Zonisamide orally disintegrating tablets and preparation method thereof
A technology of orally disintegrating tablets and zonisamide, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as unsatisfactory taste, rough foreign matter, etc. Achieve the effects of reducing market risk, no gritty feeling, and solving poor taste
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Embodiment 1
[0028] prescription:
[0029]
[0030] Preparation Process:
[0031] 1) Pass zonisamide through a 200-mesh sieve, and pass the rest of the excipients through a 100-mesh sieve for later use;
[0032] 2) Mix zonisamide, D-mannitol, 60% prescription amount of microcrystalline cellulose and corn starch evenly, and wet granulate with 70% ethanol solution;
[0033] 3) Air-dry the sample in step 2) at 60±5°C, and granulate (0.5mm);
[0034] 4) Dissolve ethyl cellulose and polyvinyl alcohol (partially saponified) in ethanol solution, and add micropowder silica gel while stirring to obtain a fully dispersed and uniform coating solution;
[0035] 5) Pour the granules from step 3) into the coating machine, spray into the coating solution from step 4), control the fluidized bed inlet air temperature to 65°C, bed temperature to 40°C, atomization pressure to 0.25MPa, and liquid spray flow rate 5ml / min, coating;
[0036] 6) Dry the coated granules in step 5), control the water content...
Embodiment 2
[0039] prescription:
[0040]
[0041] Preparation Process:
[0042] 1) Pass zonisamide through a 200-mesh sieve, and pass the rest of the excipients through a 100-mesh sieve for later use;
[0043] 2) Mix zonisamide, D-mannitol, 60% prescription amount of microcrystalline cellulose and corn starch evenly, and wet granulate with 70% ethanol solution;
[0044] 3) Air-dry the sample in step 2) at 60±5°C, and granulate (0.5mm);
[0045] 4) Dissolve ethyl cellulose and polyvinyl alcohol (partially saponified) in ethanol solution, and add micropowder silica gel while stirring to obtain a fully dispersed and uniform coating solution;
[0046] 5) Pour the granules from step 3) into the coating machine, spray into the coating solution from step 4), control the fluidized bed inlet air temperature to 65°C, bed temperature to 40°C, atomization pressure to 0.25MPa, and liquid spray flow rate 5ml / min, coating;
[0047] 6) Dry the coated granules in step 5), control the water content...
Embodiment 3
[0049] Example 3 Quality Evaluation
[0050] 1. Character inspection
[0051] Table 1 The results of character inspection
[0052]
[0053] It can be seen that the present invention meets the clinical pharmaceutical requirements of orally disintegrating tablets.
[0054] 2. Dissolution test
[0055] 2.1 Dissolution conditions: 900ml solution; paddle method; 50 rpm; temperature: 37±0.5℃
[0056] 2.2 Results: See Table 2
[0057] Table 2 Dissolution test results
[0058]
[0059] It can be seen that the present invention has specific and significant advantages.
[0060] 3. Accelerated test investigation
[0061] The sample of Example 2 of the present invention, according to the commercially available packaging, was placed at 40°C ± 2°C, RH75% ± 5% for 6 months, during which samples were taken in the first, second, third, and sixth months respectively, according to the stability Check the item detection and compare it with the 0-day data. The results are shown in Tab...
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