Title:  Soft gelatin capsule

United States Patent:  6,280,767

Assignee:  Toaki Capsule Co., Ltd. (Fuji, JP)

Filed:  October 8, 1999

Foreign Application Priority Data:  Oct 20, 1998[JP] (10-298166)

The present invention relates to a chewable soft gelatin capsule and a soft gelatin capsule of the torsional opening type, the capsule having a shell which includes: (A) gelatin (B) one or more plasticizers selected from among (b1)-(b3) below, in a total amount of 100-600 parts by weight based on 100 parts by weight of gelatin; (b1) glycerin (b2) a sugar selected from among D-sorbitol, sucrose, mannitol, fructose, sugar alcohol, and isomerized sugar (b3) a glycol selected from propylene glycol and ethylene glycol, and (C) a water-insoluble cellulose.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the present specification, the term "gelatin" refers to gelatin, acidic gelatin, alkaline gelatin, peptide gelatin, low-molecular-weight gelatin, and gelatin derivatives. The soft gelatin capsule of the present invention may contain any of these species of gelatin as ingredient (A) of the shell.

The shell contains as component (B) one or more plasticizers selected from among (b1) glycerin, (b2) a sugar, and (b3) a glycol. When a plurality of plasticizers are contained, preferably, at least (b1) glycerin is contained. More preferably, in consideration of ease of molding, the shell contains, as plasticizers, (b1) glycerin in combination with at least any one of (b2) a sugar and (b3) a glycol.

The shell contains the plasticizer preferably in a total amount of 100-600 parts by weight based on 100 parts by weight of gelatin serving as component (A), more preferably between 150 and 300 parts by weight. Amounts less than 100 parts by weight yield a hard capsule, whereas amounts in excess of 600 parts by weight yield a soft gelatin capsule that is difficult to mold.

When the shell contains glycerin (b1) alone as component (B), glycerin is preferably used in an amount of 100-300 parts by weight, more preferably 120-200 parts by weight, based on 100 parts by weight of gelatin (A).

In the present invention, the shell contains a sugar (b2) selected from among D-sorbitol, sucrose, mannitol, fructose, sugar alcohol, and isomerized sugar. Of these, D-sorbitol, sucrose, and mannitol are preferably chosen, for the purpose of providing a sweet taste upon chewing of the shell. D-sorbitol and mannitol are preferable because of their low stickiness when contained at high concentration. When a sugar is used alone as a plasticizer, the sugar is preferably incorporated in an amount of 100-300 parts by weight, more preferably 120-200 parts by weight, based on 100 parts by weight of gelatin (A).

When glycerin (b1) is used in combination with a sugar (b2), such combination improves compatibility, and thus the concentration of plasticizer can be increased. When glycerin and a sugar are used in combination, glycerin is preferably incorporated in an amount of 50-300 parts by weight, more preferably 50-250 parts by weight, based on 100 parts by weight of gelatin; and the sugar is preferably incorporated in an amount of 30-300 parts by weight, more preferably 50-150 parts by weight, based on 100 parts by weight of gelatin.

In the present invention, the shell contains a glycol (b3) selected from propylene glycol and polyethylene glycol. More preferably, polyethylene glycol which has a weight average molecular weight of 400-4000 is used. Because of the high hygroscopicity of glycol, a soft gelatin capsule produced by use of a glycol becomes difficult to handle. Therefore, incorporation of a glycol in a large amount is not preferable. If glycol alone is used as a plasticizer, the amount of glycol is preferably 100-200 parts by weight, more preferably 120-180 parts by weight, based on 100 parts by weight of gelatin (A).

When glycerin (b1) and a glycol (b3) are used in combination, a very soft gelatin shell can be obtained. When glycerin is used in combination with propylene glycol from (b3), glycerin is preferably incorporated in an amount of 40-200 parts by weight, more preferably 50-120 parts by weight, based on 100 parts by weight of gelatin (A); and propylene glycol is preferably incorporated in an amount of 20-300 parts by weight, more preferably 40-100 parts by weight, based on 100 parts by weight of gelatin (A). When glycerin is used in combination with polyethylene glycol from (b3), glycerin is preferably incorporated in an amount of 50-100 parts by weight, more preferably 60-80 parts by weight, based on 100 parts by weight of gelatin; and polyethylene glycol is preferably incorporated in an amount of 40-200 parts by weight, more preferably 50-100 parts by weight, based on 100 parts by weight of gelatin.

When three plasticizers; that is, glycerin (b1), a sugar (b2), and a glycol (b3), are used in combination, glycerin is preferably incorporated in an amount of 50-200 parts by weight, more preferably 60-150 parts by weight, based on 100 parts by weight of gelatin; the sugar is preferably incorporated in an amount of 30-130 parts by weight, more preferably 40-80 parts by weight, based on 100 parts by weight of gelatin; and the glycol is preferably incorporated in an amount of 20-120 parts by weight, more preferably 50-100 parts by weight, based on 100 parts by weight of gelatin.

Examples of component (C); i.e., water-insoluble cellulose, include crystalline cellulose, ethyl cellulose, low-substitution-degree hydroxypropyl cellulose, and starch. Water-insoluble celluloses are preferably incorporated in an amount of 5-100 parts by weight, more preferably 25-75 parts by weight, based on 100 parts by weight of gelatin (A). Amounts of water-insoluble celluloses less than 5 parts by weight based on 100 parts by weight of gelatin are not preferred, from the viewpoints of poor improvement in suppression of stickiness of a soft gelatin capsule, adhesion of a soft gelatin capsule to another soft gelatin capsule or to a container, and unfavorable sticky texture in the mouth. When water-insoluble celluloses are incorporated in amounts in excess of 100 parts by weight based on 100 parts by weight of gelatin, molding of a soft gelatin capsule becomes difficult.

The shell of the soft gelatin capsule according to the present invention may contain, in addition to components (A)-(C), a coloring agent, a preservative, a disintegrant, a surfactant, a fragrance, a sweetening agent, or a flavoring agent, as needed.

The soft gelatin capsule of the present invention can be produced according to a conventional method of producing a soft gelatin capsule. Briefly, a soft gelatin capsule is produced, for example, by the following method. Components (A), (B) and (C) are dissolved with heat. Water and other arbitrarily selected components are added to the resultant solution, to thereby obtain a composition of a shell. The composition assuming a sheet form is supplied to a soft gelatin capsule manufacturing machine, and deformed against the walls of mold cavities. Simultaneously, ingredients to be encapsulated in the capsule are injected thereto, and the composition is solidified under cooling.

The soft gelatin capsule can be opened by twisting any parts of the capsule with the fingers, because its shell has the above-described composition. If a narrow rupture portion 11 is provided at an arbitrary portion of the body 10 of the capsule, preferably at the end of the body, the soft gelatin capsule can advantageously be more easily and reliably twisted open with the fingers.

Claim 1 of 13 Claims

What is claimed is:

1. A chewable soft gelatin capsule, the capsule having a shell which comprises the following components (A), (B), and (C):

(A) gelatin

(B) one or more plasticizers selected from (b1)-(b3) below, in a total amount of 100-600 parts by weight based on 100 parts by weight of gelatin;

(b1) glycerin

(b2) a sugar selected from the group consisting of D-sorbitol, sucrose, mannitol, fructose, sugar alcohol, and isomerized sugar

(b3) a glycol selected from the group consisting of propylene glycol and polyethylene glycol, and

(C) a water-insoluble cellulose.

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