Tablet containing finenone and preparation method of tablet
A technology of tablets and tablet cores, applied in the field of tablets containing finerenone and its preparation, to achieve the effects of high stability, stable quality, and good process tolerance
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Embodiment 1-4
[0047] In the drug tablet core formulations of Examples 1-4, the particle size of the finerenone micropowder is different, which is used to investigate the influence of the particle size of the finerenone micropowder on the dissolution rate of the drug. The drug tablet core prescription of embodiment 1-4 is as shown in table 1.
[0048] The drug tablet core prescription of table 1 embodiment 1-4
[0049]
[0050] Prepare finerenone-containing tablets according to the above prescription, as follows:
[0051] (1) Finerenone is micronized to the corresponding particle size of each embodiment;
[0052] (2) Add finerenone, povidone K30, and sodium lauryl sulfate after micronization to 150 mg of purified water to prepare a granular solution;
[0053] (3) Put microcrystalline cellulose, pregelatinized starch, and crospovidone into a wet granulator, low-cut and low-stir (low speed 150r / min, shear 1500r / min) for 20min, mix well, add Granule solution, low shear and high stirring (...
Embodiment 5-8
[0063] In the drug tablet core prescription of embodiment 5-8, the type and consumption of filler and disintegrant are different, for investigating the influence of filler and disintegrant on drug disintegration time, the drug tablet core of embodiment 5-8 The prescription and drug disintegration time are shown in Table 3.
[0064] Tablets containing finerenone are prepared as follows:
[0065] (1) Micronize finerenone to a particle size of D50≤35μm, D90≤82μm;
[0066] (2) Add finerenone, povidone K30, and sodium lauryl sulfate after micronization to 200 mg of purified water to prepare a granular solution;
[0067] (3) Put microcrystalline cellulose, pregelatinized starch, and disintegrant (crospovidone or croscarmellose sodium) into the wet granulator, low-cut and low-stir (low speed 150r / min, shear 1500r / min) 20min, mix evenly, add granule solution, low shear and high stir (high speed 300r / min, shear 1500r / min) 10min, carry out granulation;
[0068] (4) the obtained gran...
Embodiment 9-12
[0075] In the drug tablet core prescription of embodiment 9-12, the type of solubilizing agent, dosage and adding method are different, and are used to investigate the influence of solubilizing agent on drug disintegration time, the drug tablet core prescription of embodiment 9-12, adding method of solubilizing agent and drug disintegration time are shown in Table 4.
[0076] Tablets containing finerenone are prepared as follows:
[0077] (1) Micronize finerenone to a particle size of D50≤35μm, D90≤82μm;
[0078] (2) Add finerenone, povidone K30, and solubilizer (sodium lauryl sulfate or poloxamer) after micronization into 170 mg of purified water to prepare a granular solution;
[0079] (3) Put microcrystalline cellulose, pregelatinized starch, crospovidone, and solubilizer (sodium lauryl sulfate) into a wet granulator, low-cut and low-stir (low speed 150r / min, shear Cut at 1500r / min) for 20min, mix evenly, add granule solution, low-cut and high-stir (high speed 300r / min, c...
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