JPS58159425A - Gel base - Google Patents

Abstract

PURPOSE:A gel base, containing ethyl cellulose in triglyceride of a medium fatty acid, and having a large variation in viscosity with temperature difference and improved operability in filling in a capsule. CONSTITUTION:A gel base obtained by adding 3-10pts.wt., preferably 5- 10pts.wt., ethyl cellulose to 100pts.wt. triglyceride of 6-10C fatty acid, e.g. caproic acid or caprylic acid. Preferably both are mixed under stirring and warming. The resultant gel base is heated and made to flow, and a drug is added thereto and mixed therewith under stirring. The resultant pharmaceutical composition is filled in a capsule and allowed to stand at ordinary temperature to gelatinize the contents to afford a soft or hard capsule.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a base that can be gelled at room temperature, and more particularly to a gel base made by adding ethyl cellulose to medium-chain fatty acid triglyceride.

When preparing oil-based drugs into soft capsules or hard capsules, a method is known in which the oil-based drug is dissolved in fatty acid triglyceride and then filled.

A method is also known in which a pharmaceutical composition consisting of an oil-based drug and fatty acid tricrycerite is gelled in a capsule by adding a gelling agent such as anhydrous magnesium silicate or aluminum stearate to the fatty acid Y liglyceride. ing.

However, with conventional gelling agents, the viscosity of the base itself changes little due to temperature differences, so there was a problem in workability when filling the gelling agent into the container.

The inventors of this invention conducted intensive research to resolve the drawbacks of conventional base materials, and discovered that by adding ethyl cellulose to medium-chain fatty acid triglyceride, a gel base whose viscosity fluctuates greatly due to temperature differences can be obtained. , completed this invention.

The gel base of this invention consists of a composition in which ethyl cellulose is added to medium chain fatty acid triglyceride. Medium-chain fatty acid triglycerides include triglycephytes of fatty acids having 6 to 10 carbon atoms, and specific examples include caproic acid triglyceride, caprylic acid triglyceride, and capric acid triglyceride. Incidentally, any mixture of these triglycerides and monoglycerides or diglycerides is included in the medium-chain fatty acid tricrycerite of the present invention. .

The addition ratio of ethyl cellulose added to medium chain fatty acid tricryceride is 100% medium chain fatty acid tricryceride.
Usually 3 to 10 parts by weight is added to the city.
~10 parts by weight.

In order to add ethyl cellulose to the medium chain fat 1l-7j acid tricrycerite, it is sufficient to simply stir and mix both at room temperature, but it is convenient to stir and mix both in a wet knife.

Mixing of the drug into the base thus obtained is usually carried out by adding the drug to the base fluidized by heating and stirring and mixing.

When the pharmaceutical composition thus obtained is made into soft capsules or hard capsules, filling of the capsules is carried out by a conventional method. The contents of a capsule filled with a pharmaceutical composition will gel simply by standing at room temperature, but gelation may be promoted by cooling.

In the Ge/I/f5 agent of the present invention, the viscosity of the base material fluctuates greatly due to temperature differences, which brings about favorable results in terms of workability during capsule filling. Moreover, this gel base contains vitamin E.
When an oil-based drug such as crotamiton is added, it unexpectedly becomes transparent. Therefore, when the gel base of the present invention is used, a pharmaceutical composition with an excellent appearance can be obtained, and contamination with a different type of drug can be easily detected by visual inspection, which is an excellent effect.

Note that the gel base of the present invention may be heated and melted, a drug may be suspended therein, and then gelled. Furthermore, it goes without saying that the use of the gel base of the present invention is not limited to medical use.

Test Example 1 Various bases were prepared with different addition ratios of ethyl cellulose to a mixture of caprylic acid triglyceride and capric acid tricrycerite (trade name: Panacet 810, manufactured by NOF Corporation). The viscosity at °C was measured using a rotational viscometer. The results are shown in Table 1. In addition, the addition ratio of ethyl cellulose is Panacet 8
10 (trade name) It is expressed as the weight of ethyl cellulose added to 100 parts by weight.

Test Example 2 Base obtained in Example 1 (containing 5% ethylylulose)
) was measured at different temperatures. The results are shown in Table 2.

Table 2 Next, the present invention will be explained with reference to examples.

Example 1 A mixture of caprylic acid triglyceride and capric acid triglyceride (85:15) (95 parts by weight) was heated at 40°C.
Ethyl cellulose (5 parts by weight) was added thereto and mixed with stirring to obtain a gel base.

This gel base (50 parts by weight) was heated to about 80°C, vitamin E (50 parts by weight) was added thereto, and the mixture was stirred.
A composition of vitamin E is obtained.

This composition is heated to about 60°C and injected into transparent hard capsules in a conventional manner. When this is left at room temperature, hard capsules containing a gel-like transparent vitamin E composition are obtained.

Example 2 A mixture of caprylic acid liglyceride and capric acid tricrycerite (85:15) (97 parts by weight) was heated at 40°
C. Ethyl cellulose (6 parts by weight) is added thereto and mixed with stirring to obtain a gel base.

This gel base (90 parts) is heated to about 80 DEG C., and 10 parts of crotamiton is added thereto and mixed with stirring to obtain a composition of crotamiton.

and obtaining a soft capsule containing a transparent gel-like rotamiton composition.

Patent applicant: Fujisawa Pharmaceutical Co., Ltd. 7-

Claims (2)

[Claims] (1) Ge/1/base made by adding ethyl cellulose to medium chain fatty acid triglyceride. (2) The gel base according to claim 1, wherein the medium chain fatty acid triglyceride is a mixture of caprylic triglyceride and capric triglyceride.