Pregabalin composition suitable for powder tabletting and application thereof
A technology of pregabalin and composition, applied in the field of medicine, can solve the problems of affecting the disintegration time limit of the product, increase the cost of the product, etc., and achieve the effects of cool and slightly sweet taste, improved material compressibility, and soft and waxy taste.
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Embodiment 1
[0053] Product 1 Prescription Form:
[0054]
[0055] Product 2 Prescription Form:
[0056]
[0057]
[0058] Product 1 preparation process:
[0059] ① Pregabalin (D90 is 900 μm, crystal habit is long needle-shaped and square) is sized by a door-type granulator with a 0.8 mm sieve, and the granulation speed is 700 rpm. After sizing, the D90 of pregabalin is 500 μm , The crystal habit is square;
[0060] ②According to the dosage in the prescription table of product 1, mix microcrystalline cellulose, granulated pregabalin, mannitol, sucralose, sodium saccharin, crospovidone SH-SL10, and mint flavor in a square cone mixing bucket Mixing, mixing speed 10rpm, mixing time 20min;
[0061] ③ Pass the mixed granules obtained in the previous step through a 20-mesh vibrating sieve, and then add magnesium stearate to the granules after sieving and mix them with a square cone mixing bucket, the mixing speed is 10 rpm, and the mixing time is 20 minutes;
[0062] ④ Use the mixed...
Embodiment 2
[0094] Product 3 Prescription Form:
[0095]
[0096] Product 3 preparation process:
[0097] ① Pregabalin (D90 is 900 μm, crystal habit is long needle-shaped and square) is sized by a door-type granulator with a 0.8mm sieve, and the granulation speed is reduced from 700rpm to 300rpm, which is the lowest speed of the equipment. The D90 of pregabalin is 550 μm, and the crystal habit is square;
[0098] ②According to the dosage in the prescription table of product 3, mix microcrystalline cellulose, granulated pregabalin, mannitol, sucralose, sodium saccharin, crospovidone SH-SL10, and mint essence in a square cone mixing bucket. Mixing, mixing speed 10rpm, mixing time 20min;
[0099] ③ Pass the mixed granules obtained in the previous step through a 20-mesh vibrating sieve, and then add magnesium stearate to the granules after sieving and mix them with a square cone mixing bucket, the mixing speed is 10 rpm, and the mixing time is 20 minutes;
[0100] ④ Use the mixed granul...
Embodiment 3
[0107] Product 4 Prescription Form:
[0108]
[0109]
[0110] Product 4 preparation process:
[0111] ① Pregabalin (D90 is 900 μm, crystal habit is long needle-shaped and square) is sized by a door-type granulator, the 0.8mm sieve is changed to a 0.9mm sieve, and the sizing speed is 700rpm. After sizing, The D90 of pregabalin is 700 μm, and the crystal habit is long needle-shaped and square.
[0112] ②Mix the microcrystalline cellulose, granulated pregabalin, mannitol, sucralose, sodium saccharin, crospovidone SH-SL10, and mint essence in a square cone mixing barrel according to the dosage in the product 4 prescription table , mixing speed 10rpm, mixing time 20min;
[0113] ③ Pass the mixed granules obtained in the previous step through a 20-mesh vibrating sieve, and then add magnesium stearate to the granules after sieving and mix them with a square cone mixing bucket, the mixing speed is 10 rpm, and the mixing time is 20 minutes;
[0114] ④ Use the mixed granules o...
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