Orally disintegrating Nifedipine prepn and its recipe
A technology of dipine prescription and nifedipine, applied in the field of pharmaceutical preparations and orally disintegrating tablet dosage forms
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Embodiment 1
[0021] Prescription 1
[0022] Nifedipine (NFDP) 3.1%
[0023] Polyethylene glycol 6000 (PEG6000) 6.2%
[0024] Starch 62.1%
[0025] Dextrin 15.52%
[0026] Low-substituted hydroxypropylmethylcellulose (L-HPC) 8.69%
[0027] Mannitol 3.1%
[0028] Talc 1.24%
[0029] Preparation: Weigh each component. First heat and melt PEG6000, add NFDP powder that has been crushed through an 80-mesh sieve in advance, stir and mix, then quench the melt at low temperature to solidify, crush and sieve. Add starch, dextrin, L-HPC, mannitol, wet granulate, add talcum powder to compress.
[0030] The disintegration time limit is 0.5h, and the dissolution rate of 1% sodium dodecylsulfonate solution at 37°C in 30 minutes is 38.7%.
Embodiment 2
[0032] Prescription 2
[0033] Nifedipine (NFDP) 3.97%
[0034] Polyethylene glycol 6000 (PEG6000) 9.93%
[0035] Polyethylene glycol 4000 (PEG4000) 1.98%
[0036] Microcrystalline Cellulose (MCC) 63.49%
[0037] Low-substituted hydroxypropylmethylcellulose (L-HPC) 15.87%
[0038] Mannitol 3.97%
[0039] Magnesium Stearate 0.79%
[0040] Preparation: Weigh each component. First heat and melt PEG6000 and PEG4000, add NFDP powder that has been crushed through an 80-mesh sieve, stir and mix well, then quench and solidify the melt at low temperature, crush and sieve, add MCC, L-HPC, and mannitol for wet granulation, add Lubricant magnesium stearate for tableting.
[0041] The disintegration time limit is greater than 2min, and the dissolution rate of 1% sodium dodecylsulfonate solution at 37°C in 30min is 58.47%.
Embodiment 3
[0043] Prescription 3
[0044] Nifedipine (NFDP) 3.74%
[0045] Polyethylene glycol 6000 (PEG6000) 7.49%
[0046] Microcrystalline Cellulose (MCC) 59.93%
[0047] Low-substituted hydroxypropylmethylcellulose (L-HPC) 14.98%
[0048] Cross-linked polyvinylpyrrolidone (PPVP) 9.36%
[0049] Mannitol 3.75%
[0050] Magnesium Stearate 0.75%
[0051] Preparation: Weigh each component. First heat and melt PEG6000, add NFDP powder that has been crushed through an 80-mesh sieve in advance, stir and mix, then quench and solidify the melt at low temperature, crush and sieve, add MCC, L-HPC, PPVP, mannitol for wet granulation, add Lubricant magnesium stearate for tableting.
[0052] The disintegration time limit is greater than 30s, and the dissolution rate of 1% sodium dodecylsulfonate solution at 37°C in 30 minutes is 80.41%.
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