A sustained release loratadine capsule and a method of preparing the same

Abstract

This invention belongs to the field of oral solid dosage form technology and relates to a loratadine sustained-release capsule and its preparation method. This application provides a loratadine-containing sustained-release capsule, wherein loratadine is melt-mixed with citric acid and salicylic acid to prepare a drug-containing core, and the core is coated with a sustained-release layer, an immediate-release layer, and a protective layer. This not only effectively solves the problem of slow dissolution of loratadine in the presence of insufficient gastric acid, but also ensures uniform drug release, achieving long-lasting effects and increased efficacy.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical oral solid dosage form technology, specifically relating to a loratadine sustained-release capsule and its preparation method. Background Technology

[0002] Allergic reactions, also known as hypersensitivity reactions, are termed antigen-antibody reactions in modern medicine. Approximately 10%-45% of the global population suffers from allergic diseases, and the incidence rate is continuously increasing. In my country, about 200 million people suffer from allergic diseases. The World Health Organization has listed allergic diseases as a "key disease for research and prevention in the 21st century." With changes in the human living environment and the increase in allergens, the incidence of allergic diseases is on the rise. The number of allergic people in my country is also constantly increasing, especially with a significant increase in seasonal allergies. Prevention and treatment of allergic diseases has become an urgent task, and the market potential for anti-allergy drugs is enormous. Loratadine, a second-generation antihistamine, has a zwitterionic molecular structure that prevents it from having significant central nervous system depressant effects. Clinically, it is mainly used to prevent and treat allergic rhinitis, chronic idiopathic urticaria, allergic asthma, and atopic dermatitis. Public information from the US FDA shows that loratadine tablets and orally disintegrating tablets are prepared using micronized raw materials. Drug micronization can significantly improve the dissolution rate of formulations, but it also has many disadvantages, such as easy re-aggregation of drug powders and difficulty in uniform mixing of raw materials and excipients.

[0003] Loratadine is a water-insoluble substance, characterized by its solubility in strong acid solutions but almost insoluble in weak acid solutions or water. Currently, the quality standards for loratadine tablets only measure their dissolution in strong hydrochloric acid solutions (pH=2). In reality, commercially available loratadine tablets have high dissolution in this environment, but lower dissolution in weakly acidic and neutral environments. For patients with insufficient gastric acid secretion, or those with iatrogenic insufficient gastric acid secretion, the release of the formulation in the stomach may be affected by the increased pH when taking regular loratadine tablets. Once the drug enters the intestines, the release rate of loratadine will be even lower, thus affecting its clinical efficacy.

[0004] To address this issue, this invention employs a method of molten combination of loratadine, citric acid, and salicylic acid, followed by extrusion and spheronization to prepare a drug-containing pellet core. This core is then coated with a sustained-release layer, an immediate-release layer, and a protective layer using a fluidized bed coating machine. Finally, the core is filled into loratadine sustained-release capsules. Creating a suitable acidic environment for the dissolution and release of loratadine significantly optimizes its high-pH dissolution performance, better meeting the needs of patients with insufficient gastric acid. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings and deficiencies of existing technologies and provide a loratadine sustained-release capsule with longer-lasting effects, fewer dosing times, stable blood drug concentrations, and higher safety. Existing technologies employ wet granulation, extrusion spheroidization, and fluidized bed coating processes, which are complex and require high levels of control.

[0006] The present invention provides a loratadine sustained-release capsule, which consists of two parts: sustained-release microspheres and empty capsules. The preparation process of the sustained-release microspheres includes a drug-containing core, a sustained-release layer, an immediate-release layer, and a protective layer. By weight percentage, the sustained-release microspheres consist of 70-75% drug-containing core, 5-10% sustained-release coating layer, 10-15% immediate-release coating layer, and a protective layer.

[0007] The loratadine sustained-release capsules described herein contain a core that ensures the granules have acceptable formability, roundness, and friability. Optional excipients include microcrystalline cellulose, starch, mannitol, sucrose, silicon dioxide, or combinations thereof; preferably selected from mannitol, microcrystalline cellulose, silicon dioxide, or combinations thereof; ultimately, microcrystalline cellulose is preferred due to its good formability, resulting in granules with high roundness and low friability. This invention specifically employs a method combining loratadine with citric acid and salicylic acid, i.e., the core comprises: loratadine, citric acid, and salicylic acid melt-mixed in a 2:1:1 mass ratio, and then combined with microcrystalline cellulose to prepare a soft material.

[0008] The loratadine sustained-release capsules described herein contain a sustained-release layer comprising a film-forming material selected from ethyl cellulose, polymethyl methacrylate, or a combination thereof. The sustained-release layer also contains a plasticizer selected from polyethylene glycol, hydroxypropyl methylcellulose, triethyl citrate, glycerin, or a combination thereof. Ethyl cellulose is preferred as the gastrointestinal-soluble film-forming material, and talc is also included as an anti-adhesive agent.

[0009] The loratadine sustained-release capsules mentioned above contain an immediate-release layer containing a mixed solution of loratadine, povidone K30, and polyethylene glycol.

[0010] The loratadine sustained-release capsules described herein contain a protective layer comprising a gastrointestinal film-forming material, hydroxypropyl methylcellulose, and purified water. Preferably, the mass ratio of each component in the drug-containing capsule core as described above is: loratadine: citric acid: salicylic acid = 2:1:1, and the melt mixture: microcrystalline cellulose: copovidone: purified water = 1:3:0.2:10;

[0011] Preferably, the mass ratio of each component in the sustained-release layer as described above is: ethyl cellulose: 95% ethanol: purified water: talc = 1:16:1:0.5;

[0012] Preferably, the mass ratio of each component in the immediate-release layer as described above is: loratadine: povidone K30: polyethylene glycol: purified water: 95% ethanol = 1:1.5:2:5:5;

[0013] Preferably, the mass ratio of each component in the protective layer as described above is: hydroxypropyl methylcellulose: purified water 1:8.

[0014] Preparation process:

[0015] 1) The preparation method of the loratadine sustained-release capsules involves heating loratadine, citric acid, and salicylic acid to a melt state, maintaining the melt state, adding microcrystalline cellulose, copovidone aqueous solution, and purified water to form a soft material, using a wet granulation machine, setting the stirring speed to 600 rpm and the chopping speed to 1000 rpm, and adding purified water during the process depending on the wetness of the soft material.

[0016] Extrusion and Spheronization: Following extrusion and spheronization, pellets containing drug cores are prepared and then dried using a fluidized bed drying process. The extrusion and spheronization process includes two steps: extrusion and spheronization. In the extrusion step, the soft material is squeezed through a sieve to form dense strips. In the spheronization step, a serrated disc cuts the extruded material strips, and centrifugation rounds and densifies the chopped particles. The extrusion speed is set at 40-50 rpm, and the spheronization speed is set at 1000-1300 rpm to control the prepared micro-pellets to be round, uniform in size, free of obvious fine powder, and non-sticky.

[0017] Drying: Fluidized bed drying is used, with the inlet air temperature set at 60℃ and the inlet air volume controlled at 100-140 m³ / h. 3 / h, control the moisture content to not exceed 4%;

[0018] Sieving: The obtained microspheres are sieved through a 20-30 mesh. The sieved microspheres are collected for the next step of coating.

[0019] 2) The preparation method of the loratadine sustained-release capsules mentioned above, wherein the sustained-release layer is prepared by mixing ethyl cellulose with 95% ethanol and purified water in a certain proportion, and coating it on dried microspheres. The fluidized bed parameters are set as follows: air volume 40-60 m3 / h, air temperature 40-60℃, atomization pressure 200-300 kPa, material temperature 30-40℃, and talc powder is added as an anti-adhesion agent.

[0020] 3) The preparation method of the loratadine sustained-release capsules, wherein the immediate-release layer is prepared by dissolving loratadine and copovidone in 95% ethanol, while simultaneously dissolving polyethylene glycol in water, and then mixing the two solutions to obtain the drug-containing coating solution for the immediate-release layer. The fluidized bed setup parameters are: inlet air volume 40-60 m³ / h, inlet air temperature 40-60℃, atomization pressure 300-400 kPa, and material temperature 30-40℃.

[0021] 4) The preparation method of the loratadine sustained-release capsules, wherein the protective layer is made of hydroxypropyl methylcellulose, which is first dispersed in hot water by stirring, then dissolved by adding cold water and stirring and cooling. The fluidized bed setting parameters are: air volume 40-60 m3 / h, air temperature 40-60℃, atomization pressure 300-360 kPa, and material temperature 30-40℃.

[0022] The method for preparing the loratadine sustained-release capsules involves filling the obtained loratadine sustained-release microspheres into gelatin capsule shells, with each capsule containing 10 mg of loratadine. Specific Implementation

[0023] The present invention will be further described in detail below with reference to specific embodiments. However, the embodiments of the present invention are not limited to the following embodiments. Any further changes, modifications, substitutions, combinations and simplifications made on the basis of the essence of the present invention should be regarded as equivalent substitutions and included within the scope of protection of the present invention.

[0024] Example 1: Loratadine sustained-release capsules

[0025] Prescription composition: 10,000 tablets

[0026]

[0027] Preparation process of drug-containing pellet cores:

[0028] 1) The preparation method of the loratadine sustained-release capsules, the core of the capsule is prepared by heating loratadine, citric acid and salicylic acid in proportion at 160 degrees Celsius until melted, maintaining the melt state for 5 minutes, adding microcrystalline cellulose and copovidone aqueous solution and purified water to make soft material, using a wet granulation machine, setting the stirring speed to 600 rpm and the chopping speed to 1000 rpm, adding purified water during the process according to the wetness of the soft material;

[0029] Extrusion and Spheronization: Following extrusion and spheronization, pellets containing drug cores are prepared and then dried using a fluidized bed drying process. The extrusion and spheronization process includes two steps: extrusion and spheronization. In the extrusion step, the soft material is squeezed through a sieve to form dense strips. In the spheronization step, a serrated disc cuts the extruded material strips, and centrifugation rounds and densifies the chopped particles. The extrusion speed is set at 40-50 rpm, and the spheronization speed is set at 1000-1300 rpm to control the prepared micro-pellets to be round, uniform in size, free of obvious fine powder, and non-sticky.

[0030] Drying: Fluidized bed drying is used, with the inlet air temperature set at 60℃ and the inlet air volume controlled at 100-140 m³ / h. 3 / h, control the moisture content to not exceed 4%;

[0031] Sieving: The obtained microspheres are sieved through a 20-30 mesh. The sieved microspheres are collected for the next step of coating.

[0032]

[0033] Sustained-release layer preparation process:

[0034] 2) The slow-release layer is prepared by mixing ethyl cellulose with 95% ethanol and purified water in a certain proportion, and then coating it on dried microspheres. The fluidized bed parameters are set as follows: air volume 40-60 m3 / h, air temperature 40-60℃, atomization pressure 200-400 kPa, material temperature 30-40℃, and talc powder is added as an anti-sticking agent.

[0035]

[0036] Immediate-release layer preparation process:

[0037] 3) The immediate-release layer is prepared by dissolving loratadine and copovidone in 95% ethanol, while simultaneously dissolving polyethylene glycol in water. The two solutions are then mixed to obtain the drug-coated immediate-release layer. Fluidized bed setup parameters: inlet air volume 40-60 m³ / h, inlet air temperature 40-60℃, atomization pressure 300-400 kPa, material temperature 30-40℃.

[0038]

[0039]

[0040] Protective layer preparation process:

[0041] 4) The protective layer is made of hydroxypropyl methylcellulose, which is first dispersed in hot water by stirring, then dissolved after being cooled by stirring in cold water. Fluidized bed settings: airflow 40-60 m³ / h, airflow temperature 40-60℃, atomization pressure 300-360 kPa, material temperature 30-40℃.

[0042] 5) Capsule filling: The obtained loratadine sustained-release microspheres are filled into gelatin capsule shells.

[0043] Example 2: Loratadine sustained-release capsules

[0044] Prescription composition: 10,000 tablets

[0045]

[0046] Preparation process of drug-containing pellet cores:

[0047] 1) The preparation method of the loratadine sustained-release capsules, the core of the capsule is prepared by heating loratadine, citric acid and salicylic acid in proportion at 160 degrees Celsius until melted, maintaining the melt state for 5 minutes, adding microcrystalline cellulose and copovidone aqueous solution and purified water to make soft material, using a wet granulation machine, setting the stirring speed to 600 rpm and the chopping speed to 1000 rpm, adding purified water during the process according to the wetness of the soft material;

[0048] Extrusion and Spheronization: Following extrusion and spheronization, pellets containing drug cores are prepared and then dried using a fluidized bed drying process. The extrusion and spheronization process includes two steps: extrusion and spheronization. In the extrusion step, the soft material is squeezed through a sieve to form dense strips. In the spheronization step, a serrated disc cuts the extruded material strips, and centrifugation rounds and densifies the chopped particles. The extrusion speed is set at 40-50 rpm, and the spheronization speed is set at 1000-1300 rpm to control the prepared micro-pellets to be round, uniform in size, free of obvious fine powder, and non-sticky.

[0049] Drying: Fluidized bed drying is used, with the inlet air temperature set at 60℃ and the inlet air volume controlled at 100-140 m³ / h. 3 / h, control the moisture content to not exceed 4%;

[0050] Sieving: The obtained microspheres are sieved through a 20-30 mesh. The sieved microspheres are collected for the next step of coating.

[0051]

[0052]

[0053] Sustained-release layer preparation process:

[0054] 2) The slow-release layer is prepared by mixing ethyl cellulose with 95% ethanol and purified water in a certain proportion, and then coating it on dried microspheres. The fluidized bed parameters are set as follows: air volume 40-60 m3 / h, air temperature 40-60℃, atomization pressure 200-400 kPa, material temperature 30-40℃, and talc powder is added as an anti-sticking agent.

[0055]

[0056] Immediate-release layer preparation process:

[0057] 4) The immediate-release layer is prepared by dissolving loratadine and copovidone in 95% ethanol, while simultaneously dissolving polyethylene glycol in water. The two solutions are then mixed to obtain the drug-coated immediate-release layer. Fluidized bed setup parameters: inlet air volume 40-60 m³ / h, inlet air temperature 40-60℃, atomization pressure 300-400 kPa, material temperature 30-40℃.

[0058]

[0059] Protective layer preparation process:

[0060] 4) The protective layer is made of hydroxypropyl methylcellulose, which is first dispersed in hot water by stirring, then dissolved after being cooled by stirring in cold water. Fluidized bed settings: airflow 40-60 m³ / h, airflow temperature 40-60℃, atomization pressure 300-360 kPa, material temperature 30-40℃.

[0061] 5) Capsule filling: The obtained loratadine sustained-release microspheres are filled into gelatin capsule shells.

[0062] Example 3: Loratadine sustained-release capsules

[0063] Prescription composition: 10,000 tablets

[0064]

[0065]

[0066] Preparation process of drug-containing pellet cores:

[0067] 1) The preparation method of the loratadine sustained-release capsules, the core of the capsule is prepared by heating loratadine, citric acid and salicylic acid in proportion at 160 degrees Celsius until melted, maintaining the melt state for 5 minutes, adding microcrystalline cellulose and copovidone aqueous solution and purified water to make soft material, using a wet granulation machine, setting the stirring speed to 600 rpm and the chopping speed to 1000 rpm, adding purified water during the process according to the wetness of the soft material;

[0068] Extrusion and Spheronization: Following extrusion and spheronization, pellets containing drug cores are prepared and then dried using a fluidized bed drying process. The extrusion and spheronization process includes two steps: extrusion and spheronization. In the extrusion step, the soft material is squeezed through a sieve to form dense strips. In the spheronization step, a serrated disc cuts the extruded material strips, and centrifugation rounds and densifies the chopped particles. The extrusion speed is set at 40-50 rpm, and the spheronization speed is set at 1000-1300 rpm to control the prepared micro-pellets to be round, uniform in size, free of obvious fine powder, and non-sticky.

[0069] Drying: Fluidized bed drying is used, with the inlet air temperature set at 60℃ and the inlet air volume controlled at 100-140 m³ / h. 3 / h, control the moisture content to not exceed 4%;

[0070] Sieving: The obtained microspheres are sieved through a 20-30 mesh. The sieved microspheres are collected for the next step of coating.

[0071]

[0072] Sustained-release layer preparation process:

[0073] 2) The slow-release layer is prepared by mixing ethyl cellulose with 95% ethanol and purified water in a certain proportion, and then coating it on dried microspheres. The fluidized bed parameters are set as follows: air volume 40-60 m3 / h, air temperature 40-60℃, atomization pressure 200-400 kPa, material temperature 30-40℃, and talc powder is added as an anti-sticking agent.

[0074]

[0075]

[0076] Immediate-release layer preparation process:

[0077] 5) The immediate-release layer is prepared by dissolving loratadine and copovidone in 95% ethanol, while simultaneously dissolving polyethylene glycol in water. The two solutions are then mixed to obtain the drug-coated immediate-release layer. Fluidized bed setup parameters: inlet air volume 40-60 m³ / h, inlet air temperature 40-60℃, atomization pressure 300-400 kPa, material temperature 30-40℃.

[0078]

[0079] Protective layer preparation process:

[0080] 4) The protective layer is made of hydroxypropyl methylcellulose, which is first dispersed in hot water by stirring, then dissolved after being cooled by stirring in cold water. Fluidized bed settings: airflow 40-60 m³ / h, airflow temperature 40-60℃, atomization pressure 300-360 kPa, material temperature 30-40℃.

[0081] 5) Capsule filling: The obtained loratadine sustained-release microspheres are filled into gelatin capsule shells.

[0082] Comparative Example 1: Loratadine Extended-Release Capsules

[0083] Prescription composition: 10,000 tablets

[0084] Meanwhile, based on the above formula, the following changes were made to prepare the control product: Loratadine, which is not molten and mixed with any acid, was used as the raw material, and other process steps were the same as in Examples 1 and 2.

[0085] Ten samples from each of the examples and comparative examples were randomly selected. Dissolution testing (Chinese Pharmacopoeia 2010 Edition, Part II, Appendix XC, Method II) was performed using 900 ml of 0.1 mol / L hydrochloric acid solution as solvent, at a rotation speed of 50 rpm. At 5, 10, 15, and 30 minutes, 5 ml of the solution was collected, filtered, and the filtrate was used as the test solution. Separately, an appropriate amount of loratadine reference standard dried to constant weight at 105℃ was accurately weighed, dissolved in 0.1 mol / L hydrochloric acid solution, and quantitatively diluted to a solution containing approximately 11 μg of loratadine per ml, as the reference solution. 20 μl each of the test solution and the reference solution were accurately injected into the liquid chromatograph, and the chromatograms were recorded. The result was calculated by peak area using the external standard method.

[0086] Table 1 shows the dissolution results for the examples and comparative examples.

[0087] Ph=1

[0088]

[0089]

[0090] As shown in Table 1, the dissolution of the comparative formulation was slightly slower at 5 minutes and 10 minutes, while the dissolution of the other examples was similar to that of the reference formulation.

[0091] Table 2 shows the dissolution results for the examples and comparative examples.

[0092] Ph=2

[0093] Example 5 minutes 10 minutes 15 minutes 30 minutes Example 1 94.6 97.8 99.5 99.8 Example 2 94.0 98.9 99.9 99.8 Example 3 93.6 99.5 99.6 100.1 Comparative Example 1 74.0 84.8 89.6 100.0 Reference formulation 1 95.4 97.8 99.9 99.7

[0094] As shown in Table 2, under the simulated pH 2 environment of gastric juice, all drugs except Comparative Example 1 can achieve rapid dissolution.

[0095] Table 3 shows the dissolution results for the examples and comparative examples.

[0096] pH=6.8 purified water

[0097] Example 5 minutes 10 minutes 15 minutes 30 minutes Example 1 66.3 68.3 77.3 88.9 Example 2 63.2 73.0 75.5 84.3 Example 3 69.5 73.2 75.4 83.2 Comparative Example 1 44.9 48.3 55.2 60.1 Reference formulation 1 59.3 62.3 70.2 77.6

[0098] Table 3 shows that the solubility of the drugs was significantly affected. Except for Comparative Example 1, the dissolution rate of the other drugs exceeded 70% within 30 minutes. The gastric acid pH of 4-7 may occur under conditions of drinking large amounts of water, eating, or illness. The poor dissolution effect means that the onset time of loratadine in the drug is significantly slower under these conditions, and it cannot fully meet the requirements for treating allergies, colds, rhinitis, and other problems.

[0099] 2. Comparison of the stability of capsules obtained in the examples and comparative examples

[0100] The capsules prepared in the examples and comparative examples were placed in a constant temperature and humidity chamber with high temperature (40°C) and high humidity (75±5% relative humidity) for 6 months for accelerated testing, and the relevant substances were detected at 0 days and 6 months.

[0101] Table 4 Comparison of the stability of the examples and comparative examples after 6 months of accelerated testing.

[0102]

[0103] As shown in Table 4, the accelerated testing results indicate that the capsules prepared using this invention have significantly lower impurity content than the examples and the original reference formulation after accelerated testing, resulting in better product quality stability. Furthermore, the impurities in the product still meet quality standards after accelerated testing, significantly improving the product's shelf life and effectively extending its shelf life.

Claims

1. A loratadine sustained-release capsule, characterized in that: The sustained-release capsule comprises a drug-containing core, a sustained-release layer, an immediate-release layer, and a protective layer. By weight, the drug-containing core consists of 70 parts loratadine, 30-45 parts salicylic acid, 30-45 parts citric acid or malic acid, 400-500 parts microcrystalline cellulose or mannitol, 20-35 parts copovidone, and 1200-1600 parts water. The sustained-release layer consists of 10-20 parts ethyl cellulose (a gastrosoluble film-forming material), 180-280 parts 95% ethanol, 10-20 parts purified water, and 5-20 parts talc. The immediate-release layer consists of 30 parts loratadine, 35-50 parts povidone K30 or copovidone, 50-70 parts polyethylene glycol, 100-200 parts 95% ethanol, and 100-200 parts purified water. The protective layer consists of a gastrosoluble film-forming material hydroxypropyl methylcellulose solution.

2. The loratadine sustained-release capsule according to claim 1, characterized in that: The protective coating of the sustained-release capsules, by weight, comprises the following components: 10-20 parts of hydroxypropyl methylcellulose 50-100 parts purified water.

3. A method for preparing the loratadine sustained-release capsules of claim 1, characterized in that, The preparation method includes the following steps; (1) Preparation of drug-containing pellet cores: The preparation process of drug-containing pellet cores includes soft material preparation, extrusion and spheroidization, fluidized bed drying, and sieving; (2) A fluidized bed coating machine coats the drug-containing pellet core with a sustained-release layer, an immediate-release layer, and a protective layer; (3) Capsule filling: The obtained loratadine sustained-release microspheres are filled into gelatin capsule shells.

4. The method for preparing loratadine sustained-release capsules according to claim 3, characterized in that: The preparation process of the loratadine sustained-release capsules is as follows: Preparation of pill core: Loratadine, citric acid, and salicylic acid are heated to melt, and microcrystalline cellulose, copovidone aqueous solution, and purified water are added to make a soft mass. The soft mass is then granulated using a wet granulation machine and purified water is added. Extrusion rounding: The extrusion rounding process includes two steps: extrusion and rounding. In the extrusion step, soft material is squeezed through a sieve to form a dense strip. In the rounding step, a serrated chassis cuts the extruded material strip into small pieces, and centrifugal force rounds the cut particles into round shapes. Drying: Use fluidized bed drying, and control the moisture content to not exceed 4%; Sieving: The obtained microspheres are sieved through a 20-30 mesh. The sieved microspheres are collected for the next step of coating.

5. The method for preparing loratadine sustained-release capsules according to claim 3, characterized in that: The sustained-release layer is prepared by coating dried microspheres with a solution of ethyl cellulose, 95% ethanol, and purified water in a specific ratio. The fluidized bed parameters are set with an inlet air volume of 40-60 m³ / h. 3 The parameters are: airflow rate / h, inlet air temperature 40-60℃, atomization pressure 200-300kPa, material temperature 30-40℃, with talc added as an anti-adhesion agent. The immediate-release layer is prepared by dissolving loratadine and copovidone in 95% ethanol, and simultaneously dissolving polyethylene glycol in water, then mixing the two solutions to obtain the drug-containing coating solution for the immediate-release layer. The fluidized bed settings are: inlet airflow rate 40-60m³ / h. 3 The parameters for the fluidized bed setup are: airflow rate 40-60 m³ / h, inlet air temperature 40-60℃, atomization pressure 300-400 kPa, and material temperature 30-40℃. The protective layer is made of hydroxypropyl methylcellulose, which is first dispersed in hot water and then dissolved after being cooled and stirred in cold water. The inlet airflow rate is 40-60 m³ / h. 3 / h, inlet air temperature 40-60℃, atomization pressure 300-360kPa, material temperature 30-40℃.

6. The method for preparing loratadine sustained-release capsules according to claim 3, characterized in that: Step (3) is as follows: Capsule filling: The obtained loratadine sustained-release microspheres were filled into gelatin capsule shells, with each capsule containing 10 mg of loratadine.

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