Drug delivery device and a method for drug delivery

Abstract

Multi-route drug delivery device designed with two modular bodies. The first body houses batteries, heaters, vials containing extracts, formulations, diluents or cleaners, and the control unit. This unit features two or more peristaltic pumps that enable precise dosage control and ensure homogeneous mixing of substances. The pumps also incorporate purging and cleaning process cross-contamination. The second body is the administration unit, which can be fitted with interchangeable nozzles to different delivery methods. These options include an atomizer, nasal spray, or sublingual spray. By changing the dispenser nozzles, it can accommodate a wide range of delivery routes, including pulmonary, sublingual, nasal, and mucosal. Designed to meet the needs of patients, clinical trial participants, general users, and livestock.

Description

[0001] DRUG DELIVERY DEVICE AND A METHOD FOR DRUG DELIVERY

[0002] Field of the invention

[0003] The present invention falls within the field of drug delivery devices and methods, specifically dosed drug delivery devices and methods for dosed drug delivery.

[0004] Background of the invention

[0005] In the field of portable drug delivery and administration devices, various types have been developed to meet diverse medical needs. In the field of inhalation and delivery of active substances, various technologies have been developed to meet the needs of users. Among these technologies are metered dose inhalers (MDIs), dry powder inhalers (DPIs), soft mist inhalers (SMIs) and nebulizers. Metered dose inhalers (MDIs) deliver a specific amount of medication in aerosol form to the lungs, while dry powder inhalers (DPIs) deliver medication in dry powder form. On the other hand, soft mist inhalers (SMIs) deliver medication in fine mist, and nebulizers subdivide liquid medications into tiny droplets for delivery.

[0006] In addition, innovative devices such as smart inhalers, which automatically record relevant information to improve treatment, have emerged.

[0007] Outside the medical field, the use of nebulizers has spread to non-pharmaceutical forms of consumption, such as e-cigarettes / vaporizers, and similar devices have been developed in the recreational cannabis sector. To date, all devices on the market have specific vials or refills, either for single use or refillable directly into the atomizer reservoir.

[0008] US patent application No. US797,295, publication No. US5860957A, discloses a low-profile multipath way automatic drug delivery system utilizing a battery powered control pad coupled to a disposable drug storage and delivery system and strapped to a patient's limb or torso. A preprogrammed or on-demand drug administration sequence is input to the control pad. When a drug is to be administered, the control pad ignites a high energy density propellant charge in the drug delivery system. Expanding propellant gas exerts pressure on a drug in a second chamber and forces it from the storage reservoir. Depending upon the type of drug delivery system required for the drug being administered, the propellant will either: (i) force a hypodermic needle into a patient's muscle tissue, propel the drug in the storage container into the needle embedded in the patient; (ii) force the drug from the storage container through a jet nozzle where the drug is injected into subcutaneous tissue; (iii) force the drug from the storage container into a patch for passive transdermal delivery;

[0009] (iv) force the drug into a patch for iontophoretic transdermal diffusion; or (v) force together two drugs stored separately that are unstable when mixed, and then administer them through one of the methods described in steps (i) to (iv).

[0010] US patent application No. US09 / 060,439, publication No. US6047861A discloses a two- component fluid dispenser which can accurately mix two liquids of varying viscosity and then precisely deliver the mixture formed in discrete amounts. The mixture of the two components is delivered from a single delivery tube in such a manner that none of the mixture remains within the delivery tube at the completion of each mixing and delivery cycle. In one form of the apparatus, the single delivery tube of the apparatus is operably coupled with conventional hypodermic syringes of various sizes so that different fluids can be mixed in different ratios.

[0011] Utility model No. ES124601 OU discloses a dual reservoir vape device comprising a reservoir with two chambers for holding two different types of liquid. The device also includes heating means, such as two heating elements, for heating one or both liquids. These reservoirs within the dual reservoir are separated so that no mixing of these is performed prior to atomization.

[0012] US patent application No. US16 / 978,923, publication No. US20210401061 A1 discloses vape devices and methods of operating the same to prevent unauthorized use, allow for remote, centralized storage of operational settings associated with unique payload identifiers, and optimize operation based on historical usage data, real-time operating conditions, and / or user information. Vapor measurement systems to determine dosage based on a measured capacitance of vaporized payload. A two-lead communication system that enables the communication of a plurality of electrical signals between a control assembly and cartridge. A cartridge temperature control system that provides localized temperature control for the cartridge.

[0013] US patent No. US10842953B2 discloses a cannabinoid delivery system that includes a vial for containing a substance containing cannabinoids, a flow regulator for controlling the release of the substance, and a controller for managing the operation of the device. It is intended to provide a controlled and precise way of administering cannabinoids for consumption. US patent application No. 13 / 460,982, publication No. US2012227752 discloses a cigarette or cigar shaped smoke inhalation device comprising a first release device associated with a first vial, and a second release device associated with a second vial. The substances from both vials get mixed in the form of vapor. The device can control the substances released by a controller and valves.

[0014] European patent application No. 21188785.6, publication No. EP39221 17, discloses a pulmonary delivery apparatus comprising: a first chamber adapted to thermally vaporize a quantity of a first liquid to form a relatively warm first vapor and a second chamber adapted to atomize a quantity of a second liquid without heating of the second liquid to form a mist of a relatively cold second vapor, and an outlet via which, in use, a user can inhale a mixture of the first and second vapors. An active ingredient such as nicotine is provided in the second chamber and an inert liquid in the first chamber GB patent application No. 1405937.2, publication No. GB2524779 discloses a method of controlling an inhalation device, the inhalation device comprises a sensor configured to generate data associated with a property of an atomized composition within a flow channel of the inhalation device. The method comprises controlling atomization of the composition based upon the generated data. The inhalation device may comprise a reservoir 4 for receiving the composition, an atomizer associated with the reservoir and configured to atomize the composition, an aperture and a flow channel configured to carry the atomized composition from the atomizer to the aperture. Preferably the device includes a further reservoir, a further atomizer, a further flow channel and a further sensor 10a. Advantageously the use of a sensor to generate data which is subsequently used in the control of the atomizer allows a quantity of active chemical delivered to the user within the composition to be accurately controlled, for example to deliver a predetermined dosage of the composition. Also disclosed is a further inventive method of controlling an inhalation device comprising a computing device such as a mobile telephone.

[0015] Main drawback of the prior art is single-route delivery of substances to a user.

[0016] Summary of the invention

[0017] The object of the present invention is a drug delivery device and a drug delivery method.

[0018] The drug delivery device comprises a mixing and dosing unit comprising a power unit, a heating unit, a vials unit comprising vials for liquid formulations and NFC stickers, a peristaltic pump unit, a control unit, a connection unit and a charging unit. The drug delivery device further comprises a connector unit for connecting interchangeable nozzles to the mixing and dosing unit for drug delivery. The nozzles may be, but not limited to, an atomizer nozzle, a nasal spray nozzle, or sublingual spray nozzle. By changing the nozzles, the drug delivery device can be used for a wide range of delivery routes, including, but not limited to, pulmonary, sublingual, nasal, intradermal, subcutaneous, and mucosal.

[0019] The drug delivery device facilitates mixing various liquid formulations with different viscosities, liquid or pasty solution, depending on its formulation and active ingredients.

[0020] In case of liquid formulations with different and / or high viscosity the heating unit located around the vials applies a thermal gradient for lowering the viscosity to facilitate passage of the formulations through a mixing channel for further input into a connected nozzle.

[0021] To identify specific properties of liquid formulations in each vial, the vials have NFC (NearField Communication) stickers comprising specifications of each vial content. The vials content data is read by a reading unit comprising an NFC reader. The NFC sticker data is transferred by a FPC (Flexible Printed Circuit) connector to the control unit. The drug delivery device identifies and interacts with each vial for formulation and / or dosage control and monitoring. The data is also sent to a screen on the main board. The main board of the drug delivery device integrates a CPU and a wireless module and controls the peristaltic pump unit. This enables the user to see which vial is always inserted.

[0022] To deliver the precise amount of each vial’s solution for the programmed mixture, the peristaltic pumps extract the specified quantity from the vials. The extracted solutions are then directed into a mixing channel, ensuring homogeneous mixing before reaching the nozzle for administration.

[0023] When a vial replacement or dosage adjustment is required, a dedicated cleaning vial containing a polar or nonpolar cleaning solution, depending on the polarity of the previously used mixture, is inserted into the vial unit. The cleaning process involves pumping the cleaning solution through the pumping channels and reversing the peristaltic pump to retrieve the residual liquid back into the cleaning vial. This purging and cleaning mechanism significantly reduces the risk of cross-contamination between solutions. Additionally, the same mechanism can be employed to purge any remaining solution from the selected nozzle reservoir, ensuring thorough cleaning and preparing the device for subsequent use. The control unit comprises a main board comprising a central processing unit (CPU) and a wireless module, a display screen for real-time monitoring and management of critical parameters. These parameters include the vial content type, the volume of liquid formulation dispensed, and the remaining content in each vial. The control unit ensures precise dosing, maintains formulation accuracy, and upholds consistency throughout the preparation process.

[0024] User configuration is managed through an application on a mobile phone, which connects to the control unit via the wireless module. This module includes an input / output port and a wireless transceiver, facilitating seamless communication and control.

[0025] The connector unit comprises two circular permanent magnets, two pogo pins, a connection needle and a ball retainer. The pogo pins serve also as electrical contacts.

[0026] The different nozzles serve as the administration unit for the resultant liquid formulations, which result from mixing and dosing of the liquid formulations within the vials. The nozzles enable delivery through various methods, including, but not limited to:

[0027] • Pulmonary administration via an atomizer.

[0028] • Nasal delivery via a nasal spray nozzle.

[0029] • Sublingual delivery via a sublingual spray nozzle.

[0030] The invention provides means for drug mixing, dosing, and intake while minimizing the risk of cross-contamination and enabling personalized administration.

[0031] Brief description of the figures

[0032] Features of the invention believed to be novel and inventive are set forth with particularity in the appended claims. The invention itself, however, may be best understood by reference to the following detailed description of the invention, which describes exemplary embodiments, given in non-restrictive examples, of the invention, taken in conjunction with the accompanying drawings, in which:

[0033] Figure 1 shows a) front view, b) top view and c) profile view of the mixing and dosing unit.

[0034] Figure 2 shows the exploded 3D view of the mixing and dosing unit.

[0035] Figure 3 shows the 3D view of the connection unit (assembled).

[0036] Figure 3A shows the exploded 3D view of the connection unit. Figure 4 shows different views of the control unit (assembled).

[0037] Figure 5 shows a) 3D view, b) side view, c) back view, and d) bottom view the of the pumping unit and its main components (assembled).

[0038] Figure 6 shows the 3D view of the reading unit which reads the NFC of the vials (assembled).

[0039] Figure 7 shows the exploded 3D view of the power unit and its main components.

[0040] Figure 8 shows the exploded 3D view of the vial and its main components.

[0041] Figure 9 shows top view and cross section view of the charging unit.

[0042] Figure 10A shows the exploded 3D view of the vial unit and its main components.

[0043] Figure 10B shows different views of the vial unit and its pieces.

[0044] Figure 10C shows the exploded 3D view of the heating unit.

[0045] Figure 10D shows the different views of the heating unit and its pieces.

[0046] Figure 11 shows the 3D view of the atomizer nozzle (assembled).

[0047] Figure 1 1 A shows the exploded 3D view of the atomizer nozzle.

[0048] Figure 11 B shows different views of the atomizer nozzle and its pieces.

[0049] Figure 12 shows the different views of the mixing and dosing unit with the atomizer nozzle attached (assembled).

[0050] Figure 13 shows the 3D view of the nasal spray nozzle (assembled).

[0051] Figure 13A shows the exploded 3D view of the nasal spray nozzle.

[0052] Figure 13B shows different views of the nasal spray nozzle.

[0053] Figure 14 shows the different views of the mixing and dosing unit and the nasal spray nozzle (assembled).

[0054] Figure 15 shows the 3D view of the sublingual spray nozzle (assembled).

[0055] Figure 15A shows the exploded 3D view of the sublingual spray nozzle.

[0056] Figure 15B shows different views of the sublingual spray nozzle .

[0057] Figure 16 shows the different views of the mixing and dosing unit and the sublingual spray nozzle (assembled).

[0058] Preferred embodiments of the invention will be described below with reference to the drawings. Each figure contains the same numbering for the same or equivalent element.

[0059] Detailed description

[0060] The drug delivery device according to the invention comprises a mixing and dosing unit (1 ), and a nozzle unit (1 1 , 13, 15).

[0061] The mixing and dosing unit (1 ) comprises a connection unit (3), a control unit (4), a pumping unit (5), a reading unit (6), a power unit (7), vials (8), charging unit (9), vials unit (10), top lid (18), inner lid casing (19), front casing (20), back casing lid (21 ).

[0062] The mixing and dosing unit (1 ) enables mixing and dosing of solutions with different viscosities, ensuring homogeneous formulation preparation before administration.

[0063] The connection unit (3) is an inner frame for the drug delivery device and comprises permanent magnets (3.1 ), right inner structure (3.2), pogo pins (3.3), battery lid (3.4), left inner structure (3.5), self tapping screws (3.6) and a connection needle (3.7). The connection unit (3) secures all parts of the drug delivery device and serves as a formulation transfer connection between the mixing and dosing unit (1 ) and nozzle unit (11 , 13, 15) and an electrical connection between the mixing and dosing unit (1 ) and the nozzle unit (11 , 13, 15). The permanent magnets (3.1 ) are preferably two and are disposed on top of the connection unit (3) so they make contact with metal plate of the nozzle unit (11 , 13, 15) to secure the mixing and dosing unit (1 ) and the nozzle unit (11 , 13, 15). Each nozzle unit (11 , 13, 15) has a ferromagnetic plate (11.10, 13.7, 15.9) at the bottom.

[0064] The pogo pins (3.3) are preferably two and positioned on top of the connection unit (3). When the nozzle unit (11 ) is an atomizer nozzle, one pogo pin touches the metal plate (11 .10) of the nozzle unit (11 ) to create negative connection, and the other pogo pin touches the coil of the atomizer nozzle for the positive current connection to transfer electrical current from the power unit (7) to the atomizer nozzle.

[0065] The connection needle (3.7) is positioned on top of the connection unit (3) so they can be stuck into the puncturing membrane (11.8, 13.6, 15.6) of the nozzle unit (11 , 13, 15) to transfer the resultant liquid formulation from the peristaltic pumping unit (5) to the nozzle unit (11 , 13, 15).

[0066] Additionally, the connection unit (3) houses both the peristaltic pumping unit (5) and the power unit (7). The power unit (7) is enclosed within the connection unit (3) by the battery lid (3.4), and all components are secured together using two self-tapping screws (3.6).

[0067] The control unit (4) comprises a switch (4.1 ), main board (4.2) which integrates the CPU and the wireless module, two pins connector (4.3) for the power unit, another two pins connector (4.4) for the peristaltic pump unit, further two pins connector (4.5) for pogo pins, FPC FFC connector (4.6) for the NFC reading unit, cabling pack (4.7) for the charging unit, casing screen (4.9) and a screen (4.10).

[0068] The control unit (4) manages the drug delivery device operation and connects with the app which the user interacts with. This app is the one that allows customization of dosage and mixture ratios.

[0069] The peristaltic pumping unit (5) is connected to the control unit (4) via two pin connectors (4-3).

[0070] The power unit (7) is connected to the control unit (4) via another two pins connectors (4.4). The connection unit (3) pogo pins (3.3) are connected to the control unit (4) via one pin connector (4.5). The reading unit is connected to the control unit (3) via an FFPC connector (4.6). The reading unit (6) is connected to the charging unit (4) via a cabling pack (4.7).

[0071] The control unit (4) also comprises a central processing unit (CPU), integrated into the main board (4.2) of the control unit (4). The control unit (4) configures the drug delivery device operation and connects with a user through a product application on a mobile phone. Data transmission and reception are handled by a wireless module located in the main board (4-2).

[0072] The control unit (4) further comprises a button (4.8). The button (4.8) and the screen (4.10) allow the user to interact with the drug delivery device through both the mobile application and the physical display. This configuration enables the drug delivery device to identify and interact with each vial, providing functionalities such as:

[0073] • Power control (on / off).

[0074] • Cleaning functions.

[0075] • Vial selection and solution specifications.

[0076] • Resultant solution specifications.

[0077] • Dosage and usage control.

[0078] • Alerts for solution volume and cleaning reminders. The screen (4.10) displays different options, including:

[0079] • On / off status.

[0080] • Vial selection and solution details.

[0081] • Resultant solution specifications.

[0082] • System alerts.

[0083] The peristaltic pump unit (5) comprises peristaltic pumps (5.1 ), a mixing channel (5.2), tubing connection (5.3) to needles that go to the vials (8), general tubes (5.4), tubing connections (5.5) to the needles that go to the connection unit (3).

[0084] The peristaltic pump unit (5) is responsible for carrying, mixing, and transferring specified amounts of each liquid formulation from the vials (8) to the nozzle unit (11 , 13, 15). A connecting needle (10.3) and the tubing connection (5.3) link the peristaltic pumping unit to the vials (7). Each liquid formulation is extracted by the peristaltic pumps (5.1 ), which precisely control the volume transferred. Each peristaltic pump (5.1 ) is autonomously controlled by the CPU on the main board (4.2). The extracted liquid formulations are mixed within the mixing channel (5.2) to ensure thorough homogenization. The resultant liquid formulation is then injected into the nozzle unit (11 , 13, 15).

[0085] When operating in reverse mode by changing current polarity in the power unit (7), the peristaltic pumping unit (5) purges all channels, including the mixing channel (5.2), the tubing connection (5.3) to needles that go to the vials, the general tubes (5.4), and the tubing connection (5.5) to the connection unit needle (3.7).

[0086] The vials NFC stickers reading unit (6) comprises a top board (6.1 ), an FPC connector (6.2), four pins connector (6.3) between boards (6.1 , 6.4), a bottom board (6.4), NFC readers (6.5) such as two or more PCB antennas for scanning vial information.

[0087] The reading unit (6) is responsible for receiving data from the vials' NFC stickers (8.1 ) and transferring it to the control unit (4) via the FPC connector (6.2). The reading unit (6) is positioned between the top lid casing (18) and the inner lid casing (19).

[0088] The power unit (7) is responsible for supplying power to the control unit (4). The control unit (4) distributes the power to the main board comprising CPU and a wireless module, the screen (4.10), the peristaltic pumps (5.1 ), the reading unit (6), the heating unit (10.2), and the atomizer nozzle coil (11 .9). The power unit comprises elements known in the art such as a battery casing (7.2) for housing the power source, for example LS14500 batteries (7.3) with a capacity of 1500mAh, and the battery contacts (7.1 , 7.4) to ensure proper electrical connectivity.

[0089] Each vial (8) comprises an NFC sticker (8.1 ), a vial cap (8.2), a leak-proof vented membrane (8.3), a vial casing (8.4), a lea-proof puncturing membrane (8.5), a membrane cover (8.6).

[0090] Each vial (8) is a container made of glass, aluminum, steel, or other suitable material and designed to hold a liquid formulation, a diluent or a cleaning solution containing a polar solution such as water, propylene glycol, vegetable glycerin, or a combination, or a nonpolar solution such as ethanol, medium-chain triglycerides, or a mixture, or a hybrid solution selected based on the polarity of the previously used liquid formulation.

[0091] The charging unit (9) replenishes the batteries of the power unit (7). The charging unit (9) comprises a cabling pack (9.1 ) to the heating unit (10.2), LED lights (9.2), a LED diffuser cover (9.3), a USB port (9.4), a pin connector (9.5) to the control unit (4), a further cabling pack (9.6) to the control unit (4), and main board (9.7).

[0092] The NFC sticker (8.1 ) comprises encrypted memory with formulation specifications. Each vial cap (8.2) comprises a slot-in tab to fit into guide rails of the vial unit’s (10) back metal section (10.2.1 ), securing the vial in place. The vial body (8.4) houses a Leak-proof vented membrane (8.3) to prevent vacuum formation, and a membrane cover (8.6) that protects the puncturing membrane and ensures a secure seal. It ensures a secure, leak-proof, and efficient connection for controlled liquid formulation transfer.

[0093] The vials unit (10) comprises vials (8) covers (10.1 ), a heating unit (10.2), a connecting needle (10.3), tubing connectors (10.4) to the connecting needle (10.3), tubing connectors (10.4) to connecting needle (10.3), the vials’ base (10.5) and self tapping screws.

[0094] The vials (8) connect with the vials unit (10) via the connecting needle (10.3) through a Leakproof puncturing membrane (8.5).

[0095] The vials unit (10) connect the vials (8) with the peristaltic pump unit (5) through the connecting needle (10.3) and the tubing connectors (10.4), and also serves to heat the vials (8) by the heating unit (10.2) in order to reduce viscosity of the liquid formulations and ease pumping. A casing is formed of the cove (10.1 ) and the base (10.5). The vial unit (10) also houses a back lid opening mechanism spring (10.7) and a ball retainer (10.8) for opening the back lid in order to insert the vials (8). The vials and heating unit is connected to the back casing lid (14) by three self tapping screws (10.6).

[0096] The vials’ (8) heating unit (10.2) comprises a back metal part (10.2.1 ), a front metal part (10.2.2), screws (10.2.3, 10.2.4), a ceramic heater (10.2.5) and a temperature sensor (10.2.6).

[0097] The heating unit (10.2) encases the vials (8) between the back metal part (10.2.1 ) and the front metal part (10.2.2). They transfer the heat provided by an independent ceramic heater

[0098] (10.2.5) to reduce viscosity of the liquid formulations and ensure smooth pumping. The ceramic heater (10.2.5) is controlled by a temperature sensor (10.2.6). The back metal part (10.2.1 ) and the front metal part (10.2.2) are connected by a connecting screw (10.2.3).

[0099] Top lid (18) is detachable and covers the top part of the mixing and dosing unit (1 ) where the reading unit (6) is positioned.

[0100] Inner lid casing (19) is detachable and comprises compartment for storing the reading unit (6) and comprises a neck comprising an indentation or a cutout for mating with a ball retainer

[0101] (11 .7. 13.5. 15.5) of a nozzle unit (11 , 13, 15). The inner lid casing (19) preferably comprises snap on securing means for securing the inner lid casing (19) to the connecting unit (3) in addition for the top lid casing (18) being adapted for mounting on the neck formed at top part of the connecting unit (3). The reading unit (6) scanner is positioned above top ends of the vials (8) for reading the vials (8) information.

[0102] Front casing lid (20) and back casing lid (21 ) cover the mixing and dosing unit (1 ) from front and back respectively for protecting the inner elements of the device.

[0103] The atomizer nozzle (11 ), the nasal spray nozzle (13), and the sublingual spray nozzle (15) are examples of administration units (1 1 , 13, 15) for attaching to the mixing and dosing unit (1 ) for interfacing with a user, i.e. for end-point administration of the mixture of compositions from the vials (8). The nozzles (11 , 13, 15) are interchangeable and do not require a separate mixing and dosing device. The connecting unit (3) is an interface unit for connecting the nozzles (11 , 13, 15) to the mixing and dosing unit (1 ).

[0104] The atomizer nozzle (11 ) can be used for pulmonary administration of the mixture of compositions from the vials (8). The atomizer nozzle (11 ) comprises two sections - upper and lower. The upper section comprises the nozzle top cap (11.1 ) which holds inside a disposable flavor-impregnated filter (11 .3) to add the vapor’s taste. The filter is made of cellulose-type material such as cotton, cellulose, cellulose acetate or perforated silicone sponge and it has been infused with flavors. The nozzle top cap (11.1 ) is held to the nozzle bottom part bottom (1 1 .4) by upper clipping magnets (11 .2).

[0105] The upper section is connected to the lower section with lower clipping magnets (11.5). The upper part comprises an atomizer reservoir (11.6) which stores the resultant formulation, while a ball retainer (11 .7) for mating with an indentation or cutout in a neck of the inner lid casing (19) ensures proper alignment and stability of the nozzle (11 ) with respect to the connecting unit (3) of the mixing and dosing unit (1 ). A puncturing membrane

[0106] (11 .8) allows for the controlled transfer of resultant formulation, and finally, the vape coil

[0107] (11 .9) heats the resultant formulation enabling effective and consistent vaporization.

[0108] The nasal spray nozzle (13) comprises a nasal administrator (13.1) serving as a contact piece for nasal application, a container cap (13.2) securely sealing the mixing and dosing unit (1 ), ensuring the protection of its contents, a diffusing mechanism (13.3) regulating the spray, ensuring a consistent and effective mist delivery, a solution reservoir (13.4) storing the resultant solution, a ball retainer (13.5) for mating with an indentation or cutout in a neck of the inner lid casing (19) providing proper alignment and stability of the nozzle (13) with respect to the connecting unit (3) of the mixing and dosing unit (1 ) with a puncturing membrane (13.6) facilitating a sterile transfer of the formulation mixture from the connection needle (3.7) to the reservoir (13.4).

[0109] The sublingual spray nozzle (15) comprises a presser (15.1 ) activating the spraying mechanism, a container cap (15.2) for securely sealing the mixing and dosing unit (1 ), protecting its contents, a diffusing mechanism (15.3) working alongside the solution diffuser (15.7) for ensuring a fine and even mist distribution, a solution reservoir (15.4) for storing the resultant mixture of formulations, a ball retainer (15.5) for mating with an indentation or cutout in a neck of the inner lid casing (19) providing alignment and stability of the nozzle (15) with respect to the connecting unit (3) of the mixing and dosing unit (1 ), a puncturing membrane (15.6) enabling sterile transfer of the resultant mixture of formulations from the connection needle (3.7) to the reservoir (15.4), a sublingual administrator (15.8) directing the spray for optimal absorption under a tongue of a user.

[0110] Advantages of the Invention

[0111] 1 . Personalized medicine delivery - enables custom formulation mixing based on user needs. 2. Interchangeable administration methods - offer versatility for different drug delivery routes.

[0112] 3. Automated cleaning system - minimizes cross-contamination and ensures device longevity.

[0113] 4. Smart vial identification - enhances accuracy and safety through NFC-based tracking.

[0114] 5. Temperature controlled viscosity adjustment: the temperature and gradient control ensures smooth solutions transfer and homogeneous mixture of the resultant solution. Even with high viscosity solutions at room temperature.

[0115] According to the second aspect of the invention the method of using the device comprises the following steps:

[0116] 1. Nozzle unit (11 , 13, 15) selection and connection. The user selects the appropriate delivery method (pulmonary, nasal, sublingual, or injection) and connects the appropriate nozzle unit (11 , 13, 15) to the mixing and dosing unit (1 ): an atomizer nozzle (11 ) for pulmonary administration, nasal spray nozzle (13) for intranasal administration, or the sublingual spray nozzle (15) for sublingual administration

[0117] 2. Vials (8) loading, identification and selection, comprising: o Turning on the device by pressing the power button (4.8) o The back lid (21 ) is held in place by a spring that keeps it elevated. Additionally, when fully closed, a small latch at the top prevents it from rotating unintentionally. To open it, the spring must be pressed, which releases the top latch and allows the cover to rotate. Once the cover is fully lowered to its lowest position, the ball retainer (10.8) locks it in place, preventing it from rising accidentally and making it easier and safer to change the vials (8). o Inserting the vials (8), into the vial unit (10), comprising two guide rails on the lid of the section that holds the vials (8), along with a vial slot-in tab. This design allows the vials (8) to be inserted vertically and secured by rotating into place, as in a quarter-turn fastener. To remove the vials (8), it has to be rotated in the opposite direction and pulled up, reversing the insertion movement.

[0118] 3. Liquid Extraction and Mixing, comprising o Selecting resultant formulation parameters (liquid formulation 1 / liquid formulation 2 ratios, dosing, and mixture via the control interface with the application. A mobile phone application configures the control unit (4) to manage the parameters. o The NFC reader (6.5) reading the NFC sticker (8.1 ) and transferring the formulation specifications data to the CPU control unit main board (4.2) which identifies the formulation type and sends data to the peristaltic pumping unit (5) o If a high-viscosity solution is used, the control unit (4) configures the heating unit sensor (10.2.6) and adjusts temperature of a ceramic heater (10.2.5) for each vial (8) to optimize flow of each solution. o The peristaltic pumps (5) extracting the required volume of each formulation from the vials (8) by means of the connecting needle (10.3) and the tubing connection (5.3) o Directing the extracted amounts of each liquid formulation into the mixing channel (5.2) to ensure homogeneity in the mixture. Transfer mixture formulation to the nozzle unit (1 1 , 13, 15) via the needle (3.7) mechanism within the connection unit (3). o Administration of mixture of formulations via the nozzle unit (11 , 13, 15), comprising

[0119] The control unit (4) adjusts output parameters accordingly with respect to settings for nozzle unit (1 1 , 13, 15) use. o The nozzle unit (1 1 , 13, 15) disperses the mixture of formulations for user inhalation or application.

[0120] Cleaning and Maintenance to prevent cross-contamination, comprising: o If a new vial is inserted or formulation changes, initiating a cleaning cycle; o inserting a cleaning vial in the first slot of the vial unit (10) containing a cleaning solution; o inserting an empty vial in the second slot of the vial unit (10) for storing contaminated solution; o where the peristaltic pumps (5.1 ) inject the cleaning solution through the pumping unit (5) channels (5.3, 5.5), the mixing channel (5.2), up to the reservoir (11 .6, 13.4, 15.4); o the peristaltic pumps (5.1 ) reverses direction to flush and remove residual liquids, into the empty vial preventing contamination; o The operation can be repeated to ensure thorough system cleaning, including complete flushing of the nozzle reservoir (11 .6, 13.4, 15.4) for optimal hygiene and performance.

[0121] Purging the injection circuits ensures the drug delivery device is completely free of residues from previous uses or formulations. This capability prevents cross-contamination and interference, marking it as a notable innovation

[0122] It enables pharmaceutical laboratories to conduct more flexible and precise clinical trials, particularly in the field of personalized medicine. Since every patient in a trial group is unique, researchers can not only monitor and measure dosage accurately but also tailor formulations to meet the specific needs of each participant. By integrating Al into the clinical trial process the innovation further enhances the precision and adaptability of treatment protocols, analyzing patient data, including age, weight, medical history, and genetic information, to this innovation can recommend optimal dosage and delivery routes for the trial participants. This ensures personalized treatment and minimizes adverse reactions, improving trial outcomes, making a perfect tool for advancing personalized medicine and clinical trial methodologies.

Claims

CLAIMS1. A drug delivery device comprising a mixing and dosing unit (1 ) comprising a control unit (4), a peristaltic pumping unit (5), a power unit (7), and vials unit (10), and a nozzle unit characterised in, that the mixing and dosing unit (1 ) further comprises a connection unit (3) for removably and interchangeably attaching the nozzle unit (11 , 13, 15) and a reading unit (6) for reading labels of the vials (8) stored in the vials unit (10) where each vial comprises a label (8.1 ) for reading by the reading unit (6).

2. The drug delivery device according to claim 1 , where the nozzle unit (11 , 13, 15) comprises a ferromagnetic plate (11.10, 13.7, 15.9) at the bottom and the connection unit (3) comprises permanent magnets (3.1 ) disposed on top of the connection unit (3) for contact with metal plate of nozzle unit (15).

3. The drug delivery device according to claim 1 or 2, where the mixing and dosing unit (1 ) comprises pogo pins (3.3) positioned on top of the connection unit (3), where one pogo pin touches the metal plate (15.10) of the nozzle unit (15) and the other pogo pin touches a coil the nozzle unit (11.10, 13.7, 15.9).

4. The drug delivery device according to any previous claim, where the mixing and dosing unit (1 ) further comprises a connection needle (3.7) positioned on top of the connection unit (3) for protruding into the puncturing membrane (11.8, 13.6,15.6) of the nozzle unit (11 , 13, 15).

5. The drug delivery device according to any previous claim, where the connection unit (3) houses both the peristaltic pumping unit (5) and the power unit (7).

6. The drug delivery device according to any previous claim, where the control unit (4) comprises a switch (4.1 ), main board (4.2) which integrates the CPU and the wireless module, two pins connector (4.3) for the power unit, another two pins connector (4.4) for the peristaltic pump unit, further two pins connector (4.5) for pogo the pins, (4.6) FPC connector for the NFC reading unit, cabling pack (4.7) for the charging unit, casing screen (4.9) and a screen (4.10).

7. The drug delivery device according to any previous claim, where the peristaltic pump unit (5) comprises peristaltic pumps (5.1 ), a mixing channel (5.2), tubing connection (5.3) to needles that go to the vials (8), general tubes (5.4), tubing connections (5.5) to the needles that goes to the connection unit (3).

8. The drug delivery device according to any previous claim, where the reading unit (6)is an NFC reading unit and the vial label (8.1 ) is an NFC readable label.

9. The drug delivery device according to any previous claim, where the vials unit (10) comprises a heating unit (10.2).

10. The drug delivery device according to any previous claim, where the nozzle unit (11 ) is an atomizer nozzle comprising a nozzle top cap (11.1 ) comprising a disposable flavor-impregnated filter (1 1 .3), an atomizer reservoir (11 .6), a ball retainer (11 .7), a puncturing membrane (11 .8), and a vape coil (11 .9).11 . The drug delivery device according to any one of claims 1 -10, where the nozzle unit (13) is a nasal spray nozzle (13) comprising a nasal administrator (13.1 ), a container cap (13.2), a diffusing mechanism (13.3), a solution reservoir (13.4), a ball retainer (13.5), and a puncturing membrane (13.6).

12. The drug delivery device according to any one of claims 1 -10, where the nozzle unit (15) is a sublingual spray nozzle (15) comprising a presser (15.1 ), a container cap (15.2), a diffusing mechanism (15.3), a solution reservoir (15.4), a ball retainer (15.5), a puncturing membrane (15.6), a sublingual administrator (15.8).

13. Method of administering formulation mixture from multiple vials (8) via a nozzle unit using a peristaltic pump unit (5) using a device comprising a mixing and dosing unit (1 ) comprising a control unit (4), a peristaltic pumping unit (5), a power unit (7), and vials unit (10), and a nozzle unit characterised in, that the method comprises steps of: a. selecting a nozzle unit (11 , 13, 15) and connecting the nozzle unit (11 , 13,15) to a connection unit (3) of a mixing and dosing unit (1 ), b. loading vials (8) into the vial unit (10); c. extracting liquid formulations from the vials (8) and mixing the extracted liquid formulations in a mixing channel (5.2) comprising: i. electing resultant formulation parameters, ii. reading vials label using internal label reader (6.5) of the drug delivery device, sending the read data to the control unit and further to an application in a computer device, where in the application the dose is regulated by a user or a doctor, the regulated dose information is sent back to the main board (4.2) and then it is sent to the peristaltic pumps (5.1 ); iii. if a high-viscosity solution is used, the control unit (4) configures theheating unit sensor (10.2.6) and adjusts temperature of a ceramic heater (10.2.5) for each vial (8); iv. extracting required volume of each formulation from the vials (8) by means of the connecting needle (10.3) and the tubing connection (5.3) using the peristaltic pumping unit (5); v. directing the extracted amounts of each liquid formulation into the mixing channel (5.2), d. transferring mixture formulation to the nozzle unit (1 1 , 13, 15) via the needle (3.7) mechanism within the connection unit (3). e. administering the mixture of formulations via the nozzle unit (1 1 , 13, 15) where the control unit (4) adjusts output parameters accordingly with respect to settings for nozzle unit (1 1 , 13, 15) use, and the nozzle unit (1 1 , 13, 15) disperses the mixture of formulations for user inhalation or application.

14. Method according to claim 13, where the method further comprises cleaning and maintenance to prevent cross-contamination, comprising: a. if a new vial is inserted or formulation changes, initiating a cleaning cycle, b. inserting a cleaning vial in the first slot of the vial unit (10) containing a cleaning solution, c. inserting an empty vial in the second slot of the vial unit (10) for storing contaminated solution, d. one of the peristaltic pumps (5.1 ) injects the cleaning solution through the pumping unit (5) channels (5.3, 5.5), the mixing channel (5.2), up to the reservoir (1 1 .6, 13.4, 13.4), e. another one of the peristaltic pumps (5.1 ) reverses direction to flush and remove residual liquids, into the empty vial preventing contamination.

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