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Terbinafine hydrochloride solid dispersoid and tablet thereof

A technology of terbinafine hydrochloride and solid dispersion, which is applied in the directions of pill delivery, antifungal agent, organic active ingredients, etc. The effect of active ingredient dosage, maintaining drug efficacy and improving in vitro dissolution rate

Active Publication Date: 2014-06-04
NANJING CHENGONG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In addition, as a poorly soluble compound, terbinafine hydrochloride has limited dissolution in the body after being made into oral solid preparations, which affects its absorption and utilization.
Patent document CN101548958A discloses a dispersible tablet containing terbinafine hydrochloride, which is made into a dispersible tablet by mixing the terbinafine hydrochloride active ingredient with a filler, binder, disintegrant, lubricant and flavoring agent, Improves the dissolution rate of the active ingredient, however, the absorption of the active ingredient in the body is not satisfactory after oral administration of the formulation

Method used

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  • Terbinafine hydrochloride solid dispersoid and tablet thereof
  • Terbinafine hydrochloride solid dispersoid and tablet thereof
  • Terbinafine hydrochloride solid dispersoid and tablet thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Preparation of Terbinafine Hydrochloride Solid Dispersion

[0026] Take 50g of poloxamer 188 into a suitable container, place it in a water bath at 65°C-68°C and heat it to a molten liquid state, add 10g of terbinafine hydrochloride fine powder, and stir rapidly at 63°C-66°C until it is evenly mixed. Stand still to remove air bubbles, spread the mixture into a thin layer and put it in a -5°C refrigerator for rapid cooling. After the mixture is completely solidified, take it out, crush it, and dry it in a vacuum dryer at 35°C for 24 hours, and crush it through an 80-mesh sieve to obtain Terbinafine hydrochloride solid dispersion.

Embodiment 2

[0028] Preparation of Terbinafine Hydrochloride Solid Dispersion

[0029] Take 10g of terbinafine hydrochloride and add it to 200mL of water and ethanol for ultrasonic dissolution; take 150g of polyoxyethylene (40) stearate and heat it to 60°C-62°C to make it into a molten liquid state, and add the prepared The ethanol solution of terbinafine hydrochloride was evaporated to dryness, put into a refrigerator at -5°C for rapid cooling, and pulverized through an 80-mesh sieve to obtain a solid dispersion of terbinafine hydrochloride.

Embodiment 3

[0031] Preparation of Terbinafine Hydrochloride Solid Dispersion

[0032] Take 20g of poloxamer 188 into a suitable container, place it in a water bath at 65°C-68°C and heat it to a molten liquid state, add 10g of terbinafine hydrochloride fine powder, stir rapidly at 63°C-66°C until the mixture is uniform, Stand still to remove air bubbles, spread the mixture into a thin layer and put it in a -5°C refrigerator for rapid cooling. After the mixture is completely solidified, take it out and pulverize it, dry it in a vacuum dryer at 35°C for 24 hours, and pulverize it through an 80-mesh sieve to obtain Terbihydrochloride Nafine solid dispersion.

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Abstract

The invention relates to a terbinafine hydrochloride solid dispersoid, which is composed of terbinafine hydrochloride and carrier materials, wherein the proportion by weight between the terbinafine hydrochloride and the carrier materials is 1 / 2-1 / 15. The invention further relates to a tablet prepared by the terbinafine hydrochloride solid dispersoid. Compared with the prior art, the terbinafine hydrochloride tablet has the advantages of (1) improving dissolution in vitro of terbinafine hydrochloride preparation; (2) solving the problem that the terbinafine hydrochloride is poor in oral administration absorption and low in biological availability; (3) covering harmful odor and irritation of the terbinafine hydrochloride; (4) keeping pesticide effects of large dose while reducing using quantity of active ingredients in the preparation per unit, and reducing drug side-effects; and (5) being simple in preparation process and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a solid dispersion of terbinafine hydrochloride and a tablet thereof. Background technique [0002] According to social epidemiological investigations and studies, fungal infection is a disease with a high incidence rate, and has the characteristics of high reinfection rate. In my country, the incidence of fungal infection has reached 78%, which has promoted the rapid growth of the antifungal drug market. According to data from the China Pharmaceutical Industry Information Center database, during 2006-2010, the annual growth rate of the antifungal drug market in sample hospitals in 22 cities in China was more than 20%, and it climbed year by year; in 2010, the antifungal drug The overall market share has reached 1.285 billion yuan, an increase of 33.3% compared with 964 million yuan in 2009. It is estimated that the overall market size of antifungal infection...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/137A61K47/38A61K47/34A61P31/10
Inventor 郭昭
Owner NANJING CHENGONG PHARM CO LTD
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