Desloratadine orally disintegrating film and method for preparing the same

Abstract

The application belongs to the technical field of pharmaceutical preparations, and particularly relates to a desloratadine orally dissolving film and a preparation method thereof. The desloratadine orally dissolving film comprises the following components: desloratadine, a film-forming material being polyvinyl alcohol, and a flavoring agent being stevioside. The desloratadine orally dissolving film prepared by using the prescription composition and the preparation process has higher stability of the preparation, better taste, good film-forming property, smaller size, can be quickly disintegrated and dissolved, has good content uniformity, and has good appearance and other advantages.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparation technology, specifically relating to a desloratadine orally soluble film and its preparation method. Background Technology

[0002] Desloratadine is a non-sedating, long-acting tricyclic antihistamine that can relieve symptoms of allergic rhinitis or chronic idiopathic urticaria by selectively antagonizing peripheral H1 receptors. Desloratadine itself has a strong bitter taste and poor stability; it is easily oxidized and discolored when prepared as a solution, and it is unstable in strong acids, strong alkalis, or at high temperatures.

[0003] CN 114306285A discloses a desloratadine orally dissolving film and its preparation method. The orally dissolving film comprises desloratadine, an antioxidant, a film-forming material, a plasticizer, a disintegrant, a flavoring agent, a colorant, and the balance being water and ethanol. The antioxidant is used in an amount of 3% to 25%, and is a combination of EDTA-2Na and vitamin C. This patent uses an ethanol-containing solvent, making it difficult to guarantee the absence of ethanol residue during production, and the addition of a large amount of antioxidant is detrimental to human health.

[0004] CN 102940617A discloses a desloratadine oral film, the composition of which includes film-forming materials, plasticizers, humectants, opacifiers, diluents, flavoring agents, and colorants. The composition is complex, resulting in high production costs. Furthermore, the oral film has a large film weight, considerable thickness, and a long dissolution time, which is not conducive to rapid dissolution and release.

[0005] CN 105616389A discloses a desloratadine oral dissolving film and its preparation method, comprising the following components: desloratadine, film-forming material, cyclodextrin, plasticizer, flavoring agent, pH adjuster, and colorant. While the cyclodextrin inclusion technology used in this patent ensures the stability of desloratadine, the preparation process is complex and the production cost is high, hindering commercial production. Summary of the Invention

[0006] The present invention aims to solve at least one of the technical problems existing in the prior art.

[0007] This invention is based on the following discoveries of the inventors:

[0008] During their research, the inventors unexpectedly discovered that desloratadine films prepared using different film-forming materials exhibit varying water content, adhesive strength, and film-forming properties. Furthermore, the different components in the desloratadine orally dissolved film interact, potentially accelerating structural changes in the inherently unstable drug and generating more impurities. These impurities could adversely affect human health. Therefore, strict control of impurity content during the pharmaceutical or storage process is essential. Moreover, because structural changes in the active drug affect its efficacy, the selection of excipients is particularly crucial.

[0009] In addition, taste is one of the factors affecting the clinical application of oral preparations. A poor taste may affect patients' medication adherence. Therefore, the taste of all preparations administered orally should be taken into consideration, especially those that will be used for the long-term treatment of chronic diseases.

[0010] To address the aforementioned technical problems, a first aspect of the present invention provides a desloratadine orally disintegrating film, comprising the following components: desloratadine, a film-forming material of polyvinyl alcohol, and a flavoring agent of steviol glycosides. The orally disintegrating film using the above combination exhibits higher formulation stability, better taste, better film-forming properties, smaller size, rapid disintegration, rapid dissolution, good content uniformity, and a good appearance.

[0011] Those skilled in the art typically add plasticizers to the formulation when preparing orally dissolving films to increase film toughness and reduce brittleness. However, the inventors unexpectedly discovered that the desloratadine orally dissolving film of the present invention does not require the addition of plasticizers, exhibits better formulation stability, and does not affect the film-forming properties of the film.

[0012] According to an embodiment of the present invention, by controlling the particle size D of desloratadine 90 When the thickness is ≤26μm, the inventors discovered that the active ingredient can be uniformly dispersed in the film-forming material in a non-dissolved state without the addition of solubilizers (such as ethanol or cyclodextrin). The film has a smooth surface, good film-forming properties, moderate thickness, and can achieve rapid release and disintegration time within 20s.

[0013] Preferably, when the particle size D90 of desloratadine is ≤20μm, 16.2μm, or 10μm, the inventors have found that the active ingredient can be uniformly dispersed in the film-forming material in a non-dissolved state without the addition of a solubilizer, and can achieve rapid release, smooth film surface, no large particles, good film-forming properties of the oral dissolution film, disintegration time within 25s, and moderate film thickness.

[0014] The inventors discovered that the proportions of all components in a desloratadine orally dissolving film determine the final film weight, which in turn affects the film's size and thickness. Film size affects medication adherence; excessive film weight leads to an overly large and thick film, making it difficult to insert into the mouth. An excessively thick film results in prolonged dissolution time in the mouth, leading to a poor taste, which is particularly important given the strong bitterness of the active ingredient.

[0015] According to an embodiment of the present invention, based on the total weight of the desloratadine orally disintegrating film, the polyvinyl alcohol is 14-30 parts by weight. Thus, the orally disintegrating film with a specific content of polyvinyl alcohol according to the embodiments of the present invention can improve the film strength or toughness, so as not to result in low tensile strength of the film due to insufficient film-forming amount, or although a high film-forming amount can improve the film performance, it will affect the film weight, thereby increasing the size and affecting the disintegration time of the film agent.

[0016] Preferably, based on the total weight of the desloratadine oral solution film, the polyvinyl alcohol is 14-24 parts by weight. This can further improve the strength or toughness of the desloratadine oral solution film, so as not to result in low tensile strength of the film due to insufficient film-forming amount, or although high film-forming amount can improve film performance, it will affect the film weight, thereby increasing the size and affecting the disintegration time of the film agent.

[0017] According to an embodiment of the present invention, based on the total weight of the desloratadine orally dissolving film, the amount of steviol glycoside is 1.0-3.0 parts by weight. Therefore, the desloratadine orally dissolving film using the specific content of steviol glycoside in the embodiment of the present invention has a better taste and better film stability.

[0018] Preferably, based on the total weight of the desloratadine orally dissolving film, the amount of steviol glycoside is 1.5-2.0 parts by weight. Therefore, the desloratadine orally dissolving film with a specific content of steviol glycoside according to the embodiments of the present invention has a better taste, better film stability, and lower cost.

[0019] According to an embodiment of the present invention, based on the total weight of the desloratadine orally dissolving film, the desloratadine is 2.5 parts by weight, the polyvinyl alcohol is 14-30 parts by weight, and the steviol glycosides are 1.0-3.0 parts by weight. Thus, by using a specific prescription dosage of desloratadine orally dissolving film, stability and palatability are improved, content uniformity is good, and the prepared film is small in size, only 2cm*2.5cm, capable of rapid disintegration within 25 seconds, and dissolving over 90% within 10 minutes. It does not require swallowing with water and is suitable for the elderly and children.

[0020] Preferably, based on the total weight of the desloratadine orally dissolving film, the desloratadine is 2.5 parts by weight, the polyvinyl alcohol is 14-24 parts by weight, and the steviol glycosides are 1.5-2.0 parts by weight. Thus, by using specific prescription dosages of desloratadine orally dissolving film, stability and palatability are further improved, content uniformity is better, and the prepared film is smaller in size, only 2cm*2.5cm, with a thickness within the range of 45.2μm. It can rapidly disintegrate within 25 seconds, dissolves more than 90% within 10 minutes, and does not require swallowing with water, making it suitable for the elderly and children.

[0021] According to an embodiment of the present invention, the desloratadine oral soluble film has a size of 2cm*2cm to 2cm*2.5cm, a thickness of ≤45.2μm, and / or a tensile strength of 11 to 27N and / or a disintegration time of 11 to 27s.

[0022] According to embodiments of the present invention, the desloratadine orally soluble film further comprises a colorant. This is beneficial for improving the appearance of the film and increasing its recognizability.

[0023] Preferably, the colorant is indigo lake, or / and based on the total weight of the desloratadine oral solution film, the indigo lake is 0.05-0.1 parts by weight, preferably 0.05 parts by weight.

[0024] A second aspect of the present invention provides a method for preparing a desloratadine oral solution film, the method being used to prepare the desloratadine oral solution film described in the first aspect of the present invention, comprising the following steps:

[0025] (1) Active ingredient pulverization: Desloratadine was subjected to air jet milling treatment;

[0026] (2) Preparation of membrane solution: Take purified water and heat it to 50°C, add flavoring agent and stir to dissolve, then add membrane material and stir to dissolve, and finally add desloratadine and stir to disperse evenly;

[0027] (3) Degassing: The membrane solution is transferred to a vacuum degassing machine for degassing;

[0028] (4) Film formation: Using an OZM-340 film forming machine, the solution obtained in step (3) is added to the feed inlet to start film formation;

[0029] (5) Cutting and packaging: The film roll obtained in step (4) is installed on an automatic film packaging machine, a suitable film length is set, and the film is cut and packaged to obtain the desloratadine oral solution film of the target film weight.

[0030] Preferably, based on the total weight of the desloratadine oral solution membrane, the amount of purified water used in step (2) is 80 parts by weight.

[0031] This invention optimizes and improves the components and preparation process of desloratadine, greatly enhancing the stability and taste of desloratadine oral dissolving film, resulting in better content uniformity. The prepared film is also smaller in size, only 2cm*2.5cm, and can rapidly dissolve within 25 seconds, with over 90% dissolving within 10 minutes. It does not require swallowing with water, making it suitable for the elderly and children. Compared to conventional preparation processes, it requires fewer excipients and steps, has better reproducibility, lower production costs, and is simpler to operate. Attached Figure Description

[0032] Figure 1 : Shows the appearance of the oral dissolution film of prescription 4b;

[0033] Figure 2 : Shows the appearance of the oral film of prescription 4c. Detailed Implementation

[0034] The present invention will be further described below with reference to the accompanying drawings and specific embodiments. Any aspects not covered herein are applicable to existing technologies. Specific embodiments of the present invention are given below, but these embodiments are merely for further detailed description and do not limit the scope of the invention.

[0035] Dissolution test method: Refer to the Chinese Pharmacopoeia 2020 edition, Part IV, <0931 Determination of Dissolution and Release>, select the fourth method of dissolution (paddle disc method), the rotation speed is 50 rpm, the dissolution medium is an aqueous solution with a medium volume of 900 ml, and the determination is performed by high performance liquid chromatography (General Rule 0512). This analytical method is used for detection and analysis in the following text.

[0036] LOD determination method: The moisture content was measured using a moisture analyzer. The sample size was 0.5g, and the parameters were set to 105℃, 1mg / 120s, and automatic mode. The following examples were all tested according to this method.

[0037] Content and content uniformity determination method: High performance liquid chromatography (HPLC) was used. Chromatographic column: octadecyl bonded silica column; mobile phase: phosphate buffer-acetonitrile-methanol (65:28:7); flow rate: 1 ml / min; detection wavelength: 258 nm. The following examples were all performed using this method.

[0038] The determination method for related substances (impurities) was as follows: High performance liquid chromatography (HPLC) was used. The chromatographic column was an octadecyl-bonded silica column; the mobile phase was trifluoroacetic acid SDS buffer-acetonitrile (57:43); the flow rate was 1.5 ml / min; and the detection wavelength was 280 nm. All the following examples were performed using this method. The structural formula of impurity F described below is:

[0039]

[0040] Tensile strength test method: Refer to "GBT1040.3-2006 Determination of tensile properties of plastics - Part 3: Test conditions for films and sheets" and "GBT1040.1-2018 Determination of tensile properties of plastics - Part 1: General rules". The specimen width should be 20.0 mm ± 0.1 mm and the length should be 70.0 mm ± 0.2 mm. The test should be conducted using a multimeter. The following examples all follow this method.

[0041] Disintegration time determination method: Take the orally disintegrating film prepared in the examples, hold it with tweezers and place it flat in a beaker containing an appropriate amount of water. Keep the beaker warm in a disintegration apparatus at 37±2℃. Timing begins as soon as the film comes into contact with the water. When the film completely disappears, record the disintegration time of each film using a stopwatch. To ensure accuracy, only one film is placed in the beaker each time, and the test is repeated for 6 films. The following examples were all tested using this method.

[0042] Taste assessment method: Ten subjects were randomly selected to have their taste assessed using oral dissolving films. The results were evaluated according to the rating scale shown in Table 1 below. For each rating scale for each oral dissolving film from the 10 subjects, the highest and lowest values ​​were removed, and the average value was calculated.

[0043] Table 1: Taste Rating Table

[0044] score 0-1 2 5 6 8 10

[0045] Active ingredient particle size determination method: The particle size was determined using a Mastersizer 3000 laser particle size analyzer from Malvern Panaco in dry mode, with a hopper gap of 2.5 mm, a dispersion pressure of 3.5 bar, and a feed rate of 40%. The determination was repeated three times, and the average value was calculated.

[0046] Example 1

[0047] Oral dissolving films were prepared according to the formulations shown in Table 2 and the following steps. The performance and stability of the oral dissolving films of formulations 1a-1e were then determined.

[0048] Table 2: Oral Dissolving Film Prescription Table for Prescriptions 1a-1e (parts by weight)

[0049]

[0050]

[0051] The preparation method includes the following steps:

[0052] (1) Active ingredient pulverization: Desloratadine was subjected to air jet pulverization;

[0053] (2) Preparation of membrane solution: Take purified water and heat it to 50°C, add flavoring agent and stir to dissolve;

[0054] Then add the film-forming material and stir to dissolve it. Finally, add desloratadine and stir to disperse it evenly.

[0055] (3) Degassing: The membrane solution is transferred to a vacuum degassing machine for degassing;

[0056] (4) Film making: Using an OZM-340 film making machine, the solution obtained after degassing is added to the feed port to start film making;

[0057] (5) Cutting and packaging: The prepared film roll is installed on an automatic film packaging machine, the appropriate film length is set, and the film is cut and packaged to obtain the target film weight of oral dissolution film.

[0058] Table 3: Performance test results of oral dissolving films for formulations 1a-1e

[0059]

[0060] The performance test results of the orally dissolving films according to formulations 1a-1e in Table 3 show that the desloratadine orally dissolving films prepared according to the above formulations are as follows: Films made of polyvinyl alcohol, polyoxyethylene, and povidone are soft, have a certain degree of toughness, are easily peeled off from the substrate film, have a uniform surface, and show no obvious particle aggregation. Films made of hydroxypropyl methylcellulose are harder, have strong adhesion to the substrate, are difficult to peel off, and are easily broken after peeling. Films made of polyvinyl alcohol-polyethylene glycol graft copolymer have almost no adhesion after drying, leading to direct separation from the substrate, which is not conducive to subsequent production processes. Table 3 shows that orally dissolving films with the same formulation dosage, process parameters, and other excipients exhibit significant differences in LOD (Level of Deficiency) due to differences in the film-forming material. An excessively high LOD can affect the stability of the formulation. Therefore, in summary, orally dissolving films prepared with polyvinyl alcohol as the film-forming material have a uniform surface particle distribution, better process feasibility, and better formulation stability.

[0061] Example 2

[0062] Taste is one of the factors affecting the clinical application of oral formulations, and a poor taste can impact patient medication adherence. Therefore, taste evaluation is usually a specific research component in drug development, and the taste of all formulations administered orally should be considered, especially those intended for long-term treatment of chronic diseases. This example examines the effects of different flavoring agents on taste.

[0063] Oral dissolving films of formulations 2a-2f were prepared according to the formulation composition shown in Table 4 and the preparation process of Example 1. Performance tests and stability studies of the oral dissolving films were conducted, and the results are detailed in Tables 5-6.

[0064] Table 4: Oral Dissolving Film Prescription Table for Prescriptions 2a-2f (parts by weight)

[0065]

[0066] Table 5: Evaluation of the taste and appearance of the orally dissolving film of prescriptions 2a-2f

[0067]

[0068] Table 6: Results of Oral Dissolution Film Stability in Examples 2a-2f

[0069]

[0070]

[0071] The results are shown in Tables 5-6: The oral films of prescriptions 2a-2d all had good taste, but only prescription 2b showed good stability; prescriptions 2a, 2c, and 2d showed poor stability. Prescription 2e had acceptable stability, but poor taste, while prescription 2f showed relatively poor stability. Therefore, steviol glycosides, as a flavoring agent, resulted in a better taste and excellent stability of the desloratadine oral film.

[0072] Example 3 (Types of Plasticizers)

[0073] Oral dissolving films of formulations 3a-3d were prepared according to the formulation composition shown in Table 7 and the preparation process of Example 1. Performance and stability tests of the oral dissolving films were conducted, and the results are detailed in Table 8.

[0074] Table 7: Oral Disintegrating Film Prescription Table for Prescriptions 3a-3d (by weight)

[0075] Desloratadine Active ingredients 2.5 2.5 2.5 2.5 Polyvinyl alcohol Film-forming materials 16 16 16 16 Steviosides Flavoring agents 1.5 1.5 1.5 1.5 Propylene glycol plasticizer 1.6 / / / Polyethylene glycol 400 plasticizer / 1.6 / / Triethyl citrate plasticizer / / 1.6 / glycerin plasticizer / / / 1.6 Purified water solvent 80 80 80 80

[0076] Table 8: Oral film stability results of prescriptions 3a-3d

[0077]

[0078]

[0079] Results: Formulas 3a-3d showed that commonly used plasticizers such as glycerol, propylene glycol, polyethylene glycol 400, and triethyl citrate all had poor stability. Formula 1a had a high proportion of film-forming materials and possessed good film-forming properties, thus eliminating the need for plasticizers.

[0080] Example 4

[0081] Oral dissolving films for formulations 4a-4d were prepared according to the formulation composition shown in Table 9 and the following steps. Performance tests of the oral dissolving films were performed, and the results are detailed in Tables 10-11. Figure 1-2(Oral dissolution film appearance of prescriptions 4b and 4c).

[0082] Table 9: Oral dissolving film prescriptions for prescriptions 4a-4d (parts by weight)

[0083]

[0084] The specific preparation method includes the following steps:

[0085] (1) Pulverization of active ingredients: The active ingredient desloratadine was subjected to air jet milling to obtain the particle size of the active ingredient shown in Table 9;

[0086] (2) Preparation of membrane solution: Take the prescribed amount of purified water and heat it to 50°C. Add stevioside and stir to dissolve. Then add polyvinyl alcohol and stir to dissolve. Finally, add indigo lake and desloratadine in sequence and stir to disperse evenly.

[0087] (3) Degassing: The membrane solution is transferred to a vacuum degassing machine for degassing.

[0088] (4) Film making: Using an OZM-340 film making machine, the solution obtained after degassing is added to the feed port to start film making;

[0089] (5) Cutting and packaging: The prepared film roll is installed on an automatic film packaging machine, the appropriate film length is set, and the film is cut and packaged to obtain the target film weight of oral dissolution film.

[0090] Table 10: Oral dissolving film evaluation of prescriptions 4a-4d

[0091]

[0092] Table 11: Dissolution results of the oral films of formulations 4a-4c in aqueous medium

[0093]

[0094] Results: From Table 10-11 and Figure 1 As shown, when the particle size D of the active ingredient... 90 With a particle size ≤26.0μm, it exhibits good appearance and film-forming properties, can be continuously cut, has a fast disintegration time, and the oral dissolution film dissolves very quickly. The content uniformity RSD is less than 2.0%, and the thickness is ≤45.2μm. The active ingredient particle size D... 90 When the thickness is 35.3 μm, the appearance is poor, the film-forming properties are poor, the film breaks during the cutting process, the oral dissolution film dissolves slowly, the content uniformity RSD is 3.2%, which does not meet the formulation requirements, and the thickness is ≤45.2 μm.

[0095] Example 5

[0096] Oral dissolving films of formulations 5a-5b were prepared according to the formulation composition shown in Table 12 and the preparation process of Example 1. The performance of oral dissolving films of formulations 1a, 2b, and 5a-5b was tested, and the results are detailed in Table 13. Figure 1 (Oral dissolution film appearance of prescriptions 4b and 4c).

[0097] Table 12 Oral Dissolution Film Formulations 5a-5b (parts by weight)

[0098]

[0099] Table 13: Oral dissolving film evaluation of prescriptions 1a, 2b, and 5a-5b

[0100]

[0101] Results: The tensile strength of the orally dissolving film of formulation 1a was too low. Formulations 5a, 5b, and 2b increased the amount of film-forming material, which improved the tensile strength of the film, but also increased the film weight, leading to an increase in size and ultimately affecting the disintegration time of the film. Therefore, the preferred mass fraction of the film-forming material in the orally dissolving film of this invention is 14-24 parts, ensuring process feasibility while shortening the disintegration time.

[0102] Comparative Example 1

[0103] The embodiments disclosed in CN 114306285A are used as comparative examples of the present invention. The desloratadine orally disintegrating film disclosed therein comprises the following components by weight: 2.5% to 10% desloratadine, 3% to 25% antioxidant, 25% to 70% film-forming material, 5% to 20% plasticizer, 2% to 10% disintegrant, 0% to 2% flavoring agent, 0% to 1% coloring agent, and the balance being water and ethanol; wherein the antioxidant is a combination of EDTA-2Na and vitamin C.

[0104] The preparation method of desloratadine oral instant dissolving film includes the following steps:

[0105] (1) Weigh the prescribed amount of desloratadine and add it to an aqueous solution of ethanol. Stir and dissolve at room temperature (10℃~35℃).

[0106] (2) Add the prescribed amounts of EDTA-2Na, vitamin C, flavoring agent and coloring agent to the solution obtained in step (1).

[0107] Dissolve the agent by stirring at room temperature.

[0108] (3) Weigh the prescribed amount of film-forming material, plasticizer, and disintegrant and add them to the solution obtained in step (2). Stir and disperse evenly, and let stand overnight (8 to 14 hours).

[0109] (4) Pour the gel obtained in step (3) onto a glass plate, adjust it to a suitable thickness using a plunger, and heat it at 40℃~

[0110] Dry at 55℃ for 1–3 hours;

[0111] (5) Peel the dried film off the glass plate, cut it and seal it in a package.

[0112] In summary, the desloratadine orally dissolving film formulation of this invention has a simple process, shortens the preparation time of existing orally dissolving films, and can significantly reduce production costs. Furthermore, through investigation, it was unexpectedly discovered that the orally dissolving film of this invention can still ensure the stability of desloratadine without antioxidants, thus exhibiting higher safety.

Claims

1. A desloratadine orally dissolving film, comprising desloratadine, a film-forming material, and a flavoring agent, wherein the desloratadine has a particle size D 90 ≤26 μm, the film-forming material is polyvinyl alcohol, the flavoring agent is steviol glycoside, and based on the total weight of the desloratadine orally soluble film, the polyvinyl alcohol is 14-30 parts by weight, and the steviol glycoside is 1.0-3.0 parts by weight.

2. The desloratadine oral dissolving membrane according to claim 1, characterized in that, The particle size D of desloratadine 90 ≤20 μm.

3. The desloratadine oral dissolving membrane according to claim 1, characterized in that, Based on the total weight of the desloratadine oral solution film, the polyvinyl alcohol is 14-24 parts by weight.

4. The desloratadine oral dissolving membrane according to claim 1, characterized in that, Based on the total weight of the desloratadine orally dissolving film, the amount of steviol glycoside is 1.5-2.0 parts by weight.

5. The desloratadine oral dissolving membrane according to claim 1, characterized in that, Based on the total weight of the desloratadine orally soluble film, the desloratadine is 2.5 parts by weight, the polyvinyl alcohol is 14-30 parts by weight, and the steviol glycoside is 1.0-3.0 parts by weight.

6. The desloratadine oral dissolving membrane according to claim 5, characterized in that, Based on the total weight of the desloratadine oral dissolving film, the desloratadine is 2.5 parts by weight, the polyvinyl alcohol is 14-24 parts by weight, and the steviol glycoside is 1.5-2.0 parts by weight.

7. A method for preparing a desloratadine oral solution film according to any one of claims 1 to 6, comprising the following steps: (1) Pulverization of active ingredients: Desloratadine was subjected to air jet milling treatment; (2) Preparation of membrane solution: Take purified water and heat it to 50°C, add flavoring agent and stir to dissolve, then add membrane material and stir to dissolve, and finally add desloratadine and stir to disperse evenly; (3) Degassing: The membrane solution is transferred to a vacuum degassing machine for degassing; (4) Film making: Using an OZM-340 film making machine, the solution obtained in step (3) is added to the feed inlet to start film making; (5) Cutting and packaging: The film roll obtained in step (4) is installed on an automatic film packaging machine, a suitable film length is set, and the film is cut and packaged to obtain the desloratadine oral solution film of the target film weight.

8. A desloratadine orally dissolving film, comprising desloratadine, a film-forming material, a flavoring agent, and a coloring agent, wherein the desloratadine has a particle size D 90 ≤26 μm, wherein the film-forming material is polyvinyl alcohol, the flavoring agent is steviol glycoside, the colorant is indigo lake, and based on the total weight of the desloratadine oral soluble film, the polyvinyl alcohol is 14-30 parts by weight, and the steviol glycoside is 1.0-3.0 parts by weight.

9. The desloratadine oral dissolving membrane according to claim 8, characterized in that, Based on the total weight of the desloratadine oral solution film, the indigo lake is 0.05-0.1 parts by weight.

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