Novel triphenyl compound salt
A technology of phenyl and benzoate salts, which is applied in the field of new triphenyl compound salts, can solve problems such as difficulties in the uniformity of pharmaceutical compositions, and achieve the effect of reducing hygroscopicity
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[0098] Oral solid dosage forms are prepared as follows. After the excipients and binders, disintegrants, lubricants, colorants, taste-masking agents or flavoring agents, etc. are optionally added to the benzoate of Compound A or the sorbate of Compound A, the The resulting mixture is formulated into tablets, coated tablets, granules, powders, capsules and the like by known methods.
[0099] Examples of excipients include lactose, sucrose, D-mannitol, glucose, starch, calcium carbonate, kaolin, microcrystalline cellulose, and silicic anhydride. Examples of binders include water, ethanol, 1-propanol, 2-propanol, simple syrup, liquid glucose, liquid alpha-starch, liquid gelatin, D-mannitol, carboxymethylcellulose, hydroxypropylcellulose , hydroxypropyl starch, methyl cellulose, ethyl cellulose, shellac, calcium phosphate, polyvinylpyrrolidone, etc. Examples of disintegrants include dry starch, sodium alginate, powdered agar, sodium bicarbonate, calcium carbonate, sodium lauryl ...
Embodiment 1
[0208] Product Example 1: 4-[5-[(3S)-3-aminopyrrolidine-1-carbonyl]-2-[2-fluoro-4-(2-hydroxy-2-methyl-propyl)phenyl ]Phenyl]-2-Fluoro-benzonitrile (Compound A) Preparation
[0209] Compound A was prepared by the synthetic method of Example Compound 37 described in PCT Publication No. WO2017 / 090756.
Embodiment 2
[0210] Product Example 2: Synthesis of Benzoate Crystals of Compound A
[0211] 260 mg of benzoic acid was dissolved in 26 mL of methyl isobutyl ketone, and the mixture was added to 1000 mg of Compound A obtained according to the method of Product Example 1. The suspension was stirred at room temperature for about 16.5 hours, filtered, and the solid was collected and dried to give 845.2 mg of the purported crystals (yield: 67%).
[0212] The obtained crystals were subjected to powder X-ray diffraction, differential scanning calorimetry (DSC) measurement and moisture absorption / desorption tests.
[0213] figure 1 is the powder X-ray diffraction spectrum of the crystal of the benzoate of Compound A. figure 2 is the differential scanning calorimetry (DSC) curve of a crystal of Compound A's benzoate salt.
[0214] exist figure 1 , the crystal of the benzoate of Compound A has characteristic peaks at diffraction angles (2θ±0.2°) of 15.3°, 16.2°, 17.8°, 21.4° and 25.5° in the p...
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