OF MINI-TABLETS

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority from US Provisional Patent Application No. 62/591,017, filed November 27, 2017, entitled “SYSTEM, APPARATUS AND METHOD FOR PERSONALIZED MEDICATION DISPENSING MANAGEMENT”, which is incorporated in its entirety herein by reference, and from US Provisional Patent Application No. 62/591,024, filed November 27, 2017, entitled“PILLS FOR PERSONALIZED MEDICATION DISPENSING”, which is incorporated in its entirety herein by reference.

FIELD OF THE INVENTION

[001] The present invention relates to medication dispensing, in particular personalized medication dispensing.

BACKGROUND OF THE INVENTION

[002] Currently, only around 20% of pharmaceutical products developed eventually end up as a commercial product. Furthermore, even the most successful drugs that get to market have the intended efficacy on about 70% of the patients. Additionally, medication dosages are typically dispensed for the "average person", such that if the actual user is not average, they will receive too little or too much medication, with unnecessary side effects.

[003] Moreover, medicine prescriptions typically exclude “Flexible Dose Combinations” for Multiple Chronic Conditions (MCC) patients. [004] About 40% of patients fail to fill an original prescription, and over 50% discontinue taking their medications within a year. Therefore, in the U.S. alone, wasted healthcare costs are estimated to be $100 billion to $280 billion annually. In the US alone, at least 1.5 million medication errors occur every year, with poison control centers logging them at a rate of one every 21 seconds.

[005] The effectiveness of prescription medicines today is limited, for a combination of reasons, including a lack in patients' adherence to medication regime over time; medication errors by patients or by medical professionals; the use of multiple medications by some patients and the variation in frequency and dosages; and limited options to personalize the dosage or combination of dosages to specific patient needs due to limited availability of dosage scales and combinations.

[006] Additionally, the conventional handling of medicines at the end of the supply chain (e.g. pharmacy to patient at the patient's home), is poor and can result in the substantial waste of products when considering expired medications, misuse by other users at home, and storage in inappropriate conditions.

SUMMARY OF THE INVENTION

[007] In accordance with embodiments of the present invention, there is provided a system and apparatus for dispensing personalized medication. The apparatus includes a removable cartridge configured to house a plurality of medications including multiple mini-tablets of one or more medications for specific patient(s), and empty capsules usable in the preparation of the personalized medication; a holding chamber configured to house a plurality of medications including multiple mini-tablets of one or more medications, and empty capsules, the holding chamber being configured to feed an encapsulation unit, the encapsulation configured to capsulate multiple medications from the removable cartridge, that are stored in the holding chamber, in the right number/quantity based on medical prescription for the patient(s), into a medicinal capsule; and a dispensing unit, designed to dispense the capsule and/or any medications from the removable cartridge.

[008] According to some embodiments, the apparatus further includes a user identification module, for authenticating the apparatus user (e.g. patient or caregiver), such that capsules are provided to the user only after user identification has been authenticated. The apparatus therefore can be used by multiple users.

[009] According to some embodiments, the cartridge includes a safety module that is adapted to verify that a cartridge is matched to the apparatus according to its users, said safety module adapted to unlock a locked cartridge only after said matching is authenticated.

[0010] According to some embodiments, the apparatus further includes one or more environment sensors, for example temperature and humidity sensors, adapted to measure the environment of the capsules and mini-tablets, and to communicate storage environment data to a safety module associated with the apparatus.

[0011 ] According to some embodiments, the apparatus further includes a processing unit and memory unit, wherein the processing unit runs code to monitor user prescription adherence/compliance, and to interact with a user to enhance prescription adherence/compliance.

[0012] According to some embodiments, the apparatus further includes a user interface for enabling one or more users to interact with the apparatus in order to manage medication dispensing.

[0013] According to some embodiments, the apparatus further includes a communication unit for communicating user prescription adherence data with one or more user related sources consisting of a medical system, medical practitioner, distribution pharmacy, filling center, care giver, other apparatuses for dispensing personalized medication, users, and users' peers. [0014] According to some embodiments, the communication unit further includes a notification module, for updating user related sources of one or more of: medication expiry warnings, contra-indications, storage environmental warnings, medication inventory data, user compliance data, apparatus usage data, and cartridge usage data.

[0015] According to some embodiments, the communication unit is adapted to communicate with a cloud-based server in order to transfer data between the apparatus and the cloud-based server.

[0016] According to some embodiments, the apparatus further includes a control unit to track apparatus usage by one or more users, the control unit adapted to communicate selected usage data to one or more system users.

[0017] In accordance with embodiments of one aspect of the present invention, there is provided a removable multiple-medication cartridge (MMC) for supplying multiple medications to a personalized medication dispensing apparatus (PMDA). The cartridge includes (a) multiple compartments for housing multiple medications and a compartment for holding empty capsules; (b) an identification mechanism for identifying one or more of: cartridge ingredients, a prescription identifier, a user identifier, an expiration date, and warning data; (c) a locking mechanism for keeping the holding container locked until the MMC has been verified by the PMDA; and (d) a medication release mechanism adapted to release medications from one or more compartments, in accordance with a capsule encapsulation instruction received from the PMDA.

[0018] According to some embodiments, the cartridge further includes a compartment for housing a desiccant.

[0019] In accordance with embodiments of another aspect of the present invention, there is provided a mini-tablet for personalized dispensing (MTPD) designed to be contained in a personalized medication capsule (PMC), the MTPD including a medication with a minimal clinically approved active ingredient dosage compressed into a tablet with a 2.5-4mm diameter size. [0020] According to some embodiments, the mini-tablet is designed to be of a size that enables 11-16 mini-tablets to be contained in a standard #0 size medicinal capsule, and/or and 16-21 mini-tablets to be contained in a standard #00 size medicinal capsule. According to some embodiments, the mini-tablet is designed for usage in a personalized medication dispensing apparatus (PMDA) using the personalized medication dispensing system (PMDS).

[0021 ] According to some embodiments, multiple MTPDs are designed to be able to optimally fit into a standard medication capsule size, maximizing the number of MTPDs and the amount of active ingredient in each of them

[0022] According to some embodiments, the mini-tablet is ball shaped, to enable efficient and fluent flow in the PMDA mechanism.

[0023] According to some embodiments, the mini-tablet is cosmetic coated, to enable efficient and fluent flow in the PMDA mechanism.

[0024] According to some embodiments, the mini-tablet is colored for active material identification.

[0025] System, apparatuses and methods are herein provided for managing personalized medication capsulation and dispensing, comprising elements described herein.

[0026] A smart medication cabinet is herein provided, for managing personalized medication prescription management, inventory management, medication capsulation, medication adherence or compliance.

[0027] Possible advantages of the present invention include preventing medication abuse; and/or increasing compliance; and/or improving efficacy. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The principles and operation of the system, apparatus, and method according to the present invention may be better understood with reference to the drawings, and the following description, it being understood that these drawings are provided for illustrative purposes only and are not meant to be limiting, wherein:

[0029] Fig. 1 is a schematic system diagram depicting components of a personalized medication dispensing system (PMDS), according to some embodiments;

[0030] Fig. 2 is a schematic diagram depicting components of the personalized medication dispensing apparatus (PMDA), and PMDS elements with which a user interacts, according to some embodiments;

[0031] Fig. 3 is a schematic diagram depicting components of an encapsulation unit of the personalized medication dispensing apparatus (PMDA), according to some embodiments;

[0032] Fig. 4 is a flow diagram depicting a process by which personalized medication is capsulized in an end-user environment, using the PMDA, according to some embodiments;

[0033] Fig. 5 is a flow diagram depicting a process by which personalized medication is dispensed to a user, in association with the PMDS, according to some embodiments;

[0034] Fig. 6 is a schematic diagram depicting various subsystems associated with and driven by the PMDS, according to some embodiments;

[0035] Figs. 7A-7C are screenshots or graphic simulations of examples of a patient dispensing apparatus or a Personalized Secure Medication Cabinet (PSMC), and related medication dispensing elements, in accordance with some embodiments;

[0036] Fig. 7D is a flow chart depicting an example of a personal prescription processing method, according to some embodiments, and [0037] Figs. 8 A- 81 are examples of graphic renditions of the patient dispensing apparatus, according the several embodiments.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0038] The following description is presented to enable one of ordinary skill in the art to make and use the invention as provided in the context of a particular application and its requirements. Various modifications to the described embodiments will be apparent to those with skill in the art, and the general principles defined herein may be applied to other embodiments. The present invention is not intended to be limited to the particular embodiments shown and described, but is to be accorded the widest scope consistent with the principles and features herein disclosed. In some instances, well-known methods, procedures, and components are not described in detail so as not to obscure the present invention.

[0039] The term "pills" as used herein may refer to capsules, gel-caps, pellets, tablets, meds, caps etc. Further, the term "mini-pills" as used herein may refer to pills that are generally of smaller dimension than standard consumer usage pills. Further, the terms "mini-tablets", "mini-tabs" or derivatives thereof, as used herein may refer to tablets or pills that are generally of smaller dimension than standard consumer usage tablets.

[0040] The terms "mini-pill" or "mini-tab" as used herein, hereinafter referred to as mini-tablet for personalized dispensing (MTPD), refers to, for example, a compressed, ball shaped, 3.5-3.6 mm diameter tablet, with a minimal acceptable active ingredient dosage, which is cosmetically coated and in some embodiments is specifically designed for usage in a personalized medication dispensing system (PMDS) and a personalized medication dispensing apparatus (PMDA), as described below.

[0041] The term "capsule" as used herein, hereinafter referred to as a personalized medication capsule (PMC), refers to, for example, a standard or non-standard capsule designed for encapsulating one or more medications, and which is specifically designed for usage in a personalized medication dispensing system (PMDS) and a personalized medication dispensing apparatus (PMDA), as described below.

[0042] The term "cartridge" or cartridge unit as used herein, hereinafter also referred to as a multi-medication cartridge (MMC), refers to, for example, a cartridge containing multiple medications, some of which are mini-pills, mini-tabs or MTPDs, and which is specifically designed for usage in a PMDS and a PMDA, as described below.

[0043] The term "chamber" or "holding chamber" as used herein, hereinafter also referred to as a MMC holding chamber (MHC), refers to, for example, a chamber, recess, cavity, module and the like, and is specifically designed for usage as a part of a PMDS and a PMDA, as described below.

[0044] Non-limiting embodiments of the present invention include a system, apparatus, device and method for facilitating personalized medication dispensing and compliance management. Embodiments of the present invention may facilitate accurate medication dosages to patients, and adjustment of dosage regimes. Further embodiments of the present invention may facilitate a reduction in medication consumption errors, and facilitate integration of a user's health network into the medication compliance process. Some embodiments of the present invention may facilitate enhanced pharmaceutics tracking and management, as well as efficacy studies and research for the medical community. Some embodiments of the present invention may also facilitate management of prescription medication consumption in a comprehensive way.

[0045] Fig. 1 is a schematic system diagram depicting components of a personalized medication dispensing system (PMDS) 100, according to some embodiments. PMDS 100 includes a personalized medication dispensing apparatus (PMDA) 110, for generating and dispensing personalized medication dosages to an end user 145. PMDS 100 is configured to be usable with a user communication device 150, such as a smartphone, tablet, wearable computer or other communication or computing device, able to run an application, software, code, algorithms etc., for assisting the user in the management of their medication management and compliance. PMDS 100 may also be configured to interact with a network of users associated with end user 145. PMDS 100 further includes a pharmacy station 140, adapted to provide medications in a format usable by PMDA 110. PMDS 100 further includes a health system module 130, for example, for sharing user health or wellness data with the health care system, as needed. PMDS 100 may further be configured to communicate with a doctor and/or medical aid or medical system 135, for enabling the user to acquire medication guidance, support and prescriptions etc. PMDS 100 further includes a PMDS server(s) 115 and PMDS database(s) 120, generally running in a communication network or cloud, for processing and managing PMDS data.

[0046] In one example, one or more users 145, whether the patient/end user of the medication, or an assistant or other system user, may visit or communicate with the doctor or medical system 135 or health system module 130, to get a prescription for one or more medications, drugs, compounds etc., optionally at a specific and/or dynamic dosage for the user. The prescription data may be entered into PMDS database 120, and optionally sent to the health care system of relevance. The prescription data may further be transmitted to pharmacy station 140, and to the end-user(s) associated PMDA 110. In some cases, the pharmacy station 140 may send alerts or communications to PMDA 110, for example, to inform that medications are waiting to be collected. End user(s) 145 or a representative associated with the user may go to the pharmacy station 140 to pick up a supply of medication, or get the medication supply delivered to user(s) 145, optionally in the form of one or more cartridges or containers adapted to be used by PMDA 110, with appropriately formatted and measured medication dosages to fulfil the user's prescription. Optionally, empty cartridges or medications may be returned to the pharmacy station 140. The medication cartridge(s) received from the pharmacy station 140 is inserted into PMDA 110, optionally into a storage or cartridge holding module. PMDA 110 is generally adapted to identify the presence of one or more capsules, and to identify the content of such capsules. PMDA 110 is adapted to initiate a process of encapsulation of medication in accordance with the prescription received, and to dispense the medication to the user. PMDS 100 is adapted to track medication dispensing, for example, to send confirmations, alerts, updates, usage data etc. of medication dispensing, to the user, the user's health care network, the pharmacy station 140, their doctor or health team and/or the health system.

[0047] In some embodiments, PMDA 110 includes one or more removable cartridges 805 (see below) with multiple compartments for multiple mini-tabs, for example, 5 to 30 compartments for holding MTPD or mini-tabs or storing one or more medications. In some embodiments, one or more compartments may contain non-MTPD medications, for example, standard tablets or pills or capsules. In some embodiments, cartridge 805 may include a storage facility for storage of empty capsules.

[0048] In some embodiments, one or more cartridges 805 may be used inside PMDA 110.

[0049] In some embodiments, PMDA 110 may include an encapsulation mechanism for encapsulating personalized medication capsules, optionally for encapsulating multiple medications into capsules. In some embodiments, PMDA 100 includes a control panel plus a processor running code for facilitating data processing and user interaction with PMDA 110. In some embodiments, the PMDA 110 includes a person recognition system (e.g. biometric security or alternative security recognition mechanism etc.); one or more parameter sensors (e.g. temperature, humidity, light etc); a power module, optionally with a backup power source; and a communication module, optionally with WiFi/Bluetooth connectivity.

[0050] In some embodiments, pharmacy station 140 maintains an inventory of medication cartridges 805, for multiple medications, optionally provided by medication manufacturers and/or distributors, and cartridge filling system 142. In some embodiments, medication cartridges 805 or units are filled from bulk storage or packages into dispenser cartridges to be supplied to users of PMDA 110. In some embodiments, the pharmacy station 140 facilitates processing of empty medication cartridges 805 and/or the loading/re-loading of such cartridges, and labelling or marketing of cartridge contents, so that the cartridge contents may be identified and used by the PMDS database(s)l20, other pharmacy stations 140, and any connected PMDA's. [0051] In some embodiments, there is a pharmacy station 140 that includes a plurality of oral drugs or medications, provided in small formats, for example, as mini-tablets or mini-pills (e.g., 2 to 4 mm diameter), to enable dispensing of accurate and flexible dosages of medication. In some embodiments, the pharmacy station 140 is configured to load medication cartridges 805 with all the required medication ingredients for each patient or end user, in accordance with a received medication prescription. The medication package may include one or more medication cartridges 805 filled with medication ingredients/tablets for a period of time, such as for one to three months. In some embodiments, packages and/or cartridges 805 are locked. In some embodiments, one or more locked medication cartridges 805 are provided to a user(s), or delivered to the user(s), to be subsequently loaded into PMDA 110 associated with one or more users.

[0052] In some embodiments, one or more PMDAs 110 are configured to service multiple end users, for example, in a home, medical facility, hospital, nursing home or old aged home or facility. For example, one or more PMDAs 110 may store medication supplies for multiple users, to be dispensed to the individual end users or by medical support staff or other system users. Prescriptions for multiple users may be entered into PMDA 110, and the PMDA may dispense medications to each user upon identification of each user, thereby helping manage dispensing of medication for multiple users.

[0053] In some embodiments, the medication ingredients include known and approved chemical entities in small dosages (e.g., 1-50% of the standard/maximum approved dosage), and may be constructed with small sizes (e.g., 2.5-4 mm diameter) and optionally with coating for reasons such as dust elimination, presentation, controlled release, identification and/or taste. In some embodiments, the medication ingredients are provided in small units, for example, to allow for provision of low dosages, accurate dosages of active compounds, flexible dosages, enable in-house capsulation, allow for multiple medications to be capsulated together etc. In some embodiments, the small profile tablets have physical attributes, for example, size, texture, shape etc. to allow for simplified encapsulation. [0054] Fig. 2 is a schematic diagram depicting components of a PMDS 200 with which a user 205 interacts, according to some embodiments. PMDA 220 is in communication with an end user device 210, for example, a mobile computing or communication device, such as a smart phone, tablet, wearable computer etc. In some embodiments user device 210 runs code or software, such as application 215, to facilitate management of medication dispensing and compliance, in association with the user 205 associated PMDA 220. Application 215 may connect to elements of the PMDS 200, such as pharmacy module 245, medical system 240, and network 230, via a cloud- based communication network and/or via direct access to such elements (e.g., personal visits to an office or dispensary). In some embodiments, user device 210 is connected to a PMDS database 250, which may enable system based Cyber protection, provide system-based patient information management, system-based prescription information management, system-based product information management, and optionally medical system applications, medical professional applications, patient applications, pharmacy applications, dispensary applications, PMDA applications, etc. PMDS database 250 may also enable big data processing and analytics.

[0055] In some embodiments, a personalized prescription for an end user is upload- able to PMDS database 250, typically by a medical practitioner connected to medical system 240. The prescription data may be sent digitally to the pharmacy module 245 and the PMDA 220, thereby allowing both the pharmacy stations 140 and the end user devices to know about the prescriptions, and allowing both the dispensary pharmacy module 245 and the PMDA 220 to follow up on the prescription status. For example, a selected pharmacy station alerts a user when their prescription is ready, is waiting, etc. In a further example, PMDA 220 is configured to alert user 205 to collect a new prescription package, for example, when the medication provided by a current prescription is coming to an end.

[0056] In some embodiments, the PMDA 220 is adapted to monitor the dispensing of medication to a user, in accordance with a provided prescription. The PMDA 220 may also alert the one or more system users when necessary, for example: at the time that the patient is supposed to take the medication; if the patient fails to take medication; load new medication supplies into the PMDA; and if the PMDA malfunctions or is incorrectly accessed. In some examples, the alert is a message or notification on a user device, or on the PMDA 220. In other examples, the alert is a voice alert, a light signal, etc.

[0057] In some cases, an alert may be evolved in increasingly serious ways if the alert has not been deal with. For example, an alert may first be initiated for the patient, and if not dealt with, may be sent to one or more family members, and still later, if still not met, to the patient's doctor or nurse etc.

[0058] PMDA 220 is designed to enable dispensing of personalized multi-medicine capsules, thereby enabling personalized flexible medication dosing prepared at or near the end user location, wherein the specific and correct dosage of medication or combinations of medications can be safely prepared and delivered to the user at the precise time required, as detailed below.

[0059] PMDA 220 modules include a processing unit 255, a communication unit 260, a cartridge unit 265, holding chamber 267, an encapsulation unit 270, and a dispensing unit 275.

[0060] In some embodiments, communication unit 260 includes a mechanism for receiving and transmitting data to external devices or systems, including cell communication capabilities, as well as supporting WiFi, Bluetooth, ZigBee, RFID, etc.

[0061] In some embodiments, cartridge unit 265 includes facilities to handle one or more medication cartridges 265, as well as empty cartridges. Cartridge unit 265 connects to holding chamber 267, which is designed to hold the medications from the cartridge, identify cartridges 265 loaded into the PMDA 220, thereby identifying the medication type(s), quantity(ies), warning(s), etc. Cartridge unit 265 may be designed to accommodate the required volume of medication(s), for example the number of mini-tablets or other medication formats required for the patient for a determined period. Cartridge unit 265 may include one or more sensors, for example, environmental control sensors, to verify that the medications are maintained under proper conditions, such as temperature, humidity, light, etc. In some embodiments, an alert is generated when such conditions are not maintained.

[0062] In some embodiments, encapsulation unit 270 includes one or more mechanisms to extract a precise quantity of medication from one or more cartridges 805 and/or cartridge compartments, in accordance with a user prescription and/or system instruction, and to encapsulate or otherwise prepare the required medication(s) into a capsule(s) or other product to provide to the user. Encapsulation unit 270 may be designed to encapsulate substantially all the medications required by the user in a dosage or at a specific time, optionally into one or more capsules that include one or more medications required by the user. In some embodiments, PMDA 220 is configured to receive feedback from the user, and/or from external sensors, and/or from wearable devices, and/or from external users, and the like. Such feedback may be collected and analyzed together with medication usage data, for example, to enable doctors to view feedback/data and adjust dosages if and how it may be necessary. Such adjustments may be entered into the processing unit 255, to change the prescription and/or preparation for the user.

[0063] In some embodiments, dispensing unit 275 includes one or more medication dispensing elements to deliver the personalized medication to an apparatus user. For example, dispensing unit 275 may include a capsule dispenser, tablet dispenser, powder dispenser, liquid dispenser, etc. In some embodiments, dispensing unit 275 includes one or more identification sensors or mechanisms (e.g., finger print, face recognition, voice recognition etc.), to enable user authentication prior to dispensing medication. In one example, dispensing unit is locked or secured to prevent the abuse of controlled drugs and human errors and/or abuse, using a personal recognition system. In some examples, removable cartridge 805 is tamper evident and/or includes multiple compartments for the different personal medications required. In some examples, the dispenser is used for conventional sized products as well, for non-standardized drugs. In some embodiments, cartridge unit 265 is disposable. In some embodiments, cartridge unit 265 is re-usable. [0064] In some embodiments, a PDMA includes Biometric identification elements, to enable multiple user identification and usage.

[0065] In some embodiments, a PDMA includes a locking mechanism to prevent errors and misuse. For example, the locking mechanism may initiate alerts for security threats.

[0066] In some embodiments, a PDMA includes a Cloud/blockchain log, for example to track every usage or dispensing of medication, optionally for authorized or unauthorized uses.

[0067] In some embodiments, a PDMA includes temperature and/or humidity monitoring, optionally with alarms, alerts, etc.

[0068] In some embodiments, a PDMA includes sound and light signals for dispensing time, and optionally triggers to enable remote calling or messaging, for example, by cellphone, home TV etc. In some example, alters and/or reports may be sent to a nurse, doctor, relative, if medications have not been taken for a pre-determined interval or period.

[0069] In some embodiments, a PDMA includes an internal cartridge holding chamber that is filled by an external or portable cartridge.

[0070] In some embodiments, a PDMA includes one or more counting mechanisms to count mini-tablets (MT) entering into a dispensing mechanism, for example, falling from cells or chambers, weighing mechanism or other relevant counting mechanism, to assure accurate mini-tab counting prior to encapsulation.

[0071] In some embodiments, a PDMA includes a capsule locking/un-locking mechanism, for unlocking one or more external or internal cartridges in the dispensing unit, once the capsule(s) has been established as being a correct, verified, or authorized capsule.

[0072] In some embodiments, a PDMA includes an inventory monitoring and replenishment procedure. For example, the communication unit may be adapted to send a signal to the capsule distributor at a pre-determined time interval (e.g. several days) before one or more drugs are due to run out or expire. [0073] In some embodiments, a PDMA collects and optionally processes information/data from the patient before and/or after dispensing/taking the medication, for example, eating data, sleep data, exercise data, reaction data etc.

[0074] In some embodiments, PDMA includes one or more sensors or data receivers, to receive information or data from users, for example, blood pressure, body temperature, pulse, etc.

[0075] In some embodiments, cartridges and/or a PDMA includes a cartridge tracking element, for tracking the cartridge from the time it leaves the“factory” until the installation time at the end user dispensing unit, as well as the status of the cartridge, for example, full, percentage used, empty, expired, damaged status etc.

[0076] In some embodiments, a PDMA includes process management software that is adapted to monitor the cartridge status and at all times.

[0077] In some embodiments, PDMA 110 includes a maintenance sub-system for testing unit performance and optionally alerting and/or fixing problems.

[0078] According to some embodiments, cartridge unit 265 includes a locking mechanism that is tamper proof.

[0079] According to some embodiments, cartridge unit 265 includes a Cloud or blockchain log Cartridge activity, for example, to store data on location, status, user identification, expiration date, cartridge type, etc.

[0080] In some examples, a removable, optionally tamper evident, cartridge with multiple compartments for the different personal medications required is provided. In some examples, dispenser could be used for conventional size products as well, for non-standardize drugs. In some embodiments the cartridge unit may be disposable. In some embodiments the cartridge unit may be re-usable.

[0081] Fig. 3 is a schematic diagram depicting components of an encapsulation unit 305 of a personalized medication dispensing apparatus (PMDA), according to some embodiments. Encapsulation unit 305 or module may include a processing unit 310, enabled to run software to manage the encapsulation processes, optionally in accordance with prescription data, user data, health system data, user feedback etc. Encapsulation unit 305 may include a controlled storage unit 315, adapted to store one or more medication elements, for example a plurality of medication cartridges holding micro dosages of a plurality of medications. Controlled storage unit 315 may enable environmental control and/or monitoring, to assure medications are maintained in a satisfactory environment. In some embodiments, storage unit 315 includes one or more desiccants or other elements to maintain an acceptable level of humidity. In some embodiments, temperature sensors are included to track unit and/or environment temperatures. Encapsulation unit 305 may include an extraction mechanism 320, to enable selected extraction of one or more medication elements. In some embodiments, a vibrating element is included to vibrate medical ingredients to enable a selected size medication element to be extracted through an exit channel. Extraction mechanism 320 may be adapted to identify different medicine ingredients. Encapsulation unit 305 may include a capsule opening mechanism 325, for example to remove the upper element of a capsule while the capsule is filled by capsule filling mechanism 330. Encapsulation unit 305 may include a capsule closing station 335, to close the capsules when they have been filled. In some embodiments, the capsule closing station 335 may mark capsules to indicate their content, type, dosage etc. Encapsulation unit 305 may include a medication control unit 340, for verifying the medication to be dispensed. For example, medication control unit 340 may be configured to scan or otherwise test the encapsulated medicine to identify, verify, communicate or otherwise determine the contents, and if any problem is found, to prevent the capsule(s) from being dispensed. For example, in some embodiments, a controller and/or counting mechanism can be used to track the counting of medical ingredients being filled in a cartridge.

[0082] Fig. 4 is a flow diagram depicting a process by which personalized medication is capsulized in an end-user environment, using PMDA 110, according to some embodiments. At step 405, prescription data for one or more prescriptions, optionally for dynamic prescriptions, are entered into processing unit 255/310 of the encapsulation unit 270/305. At step 410, one or more medication cartridges are be inserted into a controlled storage unit. At step 412, the stored medication is monitored. At step 415, a command is received to dispense personalized medication. At step 417, the aforementioned command is verified, for example, by authenticating the user’s identity, the prescription, the dispense request etc. At step 420, encapsulation instructions are prepared by the processing module, typically based on prescription data and other related data. At step 425, an extraction procedure is performed to extract the proper medication and quantity thereof to allow preparation of the relevant medical ingredients for encapsulation. At step 430, a capsule opening procedure is performed, to open the capsule that is to be filled. At step 435, a capsule filling procedure is performed, to fill the capsule with medication material in accordance with the prescription to be filled. At step 437, a capsule closing procedure is performed. At step 440, a medication control, monitoring or verification procedure is performed. At step 445, the medication is dispensed.

[0083] Fig. 5 is a flow diagram depicting a process by which personalized medication capsules are provided to a user, in association with the PMDS 100, according to some embodiments. At step 505, one or more medication prescription is entered into the system, via a doctor, a health system and/or cloud, etc. At step 510, the prescription is sent digitally to one or more pharmacies or filling stations, optionally upon request. At step 515, a filling station prepares one or more cartridges with the required medication ingredients, in according to the received prescription(s). At step 520 a locked cartridge is given to or delivered to a user, to be plugged into or setup into the Personalized Medication Dispensing Apparatus (PMDA) 110.

[0084] At step 530, the PMDA may optionally communicate or alerts the user/patient to take medication, in accordance to the prescription, and more particularly in accordance with the timing of medication(s) to be taken. At step 535 the user approaches or interacts with the PMDA, to retrieve medication, and the PMDA performs user identification, to assure the correct medications are to be dispensed to the authorized user. If the identification is negative, and/or the time, scenario etc. are not matched to the prescription requirements, medications will not be dispensed. If the identification is positive, and/or the time, scenario etc. are matched to the prescription requirements, medications are encapsulated in accordance with the needed medications to be dispensed, at step 540. For example, the encapsulation may include combining the required active molecules for one or more medication ingredients into one or more medication capsules. At step 545, the prepared capsule(s) is delivered into a dispensing unit, to be delivered to the user, for consumption at step 550. In addition, the dispensing of medication may be accompanied by instructions, questions, verification of data, input from one or more sensors etc. Optionally, the user is requested to verify the consumption of the medication, such that if the consumption of the medication is not completed or verified, an alert may be sent to other users (e.g. doctor) of the system.

[0085] Fig. 6 is a flow diagram depicting PDMS subsystems that are usable in association with PMDA usage. PMDS 605 transmits instructions, data, commands and updates to a plurality of PMDAs 610. In some embodiments, PMDA 610 is designed to support a medication compliance management subsystem 615, to enhance medication compliance. For example, PMDA 110 dispenses precisely the medication and dosages required at the time required, to authorized users only. In some examples, real-time prescription and medication dispensing updates, tracking and management include alerts and reminders to the patient, approved relatives, community nurse, medical support staff, pharmacy staff or other authorized system users, and receipt of feedback from these users. The PMDA 110 can provide compliance feedback to the PMDS 100, which may be used to change medical prescriptions, thereby enabling dynamic prescription management.

[0086] In some embodiments, PMDA 610 is designed to support a medication inventory management subsystem 620, to enhance medication supply, demand and control. For example, inventory management subsystem 620 may enable warnings, alerts, updates, etc. related to medicine levels, supplies, expiration date, problems etc. In some embodiments, such as for controlled drugs, security verifications and communications can be enabled, to help ensure authorized usage of medications, and prevent unauthorized usage of medications. This may help monitor user health, wellness, diseases and behavior, and adapt the PMDA dispensing protocols in accordance with personalized criteria. In some embodiments, the PMDA 610 is adapted to handle medication filling management, for example, by reporting on medications used, medication status, and sending orders for medication supplies etc. Medical production and filling centers may in this way be notified with real time data to increase or decrease production, and to distribute medications more efficiently.

[0087] In some embodiments, PMDA 610 is designed to support a personal health management subsystem 625, to enhance personal health tracking and support. For example, PMDA 610 can receive data from one or more sensors or systems monitoring user health, and provide such feedback to the PMDA 610, PMDS 100 and/or other elements in the health system.

[0088] In some embodiments, PMDA 610 is designed to support a big data management subsystem 615, to enhance user health and wellness as well as the health and wellness of the greater community. For example, clinical data, compliance data, behavior data etc. can be sent to the PMDS 100 for processing and analysis, to enhance drug development, drug dispensing, drug disposal etc. For example, prescription management may be enhanced by using big data collection and processing, optionally using usage data for multiple users, health system data, pharmaceutical data, etc. User data combined with general data may be used by the user's doctor or health system to help determine medical adherence, communicate medication inventory needs to the user, family, friends, medical staff, and/or a pharmacy etc., as well as to provide medication related data to pharmaceutical companies, research organizations etc. Disease, wellness and/or health management data, as well as clinical data, may be shared, processed and otherwise used by patients, health system professionals, medical aids, hospitals, drug manufacturing companies etc. Relevant anonymous statistics may be collected from multiple patients and could be used by researchers to explore further effectiveness of medications.

[0089] Figs. 7A-7C are screenshots or graphic simulations of examples of patient dispensing apparatuses, according to some embodiments. Fig. 7A shows an example of a dispensing apparatus, and many other types, sizes, formats, functionalities etc. may be used. In some embodiments, the patient dispensing apparatus is used as a Personalized Secure Medication Cabinet (PSMC). [0090] Fig. 7B shows examples of mini-tablets, which may be of a variety of types, sizes, colors, formats etc.

[0091] Fig. 7C shows an example of a mixed medication capsule that may include a specified amount of active medications/ingredients for one or more medication types, as per a user prescription(s). The capsules may be of a variety of types, sizes, colors, formats etc. In some embodiments, the capsules are marked, numbered or labelled for identification, for example, as a number in a series of capsules, capsule type, etc.

[0092] In further embodiments of the present invention, a system and methods are provided to enable personalized capsulation and dispensing of mini-tablets. In some embodiments, the system is optimized for home dispensing of medication. In some embodiments multiple pre-compressed mini-tablets are dispensed using the system, allowing for the management of personalized prescription drugs.

[0093] In some embodiments, products used by the system are "mini-tabs" or mini tablets, that consist of conventional coated compressed form tablets, for example having a diameter between 2-4 mm, in some examples having diameters between 2.5-4 mm, and in further examples, having a diameter between 3.5-3.6 mm diameter, with a reduced amount/number of excipients.

[0094] In some cases, each product is required to have a minimum already clinically approved dosage. This will allow fast approval process and utilization of most common manufacturing processes and equipment. For example, a typical lowest dosage approved tablet has up to 25mg of active ingredients in addition to around 30% of non active excipients. In some embodiments, the combination of up to 25mg of active ingredients and around 30% of excipients may be produced or provided in a single tablet of 2.5 -4mm diameter.

[0095] According to some embodiments, mini -pills may be used that are characterized by shape and size dimensions that make personal end user encapsulation feasible. For example, mini-pills may be constructed with height and diameter proportions adapted to make personal end user encapsulation feasible. [0096] In a further example, mini-pills may be constructed with coatings designed to prevent dust dispersion, enable non-sticking, enable smooth sorting and movement in the system etc. In general, such mini-pills may be of size, weight, texture, shape and/or color to enable an encapsulating unit to sort, filter, collect, and capsulate in a selected capsule format.

[0097] In some examples, different types of mini-pills may be used in unlimited combinations in a capsule, thereby avoiding the need to use polypills in order to provide personalized and effective amounts of multiple medications in a consolidated capsule.

[0098] In further examples, the mini-pills may be used that have formats, contents, concentrations of materials, and dimensions etc. to be able to include multiple mini pills in a single capsule, and still to provide sufficient active ingredients of one or more medications or supplements in substantially a standardized size single capsule. In this way, an end user may consume a single pill that includes sufficient effective dosages of multiple pharmaceuticals, or more than 1 pill if required. Furthermore, the formats, contents, concentrations of materials, and dimensions etc. of mini-pills or tablets may enable the user to consume effective amounts of multiple medications over an acceptable time period such that the user can rely on there being enough medication for an acceptable period of time. For example, the mini pills may facilitate provision of enough active ingredients of a user's multiple medications for a period of one or more weeks, one or more months etc., consolidated into one or more cartridges.

[0099] Fig. 7D illustrates a method for personalized dispensing of mini-tabs or MTPD, according to some embodiments. At step 705 a user's personal prescription is loaded onto the system, by a medical practitioner. At step 710 the prescription is sent digitally both to the home unit and to a distribution pharmacy center, for example a pharmacy that contains a cartridge filling facility capable to fill and distribute medication cartridges and other medical supplies, hereinafter referred to as a filling station. At step 715 the distribution pharmacy center verifies the prescription authentication. At step 720 the distribution pharmacy fills one or more cartridges in accordance with the prescription(s) received. In general, the distribution pharmacy will stock substantially all well used or primary oral drugs, and optionally non-oral drugs, medications, or other compounds. In general, the distribution pharmacy will have the facilities to handle the collection, sorting, storage, and filling of the "mini-tabs or MTPD for fulfilling the user's requirements, according to the received prescription(s). In some cases, one or more cartridges are filled for a period of consumption (for example, 1-3 months, or more). At step 730 the cartridge(s) may be securely locked. At step 735, the locked cartridge is delivered to the user's PMDA location. At step 740 the cartridge is plugged into the user's PMDA. At step 745 PMDA 110 verifies the cartridge, and communicates the data relating to the cartridge to PMDS 100.

[00100] At step 750, PMDA 110, based on the loaded prescription, can alert the user at the time that s/he needs to prepare and/or take her/his medication(s). PMDA 110 may alert by voice, optic signals, alarms, messages sent to a user device(s) etc. At step 755, prior to dispensing of the medication, PMDA 110 may require user identification, for example, password, finger print, voice or face recognition, or other relevant identity authentication. At step 760, once a user identification is authorized, at that time of medication dispensing, the dispensing unit encapsulates the require number of mini tabs of one or more drugs the patient is required to take, into one or more capsules. At step 765, PMDA 110 dispenses the capsule(s) into a receiving unit, such as a cup, proximal to the dispenser. In some embodiments, medication not in mini-tab format may be dispensed to a user, in addition to or instead of the capsule containing mini tabs.

[00101] At step 760, if a user does not come to the dispensing unit to get their medications, the dispensing unit initiates one or more predefined alerts for the user and/or a user assistant, such as a family member, community nurse, personal assistant etc.

[00102] In some embodiments, the he dispenser unit includes one or more environmental sensors to measure environmental factors, such as humidity, temperature, pollution etc.

[00103] In some embodiments, the he dispenser unit includes one or more environmental control mechanisms to modify environmental conditions, such as humidity, temperature, pollution etc to ensure that the drugs and/or medications are kept within approved conditions. The dispenser unit may send alerts if the defined conditions have been violated.

[00104] For example, the system will monitor the conditions of products in the dispenser and will inform the patient and the pharmacy center, so where necessary, a refill may be prepared and delivered on-time.

[00105] In some embodiments, feedback form wearable devices or other devices can be collected and analyzed together with medication usage data, to allow practitioners or doctors to adjust the dosages appropriately.

[00106] In some embodiments, relevant anonymous statistics can be collected from all or multiple patients, to be used by researchers to explore further effectiveness of these drugs.

[00107] In some embodiments, pre-compressed mini-tablets may have sizes and shapes that are optimized for maximizing the number of units to be filled, for example, #00 or #0 capsules, with approved dosages. For example, 3.5-3.7 mm diameter, ball shaped mini-tablets may be used.

[00108] In some embodiments, multiple colors may be used on mini-tablets, to enable human and/or machine related differentiation. For example, colored cosmetic coating can be used to provide a color -based identification, and optionally, the coating may be used for other purposes, such as dust prevention.

[00109] See Appendix 1, wherein is described support data about mini tablet size optimization data and guidelines. In one example, Mini-tabs can be sized between 3.5 - 3.6 mm diameter; around 16-21 mini-tabs can be filled into a #00 capsule and around 11-16 mini-tabs can be filled into a #0 capsule. Of course, other dimensions and numbers may be used. In other examples, mini-tabs sized between 2.5 - 4 mm diameter may be used, and around 12-30 mini-tabs can be filled into #00 capsule and around 5- 20 mini-tabs can be filled into a #0 capsule.

[00110] Figs. 8 A- 81 are examples of graphic renditions of the patient dispensing apparatus, according the several embodiments. [00111] Fig. 8A shows an example of PMDA 800 including cartridge 805, optionally a removable (e.g., reusable or disposable) cartridge for storing one or more medications, optionally in a mini-pill format, and optionally where the mini-pills include substantially active ingredients of medications. Cartridge 805 may enable multiple medications to be stored in PDMA 800, and may include sensors or other cartridge and/or medication identification mechanisms, to be able to identify what cartridges and/or medications are currently available in the PMDA, how much of the one or more medications are available, if a cartridge or pills are expired, if a cartridge or pills are originals or copies etc. In some examples cartridge may include 8-15 compartments for mini-tablets, to enable holding of tens, hundreds or thousands of pills. Cartridge 805 may also contain capsules and/or other materials or elements for usage by PMDA 800. PMDA 800 may further include a desiccant 830, for example a hygroscopic substance that may be used as a drying agent, to help maintain the dry conditions necessary for appropriate storage of the pills.

[00112] PMDA 800 may further include an encapsulation module or mechanism 810, for enabling placing and encapsulating one or more selected tablets or pills into one or more capsules for dispensing to a user. PMDA 800 may further include a holding chamber 815, optionally for storing medications from cartridge 805, for example, for receiving and storing unused or empty capsules, pills, medicines etc. Holding chamber 815 may be a part of replaceable cartridge 805, or may be permanently be a part of the PMDA 800. PMDA 800 may further include a control panel user interface 820, which may be an LCD panel, touch screen, or other interface to enable reading of information and entering of information, instructions etc. PMDA 800 may further include a user recognition module 825, for example, including face recognition, fingerprint identification, or other biometric or alternative identification means, to enable dispensing of medications only to an authorized or verified user(s). In some embodiments the user recognition module 825 may keep the dispenser "locked" to prevent misuse of "controlled drugs", and if any abuse is indicated or suspected, an alert may be issued to a user, pharmacy station, authority, network users, medical system etc. [00113] PMDA 800 may further include a communication module 830, for example including WiFi or Bluetooth connectivity, or other communication means, to facilitate communication between PMDA and a communication network, a communication cloud, system users, PMDA users, pharmacy stations, user network, health system, medical support personal etc. PMDA 800 may further include one or more sensors 835, for example temperature and/or humidity sensors, to help control medication storage conditions, alert to problematic conditions etc. PMDA 800 may further include a controller 840, for example a PCB. PMDA 800 may further include a power backup 845, such as a battery, in case of electric failure. PMDA 800 may further include a power supply 850, to supply regular power to the PMDA. PMDA 800 may further include a light indicator 860, for example, a RGB LED, to provide a machine status, a cup placement indication, lighting for dispenser usage in the dark etc. Of course, other elements, format of elements, size of elements, locations of elements and/or combinations of elements may be used.

[00114] Fig. 8B and Fig. 8C are a front perspective view and a side perspective view, respectively, of PMDA 800, illustrating an exemplary external design. Of course, other designs or configurations may be used.

[00115] Fig. 8D is an exploded view of PMDA 800 showing examples of cartridge 805 and the storage area 815. Of course, other dimensions or configurations may be used.

[00116] Fig. 8E is a side perspective of PMDA 800 depicting some inner elements, as described above, according to some embodiments.

[00117] As can be seen in Fig. 8F, an exploded view of some inner components of PMDA 800 are shown, according to some embodiments.

[00118] As can be seen in Fig. 8G, an external perspective of PMDA 800 is shown, depicting a transparent view of the PMDA, showing some inner elements, as described above, according to some embodiments.

[00119] As can be seen in Fig. 8H, a front perspective graphic of an example of PMDA 800 is shown, depicting an external view of a receiving cup placed in the capsule dispensing area, according to some embodiments. Also shown is the current time, on the user interface panel, to show the user the time of dispensing. Of course, other data may be displayed on the panel.

[00120] As can be seen in Fig. 81, a side perspective of PMDA 800 is shown, depicting an external view of the PMDA, according to some embodiments.

[00121] In accordance with some embodiments, PMDA as described herein may function as a personalized medication dispenser, to enable controlled dispensing only of doctor prescribed medication(s), optionally at prescribed times only. In some embodiments the dispenser may be "locked" to prevent misuse of "controlled drugs", and if any abuse is indicated or suspected, an alert may be issued to a user, pharmacy station, authority, network users, medical system etc.

[00122] In accordance with some embodiments, a PDMA may be adapted to identify the identity of one or more medications, thereby identifying if refills are required, and optionally preventing dispensing of incorrect medications.

[00123] In accordance with some embodiments, a PDMA may include a touch screen display designed to impart information to the user and collect information from the user.

[00124] In accordance with some embodiments, a PDMA may include a radio connection to a remote computer which contains patient information and treatment algorithms.

[00125] In accordance with some embodiments, a PDMA may include means of securing user identification, to help prevent unauthorized use or diversion of dispensed medication.

[00126] In accordance with some embodiments, a PDMA may be adapted to execute treatment algorithms for one or more specific users, for example, to provide different dosages of medication(s) at different times and/or in different scenarios to one or more users. [00127] In accordance with some embodiments, a PDMA may be adapted to execute algorithms to track the behavior of a user, thereby aiding dynamic prescription of medication(s) in accordance with user behavior.

[00128] In accordance with some embodiments, a PDMA may be adapted to execute algorithms to effect notifications or alerts to other parties responsible for or associated with the user’s care. For example, after identifying a deviation from a treatment protocol, the PDMA may generate an alert(s) that is sent to one or more parties listed in a remote database, for example, medical personnel, and designated friends and/or family.

[00129] In accordance with some embodiments, a PDMA may include means to verify a user's identity, for example, using fingerprint recognition, facial recognition, voice recognition, and/or a secure password.

[00130] In accordance with some embodiments, a PDMA may include ancillary sensors to measure physiologic parameters including but not limited to: pulse, blood pressure, blood glucose or other analytes, heart rhythm, body temperature, breath volume, and other such parameters. In some embodiments PDMA may connect to external sensors or systems through wired or wireless connections, to enable sensed data to be transmitted to PDMA.

[00131] In accordance with some embodiments, a PDMA may transmit directly to a remote computer, to monitor effects of medication use or compliance with medication use.

[00132] In accordance with some embodiments, a PDMA may include means for preventing erroneous medication consumption. For example, if a mistake is noted in a user action, such as removing an incorrect product, or removing a product at the wrong time, an alert may be displayed on or generated by the PDMA. In other cases, a message may be transmitted, for example in the form of a text message, listing the error and advising the user or other related followers, to take alternative action. [00133] In some examples, artificial intelligence or other suitable algorithms may be run to predict or identify deviations from preprogrammed protocols.

[00134] In accordance with some embodiments, each medication supply package or cartridge may have a defined pattern, shape, format, color etc., to enable the PDMA to identify and process the respective supply packages.

[00135] In accordance with some embodiments a PDMA may include one or more biometrics sensors, for example, to help enable user identification, tracking, safety, cyber-security, and biosecurity. In accordance with some embodiments a PDMA may include a locking mechanism to control access to medications. In some embodiments, for example, of control drugs, a security breach of the PDMA may generate a security alert, optionally to alert authorities or other system users of such a breach.

[00136] In accordance with some embodiments, a method for measuring and monitoring a correct medication at a correct time is provided, that enables observers to improve supervision of a therapy compliance of a patient, immediately or at a later stage.

[00137] In accordance with some embodiments the system, device and methods are provided for facilitating personalized medication dispensing management, including tracking medication diversion, abuse, expiration and/or counterfeiting.

[00138] In some embodiments PDMA may transmit to a user compliance related data, chronological, medicine management data, safety information etc.

[00139] The foregoing description of the embodiments of the invention is presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. It should be appreciated by persons skilled in the art that many modifications, variations, substitutions, changes, and equivalents are possible in light of the above teaching. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the scope of the invention.