| United States Patent |
5,683,712 |
| Cavazza |
November 4, 1997 |
Medical device for the administration of active ingredients or drugs at very
low doses, and particularly of homeopathic drugs, comprising a transdermal patch
with a support membrane, a layer of porous adhesive, a microporous membrane and
a gel containing the homeopathic drug to be administered.
| Inventors: |
Cavazza; Paolo (Rome, IT) |
| Assignee: |
Avantgarde S.p.A. (Rome, IT) |
| Appl. No.: |
528162 |
| Filed: |
September 14, 1995 |
| U.S. Class: |
424/449; 424/448 |
| Intern'l Class: |
A61F 013/02 |
| Field of Search: |
424/448,449 |
References Cited [Referenced
By]
U.S. Patent Documents
| 5330756 |
Jul., 1994 |
Steuart et al. |
424/405. |
Primary Examiner: Venkat; Jyothsna
Attorney, Agent or Firm: Oblon, Spivak, McClelland, Maier & Neustadt,
P.C.
Parent Case Text
This application is a Continuation of application Ser. No. 08/291,030, filed on
Aug. 16, 1994, now abandoned.
Claims
1. A transdermal patch, comprising:
a) a porous adhesive layer for contacting skin epidermis;
b) a first gel layer containing a homeopathic drug on said porous adhesive
layer;
c) a second gel layer containing said homeopathic drug on said first gel layer;
d) a microporous membrane between said first and second gel layers for
controlling release of said homeopathic drug from said second gel layer into
said first gel layer such that the concentration of said homeopathic drug in
said first gel layer is lower than the concentration of said homeopathic drug in
said second gel layer; and
e) a support membrane on said second gel layer.
2. The patch of claim 1, wherein said first and second gel layers contain
glycerin, water, lactose, poly(vinyl)alcohol, poly(vinyl-2-pyrrolidone) and
sodium citrate.
3. The patch of claim 1, wherein said porous adhesive layer is a silicone
adhesive.
4. The patch of claim 1, wherein said support membrane defines the outer surface
of said transdermal patch.
Description
The present invention relates to a medical device for the administration of
drugs or active ingredients at low concentrations, and particularly for the
administration of homeopathic drugs.
As is well known, homeopathy
is a therapeutic approach based on the concept that disease conditions should be
cured by administering drugs which, in healthy people, induce a symptom picture
similar to that manifested by the disease one intends to treat. Also typical of
homeopathic treatment is that extremely low, and sometimes infinitesimal doses
of the homeopathic remedy must be given in order to induce the desired
therapeutic effect, whereas high doses of the same drug would actually cause the
symptom picture of the disease one is seeking to cure.
Homeopathic preparations are traditionally prepared by means of a method (called
"potentization") consisting in a succession of dilutions and
succussions of the drug solution; part of the drug (of a vegetable, animal,
mineral or synthetic nature) is dissolved (or ground according to the substance)
in nine parts of distilled water or alcohol and the resulting mixture is shaken
vigorously. Nine parts of this initial solution are taken and diluted with nine
parts of water or alcohol and the resulting second diluted solution is again
subjected to vigorous succussion. This stage of dilution and succussion can
subsequently be repeated several times. Standard potentization levels include
the 3.times. (three times), 6.times., 200.times., 1000.times. dilutions, etc. A
homeopathic preparation therefore presents itself generally in the form of an
extremely dilute solution (aqueous, alcoholic or hydro-alcoholic) of active
ingredient.
This type of pharmaceutical formulation severely conditions the mode of
administration of homeopathic preparations, limiting it to the oral
administration of a number of drops of solution, repeated at one-hourly
intervals or, at least, several times a day. Furthermore, to achieve maximum
efficacy, the drops of solution must be placed under the tongue and held there
for a certain amount of time before being swallowed. For example (see
"Applied Homeopathy"
by R. Jacobs and M. E. Pinkerson. Homeopathy
Press, Santa Monica, Calif., 1983), 10-15 drops of a homeopathic drug for the
treatment of neuralgia and sciatica (consisting of Belladonna 6.times., Spigelia
6.times., Mag.phos. 6.times., and Cimifuga 6.times.) are administered until
symptoms are reduced and thereafter the same dose is given 4 times daily until
symptoms disappear, holding the solution each time under the tongue for 30
seconds before swallowing it. It will be noted that, though it is advisable to
spread the drops of the homeopathic preparation under the patient's tongue, this
is still a form of oral and not a form of percutaneous administration, as occurs
with sublingual tablets, inasmuch as the solution is actually swallowed after a
short space of time.
Sublingual tablets are also used for the administration of homeopathic drugs and
present the same drawbacks as already described for solutions.
It is clear that these administration methods, and in particular the need for
frequent administrations and for holding the drops of the preparation or the
sublingual tablets under the tongue make compliance difficult for any type of
patient and particularly difficult for disabled persons, elderly patients and
children.
The aim of the invention described herein is to provide a means or, to be more
precise, a medical device for the administration of active ingredients or drugs
at very low doses, particularly homeopathic drugs, which overcomes the drawbacks
mentioned above. According to the invention, the homeopathic drug is
administered via the trandsdermal route by means of a patch which is applied to
the skin in a preselected area of the body. The structure of an example of a
trandsdermal patch which can be used to achieve the aims of the present
invention is illustrated in the figure attached hereto. With reference to the
figure, which represents the patch in the position of use, i.e. as applied to
the patient's skin, the transdermal patch presents a sandwich-type structure
with support membrane 1 on the outer surface of the patch distal to the
patient's skin and a layer of porous adhesive (e.g. silicone) 3 on the opposite
side which defines the contact surface of the patch with the epidermis 4 of the
area of the body chosen for the application.
Between support membrane 1 and porous adhesive layer 3 there is a microporous
membrane 2 which controls the release of drug 5. Drug 5 is scattered in a gel
consisting of glycerine, distilled water, lactose, poly(vinyl alcohol),
poly(vinyl-2-pyrrolidone) and sodium citrate. To be more precise, the gel zone
6a situated between support membrane 1 and microporous membrane 2 acts as a drug
reservoir so that the concentration of drug in this zone is maximal, whereas, as
a result of the effect of membrane 2, the drug concentration in gel zone 6b
below the membrane is lower, while the drug concentration in the subcutaneous
zone 4a is even lower owing to the regulatory effect which the skin itself
exerts on the spread of the drug. (In the figure, the progressively decreasing
concentration of the drug in zones 6a, 6b and 4a, respectively, is represented
schematically by a correspondingly decreasing density of dots denoting molecules
of drug).
To sum up, then, the medical device for the administration of active ingredients
or drugs at very low doses, and particularly of homeopathic drugs, according to
the invention consists in a transdermal patch characterized by the following
components:
a) a support membrane 1 defining the outer surface of the patch distal to the
skin area chosen for the application;
b) a layer of porous adhesive 3 on the opposite side of the patch defining the
contact surface between the patch and the skin 4;
c) a microporous membrane 2 for controlling the release of the drug, placed
between support membrane 1 and porous adhesive layer 3; and
d) a gel 6 containing, scattered within it, the homeopathic drug 5 to be
administered.
The microporous membrane 2 defining, above it, a gel zone 6a acting as a
reservoir for the drug, and, below it, a gel zone 6b in which the drug
concentration is lower than that in zone 6a.
The patch can be applied on any suitable skin area, chosen, among other things,
in relation to the symptom picture to be resolved, if possible hairless,
avoiding skin folds and areas of scarred, burnt or irritated skin.
There can be no mistaking the substantial advantages to be gained with this
administration device compared to the traditional mode of administration of
homeopathic drugs:
(1) it avoids the need for multiple, repeat administrations in the course of the
day at short intervals one from another;
(2) mono-administration and, above all, not having to hold the preparation
(whether in solution or sublingual tablet form) under the tongue enormously
facilitates patient compliance, particularly in the case of disabled persons,
elderly patients and children;
(3) compliance is also facilitated by the fact that the patient does not have to
make any kind of effort of will or take part actively, since, particularly in
the case of disabled persons and children, the application of the patch on the
patient's skin can be done by some other person;
(4) administration of the drug can be interrupted at any time it may be so
desired;
(5) the administration is more effective owing to the slow release of the drug.
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