Riociguat oral fast-dissolving film and preparation method thereof
An oral instant film, riociguat technology, which is applied in pharmaceutical formulations, medical preparations without active ingredients, medical preparations containing active ingredients, etc., can solve the complex preparation process, bitter taste, low solubility of riociguat problem, to achieve the effect of high bioavailability, rapid onset of action, and improved taste
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Embodiment 1
[0033]
[0034]
[0035] (1) Take the riociguat bulk drug of the prescribed amount, and use a jet mill to pulverize until the D90 is within the range of 5-15 μm;
[0036] (2) Dissolving the polacrilin sodium and the pulverized riociguat bulk drug in an appropriate amount of solvent, and stirring for 30 minutes;
[0037] (3) Then add low-substituted hydroxypropyl cellulose, aspartame, strawberry flavor, natural carotene, triethyl citrate, chlorobutanol, use a homogenizer at a speed of 1500rpm, stir evenly, and vacuum degass ;
[0038] (4) Apply with a film coating machine, dry in a horizontal hot air circulation oven for 2 hours, and put it in the drying room to cool to room temperature;
[0039] (5) Laser cutting machine cutting, inner packaging, inspection, and outer packaging after passing the inspection.
Embodiment 2
[0041] name % by weight Rio Ciguat 2.5 Low-substituted hydroxypropyl cellulose 80 Polacrilin Potassium 15.44 Cyclamate 0.01 Tween 60 2 aspartame 0.01 Banana Spice 0.02 grape purple pigment 0.01 sodium benzoate 0.01 Ethanol solution (ethanol evaporates when dry) /
[0042] (1) Take the riociguat bulk drug of the prescribed amount, and use a jet mill to pulverize until the D90 is within the range of 5-15 μm;
[0043] (2) Dissolving the polacrilin potassium and the pulverized Riociguat bulk drug in an appropriate amount of solvent, and stirring for 30 min;
[0044] (3) Then add low-substituted hydroxypropyl cellulose, aspartame, banana flavor, grape violet, Tween 60, and sodium benzoate, use a homogenizer at a speed of 1500 rpm, stir evenly, and vacuum degas;
[0045] (4) Apply with a film coating machine, dry in a horizontal hot air circulation oven for 2 hours, and put it in the drying room to cool to ro...
Embodiment 3
[0048] name % by weight Rio Ciguat 2.5 Low-substituted hydroxypropyl cellulose 80 Polacrilin sodium 15.44 Cyclamate 0.01 triethyl citrate 2 aspartame 0.01 orange spice 0.02 Gardenia yellow pigment 0.01 sodium benzoate 0.01 Ethanol solution (ethanol evaporates when dry) /
[0049] (1) Take the riociguat bulk drug of the prescribed amount, and use a jet mill to pulverize until the D90 is within the range of 5-15 μm;
[0050] (2) Dissolving the polacrilin potassium and the pulverized Riociguat bulk drug in an appropriate amount of solvent, and stirring for 30 min;
[0051] (3) Then add low-substituted hydroxypropyl cellulose, aspartame, banana flavor, grape violet, Tween 60, and sodium benzoate, use a homogenizer at a speed of 1500 rpm, stir evenly, and vacuum degas;
[0052] (4) Apply with a film coating machine, dry in a horizontal hot air circulation oven for 2 hours, and put it in the drying room to co...
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