Colon-released preparation of Melocicon and beta-cyclodextrin or its derivative composition
A technology for meloxicam and colon localization, which is applied to the colon localized release preparations of meloxicam and β-cyclodextrin or its derivatives, and the field of meloxicam colon localized release formulations, which can solve the problem of weakening individual differences. , drug efficacy uncertainty, difficulties and other issues, to achieve the effect of increasing solubility
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Embodiment 1
[0040] Example 1 Meloxicam Colon-targeted Release Capsules of 7.5mg Specification
[0041] Take 75g of β-cyclodextrin, add 780mL of water, heat to dissolve at 80°C, add 25g of meloxicam passed through a 100-mesh sieve, add about 2mL of ammonia water, make the pH value 7.5, stir for 4 hours, and dissolve. Freeze-dry to obtain a solidified product of the meloxicam / β-cyclodextrin complex. Get 100g pectin, 170g lactose as diluent, 30g microcrystalline cellulose as disintegrant, use 5% HPMC (6cps) as binding agent to granulate, cross 16 mesh sieves, dry at 60°C for 2 hours, pass 20 mesh Sieve the granules, add 1% magnesium stearate and mix. Select No. 3 B-type enteric-coated capsules (colon-positioned release capsules) for filling. A new formulation of meloxicam colon-targeted release capsules with a specification of 7.5 mg was obtained.
Embodiment 2
[0042] Example 2 7.5 mg of meloxicam colon-targeted release matrix tablet
[0043] Take 75g of β-cyclodextrin, add 780mL of water, heat to dissolve at 80°C, add 25g of meloxicam passed through a 100-mesh sieve, add about 2mL of ammonia water, make the pH value 7.5, stir for 4 hours, and dissolve. Freeze-dry to obtain a solidified product of the meloxicam / β-cyclodextrin complex. Get 100g pectin, 170g lactose as diluent, 30g microcrystalline cellulose as disintegrant, use 5% HPMC (6cps) as binding agent to granulate, cross 16 mesh sieves, dry at 60°C for 2 hours, pass 20 mesh Sieve the granules, add 1% magnesium stearate and mix. Select a concave die with a diameter of 7mm, adjust the pressure to 5-7kg, and press the tablet. A new formulation of meloxicam colon-targeted release matrix tablet with a specification of 7.5 mg was obtained.
Embodiment 3
[0044] Example 3 Preparation of 10 mg meloxicam colon-targeted pellets
[0045] Take 75g of β-cyclodextrin, add 780mL of water, heat to dissolve at 80°C, add 25g of meloxicam passed through a 100-mesh sieve, add 2mL of ammonia water, make the pH value 7.5, stir for 4 hours, and dissolve. Add 5g of hydroxypropylmethylcellulose (12cps) as a binder, stir and dissolve at 40°C, add 5g of talcum powder as an anti-sticking agent, stir to form a uniform suspension, and set aside. Take 500 g of blank sugar pills with a diameter of 810 μm, place them in a fluidized bed (Glatt GPCG1) bottom spray container, select a nozzle with a diameter of 1.0 mm, turn on the fluidization switch, adjust the fluidization state, and preheat the material to about 30 ° C; heat Apply the drug coating solution to 30°C. Set the parameters of the fluidized bed as air inlet temperature 45°C, air inlet valve 50%, atomization pressure 1.5bar, spray rate 5ml / min, the inlet air temperature after the state is stabl...
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