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Topical composition comprising terbinafine with improved stability and preparation method thereof

A kind of technology of terbinafine and composition, applied in the external preparation field of terbinafine and its preparation field, can solve the problems such as growth, water evaporation or microbial contamination, difficulty in ensuring stability, excessive keratolysis and the like

Inactive Publication Date: 2019-06-21
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, such compositions with high concentrations of urea can cause excessive keratolysis and present stability issues since precipitation of urea can occur over time at low temperatures
[0008] In addition, terbinafine is a substance that is easily decomposed under the influence of temperature, light, humidity, oxygen, etc. during long-term storage, especially in the case of semi-solid preparations that have both solid and liquid properties, because Rheological properties (rheology), which are prone to denaturation or deformation depending on time or external environment, and can occur such as phase separation, demulsification or emulsion breaking, crystal growth, water evaporation or micro Biological contamination, etc., so it is difficult to ensure stability
An existing preparation containing terbinafine is Lamisil TM , especially with regard to skin irritation, has failed to demonstrate an adequate safety profile

Method used

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  • Topical composition comprising terbinafine with improved stability and preparation method thereof
  • Topical composition comprising terbinafine with improved stability and preparation method thereof
  • Topical composition comprising terbinafine with improved stability and preparation method thereof

Examples

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Embodiment 1 to 3

[0091] Examples 1 to 3: Preparation of Terbinafine Hydrochloride Cream

[0092] A cream containing terbinafine hydrochloride was prepared with the composition shown in Table 1 below. Specifically, cetyl alcohol, stearyl alcohol, petrolatum, and cetylpalmitate are used as bases, and polysorbate is added as an emulsifier. Ester 60 (polysorbate 60), isopropyl myristate, and sorbitan monostearate were heated to 60°C in the chamber. After the purified water was heated to 90°C, it was cooled to 60°C, and then terbinafine hydrochloride was added and completely dissolved. The above purified water in which terbinafine hydrochloride was dissolved was added to the mixture of the base and the emulsifier in a preheated 60°C chamber and mixed. While cooling the 60°C chamber to room temperature, sodium hydroxide was added to the mixture to adjust the pH, and ethanol was added to adjust the viscosity, thereby preparing a cream containing 10 mg of terbinafine hydrochloride. The final pH of th...

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Abstract

The present invention provides an external preparation composition having improved preparation stability, drug therapy safety, and excellent patient convenience. The present invention relates to a composition for external use comprising terbinafine or a pharmaceutically acceptable salt thereof, an alcohol having a melting point of 25 DEG C to 100 DEG C and a wax having a melting point of 40 DEG Cto 60 DEG C. The present invention also provides a method for preparing the composition for external use.

Description

[0001] Cross references to related applications [0002] This application claims the rights and interests of Korean Patent Application No. 10-2017-0167525 filed at the Korean Intellectual Property Office on December 7, 2017, the disclosure of which is fully incorporated herein by reference. Technical field [0003] The present invention relates to an external agent composition with antifungal activity, in particular, an external agent composition comprising terbinafine and a preparation method thereof that have been improved in terms of formulation stability, drug treatment safety and convenience. Background technique [0004] Skin fungus refers to a fungus that can parasitize or cause skin diseases in the keratinous tissues of humans and animals. Although dermatophytes can form granulomas in the subcutaneous fat layer, they mainly cause diseases of the epidermal stratum corneum, hair, and nails. In addition, diseases caused by fungi such as dermatophytes (molds) that infect the ke...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/137A61K47/44A61K47/26A61K47/14A61K47/10A61K47/02A61P17/00A61P1/02A61P1/00A61P15/00A61P15/02A61P31/10
CPCA61K9/0014A61K47/10A61K47/44A61K47/26A61K31/137
Inventor 权世浩金载镐林昊泽金用镒
Owner HANMI PHARMA
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