Nifedipine double-layer osmotic pump medicinal composition and preparation technology thereof
An osmotic pump and composition technology, applied in the field of single-chamber double-layer osmotic pump controlled-release pharmaceutical composition and its preparation, can solve difficult-to-control controlled-release tablet batch-to-batch consistency, drug release time lag, tablet core Problems such as slow hydration rate
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Embodiment 1
[0043] (1) Drug-containing layer
[0044]
[0045]
[0046] Prepare soft materials with 10% PVPK30 ethanol solution
[0047] (2) booster layer
[0048] Polyoxyethylene (molecular weight 5 million) 60g
[0049] HPMC (K4M) 12.4g
[0051] Iron Oxide Red 1.72g
[0052] Prepare soft materials with 10% PVPK30 ethanol solution
[0053] (3) Prescription of coating solution
[0054] Cellulose acetate (398-10NF) 60g
[0055] PEG 4000 6g
[0056] DEP10%
[0057] Proper amount of acetone
[0058] Preparation:
[0059] 1. Preparation of drug-containing layer particles:
[0060]Grind nifedipine, polyoxyethylene (molecular weight: 200,000) and sodium lauryl sulfate into fine powder, pass through a 100-mesh sieve, mix well, make a soft material with 10% povidone ethanol solution, pass through a 40-mesh sieve Granules, dried at 45°C for 12 hours, added with 1% magnesium stearate and 0.5% silicon dioxide, and mixed evenly to obtain drug-containing ...
Embodiment 2
[0070] (1) Drug-containing layer
[0071]
[0072] Prepare soft materials with 10% PVPK30 ethanol solution
[0073] (2) booster layer
[0074] Polyoxyethylene (molecular weight 5 million) 60g
[0075] HPMC (K4M) 12.4g
[0077] Iron Oxide Red 1.72g
[0078] Prepare soft materials with 10% PVPK30 ethanol solution
[0079] (3) Prescription of coating solution
[0080] Cellulose acetate (398-10NF) 60g
[0081] PEG 4000 6g
[0082] DEP10%
[0083] Proper amount of acetone
[0084] Preparation:
[0085] 1. Preparation of drug-containing layer particles:
[0086] Grind nifedipine, polyoxyethylene (molecular weight: 300,000) and sodium lauryl sulfate into fine powder, pass through a 100-mesh sieve, mix well, make a soft material with 10% povidone ethanol solution, pass through a 40-mesh sieve Granules, dried at 45°C for 12 hours, added with 1% magnesium stearate and 0.5% silicon dioxide, and mixed evenly to obtain drug-containing layer granu...
Embodiment 3
[0096] (1) Drug-containing layer
[0097]
[0098] Prepare soft materials with 10% PVPK30 ethanol solution
[0099] (2) booster layer
[0100] Polyoxyethylene (molecular weight 5 million) 60g
[0101] HPMC (K4M) 12.4g
[0103] Iron Oxide Red 1.72g
[0104] Prepare soft materials with 10% PVPK30 ethanol solution
[0105] (3) Prescription of coating solution
[0106] Cellulose acetate (398-10NF) 60g
[0107] PEG 4000 6g
[0108] DEP10%
[0109] Proper amount of acetone
[0110] Preparation:
[0111] 1. Preparation of drug-containing layer particles:
[0112] Grind nifedipine, polyoxyethylene (molecular weight: 200,000) and poloxamer 188 into fine powder, pass through a 100-mesh sieve, mix well, make soft material with 10% povidone ethanol solution, pass through a 40-mesh sieve to granulate , dried at 45°C for 12 hours, added 1% magnesium stearate and 0.5% silicon dioxide, and mixed evenly to obtain drug-containing layer granules. The ...
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