EP0084529A1

EP0084529A1 - Two-piece hardshell gelatin capsule and method for manufacture.

Info

Publication number: EP0084529A1
Application number: EP81902190A
Authority: EP
Inventors: Joseph A Pace
Original assignee: Catalent Pharma Solutions Inc
Current assignee: Catalent Pharma Solutions Inc
Priority date: 1981-07-30
Filing date: 1981-07-30
Publication date: 1983-08-03
Also published as: JPS58501157A; DE3175671D1; AT23975T; EP0084529B1; WO1983000477A1; EP0084529A4

Abstract

Elongated hard shell gelatin capsule, in two parts, elongated (12) to swallow, comprising a C-shaped body (10) into which a liquid can be introduced, and a digestible hard shell gelatin cover (11) formed with a free rung with rung (13) complementary to the body, and coming into register telescopically with the free upper end (14) of the body and welded on the latter in tight closing relationship by overlapping, and manufacturing method .

Description

TWO-PIECE HARDSHELL GELATIN CAPSULE AND METHOD FOR MANUFACTURE

BACKGROUND OF THE INVENTION

Liquid leach and leakage problems have plagued procedures intended for filling and sealing of liquid - containing capsules intended for oral use. Complicated filling and sealing procedures, tried in an effort to remedy the difficulties, have failed to enable production, at low cost, of consistently reliable, leak proof, practical quantity production of such products.

OBJECTS AND SUMMARY OF THE INVENTION

The invention overcomes the foregoing and other ojections to procedures in the prior art, by providing a hermetically sealed, two-piece, hardshell, liquid filled, elongated gelatin capsule, readily soluble internally of the body when swallowed, and capable of consistently practical reliable quantity production, at low cost, of such capsules. The capsule of the invention comprises two-piece hardshell gelatin capsule having a gelatin hardshell cap member formed with a stepped, controured, marginal portion for closing registration 360° with the open end of a hardshell gelatin capsule body, an elongated apron portion depending from the cap portion and telescopically contiguously overlapping the upper end of the body member.

Pursuant to the invention, ultrasonic means are applied to said telescopically overlapping portions of the cap and body member on alignment registration thereof, achieving a 360 hermetic sealing of the capsule, and further achieving a closed gelatin capsule which may be readily swallowed, rapidly dissolved and digested in the body, with prompt release of the contents of the capsule into the bloodstream, and which may be manufacturered in quantities at low cost, in consistently reliable, practical form.

The term "gelatin" is used herein to designate the material of which the capsule of the invention is made, comprises a non-synthetic, substantially tasteless and odorless dried protein, readily soluble, digestible and compatible, when taken orally, and dissolving readily when swallowed. Formed by boiling the bones, shins, and tendons of animals.

DESCRIPTION OF THE DRAWINGS

In the drawings, illustrating preferred embodiments of the invention, and wherein similar reference characters, indicate like parts: FIGURE 1 is a vertical, sectional, assembled view of a two-part digestible gelatin capsule, comprising a hard shell gelatin cap member and a hardshell gelatin body member, shown assembled preparatory to being inserted into a holding fixture,

FIGURE 2 is a side elevational view of the assembled capsule positioned in and extending out of a fixture shown in dotted lines,

FIGURE 3 is a vertical sectional view of an ultrasonic horn fixture which may be used in carrying out the invention,

FIGURE 4 is a side elevational view of the assembled capsule in the fixture (shown in dotted lines), the ultrasonic horn being applied to the capsule to weld the cap and body member, and

FIGURE 5 is a medial vertical sectional view of the upper portions of the capsule cap and body member so welded together and thus ultrasonically sealed 360º .

DESCRIPTION OF PREFERRED EMBODIMENTS

In preferred embodiments of the invention, as shown in the drawings, the hard-shelled soluble and digestible gelatin capsule comprises a U-shaped body member 10 wherein may be positioned liquids or pharmaceutical products, and a cap member 11 having a dome end portion 12 and having an outwardly stepped circumferential rim portion 13 formed to telescopically register, on assembly with the free upper end portion 14 of the body member. The cap member is provided with a depending skirt portion 15 below the stepped rim portion 13; on assembly of the parts (Fig. 1) the stepped rim portion 13 of the cap overlies the free upper end 14 of the body member 10 in closing relation, the depending skirt portion 15 of the cap member telescopically registering with and contiguously overlying the upper portion 16 of the body member.

The cap member 11 and body member 10 of the capsule are shown in closed relation in Fig. 1 and positioned in a fixture 17 in Fig. 2, with the stepped rim cap portion 13 and adjacent depending apron portion thereof disposed outwardly of the fixture 17. An ultrasonic horn 21 is positioned over the assembled parts (Fig. 4) in overlying relation to the stepped rim portion 13 of the cap and adjacent apron portion 15 telescopically registered with the upper portion 16 of the body member within the horn. Upon being energized by any well-known ultrasonic means, the horn will ultrasonically hermetic ally seal for 360º to thereby weld, as noted at 23 (Fig. 5) and unify the outwardly stepped portion 13 of the cap member to the upper end 14 of the body member.

The fixture 17 may be turntable or other practical form of a multi-unit fixture wherein a large number of capsules may be simultaneously so formed and sealed.

The preferred embodiment of the invention has been set forth above. It is to be understood, however, that variations may be made in such preferred embodiment, which variations may nevertheless be within the scope and spirit of the invention. The invention is therefore to be broadly construed, within the scope and spirit of the appended claims.

Claims

CLAIMS:

1. The method of forming a hermetically sealed, two-part soluble capsule comprising: forming one part cap member of hardshell gelatin and a stepped rim portion thereon telescopically complementary to said stepped rim portion of the cap member positioning the body member in a fixture in upwardly opening relation, positioning the cap member onto the free upper end of the body member, forming a capsule body member of hardshell gelatin and of C-shaped outline and positioning the outwardly stepped portion of the cap member in registry with the free end of the body member and in overlapping relation thereto, and welding said cap member marginal stepped portion and the free upper end of the body member together.

2. In the method of hermetically sealing a two-part, soluble digestible hardshell gelatin capsule, as set forth in claim 1, the further steps comprising: forming the cap member with an apron portion depending from the marginal stepped rim portion thereof, positioning the cap member with said apron portion in overlying relation to the upper end of the body member, and so welding cap member to the body member with the apron portion of the cap member in overlying parallel relation to the body member.

3. In the method of hermetically sealing a two-part, soluble digestible hardshell gelatin capsule, as set forth in claim 1, the further steps comprising: forming the cap member with an apron portion depending from the marginal stepped rim portion, positioning the cap member with said apron portion in overlying relation ship to the upper end of the body member, and so welding the apron portion of the cap member in overlying parallel relation to the body member.

4. In the method of hermetically sealing a two-part, soluble, digestible liquid containing hardshell gelatin capsule set forth in claim 1, the further step comprising: applying ultrasonic means to the said cap member stepped portion and to the free end of the body member, so welding them together.

5. In the method of hermetically sealing a two-part soluble liquid containig digestible hardshell gelatin capsule as set forth in claim 1, the further step comprising: so forming said weld as a continuous 360º weld.

6. In the method of hermetically sealing a two-part digestible hardshell gelatin capsule, as set forth in claim 1, the further steps comprising: positioning the body member in a fixture with the free end thereof upwardly disposed, and with said rim of the cap registered with said free end, and so welding the so positioned cap member to the body member.

7. In the method of heremetically sealing a two-part soluble, liquid containing digestible hardshell gelatin capsule, as set forth in claim 1, the further steps comprising: positioning the body member in a fixture, with the free end thereof upwardly disposed, and with the rim of the cap disposed on said free end, and so welding the cap member and body member, ultrasonically.

8. A two-piece hardshell, soluble and digestible liquid containing gelatin capsule, comprising: a U-shaped body member, said body member having a closed lower end and an open, free upper end, a cap member formed for complementary registration onto the upper end of the body mmember, an outwardly stepped, contoured marginal rim portion formed on the cap member for so registering it with said upper free end of the body member, said stepped rim portion of said cap member being welded to the upper free end of the body member and thereby closing said capsule.

9. In a two-piece hardshell soluble and digestible gelatin capsule, as set forth in claim 8, an apron portion depending from the offset rim portion of the cap member, the upper end of the body member being received within said apron portion and being held adjacent thereto upon welding the cap member and body member.

10. In a two piece hardshell digestible soluble and gelatin capsule as set forth in claim 8: said stepped rim portion of the cap member being so welded to the upper end of the body member ultrasonically.

11. In a two-piece hardshell soluble and digestible gelatin capsule, as set forth in claim 8: an apron portion on the cap member depending from the stepped rim portion thereof, and said stepped rim portion of the cap member being so welded to the free end of the body member.

12. In a two-piece soluble and digestible hardshell gelatin capsule as set forth in claim 8: said cap member offset rim portion and body member being ultrasonically so welded together for 360º .

13. A two-piece hardshell, soluble and digestible liquid containing gelatin capsule comprising: a U-shaped body member having a closed lowe and an open free end terminating in an upper edge; a cap member for receeiving the upper end of said U-shaped body member, said cap member including a continuous interior rim formed in said cap member for abuttingly engaging said upper edge of said Ushaped body member when said capsule is in the assembled state, said cap member further including an apron portion depending from said interior rim; and substantially continuous and substantially liquid impervious interior ultrasonic weld means for attaching said upper edge of said U-shaped body member to said interior rim thereby forming an interior ultrasonic weld which extends continuously 360 around said upper edge of said U-shaped body member.

14. The apparatus of claim 19 wherein said cap member is shorter in length than said U-shaped body member.