Ambroxol dry powder for inhalation use with bronchial target
A technology of ambroxol and dry powder, applied in the field of Ming Dynasty, can solve the problems of inability to rapidly relieve the disease of the patient, inconvenient to use and transport, the pain of the patient, etc., and achieves good and fast effect, good targeting, and convenient use and carrying. Effect
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no. 1 approach
[0034] According to a first embodiment, the method provides a step in which the drug product of ambroxol and / or its hydrochloride is micronized by jet milling (jet milling), thereby obtaining the desired particle size. According to one embodiment, the process gas employed will have a pressure of about 7 bar. The powder thus prepared can be homogeneously mixed with excipients and / or pharmaceutically acceptable dispersants.
[0035] The powder thus obtained is preferably inserted as a single dose hermetically in blisters or capsules made of aluminum in the amounts indicated in the description.
[0036] In a preferred embodiment of the present invention, mannitol is used as an auxiliary material.
[0037] According to another embodiment, the method provides a step a) of mixing ambroxol and / or its hydrochloride with distilled water or distilled water < 20% ethanol.
[0038] The step b) of spray-drying the mixture prepared in step a) in order to obtain fine particles according to...
Embodiment 1
[0048] In this preparation method, a micronizer: DECMCOne model was used. Ambroxol hydrochloride drug was micronized by jet milling.
[0049] The jet mill uses "process gas" 7 bar 0.09Nm3 / min (3.18CFM), the ambient temperature in the white chamber is 20°C, and the temperature in the area dedicated to the micronization device is ≤12°C. Coarse particles are separated from fine particles by grinding and crushing under high pressure and centrifugal force generated by a turbine. Particles meeting the size requirements enter the cyclone separator where they are collected. It is preferred that at least 85% of the particles have a diameter of less than 5 μm, preferably between 3 and 5 μm. Regenerates and evenly distributes excipients and dispersants at a suction level of 50 to 100 μm for good sliding ability. During inhalation, the flow creates turbulence that disperses the particles to form micronized particles that can be inhaled to reach the bronchi. The weight percentage of ac...
Embodiment 2
[0052] In this preparation method, a mini spray dryer BUCHI B-290 was used. Spray dryer nozzle opening: 0.7mm, compressed gas flow: 5~8 bar, 200~800L / h, inlet temperature 115±2℃, liquid feeding speed: 1.8ml / min, atomizing air speed: 473 liters / hour, atomization pressure: 2 bar, air flow: 0.55m 3 / min, drying time ≤ 1.5 seconds. Dissolving ambroxol and / or its hydrochloride in distilled water with or without 20% ethanol, the spray drying method is used with the solution obtained by adjusting the nebulization air speed to control the size of nebulized small droplet particles To prepare particles of micronized powder with good shape. It is preferred that at least 85% of the particles have a diameter of less than 5 μm, preferably 3 to 5 μm, and 40% of the excipient particles mixed uniformly have a diameter of 15 to 100 μm for good sliding ability. During inhalation, the flow creates turbulence that disperses the particles to form micronized particles that can be inhaled to rea...
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Abstract
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