A lurasidone hydrochloride orally disintegrating film composition, a preparation method thereof, and use thereof

Abstract

Provided are a lurasidone hydrochloride orally dissolving film composition, a preparation method and application thereof. The lurasidone hydrochloride orally dissolving film composition comprises an active drug, a film forming material, a plasticizer and a flavoring agent, and the active drug is (3aR,4S,7R,7aS)-2-((1R,2R)-2-[4-(1.2-benzisothiazole 3-yl)piperazine-1-methyl]cyclohexylmethyl)hexahydro-4.7-methylen-2H-isoindole-1,3-dione hydrochloride salt as shown in formula I. The obtained lurasidone hydrochloride orally dissolving film composition has a good dissolution rate, does not have a sand feeling after dissolving in the oral cavity, has a uniform appearance, good flexibility, and does not have sedimentation during the preparation of the film liquid, and the content uniformity meets the requirements.

Description

[0001] This application claims the priority of the prior application with the patent application number 202111301406.X, the name of invention as "a lurasidone hydrochloride orally dissolving film composition, its preparation method and application", which was filed with the State Intellectual Property Office of China on November 4, 2021. The prior application is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0002] The present application relates to the field of pharmaceutical preparations, in particular to a lurasidone hydrochloride orally dissolving film composition with simple process and good stability, its preparation method and application. BACKGROUND

[0003] Schizophrenia is a serious mental disorder. According to the statistics of the World Health Organization, more than 21 million people worldwide are suffering from schizophrenia, and this disease is the eighth leading cause of disability in the 15-44 age group. As of the end of 2016, the number of registered schizophrenic patients in China was about 4.05 million. Existing schizophrenic treatment drugs can be roughly divided into two categories: one is typical antipsychotic drugs, also known as first-generation antipsychotic drugs; the other is atypical antipsychotic drugs, which generally have dopamine D2 / 5-HT2A receptor antagonism, also known as second-generation antipsychotic drugs. Since 2010, the market size of mental drugs in domestic sample hospitals has grown from 1.25 billion yuan to 2.47 billion yuan in 2015, with a compound annual growth rate of 14.6% over the past five years. In view of the fact that the pathogenesis of schizophrenia has not been fully elucidated, the limitations and adverse reactions of existing treatment drugs, there is a clinical need for treatment drugs with better efficacy and fewer adverse reactions. Domestic mental health resources are lacking, and the potential of the mental drug market is huge. However, schizophrenic patients often refuse to take medicine, hide medicine in their mouths, and vomit medicine during the acute phase, and patient medication compliance is a common problem. Therefore, tablets and capsules, which are often used as dosage forms, often cannot play a role in patients, and for schizophrenic patients, easy-to-use dosage forms should be considered. In view of this, it is necessary to provide a new preparation with convenient use, good compliance and stable quality to solve the above problems.

[0004] Lurasidone hydrochloride is a new atypical antipsychotic drug developed by Takeda Pharmaceutical and Sumitomo Pharmaceutical for the treatment of schizophrenia, which is used for the treatment of schizophrenia and bipolar depression. The current clinical dosage form is a common tablet. However, due to the difficulty in swallowing, children and elderly patients are not suitable for taking this type of drug dosage form, and patients cannot take the medicine conveniently without water.

[0005] Therefore, there is a need to develop a dosage form of lurasidone hydrochloride to solve the problem of poor patient compliance, especially for patients with difficulty in swallowing, so as to improve patient compliance. SUMMARY

[0006] The present application provides a lurasidone hydrochloride oral dissolving film composition, which comprises an active drug, a film forming material, a plasticizer and a flavoring agent, wherein the active drug is a compound as shown in formula I, i.e. (3aR, 4S, 7R, 7aS)-2-((1R, 2R)-2-[4-(1.2-benzisothiazole 3-yl) piperazine-1-methyl] cyclohexylmethyl) hexahydro-4.7-methylene-2H-isobenzofuran-1, 3-dione hydrochloride (lurasidone hydrochloride).

[0007]

[0008] I.

[0009] According to an embodiment of the present application, the active drug has a mass percentage content of 1% to 60%, such as 10% to 55%, for example 10% to 50%, for example 52.1%, 47.2%, 41.7%, 41.3%, 38.5%, 35.7%, 33.3%, 30.0% or 25.0%, wherein the mass percentage content refers to the mass percentage of the active drug in the total mass of the lurasidone hydrochloride oral dissolving film composition.

[0010] According to an embodiment of the present application, the film forming material is a carrier for drugs, preferably one or more of xanthan gum, guar gum, pectin, gelatin, shellac, gum arabic, starch, dextrin, agar, sodium alginate, zein, hydroxypropyl methylcellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone, polyethylene glycol, polyoxyethylene, pullulan, acrylic acid copolymer, polylactic acid and silicone rubber. In some embodiments, the film forming material is polyvinyl alcohol, hydroxypropyl cellulose, a mixture of polyvinyl alcohol and polyethylene glycol 6000, or a mixture of hydroxyethyl cellulose and pullulan.

[0011] According to an embodiment of the present application, the film forming material has a mass percentage content of 20% to 60%, such as 30% to 50%, for example 57.0%, 50.0%, 47.0%, 45.8%, 41.7%, 41.3%, 38.5%, 37.7%, 35.7%, 33.0% or 31.2%, wherein the mass percentage content refers to the mass percentage of the film forming material in the total mass of the lurasidone hydrochloride oral dissolving film composition.

[0012] According to an embodiment of the present invention, the plasticizer is used to lower the glass transition temperature of the film, increase plasticity and toughness, and improve elongation. Preferably, it is one or more of polyethylene glycol, glycerin, propylene glycol, silicone oil, polypropylene glycol, and hexanediol.

[0013] According to an embodiment of the present invention, the mass percentage of the plasticizer is 0-20%, for example 16.0%, 9.4%, 8.3%, 5.2%, 5.0%, 4.7%, 4.5%, 4.3% or 0, wherein the mass percentage refers to the percentage of the mass of the plasticizer to the total mass of the lurasidone hydrochloride oral dissolving film composition.

[0014] According to an embodiment of the present invention, the flavoring agent plays a flavoring role in the film-forming agent, and is preferably one or more selected from aspartame, sucralose, fructose, sucrose, steviol glycosides, glycyrrhizin, flavoring, fragrance, menthol, sodium chloride, citric acid, saccharin and sodium saccharin.

[0015] According to an embodiment of the present invention, the flavoring agent has a mass percentage content of 0-25.0%, preferably 3.0%-25.0%, for example 17.7%, 17.1%, 16.4%, 12.5%, 10.4%, 10.0%, 9.5%, 9.4%, 8.3%, 5.0% or 3.0%, where the mass percentage content refers to the percentage of the mass of the flavoring agent to the total mass of the lurasidone hydrochloride oral disintegrating film composition.

[0016] According to an embodiment of the present invention, the lurasidone hydrochloride orally disintegrating film composition may further include a disintegrant, or a combination of a disintegrant with one or more of a saliva stimulant, a filler, a colorant, an anti-adhesive, and an antibacterial agent.

[0017] According to an embodiment of the present invention, the disintegrant refers to an excipient that causes the drug to rapidly disintegrate into small particles in the gastrointestinal tract, preferably one or more of low-substituted hydroxypropyl cellulose, crospovidone, crospovidone sodium carboxymethyl cellulose, sodium carboxymethyl starch, starch, microcrystalline cellulose and pregelatinized starch.

[0018] According to an embodiment of the present invention, the mass percentage of the disintegrant is preferably 0 to 10.0%, for example 3.6%, 6.9%, 7.0% or 7.1%, whereby the mass percentage refers to the percentage of the mass of the disintegrant relative to the total mass of the lurasidone hydrochloride oral disintegrating film composition.

[0019] According to an embodiment of the present invention, the saliva stimulant refers to a substance that stimulates saliva production, preferably one or more of tartaric acid, malic acid, and mannitol.

[0020] According to an embodiment of the present invention, the mass percentage of the saliva stimulant is 0 to 10.0%, for example 0.6%, 0.9%, 6.9%, 7.0%, 7.1% or 7.7%, wherein the mass percentage refers to the percentage of the mass of the saliva stimulant to the total mass of the lurasidone hydrochloride oral dissolving film composition.

[0021] According to an embodiment of the present invention, the filler refers to a solid substance that, when added to a material, can improve the material's properties, or increase its volume or weight, thereby reducing the material's cost. Preferably, it is one or more of mannitol, sucrose, glucose, maltose, lactose, sorbitol, xylitol, maltitol, galactitol, erythritol, dextrin, and trehalose.

[0022] According to an embodiment of the present invention, the mass percentage of the filler is 0 to 10.0%, for example 6.0% or 3.0%, where the mass percentage refers to the percentage of the mass of the filler relative to the total mass of the lurasidone hydrochloride oral dissolving film composition.

[0023] According to an embodiment of the present invention, the colorant refers to a substance that can improve the appearance color of the preparation, can be used to identify the concentration of the preparation, distinguish the method of application, and reduce the patient's aversion to taking the medication, preferably one or more of titanium dioxide, pigments, and lakes.

[0024] According to an embodiment of the present invention, the colorant has a mass percentage content of 0 to 5.0%, for example 1.1%, 1.0% or 0.8%, wherein the mass percentage content refers to the percentage of the mass of the colorant relative to the total mass of the lurasidone hydrochloride oral dissolving film composition.

[0025] According to an embodiment of the present invention, the anti-adhesion agent refers to an agent that can improve the performance of the formulation and prevent adhesion between formulations, preferably one or more of talc, magnesium stearate, and calcium stearate.

[0026] According to an embodiment of the present invention, the mass percentage of the anti-adhesive is 0 to 5.0%, for example 0.7% or 0.8%, where the mass percentage refers to the percentage of the mass of the anti-adhesive relative to the total mass of the lurasidone hydrochloride oral dissolving film composition.

[0027] According to an embodiment of the present invention, the antibacterial agent refers to a substance capable of inhibiting bacterial growth, preferably one or more of methylparaben, ethylparaben, and sodium thiosulfate.

[0028] According to an embodiment of the present invention, the mass percentage of the antibacterial agent is 0~1.0%, for example 0.6%, where the mass percentage refers to the percentage of the mass of the antibacterial agent relative to the total mass of the lurasidone hydrochloride oral dissolving film composition.

[0029] According to an embodiment of the present invention, the lurasidone hydrochloride orally dissolving film composition may be any of the following formulations:

[0030] Prescription 1: 47.2% lurasidone hydrochloride, 33.0% hydroxypropyl cellulose, 9.4% glycerin, 9.4% sucralose and 1.0% titanium dioxide;

[0031] Prescription 2: 30.0% lurasidone hydrochloride, 45.0% polyvinyl alcohol, 12.0% polyethylene glycol 6000, 5.0% sucralose, 3.5% menthol, 0.9% mannitol, 3.0% lactose and 0.6% methylparaben;

[0032] Prescription 3: 33.3% lurasidone hydrochloride, 45.8% polyvinyl alcohol, 8.3% glycerin, 3.3% sodium chloride, 4.2% citric acid, 4.3% sucralose, 0.4% flavoring and 0.4% menthol;

[0033] Prescription 4: 25.0% lurasidone hydrochloride, 50.0% polyvinyl alcohol, 16.0% glycerin, 2.5% steviol glycosides, 0.5% flavoring and 6.0% lactose;

[0034] Prescription 5: 41.3% lurasidone hydrochloride, 24.8% hydroxyethyl cellulose, 16.5% pullulan, 8.3% glycerol, 8.3% sucralose, and 0.8% titanium dioxide;

[0035] Prescription 6: 47.2% lurasidone hydrochloride, 28.3% hydroxyethyl cellulose, 9.4% pullulan, 4.7% glycerol, 9.4% sucralose, and 1.0% titanium dioxide;

[0036] Prescription 7: 52.1% lurasidone hydrochloride, 20.8% hydroxyethyl cellulose, 10.4% pullulan, 5.2% glycerol, 10.4% sucralose, and 1.1% titanium dioxide;

[0037] Prescription 8: 41.7% lurasidone hydrochloride, 25.0% hydroxyethyl cellulose, 16.7% pullulan, 5.0% glycerin, 8.3% sucralose, 1.7% menthol, 0.8% talc, and 0.8% titanium dioxide;

[0038] Prescription 9: 38.5% lurasidone hydrochloride, 23.1% hydroxyethyl cellulose, 15.4% pullulan, 4.5% glycerin, 7.7% sucralose, 1.5% menthol, 0.8% flavoring, 7.7% citric acid and 0.8% talc;

[0039] Prescription 10: 35.7% lurasidone hydrochloride, 21.4% hydroxyethyl cellulose, 14.3% pullulan, 4.3% glycerin, 7.1% sodium carboxymethyl starch, 7.1% sucralose, 1.4% menthol, 0.8% flavoring, 7.1% citric acid and 0.8% talc.

[0040] The present invention also provides a method for preparing the aforementioned lurasidone hydrochloride oral dissolving film composition, which includes the following steps:

[0041] 1) The film-forming material is heated and dissolved in water at 60℃~70℃ to form a solution;

[0042] 2) Add all components except the active drug and film-forming material to the solution obtained in step 1), stir evenly to obtain a blank gel solution;

[0043] 3) Place the active drug in the blank gel solution obtained in step 2), stir until it is evenly dispersed, and stir under vacuum to remove bubbles to obtain the drug-containing gel;

[0044] 4) The drug-containing adhesive is evenly coated onto the release film using a coating machine, heated, dried, and cut to obtain the lurasidone hydrochloride oral dissolving film composition.

[0045] According to an embodiment of the present invention, the thickness of the lurasidone hydrochloride orally dissolving film composition is 10 μm to 300 μm, for example, 10 μm to 300 μm.

[0046] According to an embodiment of the present invention, the lurasidone hydrochloride oral disintegrating film composition can completely disintegrate within 2 minutes in 1000 mL of simulated saliva at 37℃±1℃.

[0047] The present invention also provides the use of the described lurasidone hydrochloride orally disintegrating film composition in the preparation of medicaments for the treatment and / or prevention of depression.

[0048] The present invention also provides a method for treating and / or preventing depression, which involves administering a therapeutically effective amount of the said lurasidone hydrochloride oral dissolving film composition to a patient in need.

[0049] According to an embodiment of the present invention, the lurasidone hydrochloride oral dissolving film composition is a pharmaceutical preparation.

[0050] The beneficial effects of this invention are as follows: The lurasidone hydrochloride orally dissolving film composition of this invention has the advantages of thin thickness, good taste, stable properties, good dissolution rate, instant dissolution in the oral cavity without the need for drinking water, no gritty feeling after dissolving in the oral cavity, and rapid oral absorption. It also has a uniform appearance, good flexibility, simple manufacturing process, no sedimentation during film solution preparation, meets the required content uniformity, and has a high drug loading capacity. It solves the defects of existing formulations such as inconvenience in administration and poor patient compliance, and is particularly suitable for patients with dysphagia.

[0051] Terminology Definitions and Explanations

[0052] Unless otherwise stated, the definitions of terms recorded in this application specification and claims, including definitions as examples, exemplary definitions, preferred definitions, and specific definitions in embodiments, can be arbitrarily combined and combined with each other. Such combinations and combinations shall fall within the scope of this application specification.

[0053] The term "therapeutic effective amount" refers to the amount of the active pharmaceutical ingredient of this invention sufficient to achieve the intended application (including, but not limited to, the treatment of diseases as defined below). Therapeutic effective amount can vary depending on factors such as the intended application (in vitro or in vivo), the subject being treated, and the condition of the disease, such as the subject's weight and age, the severity of the disease, and the route of administration, which can be readily determined by those skilled in the art. The specific dosage will vary depending on factors such as the specific active ingredient selected, the administration regimen, whether it is administered in combination with other compounds, the timing of administration, the tissue to which it is administered, and the physical delivery system used. Attached Figure Description

[0054] Fig. 1 The dissolution curve of the oral film formulation of lurasidone hydrochloride in Example 3 in hydrochloric acid solution at pH 1.2 is shown.

[0055] Fig. 2 The dissolution curve of the oral film formulation of lurasidone hydrochloride in Example 3 in acetate buffer solution at pH 3.8 is shown. Detailed Implementation

[0056] The technical solution of the present invention will be further described in detail below with reference to specific embodiments. It should be understood that the following embodiments are merely illustrative and explanatory of the present invention, and should not be construed as limiting the scope of protection of the present invention. All technologies implemented based on the above content of the present invention are covered within the scope of protection intended by the present invention.

[0057] Unless otherwise stated, the raw materials and reagents used in the following examples are commercially available products or can be prepared by known methods. Experimental methods in the following examples that do not specify specific conditions were performed according to conventional methods and conditions, or as selected according to the product instructions.

[0058] Example 1

[0059] The prescriptions are shown in Table 1:

[0060] Table 1

[0061]

[0062]

[0063]

[0064] * indicates removal during the process;

[0065] **Indicates the weight of raw and auxiliary materials after water removal;

[0066] Percentage of each component = Mass of each component / (Total weight**) × 100%.

[0067] Preparation method:

[0068] 1) The film-forming material is heated and dissolved in water at 60℃~70℃ to form a solution;

[0069] 2) Add all components except the active drug and film-forming material to the solution obtained in step 1), stir evenly to obtain a blank gel solution;

[0070] 3) Place the active drug in the blank gel solution obtained in step 2), stir until it is evenly dispersed, and stir under vacuum to remove bubbles to obtain the drug-containing gel;

[0071] 4) The drug-containing adhesive solution obtained in step 3) after degassing is evenly coated onto the release film using a coating machine, heated, dried, and cut to obtain the lurasidone hydrochloride oral dissolving film composition.

[0072] 1. Collapse Time Limit Test

[0073] According to the formulations of Examples 1 to 10, lurasidone orally disintegrating film formulations were prepared using the preparation method provided by the present invention, and their disintegration time was determined. The specific determination method is as follows:

[0074] Take 6 tablets of the drug film obtained from each example, take 1 tablet each time, gently place it in 1000ml of artificial saliva at 37℃±1℃, and observe the time for complete disintegration of the product under static conditions. The results are shown in Table 2.

[0075] Table 2

[0076]

[0077] 2. Determination of dissolution results

[0078] The dissolution profile of the orally dissolving film formulation of lurasidone hydrochloride prepared according to the formulation of Example 3 was determined. The specific determination method is as follows:

[0079] Test media: 900 ml pH 1.2 hydrochloric acid solution (37℃±0.5℃) and 900 ml pH 3.8 acetate buffer solution (37℃±0.5℃).

[0080] Dissolution method: Chinese Pharmacopoeia 2020 Edition 0931 Dissolution and Release Determination Method II (Paddle Method), rotation speed 50 rpm.

[0081] Sampling time: 5 min, 10 min, 15 min, 20 min, 30 min.

[0082] Six tablets of lurasidone hydrochloride oral dissolving film were taken, and the dissolution curves were determined according to the above method. The results are shown in Table 3 and 4. Figs. 1-2 As shown.

[0083] Table 3

[0084]

[0085] 3. Results related to the substances

[0086] The relevant substance detection method for the lurasidone hydrochloride orally dissolving membrane prepared according to the formulation of Example 3 is as follows:

[0087] 3.1 Description of relevant material analysis methods

[0088] 1) Chromatographic conditions

[0089]

[0090] 2) Calculation

[0091] Impurities IM-2 and IM-4 were calculated using the principal component external standard method with correction factors; unknown impurities were calculated using the principal component external standard method without correction factors. The total impurities were the sum of all known impurities and unknown impurities.

[0092] 3) Impurity limits

[0093]

[0094] The results of related substance detection in the sample of Example 3 are shown in Table 4.

[0095] Table 4

[0096]

[0097] Based on the above experimental data, it can be seen that the oral dissolving film composition of lurasidone hydrochloride provided by the present invention has the advantages of thin thickness, good taste, stable properties, low impurity content, and instant dissolution in the oral cavity without drinking water, and rapid oral absorption.

[0098] The embodiments of the present invention have been described above. However, the present invention is not limited to the above embodiments. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A lurasidone hydrochloride orally dissolving film composition, characterized in that, The composition comprises an active pharmaceutical ingredient, a film-forming material, a plasticizer, and a flavoring agent, wherein the active pharmaceutical ingredient is a compound as shown in Formula I; Formula I The film-forming material is polyvinyl alcohol; The plasticizer is glycerin; The active pharmaceutical ingredient has a mass percentage content of 25.0-50%, the film-forming material has a mass percentage content of 30-50%, and the plasticizer has a mass percentage content of 5.0-16.0%. The mass percentage refers to the percentage of the mass of each component relative to the total mass of the lurasidone hydrochloride oral dissolving film composition.

2. The lurasidone hydrochloride oral dissolving film composition according to claim 1, characterized in that: The active pharmaceutical ingredient has a mass percentage content of 30% to 50%.

3. The lurasidone hydrochloride oral dissolving film composition according to claim 1, characterized in that: The flavoring agent is one or more of the following: aspartame, sucralose, fructose, sucrose, steviol glycosides, glycyrrhizin, flavoring, fragrance, menthol, sodium chloride, citric acid, saccharin, and sodium saccharin.

4. The lurasidone hydrochloride oral dissolving film composition according to claim 1, characterized in that: The flavoring agent has a mass percentage content greater than 0 and not exceeding 25.0%, where the mass percentage content refers to the percentage of the flavoring agent's mass relative to the total mass of the lurasidone hydrochloride oral dissolving film composition.

5. The lurasidone hydrochloride oral dissolving film composition according to claim 1, characterized in that: The flavoring agent has a mass percentage content of 5.0-17.7%.

6. The lurasidone hydrochloride oral dissolving film composition according to any one of claims 1 to 4, characterized in that: The oral dissolving film composition of lurasidone hydrochloride has the following formulation: 33.3% lurasidone hydrochloride, 45.8% polyvinyl alcohol, 8.3% glycerin, 3.3% sodium chloride, 4.2% citric acid, 4.3% sucralose, 0.4% flavoring and 0.4% menthol.

7. A lurasidone hydrochloride oral dissolving film composition, characterized in that: The oral disintegrating film composition of lurasidone hydrochloride is composed of an active drug, a film-forming material, a plasticizer, a flavoring agent, and a disintegrant, or is composed of an active drug, a film-forming material, a plasticizer, a flavoring agent, and a disintegrant, and a combination of one or more of a saliva stimulant, a filler, a colorant, an anti-adhesive agent, and an antibacterial agent. The active pharmaceutical ingredient is a compound as shown in Formula I; Formula I The film-forming material is selected from polyvinyl alcohol, or a mixture of polyvinyl alcohol and polyethylene glycol 6000; The plasticizer is glycerin; The active pharmaceutical ingredient has a mass percentage content of 25.0% to 60%, the film-forming material has a mass percentage content of 20% to 60%, and the plasticizer has a mass percentage content greater than 0 and not exceeding 20%. The mass percentage refers to the percentage of the mass of each component relative to the total mass of the lurasidone hydrochloride oral dissolving film composition.

8. The lurasidone hydrochloride oral dissolving film composition according to claim 7, characterized in that: The disintegrant is one or more of the following: low-substituted hydroxypropyl cellulose, crospovidone, crospovidone sodium carboxymethyl cellulose, sodium carboxymethyl starch, starch, microcrystalline cellulose, and pregelatinized starch; And / or, The saliva stimulant mentioned is one or more of tartaric acid, malic acid, and mannitol; And / or, The filler is one or more of mannitol, sucrose, glucose, maltose, lactose, sorbitol, xylitol, maltitol, galactitol, erythritol, dextrin, and trehalose; And / or, The colorant is one or more of titanium dioxide, pigments, and lakes; And / or, The anti-adhesive is one or more of talc, magnesium stearate, and calcium stearate; And / or, The antibacterial agent is one or more of methylparaben, ethylparaben, and sodium thiosulfate.

9. The lurasidone hydrochloride oral dissolving film composition according to claim 7, characterized in that: The percentage content of the disintegrant is greater than 0 and not more than 10.0%, and the mass percentage content refers to the percentage of the mass of the disintegrant relative to the total mass of the lurasidone hydrochloride oral disintegrating film composition; And / or, The saliva stimulant content is 0-10.0%, and the mass percentage refers to the percentage of the mass of the saliva stimulant to the total mass of the lurasidone hydrochloride oral disintegrating film composition; And / or, The filler content is 0-10.0%, and the mass percentage refers to the percentage of the filler mass in the total mass of the lurasidone hydrochloride oral dissolving film composition; And / or, The colorant content is 0-5.0%, and the mass percentage refers to the percentage of the mass of the colorant to the total mass of the lurasidone hydrochloride oral dissolving film composition; And / or, The anti-adhesive content is 0-5.0%, and the mass percentage refers to the percentage of the mass of the anti-adhesive relative to the total mass of the lurasidone hydrochloride oral dissolving film composition; And / or, The percentage content of the antibacterial agent is 0-1.0%, and the mass percentage content refers to the percentage of the mass of the antibacterial agent to the total mass of the lurasidone hydrochloride oral dissolving film composition.

10. A lurasidone hydrochloride oral dissolving film composition, characterized in that: The oral dissolving film composition of lurasidone hydrochloride is selected from any of the following formulations: Prescription 2: 30.0% lurasidone hydrochloride, 45.0% polyvinyl alcohol, 12.0% polyethylene glycol 6000, 5.0% sucralose, 3.5% menthol, 0.9% mannitol, 3.0% lactose and 0.6% methylparaben; Prescription 4: 25.0% lurasidone hydrochloride, 50.0% polyvinyl alcohol, 16.0% glycerin, 2.5% steviol glycosides, 0.5% flavoring and 6.0% lactose.

11. The method for preparing the lurasidone hydrochloride orally dissolving film composition according to any one of claims 1 to 10, characterized in that, The preparation method includes the following steps: 1) The film-forming material is heated and dissolved in water at 60℃~70℃ to form a solution; 2) Add all components except the active drug to the solution obtained in step 1), stir well to obtain a blank gel solution; 3) Place the active drug in the blank gel solution obtained in step 2), stir until it is evenly dispersed, and stir under vacuum to remove bubbles to obtain the drug-containing gel; 4) The drug-containing adhesive solution obtained in step 3) after degassing is evenly coated onto the release film using a coating machine, heated, dried, and cut to obtain the lurasidone hydrochloride oral dissolving film composition.

12. The method for preparing the lurasidone hydrochloride orally dissolving film composition according to claim 11, characterized in that, The thickness of the oral dissolving film composition of lurasidone hydrochloride is 10 μm to 300 μm; And / or, The described lurasidone hydrochloride oral disintegrating film composition can completely disintegrate within 2 minutes in 1000 ml of simulated saliva at 37℃±1℃.

13. Use of the lurasidone hydrochloride orally disintegrating film composition according to any one of claims 1 to 10 in the preparation of medicaments for the treatment and / or prevention of depression.

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