Note: Descriptions are shown in the official language in which they were submitted.
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B~D~GE FOR THE TOPICAL ADMINISTRATION OF
CONTROLLED AMOVNTS OF NITROGLYCERIN OINTMENT
Back~round of the Invention
Topical application of nitroglycerin to the skin
for the treatment of both Raynaud's disease and angina pectoris
is well known. Several investigators have described sub-
stantial improvement in the acrosclerosis associated with
Raynaud's disease resulting from nitroglycerin.
The treatment of angina pectoris with nitroglycerin
or rapid acting nitrites has been described by Davis et al in
the American Journal Df the Medical Sciences, Vol. 230, No. 3,
September, 1955. In this article, the authors suggested that,
nitroglycerin ointment, because of the slowed absorption through
the skin, might result in the superior vasodilating e-ffect of the
nitroglycerin being prolonged in relation to coronary circula-
tion. They reported that the results were dramatic and con-
vincing enough that they have instituted nitroglycerin ointment
treatment on a regular basis.
Summary of the Invention
It is an object of this invention to provide a bandage
for the continuous administration of a predetermined quantity
of nitroglycerin, through the skin, over a period of time.
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~ nother object of the inventi~n is to provide a
bandage in which the quantity o~ nitroglycerin ointment can
be easily deter~ined and controlled.
In accomplishing these objects, one feature ~f the
invention is the preparation of a bandage that includes an
external moisture-impervious backing and a smaller internal
backing having calibrations thereon. The calibrations may
be of different types and afford the doctor and patient a
convenient and accurate method of measuring the amount of
nitroglycerin ointment applied to the bandage. The surface area
of the internal backing of the bandage is set so that a thera-
peutically useful amount of drug will be delivered transdermally
to the patient after the drug has been measured onto the internal
backing and the bandage applied to the skin of the patient. The
internal backing is surrounded by an adhesive layer applied to the
external backing and is covered with a detachable or releasable
backing that can be removed to expose the adhesive layer for
convenient attachment to the skin. The bandage may also include
a removal tab to simplify stripping the bandage from the skin.
Brief Description of the Drawings
Figure 1 is a front view of one embodiment of the
bandage of the instant invention showing one type of calibra-
tion on the internal backing and one type of release backing.
Figure 2 is a rear view of the bandage of Figure 1.
Figure 3 is a perspective view of the bandage of
Figure 1 with the release backing removed and the adhesive
layer exposed.
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Figure 4 is a front view o~ anather embodiment of
the instant invention sho'wing another' type Qf calibration
on the internal backing and another type of release backing.
Figure 5 is a perspective view of the bandage of
Figure 4 with the 'release backing removed ~nd the adhesive
layer exposed and with nitroglycerin ointment applied to the
internal backing.
Figure 6 is a front view of still another embodiment
of the bandage of the instant invention.
Detailed Description of the Invention
In accordance with this invention, there is provided
a bandage suitable for retaining nitroglycerin ointment used
for topical treatment of Raynaud's disease and angina pectoris.
Normally, a 2% nitroglycerin ointment is used.
To use the bandage the desired amount of nitroglycerin
ointment is conveniently extruded from a tube onto the calibra-
ted area on the internal backing. The dosage of nitroglycerin
ointment may be controlled conveniently by extruding a pre-
determined length and width of the nitroglycerin ointment as
measured by the calibration on the internal backing.
After the desired amount of nitroglyce~in ointment
has been applied to the internal backing, the release backing
surrounding the internal backing is removed to expose the
adhesive layer.
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The bandage is then applied to the skin of the patient
and pressed dow~ firmly to assure that the adhesive i~
attached to the skin.
At the end of the treatment the bandage can be removed
S by grasping a skin removal tab at the edge of the bandage and
separating the band~ge from the skin.
Figures 1 and 2 are front and rear views of one
embodiment of the bandage 10 of the invention. The bandage
comprises an overall backing 14, an internal backing 12
secured to one side of the overall backing 14 and a release
backing 11 releasably secured to the overall backing 14 about
the perimeter of the internal backing 1~. The internal
backing 12 and release backing 11 may be secured conveniently
to the overall backing by-first applying a releasable adhesive
to the entirety of one surface of the overall backing 14 and
then applying the internal backing 12 and releasable backing 11
to the adhesive surface. A portion of the adhesive surface 15
applied to the overall backin~ 14 is shown in Figure 3.
The overall backing 14 is a conventional polymeric
plastic film such as a vinyl film commonly used in bandages.
The adhesive layer 15 should be composed of a hypo-
allergenic material such as an acrylic adhesive commonly used
in adhesive coated bandages.
The releasable backing 11 may be composed of paper
material having a conventional silicone-containing release
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material on the surface thereof in contact with the adhesive
layer 15. The releasable backing 11 has a cut 20 to permit easier
removal o~ the releasable backing from the adhesive layer 15.
The internal backing 12 may be composed of the same
paper material as the releasable backing 11. The paper material
should alow only minimal absorbency of the nitroglycerin
ointment.
Calibration indicia are printed on the exposed sur~ace
of the internal backing layer 12. Figures 1 and 3 illustrate
one form of the calibration indicia for measuring the amount
of nitrQglycerin ointment to be applied to the internal backing
layer 12.
Figures 4 and 5 illustrate another embodiment of the
bandage 10. The features of this embodiment, which are the same
as the features of the embodiment illustrated in Figures 1 to 3,
are identified by the same numerical designations. In the
embodiment illustrated in Figures 4 and 5, the cut 21 in the
releasable backing member 11 is located at a corner of the
bandage to facilitate removal of the releasable backing 11 from
the adhesive layer 15. Also the calibrated indicia comprise two
spaced parallel lines with calibrations in inches on one line and
in centimeters on the other line. The width of the space
between the lines is generally the width of the ointment tube
opening and the ribbon of nitroglycerin ointment, thereby ;
allowing exact measurement of the dose with minimum variabi-
lity. The ribbon of nitroglycerin ointment 18 is applied
between the two parallel lines as is illustrated in Figure 5.
Figure 6 illustrates a further embodiment of the band-
age 10. In this instance the releasable backing 11 surrounding
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the internal backing 12 is narrower than the releasable backings
illustrated in Figures 1 and 4 such that the overall backing 14
extends beyond the perimeter of the releasable backing 11. The
adhesive layer applied to the overall backing 14 does not extend
5 . ~eyond the perimeter of the releasable backing 11 to provide a
continuous tab about t~e perimeter of the overall backing 14
which may be gripped easily t~ strip the bandage from the skin.
The cut 2~ in the releasable backing 11 is located intermediate
opposite ends of the banaage.
Production of bandages in accordance with the present
invention is carried out by coating vinyl film with a hypo-
allergenic medical grade adhesive and then laminating the coated
vinyl to a release coated paper liner. The vinyl/adhesive/release
liner is wound into rolls, cut to width and rewound into rolls.
The rolls are then appropriately printed and die cut. Differential
die cutting is performed so that a band of releasable paper back-
ing 11 can be peeled away to expose adhesive whereby the bandage
can be secured to the patient. Differential die cuts 20, 21, or
22 are made to facilitate the removal of the releasable backing 11.
The bandages may be die cut so that they are produced in individual
units; or perforations may be cut between individual bandages so
that a roll of bandages can be produced such that as a bandage is
needed it is torn away from the roll along the perforations.
Obviously, modifications and variations of the inven-
tion may be made without departing from the essence and scope
thereof, and only such limitations shall be applied as are
indicated in the appended claims.
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