Method for preparing medicine taste-masking preparation from acrylic resin mixed aqueous dispersion

A technology of acrylic resin and water mixing, which is applied in the direction of pharmaceutical formulation, drug delivery, and medical preparations of non-active ingredients, etc. It can solve the problems of high coating weight gain, pollution of the environment, and insufficient flexibility to achieve good resistance to external forces. Effect

Inactive Publication Date: 2014-08-20
BEIJING UNIV OF CHEM TECH
View PDF11 Cites 17 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, coating with organic solvents has problems such as flammability and explosion, environmental pollution and solvent residues in the product, while the aqueous dispersion coating solution does not have the above problems, but for drugs with better water solubility, simply use this kind of gastric solution The aqueous dispersion coating of type acrylic resin requires a high coating weight gain to achieve a good taste-masking effect, which has the problems of long coating process time and low production efficiency
In addition, the properties of stomach-soluble acrylic resin materials are high elastic modulus, strong rigidity, and insufficient flexibility. The coating film is easily broken under the action of external force extrusion and impact, which is also one of the reasons for the need for high coating weight gain. 1. In addition, when the coated pellets need to be pressed into tablets, it is easy to cause the coating film to rupture, which cannot protect the drug as it should.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Method for preparing medicine taste-masking preparation from acrylic resin mixed aqueous dispersion
  • Method for preparing medicine taste-masking preparation from acrylic resin mixed aqueous dispersion
  • Method for preparing medicine taste-masking preparation from acrylic resin mixed aqueous dispersion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Mix fluoxetine hydrochloride (mass ratio, the same as 30% in the following examples), microcrystalline cellulose (60%), and low-substituted hydroxypropyl cellulose (10%), add wetting agent purified water to make a soft material, Pass through a 0.5mm aperture sieve, extrude through a screw extruder to make strips, set rounding equipment to spheronize to obtain pellets, and dry at 55°C to obtain drug-containing pellet cores.

[0032] Prepare a mixed aqueous dispersion coating solution containing stomach-soluble and insoluble materials: Sodium lauryl sulfate (1.5g) is dissolved in 300g pure water, add stearic acid (2.25g) to fully disperse, then add Eudragit EPO (15g ) continuously stirred to make a translucent colloidal solution; mix evenly with Eudragit NE30D (283.3g, solid content 85g) water dispersion, then add triethyl citrate (2.25g), talcum powder (85g), add pure water To 1000g, homogenize at 10000rpm high-speed shearing, fully stir and mix evenly. Stir continuousl...

Embodiment 2

[0037] Get 40-50 order microcrystalline cellulose blank ball core, take 3% hypromellose aqueous solution as binding agent, fluoxetine hydrochloride (60%), microcrystalline cellulose (38.5%) and micropowder silica gel ( 1.5%) of the mixture is powder-layered and drug-coated to obtain 40% drug-containing pellets.

[0038] Adjust the ratio of Eudragit EPO and NE30D to 1:9, prepare the aqueous dispersion coating solution containing stomach-soluble and insoluble materials according to Example 1, and perform bottom-spray fluidized coating on the core containing pills.

[0039] When the coating weight increased by 5%, the drug dissolution of the coated pellets in water in 5 minutes was 3.4%; the dissolution in 0.1mol / L hydrochloric acid aqueous solution was 55%, and the dissolution was complete in 45 minutes.

[0040] When the coating weight increased by 8%, the drug dissolution of the coated pellets in water was 1.7% in 10 minutes; the dissolution in 0.1mol / L hydrochloric acid aqueo...

Embodiment 3

[0042] Get micronized fexofenadine hydrochloride (60%), microcrystalline cellulose (28%) and micronized silica gel (2%) to put in fluidized bed, use 10% Eudragit EPO aqueous dispersion as binder system granules to obtain granules containing 60% of the drug.

[0043] Prepare a mixed aqueous dispersion coating liquid containing stomach-soluble and insoluble materials: Sodium lauryl sulfate (2g) is dissolved in 300g pure water, add stearic acid (3g) to fully disperse, then add Eudragit EPO (20g) to continue Stir to make a translucent colloidal solution; add talcum powder (80g), titanium dioxide (30g), antioxidant BHT (0.3g), triethyl citrate (4g), and mix with Mix the colloidal solution of stomach-soluble materials, then mix with Eudragit NE30D (267g, solid content 80g) aqueous dispersion, and finally add pure water to 1000g, mix well and get ready. Stir continuously during the coating process.

[0044] The drug-containing granules are subjected to bottom spray fluidized coatin...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

Abstract

The invention discloses a method for preparing a medicine taste-masking preparation from an acrylic resin mixed aqueous dispersion. The acrylic resin mixed aqueous dispersion is formed by mixing gastric-soluble acrylic resin and an insoluble high-molecular material according to a certain proportion. The coating taste-masking preparation is composed of a medicine-containing core and a taste-masking coating which coats the core. The taste-masking coating is formed by using the acrylic resin mixed aqueous dispersion as a coating solution to fluidize and coat the medicine core. As the mixed aqueous dispersion prepared from the gastric-soluble acrylic resin and the insoluble high-molecular material mixed according to a certain proportion is used as a coating material, the medicine taste-masking preparation has a good taste-masking effect when weight gain of the coating is low, and fast dissolution of the medicine in the gastric juice is not influenced.

Description

technical field [0001] The invention relates to a method for preparing a drug taste-masking preparation by using an acrylic resin mixed water dispersion, and belongs to the field of pharmaceutical preparations. Background technique [0002] Many drugs have a bad taste, such as bitter, astringent, numb, and metallic sensations. When taken orally, patients are not easy to accept and have poor compliance, which affects continuous drug use and clinical efficacy. At present, the commonly used taste masking methods include adding flavoring agents, modifying the chemical structure to form a form with low solubility, preparing microcapsules or microspheres for taste masking, preparing solid dispersions, and coating. Adding excipients is to alleviate the bad taste by interfering with the taste buds. The method is the simplest and the cost is low, but the effect is limited. It is not effective for extremely bitter and easily hydrolyzed drugs. The structure of the drug is modified to m...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/32A61K47/38A61K9/30A61K9/36
Inventor 赵会英刘玲李冬
Owner BEIJING UNIV OF CHEM TECH
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products