Ebastine dispersible tablet and preparation method thereof
A technology of ebastine and ebastine fever, which is applied in the direction of medical preparations of non-active ingredients, pharmaceutical formulas, active ingredients of heterocyclic compounds, etc., to avoid excessive drug concentration, high bioavailability, and easy to take convenient effect
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[0021] The method for preparing ebastine dispersible tablets of the present invention is as follows: firstly, ebastine is hot-melt-dispersed in an adhesive solution at a temperature of 86-100°C in proportion, and the dispersion time is 5-20 Minutes; then mix the filler, disintegrant and the hot melt adhesive together and then granulate. After 30-45 mesh wet granulation, drying at 45-55℃ for 4-6 hours, 35-40 mesh granulation Add disintegrant, corrective agent, glidant and lubricant, and then press the tablet to prepare ebastine dispersible tablet.
[0022] 60-70% of the disintegrant is used in the preliminary granulation process, and the remaining 30-40% is used in the final mixing process after granulation.
[0023] A preferred technical solution of the present invention is: first disperse 10 parts of ebastine in 105 parts of adhesive solution at a temperature of 90-95°C by hot melt, and the dispersion time is 10-15 minutes; and then 148 fillers , 35 parts of 66.7% disintegrant an...
Example Embodiment
[0025] Example 1: Comparison of the influence of different hot melt temperatures on the dispersion of ebastine hot melt dispersion.
[0026] Weigh 5 parts by weight of hypromellose into 100 parts by weight of water, stir until it is clear and transparent, heat to different temperatures, weigh 10 parts by weight of ebastine and add it to it to melt and disperse, the dispersion time is 10 minutes.
[0027] Weigh 108 parts by weight of mannitol, 40 parts by weight of microcrystalline cellulose, 11 parts by weight of cross-linked polyvinylpyrrolidone, and 11 parts by weight of cross-linked sodium carboxymethyl cellulose, add hot melt adhesive to granulate, Wet sizing through 30 to 40 mesh, drying at 45°C to 55°C for 4-6 hours, adding 5 parts by weight of cross-linked polyvinylpyrrolidone, 5 parts by weight of croscarmellose sodium, 1 part by weight of stevioside, 2 parts by weight of finely powdered silica gel, and 2 parts by weight of magnesium stearate were mixed for 20 minutes, and...
Example Embodiment
[0031] Example 2: Disintegrant selection experiment.
[0032] 66.7% disintegrant was added during granulation (process A), the entire amount of disintegrant was added during granulation (process B), no disintegrant was added during granulation (process C), and the final tablet content was uniform. degree.
[0033] Table 2: Content uniformity of process Ebastine dispersible tablets with different disintegrants
[0034] Craft
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