Apparatus for crushing packaged oral dosage forms

Abstract

A device for crushing oral formulations in the form of pharmaceutical pouches is disclosed, wherein the device for crushing oral formulations in the form of pharmaceutical pouches comprises: a conveyor structure comprising a conveyor belt and a pulley that rotates the conveyor belt, wherein two conveyor sections for transporting oral formulations in the form of pharmaceutical pouches are arranged in a front-rear direction; and a crushing section provided between the two conveyor sections, wherein the crushing section comprises a lower metal plate, an upper metal plate provided above the lower metal plate, and a vibration action structure for vibrating each of the lower metal plate and the upper metal plate.

Description

Technology Field

[0001] The present invention relates to a device for crushing oral dosage forms in the form of drug pouches. Background Technology

[0002] With the recent acceleration of population aging, prescriptions for powders have been steadily increasing due to factors such as dysphagia, polypharmacy, declining medication adherence, and rising severity. Accordingly, dispensing facilities frequently perform the task of grinding solid oral formulations, such as tablets and capsules, into powders; however, many institutions still rely on manual or rotary (grinder-type) grinding processes, leading to the accumulation of various problems. For instance, manual grinding processes repeatedly result in quantity errors (discrepancy between prescribed quantities and actual ground / dispensed quantities), the mixing of residual drugs (cross-contamination where trace amounts of drugs remaining on the inner walls or crevices of the grinder are mixed into subsequent patient prescriptions), and repackaging losses (scattering or loss during powder handling and transfer), all of which are caused by operator skill levels, accuracy of weighing inputs, and variations in grinding time and intensity. These issues undermine patient safety and quality consistency. Furthermore, workers are constantly exposed to safety issues, such as dust generated during grinding, noise in the work environment, and the risk of hand entrapment near grinding and conveying devices. These problems, coupled with the increasing volume of medications and the expanding trend of night and weekend work, tend to exacerbate fatigue accumulation and human error.

[0003] Meanwhile, although there are commercially available devices that crush internal formulations by applying physical impact from the outside of the packaging without opening the drug pouch, in actual dispensing environments, when 4 to 5 large tablets (e.g., approximately 20×10×8 mm) are contained simultaneously inside the drug pouch, incomplete crushing (residual large particles), stagnation and aggregation (forms clumping together inside the pouch, resulting in poor movement), and damage to the pouch (rupture and wrinkling) frequently occur. This is because a uniform crushing delivery path cannot be secured due to complex factors such as dispersion and repulsion of impact energy, over-packaging of the ratio of the volume of the formulation to the internal volume of the pouch (high filling rate), internal air pockets, and slippery conditions. As a result, the rework rate increases, the total dispensing time increases as the loop of crushing-checking-additional impact-rechecking is repeated, and the continuity between processes—namely, alignment → crushing → seating → winding / collection—is not systematically implemented.

[0004] In other words, despite the structural change of increased demand for powders due to an aging population, it is difficult to simultaneously achieve consistent grinding quality, process continuity, and safety for medicine bags containing multiple large tablets using only conventional manual, rotary, or simple impact grinding devices. Consequently, complex limitations persist, including reduced consistency in dispensing quality (particle size variation, residual clumps), patient safety risks (quantity errors, cross-contamination), worker safety and environmental issues (dust, noise, pinch hazards), and reduced productivity (rework, waiting times, process bottlenecks). Therefore, there is a need for new process and device designs that can guarantee a continuous flow of alignment, grinding, settling, and winding without opening the medicine bag, suppress incomplete grinding, clumping, and damage even when large and numerous tablets are included, and mitigate dust, noise, and safety risks.

[0005] Prior art related to the present invention is disclosed in Korean Patent Publication No. 10-2021-0022301. The problem to be solved

[0006] The present invention aims to solve the problems of the aforementioned conventional technology by providing a grinding device for oral dosage forms in a pouch state that grinds the drug in a continuous flow even in a pouch state, while ensuring consistent grinding quality and reducing the generation of dust and noise.

[0007] However, the technical problems that the embodiments of the present invention aim to solve are not limited to the technical problems described above, and other technical problems may exist. means of solving the problem

[0008] As a technical means for achieving the above-mentioned technical problem, a crushing device for an oral formulation in the form of a pharmaceutical pouch according to one embodiment of the present invention comprises: a conveyor structure comprising a conveyor belt and a pulley that rotates the conveyor belt, wherein two conveyor sections for transporting an oral formulation in the form of a pharmaceutical pouch are arranged in a front-rear direction; and a crushing section provided between the two conveyor sections, wherein the crushing section may include a lower metal plate, an upper metal plate provided above the lower metal plate, and a vibration acting structure that vibrates each of the lower metal plate and the upper metal plate.

[0009] In a crushing device for an oral formulation in the form of a drug pouch according to one embodiment of the present invention, the height of the lower surface of the upper metal plate may be increased so that the gap with the lower metal plate increases as it moves toward the rear in the outlet section, which is the rear end, and the height of the lower surface of the portion located in front of the outlet section may be lowered so that the gap with the lower metal plate decreases as it moves toward the rear.

[0010] In a crushing device for oral formulations in the form of a drug pouch according to one embodiment of the present invention, the upper metal plate may be formed such that its lower surface includes a non-linear inclined profile, the rate of reduction in the gap with the lower metal plate at the inlet section which is the front section is maximum, the gap with the lower metal plate at the outlet section is increased, and the rate of reduction in the gap with the lower metal plate at the main section located between the inlet section and the outlet section decreases as it moves toward the rear.

[0011] In a crushing device for an oral formulation in the form of a pharmaceutical pouch according to one embodiment of the present invention, the device further comprises an input section provided at the front end of the conveyor structure, wherein the input section comprises a notch swing part, the notch swing part is rotatably provided around a hinge axis extending in the width direction of the conveyor section which is orthogonal to the front-rear direction, and a roller is provided at the bottom end of the front end, and an oral formulation in the form of a pharmaceutical pouch can be conveyed between the notch swing part and the conveyor section located in front when the top end of the notch swing part is lying down facing forward.

[0012] A crushing device for an oral formulation in the form of a pharmaceutical pouch according to one embodiment of the present invention further comprises a discharge unit provided at the rear end of the conveyor structure, wherein the discharge unit may further comprise a pressurizing structure disposed on the rear end of the conveyor unit located at the rear and pressurizing an oral formulation in the form of a pharmaceutical pouch passing between the conveyor unit located at the rear and the discharge unit located at the rear; and a winding roller provided at the rear of the conveyor unit located at the rear and winding an oral formulation in the form of a pharmaceutical pouch. Effects of the invention

[0013] It is possible to crush oral formulations in the form of a packet by applying ultrasonic vibration without opening the packet. Accordingly, conventional problems such as hygiene, noise, loss, deterioration, and leakage caused by packet tearing can be prevented, and a device for crushing oral formulations in the form of a packet optimized for a continuous process can be realized. Brief explanation of the drawing

[0014] FIG. 1 is a conceptual perspective view of a device for crushing an oral dosage form in the form of a drug pouch according to one embodiment of the present invention. FIG. 2 is a conceptual side view of an oral formulation crushing device in the form of a drug pouch according to one embodiment of the present invention, in which a part (housing) of the crushing part is removed. FIG. 3 is a conceptual side view of the upper metal plate of a drug pouch-state oral formulation crushing device according to one embodiment of the present invention. FIG. 4 is a conceptual perspective view of a drug pouch-type oral formulation crushing device according to one embodiment of the present invention, including a fixed structure. FIG. 5 is a conceptual perspective view of a drug pouch-state oral formulation crushing device according to one embodiment of the present invention, including a fixed structure according to another example. Specific details for implementing the invention

[0015] Embodiments of the present invention are described below with reference to the attached drawings to enable those skilled in the art to easily implement the invention. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. Furthermore, in order to clearly explain the present invention in the drawings, parts unrelated to the explanation have been omitted, and similar parts throughout the specification are denoted by similar reference numerals.

[0016] Throughout this specification, when a part is described as being "connected" to another part, this includes not only cases where they are "directly connected," but also cases where they are "electrically connected" with other elements interposed between them.

[0017] Throughout the entire specification, when a component is described as being located "on," "on top," "on top," "under," "on bottom," or "on bottom" of another component, this includes not only cases where the component is in contact with the other component but also cases where another component exists between the two components.

[0018] Throughout this specification, when a part is described as "comprising" a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but may include additional components.

[0019] In addition, terms related to direction or position (upper side, upper side, upper surface, lower side, lower surface, etc.) in the description of the embodiments of the present invention are set based on the arrangement state of each component shown in the drawings. For example, when viewed in FIG. 1, the direction generally facing the 12 o'clock direction may be the upper side, the surface generally facing the 12 o'clock direction may be the upper surface, the end generally facing the 12 o'clock direction may be the upper side, the direction generally facing the 6 o'clock direction may be the lower side, the surface generally facing the 6 o'clock direction may be the lower surface, and the end generally facing the 6 o'clock direction may be the lower surface.

[0020] The present invention relates to a device for crushing oral dosage forms in the form of drug pouches.

[0021] Hereinafter, a device for crushing an oral dosage form in the form of a drug pouch (hereinafter referred to as the "device") according to one embodiment of the present invention will be described.

[0022] In the present invention, the term "oral dosage form in a sachet" may refer to a drug in an oral dosage form that is packaged in a sachet. Accordingly, the present device can crush a drug in an oral dosage form that is packaged in a sachet.

[0023] Specifically, an oral formulation in the form of a sachet refers to a drug for oral administration that is individually packaged in a sachet (e.g., a polymer laminate film composite) for the convenience of the patient. Here, the oral formulation may include all solid and semi-solid formulations taken orally, such as tablets, capsules, granules, pellets, troches, and gelatin capsule fillers, and the sachet may be in the form of a single cavity or a strip with multiple cavities arranged in a continuous sequence. Accordingly, the device can transmit vibrational energy (vibration waves) to the oral formulation inside the sachet without opening or cutting the sachet to grind it into a powder or granule state, and can be designed to minimize damage to the exterior of the sachet or scattering of the contents after grinding.

[0024] Referring to FIGS. 1 and 2, the device includes a conveyor structure (1). The conveyor structure (1) includes two conveyor sections (10).

[0025] Referring to FIGS. 1 and 2, the conveyor unit (10) includes a conveyor belt (11) and a pulley (12) that rotates the conveyor belt (11). A plurality of pulleys (12) may be included. At least one of the plurality of pulleys (12) may be a driving pulley, and at least one of the remaining pulleys (12) may be a driving pulley. Additionally, the plurality of pulleys (12) may include one or more of a tension pulley and an idler. Since such a conveyor unit (10) is obvious to a person skilled in the art, a detailed description is omitted.

[0026] The conveyor unit (10) conveys oral formulations in the form of medicine pouches. The conveyor unit (10) can continuously convey oral formulations in the form of medicine pouches from the input unit to the output unit of the device. Additionally, the oral formulations in the form of medicine pouches may be provided by connecting a plurality of medicine pouches in a continuous strip shape. Accordingly, a plurality of oral formulations in the form of medicine pouches can be sequentially conveyed forward by the conveyor unit (10).

[0027] Additionally, two conveyor sections (10) are arranged adjacently in the front-rear direction. Multiple medicine packets can be transported from the front to the rear in a manner such that they are transported from the conveyor section (10) located at the front to the conveyor section (10) located at the rear.

[0028] Also, referring to FIGS. 1 and 2, the device includes a crushing section (2) provided between two conveyor sections (10).

[0029] Referring to FIG. 2, the crushing section (2) includes a lower metal plate (23). The lower metal plate (23) may be formed of an aluminum alloy (e.g., 6061-T6, hard anodized) or stainless steel (SUS series) for thermal capacity and rigidity, and may adopt a lift-off (detachable) structure for easy replacement and cleaning.

[0030] Also, referring to FIG. 2, the crushing part (2) includes an upper metal plate (22) provided on the upper side of the lower metal plate (23).

[0031] Also, referring to FIG. 2, the crushing unit (2) includes a vibration action structure (24) that vibrates each of the lower metal plate (23) and the upper metal plate (22).

[0032] The vibration action structure (24) may include an ultrasonic probe. The ultrasonic probe may include an ultrasonic generator, a transducer, a booster, and a horn (sonotrode). The horn may be rigidly coupled to each of the upper metal plate (22) and the lower metal plate (23) to form ultrasonic vibrations on the metal plates. Optionally, it may further include a temperature / acceleration sensor, a cooling means, an impedance matching / automatic frequency tracking circuit, and an interlock. The vibration action structure (24) may vibrate the lower metal plate (23) and the upper metal plate (22) independently or synchronously, and the vibrations of the lower metal plate (23) and the upper metal plate (22) may be transmitted to the oral formulation (9) in the form of a pharmaceutical pouch, causing the oral formulation (9) to be crushed into powder. The surface roughness / pattern of the metal plates may be adjusted so that the friction characteristics with the outer layer laminate of the pharmaceutical pouch are advantageous for crushing stability.

[0033] The ultrasound operates in a single-intensity pulse mode, and the duty cycle is controlled by a dial. Depending on the mode toggle (Standard / Fine), the recommended duty cycle point (60% / 65%) can be indicated via the dial detent and LED.

[0034] In other words, the vibration action structure (24) is driven in pulse mode, the amplitude of the ultrasound is kept constant, and the pulse duty is controlled by the front dial. The mode toggle switch can be selected between standard mode and fine mode, and the respective recommended duty points are set to 60% and 65%, and the dial can form a detent (mechanical click stop) at the corresponding point and an LED indicator can be lit to guide the user.

[0035] To this end, referring to FIG. 1, the device may include a control unit (6), the control unit (6) may include a power switch (on / off control of the device), an ultrasonic duty dial, an emergency stop button, a dial for controlling the movement speed of the conveyor belt (11), and a knob for adjusting the distance between the upper and lower metal plates (22, 23). At this time, the ultrasonic duty dial may be configured to include an output application switch (on / off control of the vibration action structure (24)) and a mode toggle switch.

[0036] Referring to FIGS. 2 and 3, the height of the upper metal plate (22) can be increased so that the gap with the lower metal plate (23) increases as it moves toward the rear in the exit section (22d), which is the rear end (ramp out). This increase in the gap in this section can mitigate friction peaks that may occur at the end of passing through the crushing section, thereby guiding the medicine packet to smoothly detach and be discharged from the exit without getting stuck. Accordingly, scunging and stagnation are reduced, and the stability of the subsequent winding and collection process can be improved.

[0037] Additionally, the height of the upper metal plate (22) can be lowered so that the gap with the lower metal plate (23) decreases as the portion (22a) located at the front of the exit section faces the rear. Accordingly, the drug packet is rapidly nipped at the entrance section of the crushing section (2), and then undergoes crack propagation and crushing progress of the internal formulation through gradual compression and retention in the middle and later sections.

[0038] Specifically, the upper metal plate (22) may include a ramp-out profile formed such that the lower surface has a non-linear slope profile, the rate of reduction in the gap with the lower metal plate (23) in the shear section (22a) is maximum, the gap with the lower metal plate (23) in the exit section (22d) increases, and the rate of reduction in the gap with the lower metal plate in the main section (22b, 22c) located between the entrance section and the exit section decreases as it moves toward the rear.

[0039] For example, the upper metal plate (22) may have a non-linear inclined profile with an effective length of 80 mm in the front-rear direction, and the exit section may be configured as a ramp-out. For reference, the effective length may be the same (correspond) as the lower metal plate (22) within an error range.

[0040] Additionally, in the crushing section (2), the spacing distance (gap) between the upper metal plate (22) and the lower metal plate (23) can be adjusted. For example, the upper metal plate (22) may be provided in the form of a lift that allows for adjustable spacing and removal.

[0041] The gap between the upper and lower metal plates (22, 23) can be realized by the vertical movement of the upper metal plate (22), and the crushing unit (2) may include a transfer structure that moves the upper metal plate (22) up and down. The transfer structure may include a rail section extending vertically from the left side of the upper metal plate (22), a guide unit connecting the rail section and the upper metal plate (22) and capable of moving vertically relative to the rail section, and a motor that moves the guide unit vertically relative to the rail section. Since such a transfer structure is obvious to a person skilled in the art, a detailed description is omitted.

[0042] Alternatively, as another example of a transfer structure, the transfer structure may be implemented to move the upper metal plate (22) up and down by driving a lead screw. The amount of movement per revolution may be set to, for example, 0.25 mm. After adjustment, displacement during vibration can be suppressed by a locking knob. More specifically, the spacing between the upper and lower metal plates (22, 23) may be set by a continuous fine adjustment mechanism similar to a microscope focus adjustment screw. Specifically, backlash may be suppressed by including a fine pitch lead screw and a preload spring, and the set value may be mechanically fixed by a locking knob. The spacing value is read by a front ring scale (including a vernier), and if a setting outside the allowable range is detected, an interlock may be configured to operate to block the conveyor and ultrasonic drive.

[0043] Additionally, referring to FIG. 1, the crushing unit (2) may include a housing (21). The housing (21) may be formed such that the crushing unit (2) is provided inside, and an oral formulation in the form of a medicine pouch can pass through.

[0044] Additionally, referring to FIGS. 1 and 2, the device may include a discharge section (3) provided at the rear end of the conveyor section (10).

[0045] Referring to FIGS. 1 and 2, the discharge section (3) may include a pressure structure (31) positioned on the rear end of the conveyor belt (11) of the rear conveyor section (10) to press the oral formulation (9) in the form of a pharmaceutical pouch passing between it and the conveyor belt (11).

[0046] The pressure structure (31) can be implemented in the form of a roller or a guide finger. The pressure structure (31) can immediately ground the leading edge of the medicine pouch by pressing the oral formulation (9) in the form of a medicine pouch passing between it and the conveyor belt (11).

[0047] Additionally, referring to FIGS. 1 and 2, the discharge section (3) may include a winding roller (33) provided at the rear of the conveyor section (10). The oral formulation (9) in the form of a pharmaceutical pouch can be moved forward on the conveyor belt (11) in the form of a band in which a plurality of pharmaceutical pouches are connected to each other, and at this time, the plurality of pharmaceutical pouches can be wound onto the winding roller (33). That is, the plurality of oral formulations (9) in the form of pharmaceutical pouches can be moved forward by winding the winding roller (33) and can be wound onto the winding roller (33).

[0048] Additionally, the rotational speed of the winding roller (33) can be set so that the speed at which the oral formulation (9) in the form of a pharmaceutical pouch is moved by the winding roller (33) (the speed when the conveyor belt (11) is not operating) is less than or equal to the speed at which the oral formulation (9) in the form of a pharmaceutical pouch is moved by the conveyor belt (11) (the speed when the winding roller (33) is not operating). Accordingly, it is prevented that the oral formulation (9) in the form of a pharmaceutical pouch is excessively stretched by winding, thereby preventing damage to the pharmaceutical pouch or damage to the perforation line between multiple pharmaceutical pouches.

[0049] That is, the winding roller (33) can be configured to wind the discharged drug strip into an aligned state under low torque tension limits. The winding roller can be detached with a single touch, making replacement and disposal easy.

[0050] Additionally, the device may include an input section. The input section may be provided at the front end of the conveyor section (10). The input section is formed as a conveyor section with an open top surface so that an operator can visually check the alignment and twisting status of the oral formulation (9) in the form of a medicine packet. Referring to FIGS. 1 and 2, a notch swing part (5) may be positioned at the beginning of the input section. The notch swing part (5) may be rotatably provided around a hinge axis extending in the width direction of the conveyor section, which is orthogonal to the front-rear direction. Additionally, a roller (51) may be provided at the bottom of the front end. The notch swing part (5) may swing upward around the hinge axis, and at this time, the effective width of the input section entrance may be temporarily expanded, thereby improving accessibility and ease of insertion of the medicine packet. With the top of the notch swing part (5) lying down facing forward, an oral formulation in the form of a medicine pouch can be transported between the notch swing part (5) and the conveyor belt (11) of the conveyor unit (10) located in front. At this time, the two side portions of the medicine pouch in the width direction are located between the conveyor unit (10) and the roller (51) and can be compressed by the conveyor unit (10) and the roller (51), so that the position of the medicine pouch can be fixed during transport. Specifically, referring to FIG. 1, the conveyor unit (1) may include a frame structure (8) extending in the front and rear directions from each of the one side and the other side in the width direction of the conveyor belt (11). The frame structure (8) may include a frame (81) and an auxiliary roller (82) provided at the front end of the frame (81) located in front of the conveyor unit (1), which faces the roller (51) provided on the notch swing part (5) when the notch swing part (5) is in a lying state. Accordingly, when a drug pouch (a drug pouch containing an oral formulation) is fed in, both sides pass between the roller (51) and the auxiliary roller (82), and the position can be fixed. As a result, drug alignment and stable transport functions, as well as improved safety for the operator, can be achieved.

[0051] When the swing is opened, the upper roller rotates upward to open the opening, and when closed, it returns to its original position to recreate the surface pressure with the lower roller (51). The 'notch swing part' is an opening structure for insertion accessibility and safety, and an interlock may be linked so that operation is allowed only when the snap lock is engaged. Here, the interlock may refer to a safety linkage that detects the open / closed state and blocks operation while open.

[0052] Additionally, referring to FIGS. 4 and 5, the input section may include a fixed structure (4) that presses downward on the left and right ends of the oral formulation (9) in the form of a medicine pouch.

[0053] Referring to FIG. 4, the fixed structure (4) may include a pair of pressure units (41) extending in the front-rear direction from the upper side of each of the left and right sides of the conveyor section (10). Also, referring to FIG. 4, the fixed structure (4) may include a position adjustment rail (43) provided at the front of the conveyor section (10) and extending in the left-right direction. Additionally, the fixed structure (4) may include a guide unit (42) that connects each of the pair of pressure units (41) to the position adjustment rail (43) and is configured to be movable in the left-right direction relative to the position adjustment rail (43). Alternatively, as another example, referring to FIG. 5, the position adjustment rail (43) may be provided on the upper side of the conveyor section (10). By adjusting the position of the guide unit (42) in the left-right direction along the rail (43), the left-right position of each of the pair of pressure units (41) can be adjusted. Additionally, each of the pair of pressurizing units (41) can press the oral formulation in the form of a pharmaceutical pouch downward from the upper side of the left and right sides of the pharmaceutical pouch (in close contact with the conveyor belt (11)), thereby allowing the pharmaceutical pouch to move in the forward and backward directions while being fixed in the left and right directions.

[0054] The pressure applied by the fixed structure (4) can be set in the range of approximately 2 to 8 N (per side, based on a stationary state) to maintain alignment while preventing damage to the medicine packet, and can be finely adjusted as needed by spring preloading or cam step-by-step. The rail (43) can be a side U-shaped guide, and the pressure unit (41) can be a width-variable sliding guide. Additionally, the gap between a pair of pressure units (41) can be called the effective width, and the pressure unit (41) can be formed such that the effective width is formed only at a selected value among preset 70 / 80 / 90 / 100 mm, thereby fixing the gap between a pair of pressure units (41) (conveyor effective width) in steps, and the allowable tolerance of the effective width when preset is fastened can be managed to be ±0.5 mm. The full-open effective width can be 100 mm. Whether the preset matches can be visually confirmed by numerical notation and high-saturation color labels, for example, 70 mm=yellow, 80 mm=green, 90 mm=blue, and 100 mm=red.

[0055] Additionally, the metal plates (22, 23) may be made of a material including one or more of aluminum 6061 T6 (recommended) and hard anodizing (about 40-60 μm). Hard anodizing may be a hard oxide film treatment that increases wear resistance, corrosion resistance, and ease of cleaning. Additionally, the upper metal plate (22) may have a thickness of 8-10 mm, and the lower metal plate (23) may have a thickness of 10-12 mm. Additionally, the left-right effective width may be set to 100 mm (outer width 104-108 mm recommended, edge R0.3-0.5), and the upper and lower surfaces may each have an average roughness Ra of 0.8-1.6 μm, and a surface fine pattern (pitch 20-80 μm, depth 5-30 μm) may be formed.

[0056] Additionally, the grinding section (2) may include a replaceable liner provided on the lower surface of the upper metal plate (22). The replaceable liner may be a one-piece preform (mold molding) formed to correspond to the non-linear slope / ramp-out shape of the upper metal plate. It may be urethane or TPU, 0.5-0.8 mm, Shore A 75-85. A fine pattern (pitch 20-80 μm, depth 5-30 μm) may be formed on the lower surface, and it may be repeatedly attached to and detached from the upper metal plate (22) by at least one of a peripheral bottom screw or a magnetic insert / snap connection. The ramp-out section may be formed with a liner thickness of approximately 0.1 mm thinner than the adjacent section to alleviate friction peaks.

[0057] Additionally, referring to FIG. 3, the lower surface of the upper metal plate (22) includes a non-linear slope profile and can be continuously formed over an effective length (e.g., 80 mm) in a first section (22a) (intro, 0–15 mm) - a second section (22b) (middle, 15–55 mm) - a third section (22c) (rear, 55–75 mm) - a fourth section (22d) (ramp out, 75–80 mm).

[0058] S1, S2, and S3 represent the average slope of each section, ΔG1 to ΔG4 represent the change in separation between the upper and lower metal plates (22, 23) in each section, and ΣΔG represents the total change in separation for the entire section, which will be explained in more detail below. The intention of this profile is to maintain a relatively wide gap in the inlet section so that thick or multi-layered pharmaceutical pouches can naturally flow between the upper and lower metal plates, and to suppress initial slippage, stagnation, and deformation. Operation can be performed by inducing initial contact with gentle nipping in the inlet section (slope S1 is maximum), gradually reducing the separation reduction rate as it moves toward the middle (S2 < S1) to propagate cracks in the internal formulation, and slightly increasing the separation in the ramp-out section just before the exit (ΔG4 > 0) to alleviate friction peaks and dragging. The resulting effects include suppression of deformation, folding, and wrinkling of the bag, reduction of stagnation in the inlet section, securing of grinding residence time in the middle and later sections, and reduction of stagnation and scuffing in the outlet section.

[0059] For example, numerically, the change in separation amount in the first section (22a) (0~15 mm) is ΔG1 -0.6 to -0.9 mm with an average slope S1, and ΔG2 in the second section (22b) (15 to 55 mm). It is -0.45 to -0.6 mm and has an average slope S2, where S1:S2 A relationship of 1.2 to 1.6:1 can be satisfied. ΔG3 in the third section (22c) (55 to 75 mm). It is -0.15 to -0.3 mm and has an average slope S3, but S2:S3 A relationship of 1.5~2.5:1 can be satisfied. At the ramp-out of the 4th section (22d) (75~80 mm), ΔG4 It can be set to +0.15~+0.45 mm to mitigate the friction peak just before the exit. The total change in separation over the entire section is ΣΔG The range may be -1.2 to -1.8 mm, and the length tolerance at the boundary positions of each section can be managed to ±2 mm. The above sections are connected to satisfy geometric continuity (C¹ continuity), and if necessary, implemented with curvature continuity (C²) splines to suppress local friction peaks and jamming.

[0060] Operation can be performed sequentially in the following order. First, the power can be turned on. Additionally, the user can check via a visual label whether the effective width preset (70 / 80 / 90 / 100 mm) of the input and output sections is set identically. Next, with the notch swing part open, the tip of the medicine packet is set at the inlet of the input section, and the notch swing part is closed to engage the snap lock, thereby switching the interlock switch to a normal (operation allowed) state. After that, multiple medicine packets can be transported by passing through the conveyor section (10) and crushing section (2) located at the front to the conveyor section (10) located at the rear, and after transport stops, the separation distance, duty cycle, etc. are set, and transport and crushing can be performed again. At this time, when the transport speed is set via the speed dial (detent) of the conveyor section (10) of the control unit, transport begins, and then the user can adjust the duty dial (detent) of the control unit. For example, the duty dial can be set to standard mode (recommended 60%) or fine mode (recommended 65%). Accordingly, the medicine packet is conveyed to the crushing section (2) and passes between the upper and lower metal plates (22, 23), and crushing proceeds in the order of nipping-cracking-propagation-ramp out (ΔG4>0) along a non-linear slope profile. Meanwhile, during the conveying process, the user can control the separation distance adjustment knob, speed dial, duty dial, etc., as needed while observing the situation. Additionally, when crushing is performed and the medicine packet passes through the ramp out section, it is immediately pressurized by the pressurizing structure (31) immediately after the exit, and then can be aligned and wound onto the winding roller (33) of the discharge section (3). At this time, if the interlock is released or the cover is opened, the conveyor and ultrasonic output can be configured to be automatically shut off to ensure safety.

[0061] That is, the conveyor unit (10) can be responsible for the main transport of the oral formulation in the form of a medicine pouch, and the winding roller (33) can perform the role of a synchronous guard with low torque (allowing auto-slip). The torque of the winding roller (33) can be set in a lower limit area that protects the cut line between the medicine pouches of a plurality of oral formulations in the form of medicine pouches. In addition, the discharge unit (3) may include at least one of a spring reel type non-adhesive mini clamp (clamp type) or a starter strip as a winding start assist means, and the starter reel can stabilize the leading edge pickup and the formation of the initial winding angle.

[0062] The device can set and operate operating conditions through the control unit (6). In the description, "standard" and "fine" refer to recommended operating condition presets corresponding to the target particle size, and "OFF" may refer to a detent position for power cutoff (or disabling operation) on the corresponding dial or switch.

[0063] As described above, the control unit (6) may include a power switch (on / off control of the device), an ultrasonic duty dial, an emergency stop button, and a speed dial for controlling the movement speed of the conveyor belt (11). In the speed dial, the transfer speed of the oral formulation in the form of a drug pouch by the conveyor unit (10) can be set as a step dial having four detent points (2.0 / 2.5 / 3.0 / 4.0 cm / s) and a bottom OFF position. Although it can be structurally set up to an upper limit of 5.0 cm / s, it may be treated as unrecommended in terms of crushing quality and retention stability. The detent mechanism can facilitate reproducible settings by providing tactile feedback at each setting point.

[0064] In addition, the ultrasonic drive operates exclusively in fixed intensity (frequency and output density) and pulse modes, and is continuously variable within a duty cycle range of 50–80%. On the dial, a detent and a small LED are positioned at the recommended duty cycle points for standard and fine settings (60% and 65%, respectively), so that when the corresponding mode toggle is selected, the LED at that point remains lit to indicate the recommended point. The LED can be configured to turn off when the mode toggle is in the neutral position.

[0065] In addition, the device may extend a bridge finger or a low-friction pad in the forward and backward direction to prevent sagging of the oral formulation in the form of a drug pouch at one or more of the front and rear of the conveyor section (10). In addition, the winding roller (33) may be positioned at a distance of 5-8 nm from the conveyor section (10).

[0066] Additionally, the housing (21) of the crushing unit (2) can be rotated upwards to open like a first aid box, and the operation of the crushing unit (2) can be stopped when the housing (21) is opened by an interlock of the opening and closing states. The hinge type (lift-off / piano hinge / gas spring assist) can be modified according to manufacturing and maintenance convenience.

[0067] Additionally, the housing (21) of the crushing unit (2) may have a through hole formed therein through which the conveyor unit (10) passes in the forward and backward directions and through which an oral formulation in the form of a medicine pouch passes, and at least one of the front and rear ends of the through hole may be provided with a replaceable brush seal.

[0068] Additionally, one or more of the upper and lower metal plates (22, 23) may be formed to suppress the air layer formed between them and the medicine pouch by including an average roughness or a fine pattern.

[0069] Below, a method for crushing an oral formulation in the form of a drug pouch using the aforementioned device is described.

[0070] The crushing method of the present invention can prepare a plurality of continuously connected medicine pouches, fasten a notched swing part, and operate a transfer button to transfer the first medicine pouch (pouch) located at the rearmost position from the front to the rear. Accordingly, the first medicine pouch can pass through the conveyor section (10) and crushing section (2) located at the front and move onto the conveyor section (10) located at the rear, and can be connected to a spring reel type non-adhesive mini clamp (clamp type) or starter strip provided as a winding start assist means of the discharge section (3) (step a). For reference, a perforation line may be formed between the medicine pouches of the plurality of medicine pouches. Accordingly, the medicine pouches can be positioned between upper and lower metal plates (22, 23).

[0071] In addition, the grinding method of the present invention may include a step (step b) of setting vibration energy conditions by selecting and combining a separation distance, a transport speed, and an ultrasonic pulse duty from a predetermined range according to the characteristics of the oral formulation in the drug pouch.

[0072] Additionally, the grinding method of the present invention may include a step (step c) of grinding the oral formulation inside the drug pouch by irradiating the upper and lower metal plates (22, 23) with ultrasound.

[0073] In addition, the grinding method of the present invention may perform steps a and c after performing step b, and when a plurality of drug packets are provided in succession, steps a and c may be performed on drug packets adjacent to the rear of the drug packet that has been ground after performing step b.

[0074] In addition, the device may include a sound generating unit.

[0075] In addition, the device may include a measuring unit for measuring the rotational speed of a roller-shaped pressure structure (31).

[0076] In addition, the sound generator can output sound if the speed measured by the measuring unit falls short of a preset speed. The output sound can serve as an alarm.

[0077] If, even though grinding has been performed by the grinding unit (2), the oral formulation is not fully ground and large pellets remain, the pellets may get caught on the pressure structure (31) when passing between the roller-type pressure structure (31) and the conveyor unit (10), causing the rotation speed of the pressure structure (31) to slow down. Accordingly, if the rotation speed falls short of a preset speed, a sound may be output to indicate that the grinding has not been fully performed.

[0078] The foregoing description of the present invention is for illustrative purposes only, and those skilled in the art will understand that other specific forms can be easily modified without altering the technical concept or essential features of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. For example, each component described as a single unit may be implemented in a distributed manner, and components described as distributed may likewise be implemented in a combined form.

[0079] The scope of the present invention is defined by the claims set forth below rather than by the detailed description above, and all modifications or variations derived from the meaning and scope of the claims and the concept of equivalents thereof should be interpreted as being included within the scope of the present invention. Explanation of the symbols

[0080] 1: Conveyor section 11: Conveyor belt 12: Pulley 2: Grinding section 21: Housing 22: Upper metal plate 22a: Section 1 22b: Section 2 22c: Section 3 22d: Section 4 23: Lower metal plate 24: Vibration-acting structure 3: Discharge section 31: Pressurized structure 33: Winding roller 4: Fixed structure 41: Pressurization unit 42: Guide Unit 43: Rail

Claims

Claim 1 delete Claim 2 A device for crushing oral formulations in the form of pharmaceutical pouches, comprising: a conveyor structure including a conveyor belt and a pulley that rotates the conveyor belt, wherein two conveyor sections for transporting oral formulations in the form of pharmaceutical pouches are arranged in a front-rear direction; and a crushing section provided between the two conveyor sections, wherein the crushing section includes a lower metal plate, an upper metal plate provided above the lower metal plate, and a vibration acting structure for vibrating each of the lower metal plate and the upper metal plate, wherein the height of the lower surface of the upper metal plate increases as it moves toward the rear in the exit section, which is the rear end, and the height of the lower surface of the portion located in front of the exit section decreases as it moves toward the rear, such that the distance from the lower metal plate decreases. Claim 3 A device for crushing oral dosage forms in the form of a drug pouch, wherein the upper metal plate has a lower surface that includes a non-linear slope profile, the rate of reduction in the gap with the lower metal plate in the inlet section which is the front section is maximum, the gap with the lower metal plate in the outlet section is increased, and the rate of reduction in the gap with the lower metal plate in the main section located between the inlet section and the outlet section is formed such that it decreases as it moves toward the rear. Claim 4 A device for crushing oral formulations in the form of pouches, comprising: a conveyor structure including a conveyor belt and a pulley that rotates the conveyor belt, wherein two conveyor sections for transporting oral formulations in the form of pouches are arranged in a front-rear direction; and a crushing section provided between the two conveyor sections, wherein the crushing section includes a lower metal plate, an upper metal plate provided above the lower metal plate, and a vibration acting structure that vibrates each of the lower metal plate and the upper metal plate, and further comprises an input section provided at the front end of the conveyor structure, wherein the input section includes a notch swing part, wherein the notch swing part is rotatably provided around a hinge axis extending in the width direction of the conveyor section which is orthogonal to the front-rear direction, and a roller is provided at the lower end of the front end, and wherein the oral formulation in the form of pouches is transported between the notch swing part and the conveyor section located in front while the front end of the notch swing part is lying down facing forward. Claim 5 A device for crushing oral formulations in the form of pouches, comprising: a conveyor structure including a conveyor belt and a pulley that rotates the conveyor belt, wherein two conveyor sections for transporting oral formulations in the form of pouches are arranged in a front-rear direction; and a crushing section provided between the two conveyor sections, wherein the crushing section includes a lower metal plate, an upper metal plate provided above the lower metal plate, and a vibration acting structure that vibrates each of the lower metal plate and the upper metal plate, and further includes a discharge section provided at the rear end of the conveyor structure, wherein the discharge section further includes a pressure structure disposed on the rear end of the conveyor section located at the rear and pressurizing the oral formulation in the form of pouches passing between it and the conveyor section located at the rear; and a winding roller provided at the rear of the conveyor section located at the rear and winding the oral formulation in the form of pouches.

Images