Solid feeding device
By using a sieve plate and a self-circulating material component in the reaction vessel in the feeding device, the problem of agglomeration of solid dispersion excipients was solved, rapid dissolution was achieved, and production efficiency was improved.
Patent Information
- Application Number
- CN202422631385.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-30
- Publication Date
- 2025-11-11
- Estimated Expiration
- 2034-10-30
AI Technical Summary
In existing technologies, solid dispersion additives are prone to clumping during the feeding process, resulting in excessively long dissolution times and affecting production efficiency.
A solid feeding device is adopted, which includes a sieve plate and a material self-circulation component of the reactor. The sieve plate is used to disperse solid materials, and the material self-circulation component of the reactor sprays liquid materials onto the solid dispersion auxiliary materials that have not fallen below the material surface through a spray head to prevent agglomeration.
It effectively avoids the clumping of solid dispersion excipients, significantly shortens the dissolution time, and improves production efficiency.
Smart Images
Figure CN223530389U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of solid material feeding technology, and in particular to a solid material feeding device. Background Technology
[0002] Solid dispersions refer to systems in which drugs are uniformly dispersed in a solid excipient in the form of particles, microcrystals, or molecules. Substances with high water solubility and hydrophilicity are often used as solid dispersion excipients to increase the solubility and dissolution rate of some poorly soluble drugs, thereby increasing the bioavailability after oral administration. The dispersion state of drugs in excipients can be classified as simple eutectic mixtures, solid solutions, metacrystalline solids, glassy solid solutions, and molecular complexes. Excipients commonly used for solubilization include water-soluble polymers (such as polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG)), water-soluble small molecule compounds (such as sugars like sucrose and glucose, and organic acids like citric acid and succinic acid), and other hydrophilic excipients (such as modified starch and microcrystalline cellulose).
[0003] Since the 1980s, some water-insoluble or poorly soluble materials have also been used as drug excipients to prevent drug release and achieve sustained or controlled release. Materials used for this purpose include water-insoluble polymers (such as ethyl cellulose, cellulose acetate phthalate, polyacrylic acid resin, etc.) and lipids (such as cholesterol, palmitate glycerides, etc.).
[0004] The first problem to be solved in the preparation of solid dispersions is the dissolution of the excipients. In fact, most solid dispersion excipients are large organic molecules with a molecular weight of 10,000 or higher. In this case, conventional feeding methods often result in agglomeration of the material after it is added to the reactor, forming many large lumps with a diameter greater than 3 cm. It is difficult to break them up by stirring; only continuous stirring can gradually dissolve them layer by layer, similar to peeling an onion (see schematic diagram for details). Figure 1 This leads to excessively long dissolution time, affecting production efficiency. For some unstable materials, excessively long dissolution time will inevitably lead to impurities or other changes in the material. Utility Model Content
[0005] The technical problem to be solved by this utility model is to provide a solid feeding device that can effectively avoid the agglomeration of solid dispersion auxiliary materials, which leads to a long dissolution time.
[0006] To solve the above-mentioned technical problems, the solid feeding device provided by this utility model includes:
[0007] A feeding assembly is provided at the feed inlet of the reactor, the feeding assembly including a sieve plate for dispersing solid materials;
[0008] The reactor material self-circulation component is used to transport the material in the reactor from the bottom to the top and spray it inside the reactor.
[0009] Preferably, the reactor material self-circulation component includes:
[0010] The inlet of the transfer pump is connected to the bottom valve of the reactor via a transfer pipeline;
[0011] A spray head is installed on top of the reactor and located inside the reactor. The spray head is connected to the outlet of the delivery pump through a liquid delivery pipeline.
[0012] Preferably, the spray head is a spray ball.
[0013] Preferably, a pressure gauge is installed in the infusion line between the spray head and the delivery pump.
[0014] Preferably, the feeding assembly includes:
[0015] support;
[0016] A vibrating screen is fixedly installed on the support, and the discharge port of the vibrating screen is connected to the inlet of the reaction vessel.
[0017] A material hopper is movably mounted on the bracket, and the discharge port of the material hopper is flexibly connected to the feed port of the vibrating screen.
[0018] Preferably, the vibrating screen comprises:
[0019] The base is fixedly mounted on the bracket;
[0020] A feeding hopper is mounted to the base by a spring, and the screen plate is mounted on the feeding hopper;
[0021] A vibratory motor is installed on the outer wall of the hopper;
[0022] A cover plate is provided over the hopper, and the feed inlet of the vibrating screen is opened on the cover plate.
[0023] Preferably, the cover plate is provided with an outlet for large particles.
[0024] Preferably, the feeding assembly includes a glove box, with a feeding port on the side wall of the glove box and a discharge port on the bottom surface of the glove box, and the screen plate is disposed at the discharge port of the glove box;
[0025] The outlet of the glove box is connected to the inlet of the reactor.
[0026] Preferably, the reactor is equipped with a pressure gauge.
[0027] Preferably, the sieve plate has a plurality of discharge holes with a diameter of 1-10 mm;
[0028] The thickness of the sieve plate is not less than 0.5 mm.
[0029] This invention uses a sieve plate in the feeding assembly to disperse the solid dispersion excipients added to the reactor, reducing or eliminating the possibility of agglomeration. At the same time, the reactor is equipped with a self-circulating material component that sprays liquid material onto the solid dispersion excipients added to the reactor but not yet falling into the liquid material surface, so as to wet and dissolve them first, further preventing the possibility of agglomeration, increasing the dissolution efficiency, and significantly shortening the dissolution time. Attached Figure Description
[0030] To more clearly illustrate the technical solution of this utility model, the drawings used in this utility model will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.
[0031] Figure 1 This is a schematic diagram illustrating the principle of dissolving solid dispersion excipients in a reaction vessel in existing technology.
[0032] Figure 2 This is a structural schematic diagram of Embodiment 1 of the present utility model;
[0033] Figure 3 This is a cross-sectional view of the screen plate installed in the feed hopper in an embodiment of this utility model;
[0034] Figure 4 This is a top view of the sieve plate and inclined platform assembled in an embodiment of this utility model;
[0035] Figure 5 This is a schematic diagram illustrating the principle of dissolving the solid dispersion excipient of this utility model in a reaction vessel;
[0036] Figure 6 This is a structural schematic diagram of Embodiment 2 of this utility model.
[0037] In the diagram, 1-Reaction vessel; 11-Bottom valve; 2-Feeding assembly; 21-Support; 22-Vibrating screen; 23-Material bucket; 24-Glove box; 221-Base; 222-Feeding hopper; 223-Vibrating motor; 224-Cover plate; 225-Large particle material outlet; 226-Sieve plate; 227-Inclined platform; 241-Feeding port; 3-Reaction vessel material self-circulation assembly; 31-Transfer pump; 32-Spray head; 33-Liquid delivery pipeline; 4-Pressure gauge; 5-Solid dispersion auxiliary material; 6-Spray liquid. Detailed Implementation
[0038] The technical solutions of this utility model will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. All other embodiments obtained by those skilled in the art based on the embodiments of this utility model without creative effort are within the scope of protection of this utility model.
[0039] Example 1: Vibrating Screen Solid Feeding Device
[0040] refer to Figure 2 This invention illustrates a vibrating screen-type solid feeding device, comprising a feeding component and a reaction vessel material self-circulation component. The feeding component includes a support, a vibrating screen, and a material hopper. The reaction vessel material self-circulation component includes a pump and a spray head, preferably a spray ball. The support is typically installed around the reaction vessel for easy installation of the vibrating screen and the material hopper. The material hopper is used to feed solid dispersion additives (or other solid materials) into the vibrating screen. The vibrating screen disperses the solid dispersion additives through vibration, allowing them to pass through the holes in the screen plate for feeding. The hole spacing of the screen plate is, for example, 0.3-1.5 mm, to ensure that the fed materials are spaced apart and maintain a certain distance, preventing them from contacting and agglomerating during descent. The hole diameter is 1-10 mm; too small a hole diameter will result in a slow feeding speed, while too large a hole diameter will result in poor dispersion of the solid dispersion additives. The thickness of the screen plate is generally not less than 0.5 mm to prevent breakage, and the preferred material is metal, such as medical-grade stainless steel.
[0041] The vibrating screen includes a base, a hopper, a vibrating motor, and a cover plate. The base is used to fix the vibrating screen and is mounted on a bracket, providing stable support. The hopper is spring-loaded onto the base, and the screen plate is installed inside the hopper. (See reference) Figure 3 and Figure 4The hopper is preferably funnel-shaped, with an annular inclined platform on its inner circumference at the large-diameter position. The sieve plate covers the inner annular space of the inclined platform. The inclined platform assists in feeding, facilitating the material to converge towards the central sieve plate. The material gathered on the sieve plate passes through the holes in the sieve plate to complete dispersion. A vibrating motor is installed on the outer wall of the hopper. When the vibrating motor is turned on, the hopper vibrates because it is connected to the base via a spring. Under the action of vibration, the solid dispersion auxiliary material in the hopper falls from the holes in the sieve plate and passes through the feed inlet of the reactor, entering... Inside the reactor, the feed hopper of the vibrating screen is equipped with a cover plate, preferably an inverted trumpet shape. Material from the feed hopper falls directly into the feed hopper. The cover plate effectively prevents material from scattering into the environment, causing waste and environmental pollution. Especially during the operation of the vibrating screen, the material spreads outwards due to vibration; the cover plate effectively prevents this. It should be noted that the cover plate preferably has a large particle discharge port to facilitate the discharge of large, clumped materials that cannot be fed through the vibrating screen. In this embodiment, the feeding speed is controlled by adjusting the opening of the discharge valve at the bottom of the feed hopper or by adjusting the vibration amplitude of the vibrating screen.
[0042] The material hopper is mounted on the support, preferably in a movable manner to facilitate loading and unloading, eliminating the need for manual operation. The discharge port of the material hopper is connected to the vibrating screen via a flexible connection, making it easy to feed material into the vibrating screen. The material hopper can be moved in various ways, such as by arranging a slide rail on the support, fixing the material hopper to the slider, and having a motor drive the slider to move along the slide rail, thereby moving the material hopper. This can be achieved using existing technology and will not be elaborated further.
[0043] The inlet of the pump in the material self-circulation component of the reactor is preferably connected directly to the bottom valve of the reactor via a liquid delivery pipeline, and the outlet is preferably connected to the spray head via a liquid delivery pipeline. The pump draws the liquid material in the reactor to the spray head, from which the liquid material is sprayed out. When the spray head is a spherical spray ball, its spraying area is larger, making it easier to wet the solid dispersion excipients (the solid dispersion excipients are dispersed by the sieve plate, then wetted by the liquid material sprayed from the spray head, and dissolve under the action of stirring, as follows...). Figure 5 (As shown); the spray head is preferably located at the top of the reactor. It should be noted that since the reactor material self-circulation component directly uses the liquid material inside the reactor, it may cause blockage or poor flow in parts such as the liquid delivery pipeline. Therefore, it is preferable to install a pressure gauge between the spray head and the liquid delivery pump for pressure detection. When the pressure increases, it indicates that undissolved lumps have entered the reactor material self-circulation component, and may also exist in the reaction system. It is preferable to stop feeding and dissolve them first through stirring or other operations in the reactor to avoid the formation of more and / or larger lumps. When the pressure returns to normal, it indicates that the lumps have dissolved and feeding can continue.
[0044] The reactor may include, for example, a pressure gauge to monitor the pressure inside the reactor, as well as a stirring motor, stirring blades, etc., which are existing technologies and will not be described in detail here.
[0045] Example 2: Glovebox-type solid feeding device
[0046] refer to Figure 6 A glove box type solid feeding device is shown. Its feeding assembly includes a glove box, the bottom outlet of which is connected to the inlet of a reactor (e.g., via a butterfly valve). A sieve plate is installed at the outlet of the glove box, more preferably at the inlet end of the outlet, facilitating timely material feeding by the operator. A feeding port is provided on the side wall of the glove box for adding material into the glove box. The operator feeds the solid dispersion auxiliary material (or other solid material) from the glove box into the reactor through the sieve plate. In this embodiment, the hole distribution, size, and thickness of the sieve plate are the same as in Embodiment 1, and the reactor and reactor material self-circulation assembly are the same as in Embodiment 1, and will not be described again here.
[0047] Example 3: A vibrating screen-type solid feeding device is used to feed solid dispersion auxiliary materials.
[0048] Ethanol was used as the solvent, and hydroxypropyl methylcellulose succinate was used as the excipient (i.e., solid dispersion excipient) to be mixed with the drug. The ratio of excipient to drug was 4:1 w / w, and the solid content of the solution was 10% w / w.
[0049] In a laboratory setting, 40g of excipient is added to 450g of ethanol solvent without sieving. The excipient is manually added directly to the mixing bottle without using the self-circulation component and only the stirring function is turned on. It takes 6 hours for the excipient to be completely dissolved.
[0050] In large-scale production, to completely dissolve 160 kg of auxiliary material, based on the solid feeding device of Example 1, without adding a vibrating screen, the material is directly fed from the hopper into the reactor, and the reactor's material self-circulation component is not used; only the stirring function is activated, which takes at least 3 days. However, using the vibrating screen type solid feeding device of Example 1, it only takes about 4 hours. Therefore, it is evident that the vibrating screen type solid feeding device provided in Example 1 of this utility model can significantly improve the dissolution efficiency of solid dispersion auxiliary materials and shorten the dissolution time.
[0051] Example 4: Using a glove box type solid feeding device to complete the feeding of solid dispersion auxiliary materials.
[0052] Methanol and dichloromethane were used as solvents (methanol:dichloromethane was 1:3 w / w), and hydroxypropyl methylcellulose was used as an excipient (i.e., a solid dispersion excipient) to be mixed with the drug. The ratio of excipient to drug was 1:3 w / w, and the solid content of the solution was 12% w / w.
[0053] In a laboratory setting, 18g of excipient was added to 176g of methanol / dichloromethane solution without sieving. The excipient was manually added directly to the mixing bottle without using the self-circulation component and only the stirring function was turned on. It took 4.5 hours for the excipient to completely dissolve.
[0054] In large-scale production, to completely dissolve 90 kg of excipients, using the solid feeding device of Example 2 without adding a sieve plate and without using the reactor material self-circulation component, it takes 2.5 days; while using the glove box type solid feeding device of Example 2, it only takes about 4 hours. Therefore, it is evident that the glove box type solid feeding device provided in Example 2 of this utility model can significantly improve the dissolution efficiency of solid dispersion excipients and shorten the dissolution time.
[0055] The above description is only a preferred embodiment of the present utility model and is not intended to limit the scope of protection of the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the scope of protection of the present utility model.
Claims
1. A solid feeding device, characterized in that, include: A feeding assembly is provided at the feed inlet of the reactor, the feeding assembly including a sieve plate for dispersing solid materials; The reactor material self-circulation component is used to transport the material in the reactor from the bottom to the top and spray it inside the reactor.
2. The solid feeding device as described in claim 1, characterized in that, The material self-circulation component of the reactor includes: The inlet of the transfer pump is connected to the bottom valve of the reactor via a transfer pipeline; A spray head is installed on top of the reactor and located inside the reactor. The spray head is connected to the outlet of the delivery pump through a liquid delivery pipeline.
3. The solid feeding device as described in claim 2, characterized in that, The spray head is a spray ball.
4. The solid feeding device as described in claim 2, characterized in that, A pressure gauge is installed in the infusion pipeline between the spray head and the delivery pump.
5. The solid feeding device as described in claim 1, characterized in that, The feeding assembly includes: support; A vibrating screen is fixedly installed on the support, and the discharge port of the vibrating screen is connected to the inlet of the reaction vessel. A material hopper is movably mounted on the bracket, and the discharge port of the material hopper is flexibly connected to the feed port of the vibrating screen.
6. The solid feeding device as described in claim 5, characterized in that, The vibrating screen includes: The base is fixedly installed on the bracket; A feeding hopper is mounted to the base by a spring, and the screen plate is mounted on the feeding hopper; A vibratory motor is installed on the outer wall of the hopper; A cover plate is provided over the hopper, and the feed inlet of the vibrating screen is opened on the cover plate.
7. The solid feeding device as described in claim 6, characterized in that, The cover plate is equipped with an outlet for large particles.
8. The solid feeding device as described in claim 1, characterized in that, The feeding assembly includes a glove box, with a feeding port on the side wall of the glove box and a discharge port on the bottom surface of the glove box; the sieve plate is disposed at the discharge port of the glove box. The outlet of the glove box is connected to the inlet of the reactor.
9. The solid feeding device as described in claim 1, characterized in that, The reactor is equipped with a pressure gauge.
10. The solid feeding device according to any one of claims 1-9, characterized in that, The sieve plate has multiple discharge holes with a diameter of 1-10mm; The thickness of the sieve plate is not less than 0.5 mm.