Method for preparing S-Oxiracetam orally disintegrating tablets from pressed powder pellets
An oral disintegrating tableting and tableting technology, which is used in pharmaceutical formulations, pill delivery, cardiovascular system diseases, etc., can solve the problems of difficulty in obtaining uniformly mixed granules, increase the difficulty of granulation, and be unfavorable for preparation production, and achieve guaranteed production. The effect of compliance, low cost and short production cycle
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Embodiment 1
[0044] (1), preparation of solid dispersion
[0045] 1 part of levoxiracetam and 1 to 8 parts of poloxamer 188 are uniformly dissolved in 20 to 50 parts of absolute ethanol, stirred for 5 to 25 minutes, and the solvent is recovered by a rotary evaporator until no more liquid drips. Dry naturally, crush, and pass through a 100-mesh sieve to obtain a solid dispersion.
[0046] (2), preparation of orally disintegrating tablet
[0047] The orally disintegrating tablet contains 0.7-15% levoxiracetam solid dispersion, 58-72% filler (mixture of microcrystalline cellulose and mannitol, wherein the weight ratio of microcrystalline cellulose: mannitol=1~3: 1), 5-25% disintegrant (a mixture of low-substituted hydroxypropyl cellulose and cross-linked carmellose sodium, wherein the weight ratio of low-substituted hydroxypropyl cellulose: cross-linked carmellose sodium 2-5:1), 2-6% lubricant (micronized silica gel), 0.1-1% flavoring agent (sucralose or aspartame);
[0048] The specific p...
Embodiment 2
[0051] (1) Preparation of solid dispersion:
[0052] Dissolve 10g of levoxiracetam and 50g of poloxamer 188 in 350mL of absolute ethanol evenly, stir for 20-22min, recover the solvent with a rotary evaporator until there is no more liquid dripping, dry naturally, and pulverize. Pass through a 100-mesh sieve to obtain a solid dispersion of levoxiracetam.
[0053] (2) Preparation of orally disintegrating tablets:
[0054] The levoxiracetam solid dispersion (8g) that step (1) sieves obtains is added filler (the mixture of microcrystalline cellulose 45g and mannitol 18g), disintegrant (low-substituted hydroxypropyl cellulose 18g and Mixture of croscarmellose sodium 7g), flavoring agent (aspartame 1g), lubricant (micropowder silica gel 3g) mix uniformly, put into rotary tabletting machine and compress into tablets, wherein the turntable speed is 28r / min, the filling pressure is 40N, and the filling depth is 10mm.
Embodiment 3
[0056] (1) Preparation of solid dispersion:
[0057] Dissolve 5g of levoxiracetam and 40g of poloxamer 188 in 250mL of absolute ethanol evenly, stir for 20-22min, recover the solvent with a rotary evaporator until there is no more liquid dripping, dry naturally, and pulverize. Pass through a 100-mesh sieve to obtain a solid dispersion of levoxiracetam.
[0058] (2) Preparation of orally disintegrating tablets:
[0059] The levoxiracetam solid dispersion (5g) obtained by sieving step (1) is added to a filler (a mixture of microcrystalline cellulose 35g and mannitol 32g), a disintegrant (20g of low-substituted hydroxypropyl cellulose and The mixture of croscarmellose sodium 5g), flavoring agent (sucralose 0.5g), lubricant (micropowder silica gel 2.5g) are mixed evenly, put into the rotary tabletting machine and press into tablets, wherein the rotary table speed 30r / min, the filling pressure is 30N, and the filling depth is 16mm.
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