Note: Descriptions are shown in the official language in which they were submitted.
CA 02595110 2007-05-22
PRIMARY pA.CKAGING UI'tiT FOR FLAT FORMS OF
A.DMa,~iYSTRATI ON
The present invention rolates to a primary packaging unit for flat
forms of administration with active ingredients. In particular, it relates to
a primary
packaging unit in card form, wbich is formcd by a varying number of flat forms
of
adminisfiratior,, r~'vhieh are to be paclcaged, a section of a rigid sbeet of
pAckagiztg
mator.ial, on which the individual flat f'orms of adrtministration are applied
on both
sides and form each case one or more sections of a thin upper and lowGr sheet
of
packaging material.
Within the meaning of this application, examples of flat forntis oF
administration are, for instance, cosmetic, medicinal or active ingredient-
containing
band-aids, such as awart band-aids, insect bito band-aids or nail band-aids,
muco-
adhesive band-aids or oral mouth filrns.
The latter are thin filma or platelets for an oral application, which
dissolve upon contact with saliva. For this reason, no beverage is requivred
when
these niouth filtns are ingested. This forr.c of medicinal drug is therefore
particularly
suitable when traveling or for activities or situations, whe7t it is
clesirable to bc able
to take the medication quickly and eonveniently without a liquid.
The fact that these fotms of administration offer rapid help, especially
when away from home, for exarnple, when traveling, is a property, whicli is to
be
emphasized and is ii common fcature of all forms of ldministration, which comc
under tho heacling of f]at fornzs of admioistration within the mEaning of this
appli,cation. Idea)ly, these forms of adminisrration can be carried along
conveniently
and unobtrusively ready, as well as at hand, at all times on the person of the
user, i'or
example, in a money purse or in a shirt pocket or trouser pocket.
Nevertheless, since the foim of administration mav be a medicinal
drug, each dose mtist be packaged individually.
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CA 02595110 2007-05-22
Moreover, because of the special ratio of thickress to area of said
forsrrs of administration, a thin, flat packagixtg suggests itself.
A start fox solving the problem of cteating such a primaty packaging
unit is found in the DE 298 23 463 U1. Nevertheless, this application,
although it
describes the prior art that comes closest to the present inLGntioa, does not
fulfill all
the requiremcnts, which must be met by a primary packaging unit, which is
intended
for and therefore particularly suitable for the purpose described above.
On the one h,and, the prxmary packaging tinit proposcd there consists
ottly of one section of an uppcx and a lower sheet of a packaging niaterial,
so that the
area of the ptimary packaging unit, wh4th is available, is used onlv on one
sidc. As a
result, in coinparison to the invention described hcre, twice the area of the
primary
packaging unit is required for the same size of the individually packaged,
flat fonn$
of adxninistration. If a meaningful number of individual doses of flat forzns
of
administration of a particularly preferred size of 4 - 7 cm2 arc to be carried
along,
this leads to a package unit, which is so rarge, that it can no longer be
carried
convcniently on the person of the user without bending or buckling, which
could
cause the integrity of the packaging and, with that, of the fonn oi
xdministratioTi to
be lost.
Moreovcrr, the perforations, which are provided in the DE 298 23 463
U1 betweem the compat-tcnEntS, in which the individual forms of administration
are
Located, and which enable the i,ndividual compardxyents to be detaclicd Nvhen
required, prove to be unsuitable for t'he purpose, ott which this invention is
based.
Due to the perforations, the sti,ffnoss of the primary packaging unit
inevitably is lost,
so that, especially under a mechanical stress, 'the bcnding and pulling apart
into the
individual compat'tments, which have already been described previously, easily
comc about, so that it is no longer possible to carry this pack:tgina urit
olortg ]ooselv.
Furthecmore, it is regarded as rather impractical, if individual
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compartments of'the pritnary packaging unit can be detached since, as a
result, there
is no active control over the individual doses already used. For.example, in
the casc
of a rnedical, drug, which is to be used no more than three times daily, it is
difficult to
detetmine how many individual doses have alrcady been ttsed during a day, if
it is
possiblc to detach only one or two Sttoh compartments and to carry them along.
It is therefore an object of the prese t invention to create a primary
packaging unit for flat forms of administration with active ingzedients, which
satisfies all the aforementioned requirements, without having the
disadvantagcs
described.
This objective is accomplished by making available a primary
packaging unit for flat forms of administration (Figure 2, 4) with, a section
of a rigid
packaging material middle sheet (Figure 2, 1) and with, in each case one or
more
sections of a flexible packaging matezial upper and lower sheet (Figure 2, 2),
which
is characterized in that the rigid middle shect of packaging material, on
either side of
which a vaX;,able number of flat fotms of administration may be applied
(Figure 2b),
may be combined, by sealing or gluing, on the one side witlz one or more
sections of
a flexible sheet of packaging material and, on the opposite side with onc or
more
sections of a flexible sheet of packaging material into a unit in such a
manner, that a
stable, yet flexible card, which is not more than I n1m thick, is obtained,
for which
the flat forms of administration arc and remain packaged individually, even if
one of
the several forms of administration is removed, without tlze card having
pexForations
betwcen the ii-xdividually packaged forms of administcatiori.
This combination of distinguishi,ng features is neccssaty, in order to
ariive at the required, practicable primary packaging unit in a card format,
which is
refcrred to in the following as R,apidcard.
In principle, a Rapidc2.rd of any convenient size is possible.
Howeve=r, an embodiment, which corresponds in its dimensions to a credit card,
as
shown in Figures 1 and 2, is particuIarly preferred. These standard dimensions
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enable the Rapidcard to be carried conveniently in the breast pocket of a
shirt, the
back pocket of trousers or in the money purse.
ln a preferred embodiment of the credit card format, a variation is a
specialty prefErrcd, for which 2-10 flat forms of administration, having an
irea of 2-
crn~ and preferably 3 flat forms of administration, having an area of 4-7
ernY, can
bc packaged on aach side of the card.
An inventive example of a variation with 6 rectar,gular flat forms of
administra,tion having an area of, 6 cm2 is given in Figures ] and 2 and
described in
gxeater detail itt the following, without thereby iimiting the already listed
possible
variations in any way.
The l,tapidcard is eharaeterized in that 6 rectangular flal forms of
administration, having an area of 6 cm=, are applied on a sealablc, flat,
stiff middle
sheet of packaging rnaterial, having a maximurn thickness of 0.6 rnm (Figure
3,
rcferred to, in the following, as carrier sheet), for exunple, of PE, PP, PVC,
PETG.,
PETGAG, COC or multilayer laminates, such as PE/paper/PE, PE/PVC/PE etc.
Moreover, in each oase 3 forms of administration are applied on the
front side as well as on rhe back side,of the carrier sheet in such a way,
that thcy do
not mutually touch olie another and that theTe is sufficient distance bem~cen
them, in
order to enclose eorrzpletcly cach form of adininistration individually by
scaling or
g,luing it onto one or more scctions of a~lexible upper or lower sheet of
packaging
material and, with that, protect it against extemll influences (carnpare
Figure 2b).
A flat, thin materigl, which has a maximum tluclmess of 0.2 mm and
represents a barrier for the moisture arad oxygen of the air (Figura 2; 2 and
rigure 4,
referred to in the following as protective film) is used as the upper and
lower sbcet of
packaging nzatetial respectively. After thc sealing or giuing, this material
must bavc
the property of peelability, that is, after one or several sections of this
protective fllm
h-ave been scaled or glued onto the rigid csrrier shect, it must be possiblL
to pull it off
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again from the carrier sheet at a later time with little expenditurc of forcc,
in order to
remove the corresponding form of administration. For tivis purpose, fiirn-like
matcriaIs with diffbren,t barrier properties corne into consideration,
depend'uib on the
properties of the fozms of adm.inistration, which are to be packagcd. For
example, a
tra.nsparcnt film having barrier properties with respeet to the humidity of
the air, sucli
as pEIPCTk'~lPE, can be used if the product is to be seen and thcrc is no
light
sensitivity. In order to be a sufficient barrier for water vapor, the pC1'pE
aiust havc
a minimum sickness of 54 r,a.
If the product is light sensitivc, a film car, be ttsed, which is colored or
coated or contains an aluminum layer and by means of which, aside from
pTotection
against life, tberc is also protection against rnoisture and oxygen from the
air.
-rhe 3 flat forms of administration on each side of the cairier sheet are
now sealed with the protective film or the latter is glued. on in such a
manneT, that
each form of administration is enclosed cornpleteIy, on all sides, and sealed
frorri its
environment, without parts of the form of administration being enclosed in the
sealing scam or adhesion surface (Figure 2, 3) between the carrier sheet and
thc
protectivc film. Yn Figure 5, the adhesion or $caiing stiirfaces are shown in
a rccl.
The machine parameters during the sealing or gluing process, as well
as the width of the sealing seam or adhesion surfacc, obtained during the
corresponding process, are selected so that the product is protected
efi7cicntly against
external, stability-affecting factors for the pEriod of the shelf life that
has beett
determincd an.d that neverthelcss, at a later time, a simple opening of the
sealing
seam or of the adhesion surfaoe for retnoval is possible.
Unless this is already possible due to the nature of tlsc scnling or
adhesion process, the section or sections of the protective film are to be
procEsscd
ntrthcm-tore in such a manncr, that it is possible to open the sealir,g kearr
or adi-icsion
surface of only one individual form of adnainisuation and to renzove the
latter,
without thereby opening: or damaging the protective packaging of a
rieighboring
CA 02595110 2007-05-22
form of administration. Tltis can be achieved, for example, owing to the fact
that thc
protective film has a notch between the individual forms of administ,ration
(Figtire 2,
S).
Moreover, the protective film may be configtlred so that it has a tcar.-
open tab for each individual form of administration in order to sirnplify the
opening
process (Figure 2, 2). Such a tab represents part of the protective film,
which is in
direct contact with the individuatly packaged form of administration, biu is
not
connected with the carrier sheet by scaling, adhesion or other measures and,
instead,
rests loosely on the carrier shcet. By lifting this tap artd pulling in the
direction of
the lower edge of the card, the sealing seam or adhesion surface of the
corresponding
rcgioti of the card can be opened and the flat form of administration removod.
Instead of a tear-open tab, a predetermined breaking point may also be
provided
here.
The carrier sheet, as well as the protective films may, if t-equirect, be
printed with information (Figurc 1).
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