tracking of patient compliance information, for example, in terms of adherence to directions provided in the patient interface, including taking the medication at the prescribed time, how consistently same is addressed over time, reported symptomatology, etc.

[0373] Another feature may be a communication tab / button in the interface for ease of communication between health care team members and / or the patient. For example and in some embodiments, a point and click button “send message” 7-370, which, may provide a further drop-down menu 7-80 for selecting a message category that in some embodiments, will be displayed on the personal device of the patient, for example advising of a change in the distribution program, pausing therapy, ending therapy, etc. as well as, for example, providing a free text option to enable display of a more specific message between care giver and patient. In some embodiments, as will be apparent to the skilled artisan, similar options may be included as part of the user interface in the personal device accessed by the patient to view the prescribed medication, dosage regimen, and other aspects that the patient would be expected to / expects to be able to access. The messaging option and display, in some embodiments, would be enabled on the device interface at the patient end, as well, for example as depicted in Figures 2D-2E, 3A, 3B, and others.EXAMPLE 3OVERVIEW OF SYSTEMS FOR CARE TEAM ADJUSTMENT OF PERSONAL ORAL SOLID DOSAGE FORM DISTRIBUTION PROGRAM

[0374] Figure 8 provides a non-limiting example of an embodied system of the invention, for use in conjunction with any exemplified device for personal secure administration of oral solid dosage forms, whether hand-held or bulk distribution devices. According to this aspect and in some embodiments, oral dosage form dispensing to specifically adjust a dosage of a particular oral dosage form is envisioned. In some embodiments, as illustrated in a nonlimiting example in the figure, the care team can remotely adjust the dosage being provided to the patient, for example, by relating to a particular patient with a known diagnosed condition, whereby a specific medication was prescribed for the subject and then administered to the subject using any exemplified device for personal secure administration of oral solid dosage forms, as described herein. According to this aspect, after the patient is administered the medication, and in some embodiments, for example, after verification of patient placement of the oral dosage form within his / her oral cavity, as an added confirmation of the taking of the prescribed medication, the patient is provided a questionnaire, for example through the patient interface.

[0375] Further according to this aspect and in some embodiments, the patient responses are reviewed by authorized care team personnel, to assess whether adjustment of a medication regimen is warranted. According to this aspect and in some embodiments, the questionnaire includes questions related to, in some aspects all common side effects, and in some embodiments, every known side effect, and in some embodiments, any potential significant side effects, which may not be known when e.g. the given medication is administered, but nonetheless the patient may be questioned about such side effects regardless.

[0376] Following review of the questionnaire results, the health care provider, for example, or in some embodiments, pre-programmed into the device interface is a flow decision chart to similarly assess the responses such that if the responses regarding the side effects are consistent with the patient experiencing no or mild side effects that are not deemed a priori to warrant adjusting the dosage regimen, then the subject remains on the existing treatment protocol.

[0377] In some aspects, if the subject experiences severe side effects, which are deemed a priori to warrant changing the treatment protocol. In some aspects, such change may comprise ceasing treatment altogether and in some aspects, such change may comprise administering a different medication and / or in some embodiments, such change may also compriseadministering additional medications to specifically address the side effects experienced by the subject.

[0378] In some aspects, if the subject experiences moderate side effects, then, in some aspects, depending on the side effects, same may be deemed a priori to not warrant adjusting the dosage regimen, but in other aspects, depending on the responses (and contrary to what is displayed in Figure 7) same may be deemed a priori to warrant adjusting the dosage regimen, similar to the changes described hereinabove when severe side effects are reported.

[0379] Further according to this aspect, adjusting the medication is conducted on device, for example, on the personalized hand-held device, whereby, for example a first distribution program is altered to dispense a second distribution program, for example, altering the first order of dispensing oral dosage forms from containment chambers, e.g. skipping a next chamber, or in some embodiments, changing the orientation of the drug containment chambers, for example, changing from a clockwise to a counter-clockwise orientation, as described herein. As depicted in Figure 8A, such adjustment, prior to enabling commencement of the second oral dosage form distribution program to alter any treatment protocol, or in some embodiments, to arrive at a decision to remain on the existing treatment protocol (and therefore oral distribution program), authorization for proceeding must be conveyed by a care team member.

[0380] It will be appreciated that any number of means can be used to alter dispensing medication from a first to a second program can be accomplished using the devices / sy stems of this invention and any and all of same are envisioned as embodied aspects of this invention.

[0381] In some embodiments, when no or mild or even certain moderate side effects are evident, the treatment regimen may be altered to a second, more aggressive treatment protocol, which in some embodiments, may increase the dosage and / or frequency of administration of the medication to the subject.

[0382] In other embodiments, when reported severe side effects are encountered, warranting a change in the treatment protocol, in some aspects, the treatment protocol is changed to a less aggressive Treatment Protocol, for example, in some aspects, reducing the dose and / or frequency of administration of the given medication.

[0383] According to this aspect and in some embodiments, the adjustments in the Treatment Protocol will be coordinated by the Care Team, but in some embodiments, it is possible that the device is pre-programmed with authorized instructions to automatically adjust the distribution program, for example, as depicted in Figure 8B. According to this aspect and in some embodiments, if device-triggered changes or address of remaining on the existingtreatment protocol is taken in response to patient reported side effects, and in some embodiments, even if pre-programmed alterations commence, a message to a care team member is coordinately sent so that authorized health care personnel can review and / or further adjust same, as warranted, in some aspects.

[0384] In some aspects, the systems of this invention provide additional versatility and unexpected superior control to tailor treatment regiments to a patient in need, whereby complex considerations of patient’s experienced side effects are considered in the context of additionally obtained extrinsic information, such as blood test, imaging, vital sign and other data, which can add additional complexity in assessing and personalizing the treatment regiment for the subject. For example, and referring to Figure 9A-9B, when a patient is prescribed a particular Medication, in accordance with the devices / systems / methods of this device, the medication dispensing program, which in some aspects is included within a first non-transitory computer-readable storage medium having computer executable instructions stored thereon, which when executed by a processor in the device, for example, causes the processor to perform the oral solid dosage form distribution to the subject, which medium is enabled for remote secure communication in real time and which computer executable instructions facilitate distribution of said oral dosage form according to an at least a first distribution program.

[0385] According to this aspect, the device execution will include having a patient address questionnaires which may be a part of specific, relevant questions related to the condition and medication side effects that are posed to the patient and responses to same are recorded, whereby following administration of the therapy including the medication via the Device in accordance with a first distribution program, the patient answers the specifically posed questions and in some embodiments, the Device on which the patient submits his / her replies, may communicate with an external secure non-transitory computer-readable storage medium, which medium is enabled for remote secure communication in real-time and which medium has computer executable instructions stored thereon, which when executed by a processor, promotes collection, input or a combination thereof of subject response data, sensor collected data, or testing result data or any combination thereof to determine whether the first distribution protocol promotes a desired clinical endpoint being reached and imports the patients results, for example, via external device collection of such information.

[0386] In other embodiments, the devices / systems / methods of this invention enable device sensors to collect such information relating to specific test results, imaging results, etc., whichin addition to patient questionnaire response analysis provide an indication of whether side effects and / or clinically significant collected data is present.

[0387] According to this aspect, an assessment of patient side effects, derived from the patients answers of the questionnaire are analyzed. Further according to this aspect and in some embodiments, if no or mild side effects are found, a further analysis may be conducted in parallel or sequentially to further analyze whether clinically significant results from extemal / additional sources are evident.

[0388] According to this aspect, and in some embodiment, the device may comprise sensors that assess vital signs of the patients with established norms, wherein values obtained that deviate from same may be considered in this context as to whether altering a treatment protocol is warranted. In some aspects, sensor data may include sensor assay of blood chemistry and / or blood gas results. In other embodiments patient blood tests may be assessed on- or off-device and the results input into the user profile for consideration in this context. In still other embodiments, imaging results can be further analyzed in this context..

[0389] Still further according to this aspect, if the results from the patient questionnaire and / or the results obtained from sources other than the questionnaire are negative or suggest no negative impact of the treatment regimen on the subject, then, depending on a decision provided by the care team, or based on pre-established response profiles, the Treatment Protocol may be altered to provide a more aggressive Treatment Protocol. In other embodiments, if the results from the patient questionnaire and / or the results obtained from sources other than the questionnaire are negative or suggest no negative impact of the treatment regimen on the subject, then, depending on a decision provided by the care team, or based on pre-established response profiles, the Treatment Protocol may be kept contstant, i.e. maintaining the patient on the same Treatment Protocol.

[0390] Still according to this aspect, and in some embodiments, if / when the results from the patient questionnaire are positive and the results obtained from sources other than the questionnaire are positive, then, there is a change in the Treatment Protocol that will commence. In some aspects for example, when only moderate effects are observed, yet there are no clinically significant results from external assessment sources, the in some embodiments, there may be a further change in the Treatment Protocol to commence a second distribution program, which in some aspects comprises a more aggressive Treatment Protocol or, in some embodiments, alternatively, a care team decision may include a decision to remain on the same Treatment Protocol for a defined period of time, or in some embodiments, until adifferent outcome is observed from either patient questionnaire data collected, or external assessment indicia or both.

[0391] In some embodiments, if / when the results from the patient questionnaire are positive and the results obtained from sources other than the questionnaire are positive, and indicate clinically significant side effects, or in some aspects, concern with continuing the existing regimen for the subject, then in some aspects, the second distribution program is engaged to change the Treatment Protocol to a less aggressive Treatment Protocol. In other embodiments, if the results from the patient questionnaire are positive and the results obtained from sources other than the questionnaire are negative, and optionally indicate clinically significant side effects, or in some aspects, no side effects are evident, ,then a care team decision may include a decision to remain on the same Treatment Protocol for a defined period of time, or in some embodiments, until a different outcome is observed from either patient questionnaire data collected, or external assessment indicia or both.

[0392] In another embodiment, as depicted in Figure 9C, the results obtained from sources other than the questionnaire are input by a care team member directly so that the side effects experienced by the patient, as well as the assessment of a clinically significant result, such as for example, a desired clinical endpoint being reached, which comprises a therapeutic effect, a lack of adverse event of pre-determined scale, or a combination thereof, and as can be seen from the flow diagram of Figure 9C, similar assessment of the concurrent absence / low incidence of side effects or information gleaned from questionnaire data and absence of significant results input by the care giver, may result in the programming to provide for maintaining the subject on the existing treatment regimen for a defined period of time. According to this aspect and in some embodiments, the presence of significant results input by the care giver, with no or minimal side effects as assessed from questionnaire data may result in the programming promoting switching from the first distribution program to a second distribution program (i.e. altering the existing distribution program). In other aspects of this embodied flow chart, when the side effects are moderate, yet significant results obtained are input by the care giver, this may result in programming instituted changes or adjustment of a treatment protocol. In still other aspects, such concordance of positive results by external assessment means with concurrent feedback of moderate side effects may nonetheless result in a decision by a care giver to remain on the existing treatment protocol with a ‘watch and wait” approach by the care giver, to determine if ultimately a positive endpoint desired is reached, at which time the treatment protocol will then be cancelled or otherwise adjusted. In still other embodiments, when side effects are severe yet positive results by external assessment meansare obtained, a change in the treatment protocol may be introduced, which in some embodiments, changes the treatment regimen altogether or in some embodiments, provides additional agents that reduce the severity or otherwise improves the side effects experienced by the patient.

[0393] In another embodiment, as depicted in Figure 10, the results obtained from sources other than the questionnaire are input by a care team member or by the patient into the systems / devices / and in use by the methods of the invention directly so that the side effects experienced by the patient, as well as the assessment of a clinically significant result, such as for example, a desired clinical endpoint being reached, which comprises a therapeutic effect, a lack of adverse event of pre-determined scale, or a combination thereof, and as can be seen from the flow diagram of Figure 9, similar assessment of the concurrent absence / low incidence of side effects or information gleaned from questionnaire data and absence of significant results input by the care giver, may result in the programming to provide for maintaining the subject on the existing treatment regimen for a defined period of time.

[0394] In another embodiment, , as depicted in Figure 11A-11B, patient replies to the questionnaire are input and additional sensor collected data is input into the device directly so that the side effects experienced by the patient, as well as the assessment of a clinically significant result, such as for example, a desired clinical endpoint being reached, which comprises a therapeutic effect, a lack of adverse event of pre-determined scale, or a combination thereof, can be assessed on the device. Similar to previous flow diagrams, assessment of the concurrent absence / low incidence of side effects or information gleaned from questionnaire data and absence of significant results input by the sensor retrieved data, may result in the programming to provide for maintaining the subject on the existing treatment regimen for a defined period of time. According to this aspect and in some embodiments, the presence of significant results as collected from the sensor retrieved data, with no or minimal side effects as assessed from questionnaire data may result in the care team personnel / programming promoting switching from the first distribution program to a second distribution program (i.e. altering the existing distribution program). In other aspects of this embodied flow chart, when the side effects are moderate, yet significant results obtained are input by sensor retrieved data, this may result in programming instituted changes or care team adjustment of a treatment protocol. In still other aspects, such concordance of positive results by sensor collected data with concurrent feedback of moderate side effects may nonetheless result in a decision by a care giver / programming to remain on the existing treatment protocol with a ‘watch and wait” approach by the care giver / programming, to determine if ultimately apositive endpoint desired is reached, at which time the treatment protocol will then be cancelled or otherwise adjusted. In still other embodiments, when side effects are severe yet positive results by sensor collected data are obtained, a change in the treatment protocol may be introduced, which in some embodiments, changes the treatment regimen altogether or in some embodiments, provides additional agents that reduce the severity or otherwise improves the side effects experienced by the patient.

[0395] Similarly, as depicted in Figure 11C-1 ID, as opposed to sensor collected data being input directly as part of the operational connection / inclusion of the sensors to the device directly, externally connected data can be imported to the device through any recognized means (wired or wireless connection, for example, as described herein), with the same downstream decision points as described for Figures 11A-11B being relevant for the flow chart of Figure 11C-11D, as well, whereby if a treatment protocol is to be adjusted, i.e. a first dosage form distribution program is modified to dispense according to the second oral dosage form distribution program, then same may be following input / instructions by a care team member or via programming on-device.

[0396] In other embodiments, the patient is diagnosed with a specific condition, for which a particular medication is described and dispensed, in accordance with the devices / systems / methods of this device. According to this aspect, for example as described by the flow charts of Figures 12A-12B, the medication dispensing program, which in some aspects is included within a first non-transitory computer-readable storage medium having computer executable instructions stored thereon, which when executed by a processor in the device, for example, causes the processor to perform the oral solid dosage form distribution to the subject, which medium is enabled for remote secure communication in real time and which computer executable instructions facilitate distribution of said oral dosage form according to an at least a first distribution program.

[0397] According to this aspect, the device execution will include having a patient address questionnaires which may be a part of specific, relevant questions related to the condition and medication side effects that are posed to the patient and responses to same are recorded, whereby following administration of the therapy including the medication via the Device in accordance with a first distribution program, the patient answers the specifically posed questions and in some embodiments, the Device on which the patient submits his / her replies, may communicate with an external secure non-transitory computer-readable storage medium, which medium is enabled for remote secure communication in real-time and which medium has computer executable instructions stored thereon, which when executed by a processor,promotes collection, input or a combination thereof of subject response data, sensor collected data, or testing result data or any combination thereof to determine whether the first distribution protocol promotes a desired clinical endpoint being reached and imports the patients results, for example, via external device collection of such information. According to these aspects and in some embodiments, the test results are incorporated / introduced by a patient or by a health care provider.

[0398] Further according to this aspect, and in some embodiments, the device / system of this invention will comprise at least one sensor whereby sensor collected information is incorporated within the programming as described herein.

[0399] Still further according to this aspect, and in some embodiments, the device / system of this invention will enable introduction of lab test result data within the programming of the systems / devices and in accordance with the methods of this invention, which in addition to patient questionnaire response analysis and sensor collected data provide an indication of whether side effects and / or clinically significant collected data is present.

[0400] According to this aspect, an assessment of patient side effects, derived from the patients answers to the questionnaire are analyzed. Further according to this aspect and in some embodiments, if no or mild side effects are found, a further analysis may be conducted in parallel or sequentially to further analyze whether clinically significant results from sensor collected data are evident.

[0401] According to this aspect, and in some embodiment, the device will comprise at least one sensor to assess clinically relevant indicators for the patients receiving treatment against established norms, wherein values obtained that deviate from same may be considered in this context as to whether altering a treatment protocol is warranted. In some aspects, sensor data may include sensor assay of blood chemistry and / or blood gas results or vital signs. In other embodiments patient blood tests may be included in the assessment, as relating or validating the sensor collected data, in some embodiments, and in other embodiments, as providing further information regarding the patient clinical outcome profile and / or symptomatology, for consideration in this context. In still other embodiments, imaging results, though not shown, can be further analyzed in this context.

[0402] Still further according to this aspect, if the results from the patient questionnaire / lab test results and / or the results obtained from sensor collected data are negative or suggest no negative impact of the treatment regimen on the subject, then, depending on a decision provided by the care team, or based on pre-established response profiles, the Treatment Protocol may be altered to provide a more aggressive Treatment Protocol. In otherembodiments, if the results from the patient questionnaire / lab test results and / or the results obtained from sensor collected data are negative or suggest no negative impact of the treatment regimen on the subject, then, depending on a decision provided by the care team, or based on pre-established response profiles, the Treatment Protocol may be kept constant, i.e. maintaining the patient on the same Treatment Protocol.

[0403] Still according to this aspect, and in some embodiments, if / when the results from the patient questionnaire / lab test results are positive and the results sensor collected data are positive, then, there is a change in the Treatment Protocol that will commence. In some aspects for example, when only moderate effects are observed, yet there are no clinically significant results from sensor collected sources, the in some embodiments, there may be a further change in the Treatment Protocol to commence a second distribution program, which in some aspects comprises a more aggressive Treatment Protocol or, in some embodiments, alternatively, a care team decision may include a decision to remain on the same Treatment Protocol for a defined period of time, or in some embodiments, until a different outcome is observed from either patient questionnaire data / blood test results collected, or sensor collected data or both.

[0404] In some embodiments, if / when the results from the patient questionnaire / blood test results are positive and the results obtained from sensor collected data are positive, while clinically significant side effects occur, in some aspects, supporting a concern with continuing the existing regimen for the subject, then in some aspects, the second distribution program is engaged to change the Treatment Protocol to a less aggressive Treatment Protocol. In other embodiments, if the results from the patient questionnaire / blood test results are positive and the results obtained from sensor collected data are negative, and optionally indicate moderate to severe side effects, then in most embodied aspects, the treatment program will be altered, however, in some embodiments, a care team decision may include a decision to remain on the same Treatment Protocol for a defined period of time, or in some embodiments, until a different outcome is observed from either patient questionnaire data / blood test results collected, or sensor collected data or both. In some aspects, if / when the results from the patient questionnaire / blood test results are positive and the results obtained from sensor collected data are positive, while clinically significant side effects occur, yet clinically significant data is collected from the sensors, then in some embodiments, the treatment protocol may be altered to include agents to reduce the severity of symptoms in the subject, for example, and not necessarily to change the original medication being provided, however thetreatment protocol is changed to add the additional palliative agent to address symptomatology seen.

[0405] In still other embodiments, for example as described by the flow chart of Figure 12C-12D, in addition to the incorporation of patient response information to questionnaires, the devices / sy stems may comprise and methods may incorporate additional data collected from sensors and further incorporate additional data collected from external devices, which data can be uploaded to be incorporated in the device programming as well. Such external device connection may be direct or indirect, as described herein, and may further be assessed in view of patient lab result information, which is incorporated into device programming as well. According to this aspect and in some embodiments, the lab test result data is collected and, in some aspects, may be separately reviewed by a care team member, and incorporated as appropriate within the programming as described herein, or in other embodiments, the patient may enter the lab test result or such result data may be remotely accessed by the device / system programming, with the remaining branch points and considerations described in the context of the flow diagrams of Figures 12A-12B are applicable in the scenario described in Figure 12C- D, as well.

[0406] In still further embodiments, for example, as depicted by the flow charts of Figures 12E-12F, patient response information to questionnaires is included in on-device programming and the devices / systems may comprise and methods may incorporate data collected from sensors and further incorporate additional data collected from external devices, which data can be uploaded to be incorporated in the device programming as well, as depicted in Figures 12C- 12D. According to this aspect, the additional branch points and decisions / actions as described in Figures 12A-12D are similar, whereby in some embodiments, when a treatment protocol is altered or changed, the care team may be involved in such decision or change or in refining such decision or change and in some embodiments, programming provided within the devices / systems of the invention and / or in accordance with the methods of the invention, will arrive a treatment protocol change, which considers all the information collected from questionnaire replies, sensor collected data, externally provided data, patient symptomatology and other sources, to arrive at the ideal treatment protocol changes / adjustment.

[0407] It will be appreciated that any changes in the treatment protocol may comprise, increasing a dosage of a medication previously administered to a subject, or in some embodiments, replacing the medication previously administered to a subject with a new medication or in some embodiments, combining medications including with the medication previously administered to a subject, or in some embodiments, providing a new combinationof medications to a subject. In other embodiments, changes in the treatment protocol may comprise including agents to address symptoms experienced by the subject, for example, when the medication previously administered to a subject is to be continued, or in other embodiments, when medication previously administered to a subject is to be discontinued, as the circumstances warrant, as will be appreciated by the skilled artisan. In still other embodiments, changes in the treatment protocol may comprise including providing the medication previously administered to the subject, but at a lower dosage than what was previously administered. In some embodiments, reducing the dosage of a previously provided medication may also be accompanied by providing a new medication or combination of medications, which in some embodiments, may include agents to address symptomatology experienced by the patient.

[0408] It will be appreciated that certain embodied aspects are herein described, however improvements and alterations of the basic design of each embodied dispensing device is envisioned, which is not to be interpreted as departing from the embodied invention herein.

[0409] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

[0410] It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as set forth in the appended claims. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed in the scope of the claims.

[0411] All publications, patents, and patent applications mentioned herein are hereby incorporated by reference in their entirety as if each individual publication or patent was specifically and individually indicated to be incorporated by reference. In case of a conflict between the specification and an incorporated reference, the specification shall control. Where number ranges are given in this document, endpoints are included within the range. Furthermore, it is to be understood that unless otherwise indicated or otherwise evident from the context and understanding of one of ordinary skill in the art, values that are expressed as ranges can assume any specific value or subrange within the stated ranges, optionally including or excluding either or both endpoints, in different embodiments of the invention, to the tenth of the unit of the lower limit of the range, unless the context clearly dictatesotherwise. Where a percentage is recited in reference to a value that intrinsically has units that are whole numbers, any resulting fraction may be rounded to the nearest whole number.

[0412] In the claims articles such as "a,", "an" and "the" mean one or more than one unless indicated to the contrary or otherwise evident from the context. Claims or descriptions that include "or" or "and / or" between members of a group are considered satisfied if one, more than one, or all of the group members are present in, employed in, or otherwise relevant to a given product or process unless indicated to the contrary or otherwise evident from the context. The invention includes embodiments in which exactly one member of the group is present in, employed in, or otherwise relevant to a given product or process. The invention also includes embodiments in which more than one, or all of the group members are present in, employed in, or otherwise relevant to a given product or process. Furthermore, it is to be understood that the invention provides, in various embodiments, all variations, combinations, and permutations in which one or more limitations, elements, clauses, descriptive terms, etc., from one or more of the listed claims is introduced into another claim dependent on the same base claim unless otherwise indicated or unless it would be evident to one of ordinary skill in the art that a contradiction or inconsistency would arise. Where elements are presented as lists, e.g. in Markush group format or the like, it is to be understood that each subgroup of the elements is also disclosed, and any element(s) can be removed from the group. It should it be understood that, in general, where the invention, or aspects of the invention, is / are referred to as comprising particular elements, features, etc., certain embodiments of the invention or aspects of the invention consist, or consist essentially of, such elements, features, etc. For purposes of simplicity those embodiments have not in every case been specifically set forth in haec verba herein. Certain claims are presented in dependent form for the sake of convenience, but Applicant reserves the right to rewrite any dependent claim in independent format to include the elements or limitations of the independent claim and any other claim(s) on which such claim depends, and such rewritten claim is to be considered equivalent in all respects to the dependent claim in whatever form it is in (either amended or unamended) prior to being rewritten in independent format.

Claims

[00413] WHAT IS CLAIMED IS:

1. A method for personal, secure authenticated provision of oral solid dosage forms, administered as a dosage regimen which may be altered over time, the method comprising the steps of:• providing a device for personal secure administration of oral solid dosage forms to a subject, said device comprising: o a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of at least a second oral dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said solid oral dosage form, or any combination thereof; o wherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following a personal authentication protocol; and o wherein said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program; o wherein said device comprises a user interface and optionally at least one sensor; and o wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and o whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof;• completing an authentication protocol for dispensing said oral dosage form to said subject and dispensing said first oral dosage form within an oral cavity of said subject;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral dosage form distribution program in said device; and• dispensing said oral dosage forms of said second oral dosage form distribution program to said subject; whereby an oral dosage form regimen is adjusted, altered or overwritten in said device resulting in altering dispensing of said oral dosage form, by means of a secure authenticated protocol.

2. The method of claim 1, wherein said device is equipped with communications infrastructure whereby authorized medical personnel may introduce a second dispensing program, which is distinguished from the first dispensing program, so that oral dosage forms dispensed to the subject differ from that which would have been dispensed to the subject, by means of the first dispensing program.

3. The method of claim 1, wherein said subject has a condition, whereby a treatment regimen provides for increasing the dosage of the treatment over time.

4. The method of claim 3, whereby said programming refers to subject response data, sensor collected data, or testing result data or any combination thereof collected from said subject and promotes altering said first secure distribution program, such that said second distribution program may commence or may be itself further altered if said collected subject response data, sensor collected data, or testing result data or any combination thereof differs from established values for said collected subject response data, sensor collected data, or testing result data or any combination thereof.

5. The method of claim 3, whereby said programming can promote said second dispensing program to increase a solid oral form dosage rapidly if the subject does not display significant negative symptomatology as the dosage is increased, as determined by said subject response data, sensor collected data, or testing result data or any combination thereof as collected from said subject.

6. The method of claim 3, whereby said programming can promote said second dispensing program to increase a solid oral form dosage rapidly if the subject does not display significant negative symptomatology as the dosage is increased, as determined by data input by a medical caregiver of the subject.

7. The method of claim 3, whereby said programming can promote said second dispensing program to increase a solid oral form dosage rapidly if the subject displays therapeutic effects as a result of increasing the dosage.

8. The method of claim 3, wherein said second dispensing program increases the dosage or the frequency of distribution of the oral dosage form, or a combination thereof.

9. The method of claim 3, wherein said subject has cancer and said first oral dosage form or second oral dosage form or any combination thereof is a chemotherapy agent.

10. The method of claim 1, wherein said device comprises at least a third solid oral dosage form, which treats or alleviates a side effect in a subject dispensed the first oral dosage or the at least a second oral dosage form or any combination thereof, whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensorcollected data, or testing result data or any combination thereof to further provide said third solid oral dosage form to said subject, as well.

11. The method of claim 10, wherein said third oral dosage form is an analgesic, an antiemetic, an anti-diarrheal, a steroid, an immunosuppressant, a growth factor, or any combination thereof.

12. The method of claim 1, wherein said subject has a condition, whereby a treatment regimen provides for decreasing the dosage of the treatment over time.

13. The method of claim 12, whereby said programming refers to subject response data, sensor collected data, or testing result data or any combination thereof collected from said subject and promotes altering said first secure distribution program, such that said second distribution program may commence or may be itself further altered if said collected subject response data, sensor collected data, or testing result data or any combination thereof differs from established values for said collected subject response data, sensor collected data, or testing result data or any combination thereof.

14. The method of claim 12, whereby said programming can promote said second dispensing program to decrease a solid oral form dosage rapidly if the subject displays significant negative symptomatology following the first dispensing program, as determined by said sensor collected data, subject response data, or testing result data or a combination thereof as collected from said subject.

15. The method of claim 12, wherein said second dispensing program decreases the dosage or the frequency of distribution of the oral dosage form, or a combination thereof.

16. The method of claim 3, wherein said subject has cancer and said first oral dosage form or second oral dosage form or any combination thereof is a chemotherapy agent.

17. The method of claim 1, wherein said subject response data comprises responses input by said subject to questions posed in a questionnaire.

18. The method of claim 17, wherein said responses relate to symptomatology, pain existence, pain severity, or any combination thereof.

19. The method of claim 18, wherein said symptomatology comprises gastrointestinal symptoms, fatigue, or respiratory function or any combination thereof.

20. The method of claim 1, wherein said sensor collected data comprises vital signs, body temperature, oxygenation, circulating glucose levels or any combination thereof.

21. The method of claim 1, wherein said testing result data may comprise blood test results, imaging results, or a combination thereof.

22. . The method of claim 1, wherein sensor data may be collected from sensors located externally to said device, but in communication with said device, said authorized medical personnel or a combination thereof.The methos of claim 1, wherein said method further provides for secure authenticated provision of an oral cancer therapeutic, wherein said plurality of individually addressable oral dosage forms contained therein comprise oral cancer therapeutics, and wherein a first oral cancer therapeutic of said plurality contained therein differs from that of at least a second oral cancer therapeutic of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral cancer therapeutics, or any combination thereofand whereby an oral cancer therapeutic regimen is adjusted, altered or overwritten in said device resulting in altering dispensing of said oral cancer therapeutic, by means of a secure authenticated protocol.

23. The method of claim 1, which method further provides for optimization of secure authenticated provision of oral solid dosage forms to a subject in need thereof,• whereby an oral solid dosage form regimen is adjusted, altered or overwritten in said device as a consequence of said collected subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof, resulting in optimized dispensing of said oral solid dosage forms, by means of a secure authenticated protocol.

24. A system for personal secure administration of oral solid dosage forms to a subject, said system comprising:• a secured personal oral solid dosage form delivery device dispensing a solid oral dosage form to a subject, said device comprising: o a first non-transitory computer-readable storage medium having computer executable instructions stored thereon, which when executed by a processor, causes the processor to perform the oral solid dosage form distribution to a subject, which medium is enabled for remote secure communication in real time and which computer executable instructions facilitate distribution of said oral dosage form according to an at least a first distribution program, a second distribution program or a combination thereof; o a subj ect user interface; o optionally at least one sensor;o a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality differs from that of at least a second oral dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form, or any combination thereof; and■ wherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following at least a personal authentication protocol; and■ wherein operation of dispensing in said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program; and o a second secure non-transitory computer-readable storage medium, which medium is enabled for remote secure communication in real-time and which medium has computer executable instructions stored thereon, which when executed by a processor, promotes collection, input or a combination thereof of subject response data, sensor collected data, or testing result data or any combination thereof to determine whether a first distribution protocol promotes a desired clinical endpoint being reached,■ wherein the desired clinical endpoint comprises a therapeutic effect, a lack of adverse event of pre-determined scale, or a combination thereof,■ which reaching of the desired clinical endpoint reflects collected subject response data, sensor collected data, or testing result data or any combination thereof meeting established values;■ wherein reaching said desired clinical endpoint results in maintenance of said first distribution program; and■ wherein lack of a therapeutic effect, presence of an adverse event of pre-determined scale, or a combination thereof results in performing a second distribution program.

25. The system for personal secure administration of oral solid dosage forms of claim 24, wherein the first non-transitory computer-readable storage medium having computer executable instructions stored thereon, which when executed by a processor, causes the processor to perform a personal authentication protocol comprising authentication of a user through at least partial facial recognition, electronic key or tag authentication; or a combination thereof.

26. The system for personal secure administration of oral solid dosage forms of claim 24, wherein the plurality of oral dosage forms which differ in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form are sorted into separate individually addressable compartments in said device.

27. The system for personal secure administration of oral solid dosage forms of claim 24, wherein the device dispenses a single oral dosage form at a time.

28. The system for personal secure administration of oral solid dosage forms of claim 24, wherein the device dispenses a defined plurality of said dosage forms, controlled by said programming.

29. The system for personal secure administration of oral solid dosage forms of claim 28, wherein the programming promotes increasing the number of oral dosage forms dispensed to a subject.

30. The system for personal secure administration of oral solid dosage forms of claim 90, wherein the programming promotes decreasing the number of oral dosage forms dispensed to a subject.

31. The system for personal secure administration of oral solid dosage forms of claim 24, wherein the oral solid dosage form secure distribution device is a hand-held device, having a plurality of individually contained, individually addressable oral dosage forms contained therein32. The system for personal secure administration of oral solid dosage forms of claim 31, wherein the hand-held oral solid dosage form secure distribution device contains a tamper proof casing within which the solid dosage form holder is contained.

33. The system for personal secure administration of oral solid dosage forms of claim 32, wherein the tamper-proof container prevents access to the oral dosage forms housed therein and only through coordinated, authorized use with the hand-held oral solid dosage form secure distribution device can specific oral dosage forms be dispensed to a specific user.

34. The system for personal secure administration of oral solid dosage forms of any one of claims 32-33, wherein the tamper-proof container will encase a multi-chamber holder, which multi-chamber holder is individually addressable so that the multiple chambers in which the oral dosage forms are contained each comprise access portals sized to accommodate pass- through of the oral solid dosage forms contained therein; whereby upon regulated and authenticated alignment of the chamber access portal with an appropriate dispensing structure in the device, can the oral solid dosage forms for a single dosage regimen be dispensed.

35. The system for personal secure administration of oral solid dosage forms of any one of claims 32-34, wherein the regulated and authenticated alignment is subject to securityprotocols encoded in said first non-transitory computer-readable storage medium having computer executable instructions stored thereon, which when executed by a processor, regulate movement of the multi-chamber holder within the tamper-proof container.

36. The system for personal secure administration of oral solid dosage forms of any one of claims 32 - 35, wherein only upon authentication of the user following specific security protocols, can the user access the dispensing program, and only when the suer inserts the dispenser part into the oral cavity of the user will dispensing of the solid oral dosage form occur.

37. The system for personal secure administration of oral solid dosage forms of any one of claims 32 - 36, wherein the solid dosage form holder may be a rotatable or advanceable carousel structure containing multiple compartments, each compartment containing one or more oral dosage forms for dispensing for a single dosage regimen.

38. The system for personal secure administration of oral solid dosage forms of claim 37, wherein said programming promotes skipping a compartment, to align the desired compartment so that dispensing of the solid dosage forms located therein can be specifically addressed.

39. The system for personal secure administration of oral solid dosage forms of claim 37, wherein said programming promotes rotation of said container in an opposing direction, to align the desired compartment so that dispensing of the solid dosage forms located therein can be specifically addressed.

40. The system for personal secure administration of oral solid dosage forms of claim 24, wherein for any authenticated user, a dispensing program for dispensing the oral dosage forms contained in the device has been established.

41. The system for personal secure administration of oral solid dosage forms of claim 24, wherein authorized medical personnel may securely access said first or second non-transitory computer-readable storage mediums or a combination thereof in order to introduce or modify said second dispensing program, which is distinguished from said first dispensing program, so that the oral dosage forms dispensed to the subject differ from that which would have been dispensed to the subject, by means of the first dispensing program.

42. The system for personal secure administration of oral solid dosage forms of claim 24, wherein the solid dosage form holder may accommodate blister pack encased solid dosage forms and be further equipped with a blister-pack releasing element to specifically and addressably release the oral dosage forms for dispensing for a single dosage regimen located in a given blister pack, contained in the holder compartment, for programmed release.

43. The system for personal secure administration of oral solid dosage forms of claim 24, wherein the oral solid dosage form secure distribution device ensures secure dispensing of the oral solid dosage forms contained therein through components in the device in coordination with secure protocols enabling operation of the device to dispense the oral solid dosage form only to the subject for which such dispensing is intended.

44. The system for personal secure administration of oral solid dosage forms of claim 24, wherein the oral solid dosage form secure distribution device is a bulk device, having a plurality of individually contained, individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of a subsequent oral dosage form of said plurality, in terms of an active ingredient type, dosage, or composition component of said oral dosage form, or a combination thereof.

45. The system for personal secure administration of oral solid dosage forms of claim 44, wherein said bulk device contains a tamper proof locking mechanism preventing access to the solid dosage forms contained therein in the absence of user identification following secure protocols.

46. . The system for personal secure administration of oral solid dosage forms of claim 44, wherein said bulk device may further comprise a secure hand-held device, which can be loaded through a secure program in said bulk device.

47. The system for personal secure administration of oral solid dosage forms of claim 44, wherein said device prevents access to the oral dosage forms housed therein and only through coordinated, authorized use with the secure distribution protocol can specific oral dosage forms be dispensed to a specific user.

48. The system for personal secure administration of oral solid dosage forms of claim 144, wherein said device comprises multiple individually addressable oral dosage form reservoirs, so that the multiple reservoirs in which the oral dosage forms are contained each comprise access portals sized to accommodate pass-through of the oral solid dosage forms contained therein; whereby upon regulated and authenticated alignment of the chamber access portal with an appropriate dispensing structure in the device, can the oral solid dosage forms for a single dosage regimen be dispensed.

49. The system for personal secure administration of oral solid dosage forms of claim 48, wherein said regulated and authenticated alignment is subject to security protocols built into the device that regulate movement of the oral dosage forms within the bulk device to the dispensing channels.

50. The system for personal secure administration of oral solid dosage forms of claim 48, wherein for any authenticated user, a dispensing program for dispensing the oral dosage forms contained in the device has been established.

51. The system for personal secure administration of oral solid dosage forms of claim 48, wherein the device is equipped with communication means whereby authorized medical personnel may introduce said second dispensing program, which is distinguished from the first dispensing program, so that the oral dosage forms dispensed to the subject differ from that which would have been dispensed to the subject, by means of the first dispensing program.

52. The system for personal secure administration of oral solid dosage forms of claim 48, wherein the bulk oral solid dosage form secure distribution device ensures secure dispensing of the oral solid dosage forms contained therein through components in the device in coordination with secure protocols enabling operation of the device to dispense the oral solid dosage form only to the subject for which such dispensing is intended.

53. The system for personal secure administration of oral solid dosage forms of any one of claims 24-52, wherein said user interface provides for input of information directly from said user.

54. The system for personal secure administration of oral solid dosage forms of any one of claims 24-52, wherein said user interface provides for input of information from an authorized caregiver through a secure protocol.

55. The system for personal secure administration of oral solid dosage forms of claim 53 or claim 54, wherein said user interface includes input of medical information by both said user and said authorized caregiver through a secure protocol.

56. The system for personal secure administration of oral solid dosage forms of any one of claims 24-52, wherein said sensors collect information from the subject during use of said device, and depending on the sensor data obtained, said programming provides for adjusting, altering or overwriting said programming to alter said first distribution program.

57. The system for personal secure administration of oral solid dosage forms of claim 56, wherein said programming further provides for adjusting, altering or overwriting said programming to alter said first distribution program as a function of results obtained from said subject response data, or testing result data or a combination thereof.

58. The system for personal secure administration of oral solid dosage forms of any one of claims 24-52, wherein said programming provides for adjusting, altering or overwriting said programming to alter said first distribution program as a function of results obtained from said subject response data, or testing result data or a combination thereof.59 The system for personal secure administration of oral solid dosage forms of any one of claims 24-52, wherein said oral solid dosage form secure distribution device is subject tosub oct.

60. The system for personal secure administration of oral solid dosage forms of any one of claims 24-59, wherein said device comprises at least a third solid oral dosage form, which treats or alleviates a side effect in a subject dispensed the first oral dosage or the at least a second oral dosage form or any combination thereof.

61. The system for personal secure administration of oral solid dosage forms of any one of claims 24-59, wherein said system is used as part of a method for personal, secure authenticated provision of oral solid dosage forms, administered as a dosage regimen which may be altered over time, the method comprising the steps of:• providing the device for personal secure administration of oral solid dosage forms to the subject;• completing an authentication protocol for dispensing said oral dosage form to said subject and dispensing said first oral dosage form within an oral cavity of said subject;• wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and• whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral dosage form distribution program in said device; and• dispensing said oral dosage forms of said second oral dosage form distribution program to said subject; whereby an oral dosage form regimen is adjusted, altered or overwritten in said device resulting in altering dispensing of said oral dosage form, by means of a secure authenticated protocol.

62. The system for personal secure administration of oral solid dosage forms of claim 61, wherein said subject has a condition, whereby a treatment regimen provides for increasing the dosage of the treatment over time.

63. The system for personal secure administration of oral solid dosage forms of claim 61, wherein said subject has a condition, whereby a treatment regimen provides for decreasing the dosage of the treatment over time.

64. The system for personal secure administration of oral solid dosage forms of any one of claims 24-59, wherein said system is used as part of a method for secure authenticated provision of an oral cancer therapeutic, the method comprising the steps of:• providing the device for personal secure administration of oral cancer therapeutics to the subject;• completing an authentication protocol for dispensing said cancer therapeutic to said subject and dispensing a first cancer therapeutic within an oral cavity of said subject;• wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and• whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second cancer therapeutic distribution program in said device; and• dispensing said oral cancer therapeutic of said second oral cancer therapeutic distribution program to said subject;• whereby an oral cancer therapeutic regimen is adjusted, altered or overwritten in said device resulting in altering dispensing of said oral dosage form, by means of a secure authenticated protocol.

65. The system for personal secure administration of oral solid dosage forms of claim 64, wherein said subject has a condition, whereby a treatment regimen provides for increasing the dosage of the treatment over time.

66. The system for personal secure administration of oral solid dosage forms of claim 64, wherein said subject has a condition, whereby a treatment regimen provides for decreasing the dosage of the treatment over time.

67. The system for personal secure administration of oral solid dosage forms of any one of claims 24-59, wherein said system is used as part of a method for optimization of secureauthenticated provision of oral solid dosage forms to a subject in need thereof, the method comprising the steps of:• providing the device for personal secure administration of oral cancer therapeutics to the subject;• completing an authentication protocol for dispensing said oral solid dosage forms to said subject and dispensing said first oral solid dosage form to said subject; o wherein subject compliance with said first secure distribution program is collected and incorporated in said programming; o wherein subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof is collected and incorporated in said programming; and o whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof;• following secure communication with an authorized provider, enabling adjustment, alteration or overwriting of said programming to activate said second oral solid dosage form distribution program in said device; and• dispensing said oral solid dosage form of said second oral solid dosage form distribution program to said subject;• whereby an oral solid dosage form regimen is adjusted, altered or overwritten in said device as a consequence of said collected subject response data, sensor collected data, testing result data, subject compliance information or any combination thereof, resulting in optimized dispensing of said oral solid dosage forms, by means of a secure authenticated protocol.

68. A device for personal secure administration of oral solid dosage forms, comprising a plurality of individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of at least a second oral dosage form of said plurality, in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form, or any combination thereof; owherein the device provides for dispensing at least one individually addressable oral dosage form contained therein following a personal authentication protocol; ando wherein said device is subject to programming, which programming controls distribution of said oral dosage forms contained therein according to a first secure distribution program; owherein said device comprises a user interface and optionally at least one sensor; and o wherein subject response data, sensor collected data, or testing result data or any combination thereof is collected and incorporated in said programming; and whereby said programming controls adjusting, altering or overwriting said first distribution program via a secure protocol to a second distribution program, as a function of said collected subject response data, sensor collected data, or testing result data or any combination thereof.

69. The oral solid dosage form secure distribution device of claim 68, wherein the personal authentication protocol comprises authentication of a user through at least partial facial recognition, electronic key or tag authentication; or a combination thereof.

70. The oral solid dosage form secure distribution device of claim 68, wherein the plurality of oral dosage forms which differ in terms of an active ingredient type, an active ingredient dosage, or a composition component of said oral dosage form are sorted into separate individually addressable compartments in said device.

71. The oral solid dosage form secure distribution device of claim 68, wherein the device dispenses a single oral dosage form at a time.

72. The oral solid dosage form secure distribution device of claim 68, wherein the device dispenses a defined plurality of said dosage forms, controlled by said programming.

73. The oral solid dosage form secure distribution device of claim 72, wherein the programming promotes increasing the number of oral dosage forms dispensed to a subject.

74. The oral solid dosage form secure distribution device of claim 72, wherein the programming promotes decreasing the number of oral dosage forms dispensed to a subject.

75. The oral solid dosage form secure distribution device of claim 68, wherein the oral solid dosage form secure distribution device is a hand-held device, having a plurality of individually contained, individually addressable oral dosage forms contained therein76. The oral solid dosage form secure distribution device of claim 75, wherein the handheld oral solid dosage form secure distribution device contains a tamper proof casing within which the solid dosage form holder is contained.

77. The oral solid dosage form secure distribution device of claim 76, wherein the tamperproof container prevents access to the oral dosage forms housed therein and only throughcoordinated, authorized use with the hand-held oral solid dosage form secure distribution device can specific oral dosage forms be dispensed to a specific user.

78. The oral solid dosage form secure distribution device of any one of claims 76-77, wherein the tamper-proof container will encase a multi-chamber holder, which multi-chamber holder is individually addressable so that the multiple chambers in which the oral dosage forms are contained each comprise access portals sized to accommodate pass-through of the oral solid dosage forms contained therein; whereby upon regulated and authenticated alignment of the chamber access portal with an appropriate dispensing structure in the device, can the oral solid dosage forms for a single dosage regimen be dispensed.

79. The oral solid dosage form secure distribution device of any one of claims 76-78, wherein the regulated and authenticated alignment is subject to security protocols built into the device that regulate movement of the multi -chamber holder within the tamper-proof container.

80. The oral solid dosage form secure distribution device of any one of claims 76-79, wherein only upon authentication of the user following specific security protocols, can the user access the dispensing program, whereby the device, when inserted into the oral cavity of the user will dispense a prescribed dosage regimen into the oral cavity of the user.

81. The oral solid dosage form secure distribution device of any one of claims 76-80, wherein the solid dosage form holder may be a rotatable or advanceable carousel structure containing multiple compartments, each compartment containing one or more oral dosage forms for dispensing for a single dosage regimen.

82. The oral solid dosage form secure distribution device of any one of claims 81, wherein said programming promotes skipping a compartment, to align the desired compartment so that dispensing of the solid dosage forms located therein can be specifically addressed.

83. The oral solid dosage form secure distribution device of any one of claims 81, wherein said programming promotes rotation of said container in an opposing direction, to align the desired compartment so that dispensing of the solid dosage forms located therein can be specifically addressed.

84. The oral solid dosage form secure distribution device of claim 68, wherein for any authenticated user, a dispensing program for dispensing the oral dosage forms contained in the device has been established.

85. The oral solid dosage form secure distribution device of claim 68, wherein the device is equipped with communication means whereby authorized medical personnel may introduce said second dispensing program, which is distinguished from the first dispensing program, so that the oral dosage forms dispensed to the subject differ from that which would have been dispensed to the subject, by means of the first dispensing program.

86. The oral solid dosage form secure distribution device of claim 68, wherein the solid dosage form holder may accommodate blister pack encased solid dosage forms and be further equipped with a blister-pack releasing element to specifically and addressably release the oral dosage forms for dispensing for a single dosage regimen located in a given blister pack, contained in the holder compartment, for programmed release.

87. The oral solid dosage form secure distribution device of claim 68, wherein the oral solid dosage form secure distribution device ensures secure dispensing of the oral solid dosage forms contained therein through components in the device in coordination with secure protocols enabling operation of the device to dispense the oral solid dosage form only to the subject for which such dispensing is intended.

88. The oral solid dosage form secure distribution device of claim 68, wherein the oral solid dosage form secure distribution device is a bulk device, having a plurality of individually contained, individually addressable oral dosage forms contained therein, wherein a first oral dosage form of said plurality contained therein differs from that of a subsequent oral dosage form of said plurality, in terms of an active ingredient type, dosage, or composition component of said oral dosage form, or a combination thereof.

89. The oral solid dosage form secure distribution device of claim 88, wherein said bulk device contains a tamper proof locking mechanism preventing access to the solid dosage forms contained therein in the absence of user identification following secure protocols.

90. . The oral solid dosage form secure distribution device of claim 88, wherein said bulk device may further comprise a secure hand-held device, which can be loaded through a secure program in said bulk device.

91. The oral solid dosage form secure distribution device of claim 88, wherein said device prevents access to the oral dosage forms housed therein and only through coordinated, authorized use with the secure distribution protocol can specific oral dosage forms be dispensed to a specific user.

92. The oral solid dosage form secure distribution device of claim 88, wherein said device comprises multiple individually addressable oral dosage form reservoirs, so that the multiple reservoirs in which the oral dosage forms are contained each comprise access portals sized to accommodate pass-through of the oral solid dosage forms contained therein; whereby upon regulated and authenticated alignment of the chamber access portal with an appropriate dispensing structure in the device, can the oral solid dosage forms for a single dosage regimen be dispensed.

93. The oral solid dosage form secure distribution device of claim 92, wherein said regulated and authenticated alignment is subject to security protocols built into the device that regulate movement of the oral dosage forms within the bulk device to the dispensing channels.

94. The oral solid dosage form secure distribution device of claim 92, wherein for any authenticated user, a dispensing program for dispensing the oral dosage forms contained in the device has been established.

95. The oral solid dosage form secure distribution device of claim 92, wherein the device is equipped with communication means whereby authorized medical personnel may introduce said second dispensing program, which is distinguished from the first dispensing program, so that the oral dosage forms dispensed to the subject differ from that which would have been dispensed to the subject, by means of the first dispensing program.

96. The oral solid dosage form secure distribution device of claim 92, wherein the bulk oral solid dosage form secure distribution device ensures secure dispensing of the oral solid dosage forms contained therein through components in the device in coordination with secure protocols enabling operation of the device to dispense the oral solid dosage form only to the subject for which such dispensing is intended.

97. The oral solid dosage form secure distribution device of any one of claims 68-95, wherein said user interface provides for input of information directly from said user.

98. The oral solid dosage form secure distribution device of any one of claims 68-95, wherein said user interface provides for input of information from an authorized caregiver through a secure protcol.

99. The oral solid dosage form secure distribution device of claim 98, wherein said user interface includes input of medical information by both said user and said authorized caregiver through a secure protocol.

100. The oral solid dosage form secure distribution device of any one of claims 68-95, wherein said sensors collect information from the subject during use of said device, and depending on the sensor data obtained, said programming provides for adjusting, altering or overwriting said programming to alter said first distribution program.

101. The oral solid dosage form secure distribution device of claim 100, said programming further provides for adjusting, altering or overwriting said programming to alter said first distribution program as a function of results obtained from said subject response data, or testing result data or a combination thereof.

102. The oral solid dosage form secure distribution device of any one of claims 68-95, said programming provides for adjusting, altering or overwriting said programming to alter saidfirst distribution program as a function of results obtained from said subject response data, or testing result data or a combination thereof.

103. The oral solid dosage form secure distribution device of any one of claims 68-95, wherein said oral solid dosage form secure distribution device is subject to image recognition-104. The oral solid dosage form secure distribution device of any one of claims 68-103, wherein said device comprises at least a third solid oral dosage form, which treats or alleviates a side effect in a subject dispensed the first oral dosage or the at least a second oral dosage form or any combination thereof.

Images