A tadalafil tablet and its preparation method

Abstract

The present invention discloses a tadalafil tablet comprising a tadalafil liquid self-emulsifying drug delivery system, a solid adsorbent, and tablet excipients; the tadalafil liquid self-emulsifying drug delivery system and the solid adsorbent have a content ratio of 1:1-2; the tadalafil liquid self-emulsifying drug delivery system comprises a tadalafil API, an oil phase solvent, a nonionic surfactant, and a co-surfactant; the tadalafil content is 15-25%; the oil phase solvent content is 40-50%; the nonionic surfactant content is 30-40%; and the co-surfactant content is 5-15%. The tadalafil tablets prepared by the present invention have good uniformity, high solubility, and few impurities.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations, and in particular to a tadalafil tablet and a preparation method thereof. Background Art

[0002] Tadalafil is a PDE5 inhibitor that was approved for marketing by the U.S. Food and Drug Administration (FDA) in 2003 and has been widely used in the market. 22 H 19 N3O4, with a molecular weight of 389.41, is almost insoluble in water.

[0003] Tadalafil is a poorly soluble drug with low bioavailability. Consequently, ineffective doses can be high, leading to a variety of adverse reactions. Irrational use can exacerbate adverse reactions such as headache, dizziness, eye pain, eyelid swelling, and conjunctival congestion. Therefore, improving tadalafil's solubility and bioavailability to reduce adverse reactions is crucial.

[0004] Currently, methods for increasing drug solubility primarily include micronizing the API, improving the preparation process, and blending the API with hydrophilic excipients. For example, Patent Publication No. CN107303284A provides a method for preparing tadalafil tablets and tadalafil tablets. The method comprises: mixing tadalafil with a surfactant, micronizing the resulting mixture to obtain a micronized mixture; then mixing the micronized mixture with a filler, a disintegrant, a binder, a glidant, and a lubricant, and tableting the resulting mixture to obtain the tadalafil tablets. Similarly, Patent Publication No. CN110638770 A discloses a method for preparing tadalafil tablets, comprising micronization, excipient pretreatment, premixing, granulation, granulation, drying, final mixing, and tableting. The micronization step involves mixing the tadalafil raw material with a portion of a hydrophilic diluent, sieving, and airflow milling to obtain a micronized composition containing tadalafil. In the original drug, the particle size D90 of the tadalafil raw material is controlled below 40μm (air flow milling technology is used to control the D90 particle size to ≤10μm) to improve solubility. Due to the micronization of tadalafil, the fluidity of the powder will deteriorate, affecting the uniformity of the drug and tableting. In addition, after the drug is micronized, the specific surface area increases, and the stability of the drug will deteriorate.

[0005] Patent Publication No. CN110812336 A discloses a method for preparing a tadalafil tablet composition, wherein the tadalafil API is co-pulverized with lactose and polyethylene glycol 6000 to prepare a tadalafil blend with a particle size of less than 38 microns. This method utilizes lactose and polyethylene glycol, which have good solubility, to coat the API to improve the solubility of tadalafil; however, due to the low density of the mixed powder, the improvement in tadalafil solubility is limited, making this method less practical. In addition, Patent Publication No. CN109157520A discloses that the poorly soluble tadalafil is dispersed in an oligosaccharide polyhydroxy backbone, reducing hydrophobicity, facilitating dissolution, and promoting dissolution. However, due to the low molecular weight of the oligosaccharide itself, the amount of tadalafil API that can be accommodated is limited, and the addition of large amounts of oligosaccharides and sodium alginate may increase the drug's hygroscopicity, thereby affecting the drug's stability.

[0006] Therefore, in view of the various defects of the existing technology, it is necessary to develop a tadalafil tablet with good uniformity, high solubility and few impurities. Summary of the Invention

[0007] The present invention aims to overcome at least one of the defects of the above-mentioned prior art and provide a tadalafil tablet and a preparation method thereof, wherein the prepared tadalafil tablet has good uniformity, high solubility and few impurities.

[0008] Specifically, the present invention provides a tadalafil tablet, comprising a tadalafil liquid self-emulsifying drug delivery system (Ta-SEDDS), a solid adsorbent, and tablet excipients; the content ratio of the tadalafil liquid self-emulsifying drug delivery system to the solid adsorbent is 1:1-2; the Ta-SEDDS comprises a tadalafil bulk drug, an oil phase solvent, a nonionic surfactant, and a cosurfactant; wherein the tadalafil content is 15-25%; the oil phase solvent content is 40-50%; the nonionic surfactant content is 30-40%; the cosurfactant content is 5-15%; the oil phase solvent content is 10-25 ... cosurfactant content is 5-15%; the cosurfactant content is 5-15%; the cosurfactant content is 5-15%; the cosurfactant content is 5-15%; the cosurfactant content is 5-15%; the cosurfactant content is 5-15%; the cosurfactant content is 5-15%; the cosurfactant content is 5-15%; the cosurfactant content is 5-15%; the cosurfactant content is 5-15%; the cosurfactant content is 5 The surfactant includes one or more of ethanol monooleate polyethylene glycol glyceride or ethyl oleate; the nonionic surfactant includes one or more of castor oil polyoxyethylene ether or polysorbate; the cosurfactant includes one or more of polyglycerol ester or polyethylene glycol; the solid adsorbent is one or more of mesoporous silica (MCM-41), PEG4000 or mannitol; the tablet excipient content is 30-90%, and the tablet excipients are composed of the following components: 2-20% binder, 5-30% disintegrant, 50-75% filler, 0.2-0.5% glidant and 0.3-0.9% lubricant, the binder is hydroxypropyl cellulose (HPC), the disintegrant is sodium carboxymethyl starch, the filler is lactose and microcrystalline cellulose, the glidant is micropowder silica gel, and the lubricant is magnesium stearate.

[0009] Preferably, in the tadalafil liquid self-emulsifying drug delivery system, the tadalafil content is 20%; the oil phase solvent content is 40%; the nonionic surfactant content is 30%; and the co-surfactant content is 10%.

[0010] Preferably, the oil phase solvent is ethanol monooleate polyethylene glycol glyceride; the nonionic surfactant comprises castor oil polyoxyethylene ether and polysorbate 80, mixed in a ratio of 1:1; and the co-surfactant is a polyglycerol ester. This results in a short emulsification time and a high emulsification grade.

[0011] Preferably, the solid adsorbent is MCM-41. Preferably, the content ratio of the tadalafil liquid self-emulsifying drug delivery system to the solid adsorbent is 1:1.2. As a result, after adding tablet excipients, tablets are smoothly ejected during tableting, do not stick to the punch, and the compressed tablets are smooth.

[0012] More preferably, tadalafil tablets are composed of the following components and proportions: 5% tadalafil, 10% ethanol-oleate macrogol glyceride, 3.75% castor oil polyoxyethylene ether, 3.75% polysorbate 80, 2.5% polyglycerol esters, 30% MCM-41, 4% hydroxypropyl cellulose (HPC), 9.5% sodium starch glycolate, 15% lactose, 16% microcrystalline cellulose, 0.2% micropowdered silica gel, and 0.3% magnesium stearate. Thus, the compressed tadalafil tablets have the best uniformity, the highest solubility, and fewer impurities.

[0013] In order to achieve the above object, the present invention also provides a method for preparing tadalafil tablets, which comprises the following steps:

[0014] Preparation of S1 liquid self-emulsifying drug delivery system: Weigh a certain amount of tadalafil, oil phase solvent, nonionic surfactant, and co-surfactant respectively, heat in a water bath at 55-65°C, and mix by magnetic stirring for 10-30 minutes to obtain a liquid self-emulsifying drug delivery system, which is then stored at room temperature for later use;

[0015] S2 Liquid-solid powder preparation: Add a certain amount of solid adsorbent to the above-mentioned liquid self-emulsifying drug delivery system, mix and grind and stir evenly so that the drug is evenly distributed in the powder; then spread the formed liquid-solid powder into a uniform layer and place it at room temperature for 12 hours;

[0016] S3 tablet forming: the liquid-solid powder prepared in step S2 is added to pharmaceutically acceptable excipients and mixed, and the powder is directly compressed using a No. 10 punch to obtain tadalafil tablets with a specification of 5-20 mg.

[0017] Furthermore, the preparation method also includes the step of pre-preparing a non-ionic surfactant, wherein the non-ionic surfactant includes castor oil polyoxyethylene ether and polysorbate 80, which are mixed in a ratio of 1:1 in a water bath at 60°C for 30 to 60 seconds.

[0018] Furthermore, in step S1, tadalafil is preliminarily mixed with the oil phase solvent ethanol monooleate polyethylene glycol glyceride, and the co-surfactant polyglycerol ester is added and stirred for 30 to 60 seconds. Finally, a non-ionic surfactant is added and heated in a 60° C. water bath, and magnetically stirred for 20 minutes.

[0019] Beneficial effects of the present invention:

[0020] (1) The tadalafil tablets prepared by the present invention have good uniformity, high solubility and few impurities;

[0021] (2) The present invention combines a solid self-emulsifying drug delivery system with powder direct compression technology. The preparation method is relatively simpler and has low requirements on equipment. Compared with preparation methods such as drug micronization and wet granulation tableting, it can save production costs. Implementation Method

[0022] To make the objectives, technical solutions, and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with specific embodiments. It should be understood that the specific embodiments described herein are only intended to explain the present invention and do not limit the scope of protection of the present invention.

[0023] Examples 1 to 6 are used to prepare a tadalafil liquid self-emulsifying drug delivery system (Ta-SEDDS).

[0024] Preparation of Ta-SEDDS: A certain amount of tadalafil, oil phase solvent, nonionic surfactant, and co-surfactant were weighed separately, heated in a 60°C water bath, and magnetically stirred for 20 minutes to mix evenly to obtain Ta-SEDDS. The specific prescription ratio is shown in Table 1 below.

[0025] Table 1 Ta-SEDDS formulation composition of Examples 1 to 6 (g)

[0026] Example API Oil phase solvent nonionic surfactants Cosurfactant Example 1 Tadalafil 15 Ethyl monooleate macrogol glyceride 40 Castor Oil Polyoxyethylene Ether 40 Polyglycerol ester 5 Example 2 Tadalafil 15 Ethyl oleate 40 Castor oil polyoxyethylene ether 40g Polyglycerol ester 5 Example 3 Tadalafil 25 Ethyl monooleate macrogol glyceride 40 Polysorbate 80 30 Polyglycerol ester 5 Example 4 Tadalafil 20 Ethyl oleate macrogol glyceride 45 Castor Oil Polyoxyethylene Ether 30 Polyethylene glycol 5 Example 5 Tadalafil 15 Ethyl monooleate macrogol glyceride 40 Polysorbate 80 32 Polyethylene glycol 10 Example 6 Tadalafil 20 Ethyl monooleate macrogol glyceride 40 Castor Oil Polyoxyethylene Ether 15 Polysorbate 80 15 Polyglycerol ester 10

[0027] Examples 7 to 12 are used to prepare liquid-solid powders containing Ta-SEDDS and a solid adsorbent.

[0028] The specific method is to take Ta-SEDDS prepared in Examples 1 to 6 respectively, add a certain amount of solid adsorbent thereto (proportion see Table 2), mix and grind and stir evenly, then spread the formed liquid-solid powder into a uniform layer and place it at room temperature for 12 hours.

[0029] Table 2 Composition of formulas of Examples 7 to 12 (g)

[0030] Example Ta-SEDDS MCM-41 PEG4000 Mannitol Example 7 50 100 / / Example 8 50 / 50 / Example 9 50 / 75 / Example 10 50 / / 50 Example 11 50 / / 100 Example 12 50 60 / /

[0031] Examples 13 to 18 are used to prepare tadalafil tablets.

[0032] The specific method is as follows: take the liquid-solid powders prepared in Examples 7 to 12 respectively, add tablet excipients thereto and mix (proportions are shown in Table 3), and use a No. 10 punch to directly compress the powder to obtain 20 mg tadalafil tablets.

[0033] Table 3 Tadalafil Tablets Prescription Composition (g)

[0034] Example Liquid-solid powder Adhesive HPC Disintegrant CMS-Na Filler lactose Filler (MCC) Flow aid micro powder silica gel Lubricant magnesium stearate Example 13 68.75 2 5 10.25 13 0.5 0.5 Example 14 41.25 2 5 27.95 23 0.3 0.5 Example 15 27.5 3 15 21.9 32 0.2 0.4 Example 16 27.5 6 6 15.5 44 0.5 0.5 Example 17 13.75 5 15 30 37.25 0.5 0.5 Example 18 55 4 9.5 15 16 0.2 0.3

[0035] Comparative Examples 1 to 6 were used to prepare tadalafil liquid self-emulsifying drug delivery systems (Ta-SEDDS); the preparation methods were the same as those of Examples 1 to 6, except for the types and proportions of the selected oil phase solvents, surfactants, or co-surfactants. The specific formulations are detailed in Table 4 below.

[0036] Table 4 Ta-SEDDS formulation composition of Comparative Examples 1 to 6 (g)

[0037] Comparative Example API Oil phase solvent surfactants Cosurfactant Comparative Example 1 Tadalafil 20 Oleic acid 40 Castor Oil Polyoxyethylene Ether 15 Polysorbate 80 15 Polyglycerol ester 10 Comparative Example 2 Tadalafil 20 Ethyl monooleate macrogol glyceride 40 Liquid lecithin 30mg Polyglycerol ester 10 Comparative Example 3 Tadalafil 20 Ethyl monooleate macrogol glyceride 40 Castor Oil Polyoxyethylene Ether 15 Polysorbate 80 15 Propylene glycol 10 Comparative Example 4 Tadalafil 15 Ethyl monooleate macrogol glyceride 60 Castor Oil Polyoxyethylene Ether 10 Polysorbate 80 10 Polyglycerol ester 5 Comparative Example 5 Tadalafil 15 Ethyl oleate macrogol glyceride 30 Castor Oil Polyoxyethylene Ether 25 Polysorbate 80 25 Polyglycerol ester 5 Comparative Example 6 Tadalafil 30 Ethyl monooleate macrogol glyceride 40 Castor Oil Polyoxyethylene Ether 12 Polysorbate 80 12 Polyglycerol ester 6

[0038] Comparative Examples 7-12 were used to prepare liquid-solid powders containing Ta-SEDDS and a solid adsorbent. The Ta-SEDDS prepared in Example 6 was prepared using the same methods as in Examples 7-12, except that the ratios and / or proportions of Ta-SEDDS and the solid adsorbent were varied. Specific formulation ratios are shown in Table 5.

[0039] Table 5 Liquid-solid powder formulation composition of Comparative Examples 7 to 12 (g)

[0040] Comparative Example Ta-SEDDS Anhydrous calcium hydrogen phosphate MCM-50 MCM-41 Comparative Example 7 50 50 / / Comparative Example 8 50 100 / / Comparative Example 9 50 / 50 / Comparative Example 10 50 / 100 / Comparative Example 11 100 / / 50 Comparative Example 12 60 / / 50

[0041] Comparative Examples 13 to 18 were used to prepare tadalafil tablets.

[0042] Comparative Examples 13 to 15: The liquid-solid powders prepared in Comparative Examples 7 to 9 were respectively taken, and tablet excipients were added according to the proportions and methods of Examples 13, 14, and 15, respectively. The powders were directly compressed to prepare 20 mg tadalafil tablets.

[0043] Comparative Examples 16-18: The liquid-solid powders obtained in Examples 10-12 were respectively taken, tablet excipients were added according to the ratio and method in Table 6 below, and the powders were directly compressed to prepare tadalafil tablets.

[0044] The specific ratios are shown in Table 6.

[0045] Table 6 Composition of Tadalafil Formulas in Comparative Examples 13-18 (g)

[0046] Comparative Example Liquid-solid powder MCC disintegrants lactose Micro-powder silica gel magnesium stearate Comparative Example 13 68.75 15 5 10.25 0.5 0.5 Comparative Example 14 41.25 25 5 27.95 0.3 0.5 Comparative Example 15 27.5 35 15 21.9 0.2 0.4 Comparative Example 16 55 20 Dry starch 9.5 15 0.2 0.3 Comparative Example 17 55 20 Low-substituted hydroxypropyl cellulose 9.5 15 0.2 0.3 Comparative Example 18 55 20 Cross-linked polyvinylpyrrolidone 9.5 15 0.2 0.3

[0047] Example 19

[0048] Example 19: Comparative Study of the Quality of Ta-SEDDS Prepared in Example and Comparative Example

[0049] 500 μL of Ta-SEDDS prepared in Examples 1-6 and Comparative Examples 1-6 was diluted into 50 mL of distilled water and magnetically stirred at 37°C to assess self-emulsification. After complete self-emulsification, the resulting emulsion was observed for clarity, color, and the presence of oil droplets to determine whether the formulation could form an emulsion. Generally, self-emulsification rates are classified into the following five grades, with grades A and B meeting experimental requirements. Evaluation criteria are shown in Table 7; test results are shown in Table 8.

[0050] The experimental results show that Examples 1 to 6 have short emulsification times and good emulsification properties, with Example 6 being the best; while the comparative examples do not meet the requirements.

[0051] Table 7 Self-emulsification rate grades

[0052] Self-emulsification time color Self-emulsifying grades Rapid emulsification (<1min) clarify A Rapid emulsification Slightly unclear B Emulsion formed within 2 minutes Brightening, milky C Emulsification is slow (>2min) Dark, off-white D Difficulty in emulsification There are always oil droplets E

[0053] Table 8 Self-emulsification rate grades

[0054] Example color Self-emulsification time (s) Self-emulsifying grades Example 1 clarify 25 A Example 2 clarify 23 A Example 3 clarify 20 A Example 4 clarify 35 B Example 5 clarify 30 B Example 6 clarify 12 A Comparative Example 1 clarify 160 D Comparative Example 2 clarify 150 D Comparative Example 3 Slightly unclear 69 C Comparative Example 4 milky 84 C Comparative Example 5 milky 108 C Comparative Example 6 Off-white 113 C Example

[0055] Example 20 is used to investigate the tableting process of Examples 13 to 18 and Comparative Examples 13 to 15

[0056] Observation of the tableting process of Examples 13 to 18 shows that the tablets are discharged smoothly, without sticking, and the tablet surfaces are smooth and complete.

[0057] From the tableting process of Comparative Examples 13 to 15, it can be seen that if anhydrous calcium hydrogen phosphate is used as the solid adsorbent, or the ratio of Ta-SEDDS to the solid adsorbent is greater than 1:1, the liquid-solid powder is very sticky, sticks to the punches during tableting, and the tablets pressed out are not smooth, which does not meet the basic requirements of tablets. Example

[0058] Example 21 is used to examine the quality of the tablets prepared in Examples 13 to 18 and Comparative Examples 16 to 18

[0059] 1. Investigation of mixing uniformity, angle of repose, friability and dissolution

[0060] The performance of the tablets prepared in Examples 13 to 18 and Comparative Examples 16 to 18 was evaluated, including the mixing uniformity: after mixing, samples were taken from different parts of the mixing container (5 parts of the upper layer, 5 parts of the middle layer, and 1 part of the lower layer) to test the mixing uniformity. The RSD should be less than 5%.

[0061] Friability test method: According to the "0923 Tablet Friability Test Method" in the fourth part of the 2020 edition of the "Chinese Pharmacopoeia", take the tablets so that the total weight is about 6.5g, blow off the powder from the tablets with a hair dryer, accurately weigh them, place them in a cylinder, and rotate them 100 times. Take them out, remove the powder in the same way, and accurately weigh them. The weight loss should not exceed 1%, and no broken, cracked, or crushed tablets should be detected. This test is generally performed only once. If the weight loss exceeds 1%, it should be repeated twice. The average weight loss of the three times should not exceed 1%, and no broken, cracked, or crushed tablets should be detected.

[0062] Dissolution determination method: Take this product and follow the second method of "0931 Dissolution and Release Determination Method" in the general rules of Part IV of the 2020 edition of the "Chinese Pharmacopoeia", use 900mL of 0.1M hydrochloric acid buffer as the dissolution medium, rotate at 50rpm, operate according to the law, take samples after 30 minutes to determine the dissolution rate, the standard requirement is: the dissolution amount in 30 minutes is not less than 85% of the labeled amount.

[0063] Table 9 Performance evaluation of tablets in Examples 19 to 24

[0064] Example Mixing uniformity RSD Angle of repose friability Dissolution Example 13 1.3% 36 0.21 99.8% Example 14 1.1% 34 0.25 99.2% Example 15 1.2% 38 0.24 98.7% Example 16 1.2% 37 0.25 99.0% Example 17 1.0% 33 0.23 99.4% Example 18 1.1% 35 0.20 99.9% Comparative Example 16 1.0% 30 0.20 83.5% Comparative Example 17 1.1% 34 0.18 84.5% Comparative Example 18 1.2% 35 0.23 83.3%

[0065] As shown in the table above, the tablets prepared in Examples 13-18 met all quality standards, exhibiting good uniformity and high dissolution. Comparative examples using dry starch, crospovidone, or low-substituted hydroxypropyl cellulose as disintegrants failed to meet dissolution requirements. The disintegrant CMS-Na significantly improved dissolution.

[0066] II. Investigation of relevant substances

[0067] Appropriate amounts of the tadalafil tablets prepared in Examples 13-18, as well as a commercially available tadalafil tablet (Cialis 20 mg) sample as a control, were weighed and dissolved and diluted with 0.5% sodium lauryl sulfate solution. The filtrate was used as the test solution for related substance determination. The results are shown in Table 10.

[0068] Table 10 Investigation results of related substances in Examples 13 to 18

[0069]

[0070] As can be seen from the above table, compared with commercially available products, the tadalafil tablets prepared by the method of the present invention have fewer impurities, slower impurity growth, and higher stability.

[0071] Obviously, the above embodiments of the present invention are merely examples for the purpose of clearly illustrating the technical solutions of the present invention, and are not intended to limit the specific implementation methods of the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the claims of the present invention shall be included within the scope of protection of the claims of the present invention.

Claims

1. A tadalafil tablet, characterized in that: It includes a tadalafil liquid self-emulsifying drug delivery system, a solid adsorbent, and tablet excipients; The content ratio of the tadalafil liquid self-emulsifying drug delivery system to the solid adsorbent is 1:1-2; The tadalafil liquid self-emulsifying drug delivery system comprises a tadalafil API, an oil phase solvent, a nonionic surfactant, and a co-surfactant; in terms of the mass percentage of the tadalafil liquid self-emulsifying drug delivery system, the tadalafil content is 15-25%; the oil phase solvent content is 40-50%; the nonionic surfactant content is 30-40%; and the co-surfactant content is 5-15%. The oil phase solvent includes one or more of ethanol monooleate polyethylene glycol glyceride or ethyl oleate; the nonionic surfactant includes one or more of castor oil polyoxyethylene ether or polysorbate; the cosurfactant includes one or more of polyglycerol ester or polyethylene glycol; The solid adsorbent is one or more of mesoporous silica (MCM-41), PEG4000 or mannitol; The tablet excipient content is 30-90% by mass of the tablet. The tablet excipient is composed of the following components by mass: 2-20% binder, 5-30% disintegrant, 50-75% filler, 0.2-0.5% glidant, and 0.3-0.9% lubricant. The binder is hydroxypropyl cellulose (HPC), the disintegrant is sodium carboxymethyl starch, the filler is lactose and microcrystalline cellulose, the glidant is micropowdered silica gel, and the lubricant is magnesium stearate.

2. The tadalafil tablet according to claim 1, wherein In the tadalafil liquid self-emulsifying drug delivery system, the tadalafil content is 20%; the oil phase solvent content is 40%; the nonionic surfactant content is 30%; and the co-surfactant content is 10%, calculated as a percentage by mass of the tadalafil liquid self-emulsifying drug delivery system.

3. The tadalafil tablet according to claim 1 or 2, characterized in that The oil phase solvent is ethanol monooleate polyethylene glycol glyceride; the nonionic surfactant includes castor oil polyoxyethylene ether and polysorbate 80, which are mixed in a ratio of 1:1; and the cosurfactant is polyglycerol ester.

4. The tadalafil tablet according to claim 3, characterized in that The content ratio of the tadalafil liquid self-emulsifying drug delivery system to the solid adsorbent is 1:1.2, and the solid adsorbent is mesoporous silica (MCM-41).

5. The tadalafil tablet according to claim 4, characterized in that: Calculated by mass percentage of the tablet, the tadalafil tablets are composed of the following components and proportions: 5% tadalafil, 10% ethanol-oleate macrogol glyceride, 3.75% castor oil polyoxyethylene ether, 3.75% polysorbate 80, 2.5% polyglycerol ester, 30% MCM-41, 4% hydroxypropyl cellulose (HPC), 9.5% sodium carboxymethyl starch (CMS-NA), 15% lactose, 16% microcrystalline cellulose (MCC), 0.2% micropowdered silica gel, and 0.3% magnesium stearate.

6. The method for preparing a tadalafil tablet according to any one of claims 1, 2, 4 and 5, wherein: The preparation method comprises the following steps: Preparation of S1 liquid self-emulsifying drug delivery system: Weigh a certain amount of tadalafil, oil phase solvent, nonionic surfactant, and co-surfactant respectively, heat in a water bath at 55-65°C, and mix by magnetic stirring for 10-30 minutes to obtain a liquid self-emulsifying drug delivery system, which is then stored at room temperature for later use; S2 Liquid-solid powder preparation: Add a certain amount of solid adsorbent to the above-mentioned liquid self-emulsifying drug delivery system, mix and grind and stir evenly so that the drug is evenly distributed in the powder; then spread the formed liquid-solid powder into a uniform layer and place it at room temperature for 12 hours; S3 tablet forming: the liquid-solid powder prepared in step S2 is added to pharmaceutically acceptable tablet excipients and mixed, and the powder is directly compressed using a No. 10 punch to form tadalafil tablets with a specification of 5-20 mg.

7. The preparation method according to claim 6, characterized in that The method further includes the step of pre-preparing a non-ionic surfactant, wherein the non-ionic surfactant comprises castor oil polyoxyethylene ether and polysorbate 80, which are mixed in a ratio of 1:1 in a water bath at 60° C. and stirred for 30 to 60 seconds.

8. The preparation method according to claim 7, characterized in that In the step S1, tadalafil is preliminarily mixed with the oil phase solvent, and then a co-surfactant is added and stirred for 30-60 seconds. Finally, a non-ionic surfactant is added and heated in a 60° C. water bath, followed by magnetic stirring for 20 minutes.

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