|Publication number||US3702653 A|
|Publication date||Nov 14, 1972|
|Filing date||Sep 14, 1970|
|Priority date||Sep 14, 1970|
|Publication number||US 3702653 A, US 3702653A, US-A-3702653, US3702653 A, US3702653A|
|Inventors||Ralph E Mottin, Anthony L Oldani|
|Original Assignee||Parke Davis & Co|
|Export Citation||BiBTeX, EndNote, RefMan|
|Referenced by (23), Classifications (18)|
|External Links: USPTO, USPTO Assignment, Espacenet|
Nov. 14, 1972 R. E. M OTTIN ETA!- PACKAGE MEANS Filed Sept. 14, 1970 INVENTORS. RALPH E.MOTT|N BY ANTHONY .OLDAN| ATTY United States Patent 3,702,653 PACKAGE MEANS Ralph E. Mottin, Grosse Pointe Park, and Anthony L. Oldani, St. Clair Shores, Mich., assignors to Parke, Davis & Company, Detroit, Mich.
Filed Sept. 14, 1970, Ser. No. 71,851 Int. Cl. B65d 83/04, 85/62 US. Cl. 206-42 9 Claims ABSTRACT OF THE DISCLOSURE SUMMARY AND DETAILED DESCRIPTION This invention relates to novel package means and more particularly to unit dose packaging for the dispensing of pharmaceuticals.
In the prior art solid pharmaceuticals have been available in unit dose packages for distribution to the patient in a hospital or at the bedside. The unit dose packages employed for this purpose have various forms such as printed strips of film-and-foil unit doses. Some of the prior art packages of this type lack adequate labelling so that the nature of the medication dispensed is sometimes open to question. Also, in some cases the packages are not tamper-proof and lack means for assuring in advance that the medication is in agreement with the labelling.
The object of the present invention therefore is to provide a unit dose package which can be dispensed to the patient in a convenient container with complete labelling for the container itself as well as the pharmaceutical dispensed.
Another object is to provide economical unit dose packaging for pharmaceuticals.
Still another object is to provide a unit dose package which is completely ingestible without risk to the patient.
Another object of the invention is to provide pharmaceutical forms which are dispensable in unit doses by mechanical dispensing systems.
These and other objects, purposes and advantages of the invention will be seen from the following description and the accompanying drawing in which:
FIG. 1 is a view in assembly of a cap and body container and a solid pharmaceutical form of a unit dose package according to a preferred form of the invention;
FIGS. 2 and 3 are views of upright and inverted unit dose packages of the invention;
FIGS. 4 and 5 are side views of packages, according to the invention, showing means of sealing the same;
FIG. 6 is a cross-sectional view taken on lines 66 of FIG. 4;
FIG. 7 is an illustration of a preferred way of opening a unit dose package according to the invention;
FIGS. 8a, 8b and 8c are fragmented sections of a package locking construction according to the invention; and
FIGS. 9 and 10 are a plan view and a side view, respectively, of a preferred cartridge for unit dose packaging according to the invention.
Referring to FIG. 1, the unit dose package or container 10 includes a hard shell gelatin capsule cap with a 3,702,653 Patented Nov. 14, 1972 ice telescopically matching body 25. The cap 20 has an open end 21 defined by the cut line 22, a closed end or top- 23 and a cylindrical side wall 24. The body likewise has an open end 26, out line 27, bottom 28 and side wall 29. The matching cap and body join together in conventional fashion to provide a hollow container in which is contained a pharmaceutical form 30 which may be any solid, medicament-including body such as a hard shell or soft shell gelatin capsule, a tablet, pill, etc. The capsule 30, as illustrated, has a conventional cap and body joined together and sealed by a band 32 overlying the cut line of the cap. The capsule has closed ends 33 and 38 and side walls 34 and 39. It is separate from the container 10 and freely moveable on the inside of the container.
In a preferred form of the invention at least one of the parts of the container 10 is clear or light-transmissive or includes a clear or light-transmissive portion. In this way the contents of the container can be readily seen through the wall. One such preferred form illustrated in FIG. 2 has a clear or transparent body; the cap is opaque. Also, the pharmaceutical form 30 (whether a capsule, tablet, pill, etc.) contained in container 10 is shaped, colored and/or labelled by a code which identifies the source, dosage and medication. Correspondingly, the opaque cap 20 has the same information printed in a legend contrasting with the opaque surface of the cap together with indications for administration.
For purposes of definition, the characterizing, informational and medicament-identifying features of the instant unit dose package, howsoever located on the package, will sometimes be referred to as indicia means. As used herein, the term includes manufacturer identity, code numbers or other legend, color codes, design features, color banding, medicament shapes or configurations, lot numbers, dosage symbols, warnings, indications, etc. (see Physicians Desk Reference, s.IV, 1970).
According to the invention, when the container 10 is held upright, as in FIG. 2, the identity of the contents can be checked by comparing the information or indicia means associated with the pharmaceutical form itself with that on the exterior of the container. When the same item is inverted, as shown in FIG. 3, no such comparison can be made. This feature is advantageous for use in dispensing machines where it is desired to display a portion of the contents by window means to the operator but without revealing the complete identity of the article.
In another embodiment the unit dose package of the invention is tamper-proof. In this embodiment the cap and body parts are partly joined as in FIG. 4 so that the side walls 24 and 29 overlap in a double-walled portion 41. The double-walled portion 41 includes a seal 42 located in the overlap, preferably about halfway between the cut lines 22 and 27. The seal 42 is made in the joined capsule conveniently by branding, i.e., by briefly applying a heated wire, probe or similar tool laterally or radially inward upon the wall to cause the Wall to soften or melt and to deform. In particular, the heated end of the tool softens the cap side wall 24 and forms an indentation 42a as shown in FIG. 8a. The tool correspondingly transfers a portion of the wall 24 to wall 29, in the form of a disc-like offset 42b. The latter presses into and cohesively deforms the softened body side wall 29 at interface 420. As the tool is withdrawn, the Weld quickly sets or becomes rigid in the configuration illustrated. The resulting seal locks the parts together so that, prior to dispensing, they cannot be accidentally rotated with respect to each other, joined further, disjointed, or otherwise changed in relative position.
When it is desired to open the container for administration, the same can be accomplished by a shearing movement of the cap and body with respect to each other. This canbe done by manually twisting the cap and body parts against each other or preferably, as illustrated in FIG. 7, by pinching the two parts together to a position (FIG. of more complete joining. This serves to break the seal so that the cap and body parts are freely moveable, radially or axially, with respect to each other. Once the seal has been broken the cap can be readily lifted from the body and the contents dispensed using the body as a convenient carrying cup for administration to the patient. The cap is retained as a record or history of the ultimate disposition of the medication.
As indicated, the container is tamper-proof: once the seal 42 has been broken, whether or not the contents have actually been removed, the visual telltale appearance of the area of the seal demonstrates that the container parts have been disturbed. In particular, the seal will be loose and the parts easy to separate. Furthermore, cursory examination of the body in the seal area 42, as shown in FIGS. 8b and 81:, will show in a typical case that the offset 42b has been fractured leaving a sharp collar 42d on the margin of the seal opening of the cap side wall. In this case the offset itself, adhering to the body, stands out prominently because of its opaque color in contrast to the clear appearance of side wall 29. Also, when the parts are separated and then rejoined, the cut line of the body will invariably catch on the collar 42d. Again, in another case which is common (FIG. 80), fracturing of the seal tears away part of the wall 29 and leaves a hole in both side walls 24 and 29; the disc-like offset 42b is broken loose from both cap and body. To avoid discovery, attempts to reseal an opened container by heat means or other means are generally unsatisfactory since these merely cause the opening in the seal area to become excessively large.
As will be appreciated, the unit dose package of the invention is completely ingestible inasmuch as the container 10 is of pharmaceutical grade gelatin or, if desired, an equivalent substance having the characteristics of gelatin. If by accident the container were to be ingested by an infant, for example, the container itself would be essentially harmless. Such containers produced by the dip molding process in sizes ranging from small (#5) up to large (#000) and larger are commercially available. The containers can also be made available in self-locking form, e.g., of the types described in U .S. Patents 3,399,803 and 3,508,678. For purposes of the invention, the size of the container 10 should ordinarily exceed that of the contained medicament form 30 such that the latter is freely slideable into and from the container. For instance, in one preferred embodiment the form 30 is a #3 banded hard shell gelatin capsule and the container is a #000 capsule. The pharmaceutical form 30 suitably is finished with an exterior surface inert to or compatible with the interior surface of the container 10. Conventional finishes such as sugar coating, talc, enteric coating, etc., may be used, for example.
The invention also contemplates the provision of cartridges 50 containing a plurality of unit dose forms. One preferred cartridge, having an open display surface 50a, is a corrugated paper board of suitable length having a flat base 50b supporting a row of evenly spaced juxtaposed compartments 51 to receive a like number of capsule containers 10 end-for-end. The compartment walls 53 are self-adjustably flexible in relation to each other and are located to receive each container in a snug fit. The fit should preferably be such that the container, once in place, remains stationary, i.e., does not rotate within the compartment. This arrangement permits assembling large numbers of a given size of container 10 on the production line in continuous fashion for handling and stacking (e.g., each cartridge with base down or on edge with the medicament forms 30 partly or wholly viewable) in groups of predetermined number, e.g., ten units each. The cartridge has particular advantage for dispensing from inventory using selection and retrieval hardware. One preferred embodiment shown in FIG. 9 is a cartridge standing on its length edge with its display surface foremost and with its compartments 51 loaded with unit dose packages 10 all positioned with the body 25 down. Preferably the body wall 29 is clear so that the pharmaceutical content 30 is viewable Whereas the cap wall 24 is opaque and is labelled in a color ,contrasting with the opaque wall. Optionally, the packages 10 are locked by heat seal means 42 and each seal is located for viewing at the display surface. For dispensing purposes suitable means can be provided such as selector finger means for dislodging the individual unit dose from an open end 52 of the cartridge as desired. In a large hospital, for example, distribution can be decentralized from a central pharmacy into an appropriate number of satellite centers each equipped with the mentioned cartridge supply hardware containing an inventory of one or more types of unit dose medication according to the invention.
In order to further protect the contents of the unit dose package, the invention contemplates enclosing the container 10 (or cartridge 50, whether singly or in quantity) in a sealing envelope of a sterility-and-moistare-barrier film material such as aluminum foil, polyalkylene plastic film, cellophane, etc. This can be done in any suitable way such as strip packaging for the containers 10 or skin-packaging, thermoforming, etc., for the cartridge 50. For dispensing the unit dose the barrier envelope can be opened by conventional means such as a tear strip, tear notching, end punching, etc.
While the invention has been described in considerable detail in the specification, it will be realized by those skilled in the art that wide variation can be made in such detail within the spirit of the invention claimed below; it is intended that the claims be interpreted to cover both the invention particularly described and any such variation.
1. In a unit dose package for pharmaceutical dispensing,
a cylindrical orally ingestible hard shell pharmaceutical capsule comprising an open-end body part and a telescopically matching open-end cap part adapted for controlled joining together at their open ends in positions ranging from partial to complete joining with side walls of the cap overlapping side walls of the body, the parts being separably joined to form a container and at least one part being opaque and the other part comprising light transmissive wall means adapted for viewing the contents of the joined capsule, the parts further being thermoplastic and sealed in a joined position short of the point of full joining by spot weld seal means comprising local deformation of the overlapping side walls under heat and pressure, the seal in this position being breakable by shearing movement of the cap and body parts relative to each other,
a pharmaceutical within the capsule, in orally ingestible solid unit dose form, the form existing as a single finished mass detached from the capsule and independently moveable therein, and
indicia means integrally associated with the mass, the indicia means being viewable through said light transmissive wall means when the capsule is held upright on one end but being blocked from view when the capsule is held upright in the inverted position.
2. A unit dose package according to claim 1 wherein the pharmaceutical form is a capsule.
3. A unit dose package according to claim 1 wherein the pharmaceutical form is a hard shell capsule.
4. A unit dose package according to claim 1 wherein the pharmaceutical form is a tablet.
5. A package according to claim 1 wherein the capsule comprises transparent body wall means and opaque cap wall means, the opaque wall means bearing indicia contrasting therewith, being correlatable with the indicia means viewable through the transparent wall means.
6. A package according to claim 1 wherein the seal is breakable by converging pressure upon the opposite ends of the capsule.
7. A package according to claim 1 wherein the seal is breakable by manual pressure exerted axially inward upon the opposite ends of the capsule.
8. A combination package for pharmaceutical dispensing comprising a cartridge having a plurality of juxtaposed flexible corrugations defining open-end receiver pockets of uniform dimension, each of the pockets being adapted to receive end-for-end a capsule of the package according to claim 1 and to hold opposite side walls of the same under compressive tension, and a unit dose package according to claim 1 in each of the pockets, whereby the latter package is held in the cartridge prior to dispensing and is removable from the pocket by pushing the same through an open end of the pocket or by lifting from the pocket.-
9. A combination package according to claim 8 wherein the cap and body parts of the capsule of each unit dose package are thermoplastic and are heat-seal joined in a position short of the point of full joining, the heatseal in this position being subject to breakage by converging pressure exerted axially inward upon the opposite ends of the capsule.
References Cited UNITED STATES PATENTS 1,774,258 8/1930 English 20647 A 3,472,368 10/1969 Hellstrom 206S6 AA 721,880 3/1903' Fitch et al. 206-DIG. 29 1,863,001 6/1932 Barok et al. 20656 AA 2,767,532 40/ 1956 'Bossi 206--65 A 1,259,964 3/1918 Davis 128--272 2,302,933 11/1942 Barol 2l56 2,102,885 12/ 1937 Carroll 20646 CC WILLIAM T. DIXSON, JR., Primary Examiner US. Cl. X.R.
20656 AA, 65A; 220-27 1
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|US3783998 *||Mar 22, 1972||Jan 8, 1974||Sherwood Medical Ind Inc||Sampling syringe|
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|DE2341103A1 *||Aug 14, 1973||Dec 19, 1974||Parke Davis & Co||Pharmazeutische kapseln|
|DE9109207U1 *||Jul 25, 1991||Nov 26, 1992||Thera Patent Gmbh & Co Kg Gesellschaft Fuer Industrielle Schutzrechte, 8031 Seefeld, De||Title not available|
|EP0435726A2 *||Dec 12, 1990||Jul 3, 1991||Bristol-Myers Squibb Company||Capsule and caplet combination|
|U.S. Classification||206/534, 206/459.5, D24/104, 206/539, 220/265, 206/807, 220/DIG.340, 206/530|
|International Classification||A61J3/07, A61J1/03|
|Cooperative Classification||A61J1/03, Y10S220/34, A61J3/071, A61J3/072, Y10S206/807|
|European Classification||A61J3/07B, A61J3/07B1, A61J1/03|