Taste-masked drug granules and preparation method thereof

A technology of drugs and granules, applied in the field of pharmaceutical preparations, can solve the problems of difficulty in control, limited application, large amount of plasticizer, etc., and achieves the effects of short time consumption, rapid in vitro release, and simple operation.

Active Publication Date: 2021-01-26
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although dry powder coating is a green and environmentally friendly taste-masking technology, it also has certain disadvantages, such as: electrostatic dry powder coating requires special coating equipment (electrostatic spray gun and grounded coating pan), plasticizer dry powder coating The amount of plasticizer in the medium is large and difficult to control, these factors limit its application in production

Method used

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  • Taste-masked drug granules and preparation method thereof
  • Taste-masked drug granules and preparation method thereof

Examples

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preparation example Construction

[0031] Specifically, the preparation method of the taste-masked drug particles of the present invention comprises the following steps:

[0032] 1. Preparation of dry water: Add a certain amount of hydrophobic silicon dioxide to the container, add the inner core aqueous phase solution into the powder bed drop by drop, stir at low speed for 5-20 minutes, and then stir at high speed for 1-10 minutes. Wherein, the inner core water phase: hydrophobic silica = 9-17:1 (w / w), and the prepared dry water particle size is 20 μm-300 μm. The obtained dry water powder is passed through a 60-100 mesh sieve for later use.

[0033] 2. Preparation of drug granules: Weigh a certain amount of drug powder, add 0-2 times the mass of filler and mix evenly, add an appropriate amount of binder to prepare soft material granules, dry at 40-60°C and sieve to 100 mesh - 60 mesh particles.

[0034] 3. Isolation layer mixing powder coating: transfer the bitter drug granules to a mixer or coating pan, add th...

example 1

[0041] Example 1: Preparation of cetirizine hydrochloride taste-masking granules

[0042] 1. Preparation of dry water: add an appropriate amount of hydrophobic silica to the container, add 2.5wt.% sodium alginate aqueous solution dropwise into the powder bed, stir at a low speed of 1000 rpm for 10 min, then increase the speed to 1600 rpm for stirring Serve in 5 minutes. Among them, the inner core water phase: hydrophobic silica = 12: 1 (w / w), and the prepared dry water particle size is 20 μm - 300 μm. The obtained dry water powder is passed through a 60-mesh sieve for subsequent use.

[0043] 2. Preparation of drug granules: Weigh cetirizine hydrochloride powder, use 5wt.% PVP K30 aqueous solution as a binder, add an appropriate amount of binder to make soft materials, and use a 60-mesh sieve for granulation. The wet granules were dried in an oven at 60°C for 30 min and then taken out, and the drug granules with a particle size of 60-100 mesh were screened for use.

[0044]...

example 2

[0052] Example 2: Preparation of ibuprofen taste-masked granules

[0053] 1. Preparation of dry water: Add hydrophobic silicon dioxide to the container, add 5% calcium chloride aqueous solution dropwise into the powder bed, stir at 1300 rpm for 20 min at a low speed, then increase the speed to 10000 rpm and shear for 30 min. have to. Among them, the inner core water phase: hydrophobic silica = 12 : 1 (w / w), and the prepared dry water particle size is 20 μm ~ 300 μm. The obtained dry water powder is passed through a 60-mesh sieve for subsequent use.

[0054] 2. Preparation of drug granules: mix ibuprofen powder and lactose evenly at a mass ratio of 7:3 (w / w), use 5% HPC aqueous solution as a binder, and add an appropriate amount of binder to make a soft material, 60 mesh Sieves are used for granulation. The wet granules were dried in an oven at 60°C for 30 min and then taken out, and the drug granules with a particle size of 60-100 mesh were screened for use.

[0055] 3. Ta...

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Abstract

The invention discloses a powder mixing hot-melt coating technology for preparing bitter taste drug taste masking particles. According to a taste masking technology, the adsorption principle of micropowder on the surfaces of large particles is utilized, bitter taste drug particles are mixed with taste masking auxiliary powder, or dusty dry water is taken as a binder / wetting agent in a coating process for anterior adsorption, the taste masking auxiliary powder coats the surfaces of the drug particles, and then film forming is achieved through later thermal treatment to achieve the effect of taste masking. The taste masking technology can achieve the effect of taste masking on water-soluble and poorly soluble bitter drugs, and ensure relatively rapid in-vitro release.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a taste-masked drug granule and a preparation method thereof by a powder-mixing and hot-melting method. Background technique [0002] Children are very sensitive to bitter taste. When taking medicine orally, the bitter taste produced in the mouth is one of the main reasons for their resistance to taking medicine or not taking medicine on time and in the right amount. Therefore, palatability is a key factor in the development of oral preparations for children. Young children have difficulty swallowing, and the dosage forms suitable for oral administration by children are mostly oral liquids, suspensions, granules, dispersible tablets or chewable tablets, etc., and it is undoubtedly more difficult to mask the taste of these dosage forms. [0003] Coating technology is suitable for the taste-masking of solid oral dosage forms of various bitter drugs. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/50A61K47/04A61K47/36
CPCA61K9/501A61K9/5036A61K9/5089
Inventor 平其能陈丹丹于鲲梦
Owner CHINA PHARM UNIV
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