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Taste masking preparation and preparing method thereof

A technology of preparation and centrifugation, which is applied in the field of pharmaceutical preparations, can solve problems such as the unsatisfactory taste masking effect of solvent evaporation method, the inability to cover the bitter taste and numbness of drugs, and the complicated production process, so as to achieve simple production process, low cost and high product quality. High safety effect

Inactive Publication Date: 2016-10-12
BEIJING UNIV OF CHEM TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] We tried to use the above methods to mask the taste, and found that simply adding flavoring agents to mask the taste cannot mask the bitterness and numbness of the drug
The taste masking effect of solvent evaporation method is not ideal
The drug-resin compound method is used to mask the taste of the drug. Although the taste masking effect is good, the problem is that the drug cannot be completely dissolved.
In the method of patent CN 102958515 A, a large amount of organic solvents are used, which has high requirements for safety protection devices in the production workshop, and there is also the problem of solvent residues
However, the taste-masking method of powder coating in a fluidized bed has higher requirements for coating equipment and processes, the production process is complicated, the operation is difficult, and the cost is also high.

Method used

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  • Taste masking preparation and preparing method thereof
  • Taste masking preparation and preparing method thereof
  • Taste masking preparation and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Take 30g of enteric-coated material Eudragit L55 and place it in 600ml of water to disperse evenly, add dropwise 1moL / L sodium hydroxide solution to dissolve the enteric-coated material, at this time the pH is 6, add 7g of 300 mesh micro-powdered silica gel, stir for 30min while stirring While adding 30g of fexofenadine hydrochloride powder to disperse evenly, continue stirring for 30min, the amount of precipitation increases until it is stable, suction filtration, the precipitation is dried in a 45°C drying oven, crushed, and passed through a 120-mesh sieve to obtain fexofenadine hydrochloride That definite taste masking powder. Suspend the taste-masking powder in 500ml of 1% gelatin aqueous solution, add 36g of mannitol and 3g of acesulfame potassium, stir evenly, divide into 0.5ml per hole, and freeze-dry to obtain freeze-dried orally disintegrating tablets. The prepared freeze-dried orally disintegrating tablet has good shape, is smooth, has no bitter taste, is swee...

Embodiment 2

[0056] Weigh 100g of enteric-coated acrylic resin Eudragit L30D-55 aqueous dispersion, add 400mL of water, stir well to obtain diluted resin aqueous dispersion solution; disperse 30g of fexofenadine hydrochloride drug powder in 120mL of water, stir well, and shear Cut for 20 minutes to obtain a drug suspension; add the diluted aqueous resin dispersion solution dropwise to the drug suspension, then add 20 g of maltodextrin and 6 g of 300-mesh micronized silica gel, and stir evenly. When the inlet air temperature is 160°C, the outlet air temperature is 105°C, and the feed rate is 420mL h -1 Under the condition of spray drying, obtain the taste-masking preparation containing fexofenadine hydrochloride and enteric acrylic resin. Give 6 volunteers a taste-masking powder equivalent to 30 mg of the drug, put it in the mouth for 30 seconds, spit it out, and rinse the mouth. The results are all considered to be non-bitter and easy to accept.

Embodiment 3

[0058] Measure 300mL of deionized water, add 30g of fexofenadine hydrochloride, and shear and disperse for 15min to obtain a drug suspension; weigh 30g of enteric-coated acrylic resin Eudragit L55, dissolve it with 1moL / L sodium hydroxide solution, and obtain Clarify the solution; add the drug suspension to the above solution, and keep stirring to obtain a drug resin solution; weigh 3 g each of aspartame and acesulfame K, 8 g of 300 mesh micro-powdered silica gel, add 40 mL of water, and mix evenly to make a suspension solution, added to the above drug resin solution, and continued to stir until the amount of precipitation no longer increased, and the solid product was collected by suction filtration, dried at 45°C, crushed through a 120-mesh sieve, and obtained containing fexofenadine hydrochloride and enteric acrylic resin. Taste-masking powder. Orally disintegrating tablets are prepared according to the following prescription:

[0059] Fexofenadine hydrochloride orally dis...

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Abstract

The invention discloses a taste masking preparation and a preparing method thereof, belongs to the field of pharmaceutic preparations, and aims at providing a coating-free taste masking preparation of fexofenadine hydrochloride and a preparing method thereof. The preparing method of the taste masking preparation includes the steps that fexofenadine hydrochloride is dispersed into a solution of a taste masking material, and the taste masking material is separated out and precipitated on the surfaces of medicine particles through stirring and mixing or by adding a neutral or alkaline aqueous solution for dilution. The taste masking material is an enteric solubility material or stomach-solubility-type polyacrylic resin. The enteric solubility material comprises but is not limited to one or more of methacrylic acid copolymers, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate and polyvinyl acetate phthalate. By means of the taste masking preparation and the preparing method, an original coating taste masking method is avoided, coating equipment is avoided, the production technology process is simple and convenient, cost is low, and the safety of the product is high; the product has the advantages of being small in tablet weight, free of coating and masticable.

Description

technical field [0001] The invention relates to a taste-masking preparation of fexofenadine, and a preparation made by dispersing fexofenadine hydrochloride in a solution of taste-masking material, stirring and mixing, or adding neutral or alkaline aqueous solution to dilute The invention relates to a preparation method for precipitation and precipitation of a taste-masking material on the surface of drug particles, belonging to the field of pharmaceutical preparations. Background technique [0002] Fexofenadine hydrochloride is a second-generation H1 receptor antagonist, a carboxylated metabolite of terfenadine, which selectively blocks H1 receptors and has good antihistamine effects. Compared with the parent terfenadine, it has the advantages of strong antihistamine effect and less toxic and side effects. Clinically, it is mainly used for allergic seasonal rhinitis, idiopathic chronic urticaria and other diseases. Making fexofenadine hydrochloride into an oral disintegra...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/445A61K47/38A61K47/32A61P37/08A61P17/00A61P11/02
CPCA61K31/445A61K9/0056A61K9/2027A61K47/32A61K47/38
Inventor 赵会英郭婷婷刘玲
Owner BEIJING UNIV OF CHEM TECH
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