Note: Descriptions are shown in the official language in which they were submitted.
1640
The present invention provides a novel pharmaceutical
composition for use in treating viral infections in mammals, of
the herpes viral family or common cold virus, by topical
application to the external site of the infection. The
composition comprises simple, economical ingredients in
specified proportions, is safe and easy to prepare and apply, by
the patient, and provides rapid alleviation of symptoms and
sufferings of such virus infections.
Thus according to one aspect of the present invention,
there is provided a pharmaceutical composition for use in
topical application to alleviate virus infections of the herpes
family of viruses and common cold virus, which comprises from
about 2.5 to 5.0 parts by weight of glycerine, from about 1 to
about 10 parts by weight of ethyl alcohol, and from 0 to about l
part by weight of a physiologically acceptable alkali metal
halide salt.
Preferably, such formulations are provided in a
pharmaceutically acceptable carrier base. In a preferred
embodiment of the invention, a liquid formulation is used, in
which the above ingredients are dissolved in water, a suitable
amount of water for use with the above formulation being from
about 80 to about 120 parts by weight. The ingredients dissolve
readily in water in the required amounts. It is, however,
preferable that the solution o the pharmaceutical composition
as above be relatively freshly made up, e.g. within about four
weeks of use, since glycerine when used in amounts towards the
upper limit of the specified range tends to come out of solution
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after a period of time, unless the solution is kept ~n a cold
environment.
The above formulation may also be prepared as a cream,
using a standard cream base as carrier, including
physiologically acceptable waxes, gums, emollients and the like,
as is well-known in the art. A suitable relative amount of
carrier to form a cream with the formulation of the invention is
in the range 80-120 parts by weight.
The formulation according to the present invention may
of course include other physiologically acceptable, inert
ingredients in addition to those specified above, to improve the
esthetic qualities thereof. Thus, colorants, perfumes, etc.,
may be added, in amounts sufficient to impart esthetic quality
improvements thereto, but not sufficient to interfere with the
general effectiveness of the composition.
According to a further aspect of the present invention,
there is provided a prccess for treating viral infections in
mammals, which comprises the topical administration to the
virally infected site of the mammal of an effective amount of a
pharmaceutical composition comprising from about 2.5 to about 5
parts by weight of glycerine, from about 1 to about 10 parts by
weight of ethyl alcohol, and from about 0 to about 1 part by
weight of a physiologically acceptable alkali metal halide salt.
For treatment of cold virus infections with
compositions according to the present invention, it is preferred
to use a liquid, solution formulation, and to apply it as nasal
drops, deposited into the nostril of the patient, and thence
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into the nasal and post-nasal passageways. Suitably, the
sufferer applies about 1-2 cc of the liquid solution formulation
e.g. from a dropper, directly into the nostrils, initially at
intervals of about 1 hour, but gradually decreasing the
frequency of application, e.g. to 2 hours or longer, as the
symptoms of the cold virus infection start to recede. In
practice it is found that the patient's discomfort resulting
from the cold viral infection is effectively completely
alleviated after about 48 hours of the above treatment with the
formulation according to the present invention.
In treating the sore or blister manifesting a herpes
viral infection, either liquid or cream formulations can be
suitably used. The liquid formulation is suitably applied, at
room temperature, by means of a swab or other suitable
applicator, to the location of the infection. Such application
to the location is repeated at intervals of about 1 hour, until
the patient experiences an alleviation of the pain and can
observe a reduction in the size and swelling of the sore,
whereupon the frequency of dosage can be reduced, e.g. to
intervals of about 2 hours. Quicker and more effective
treatment is obtained, of course, if applications start during
the early visible manifestations of the infection. If
application of the formulations according to the invention
commences before the sores or blisters burst, a noticeable
decrease in the swelling and a substantial relief of the
discomfort is obtained after about 24 hours, whereupon the
frequency of application can be reduced. After three days, with
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very infrequent application during the third day, th~ visible
and painful manifestations of the infection have normal~y
disappeared.
If, however, treatment with the present composition
does not commence until the viral infection has progressed to
the stage where the sores or blisters have burst, treatment
takes somewhat longer. Once again, it is suitable to apply the
composition to the infected area at intervals of about 1 hour
initially, whereupon the sores normally dry, crust and start to
shrink 24 hours, and complete disappearance of the external
manifestations is obtained in 3-4 days, normally.
The glycerine in the formulation is believed to perform
the function of maintaining tissue flexibility, and increasing
the permeability of the cell membrane (surface vulnerability) to
allow ready entry thereto of the ethyl alcohol, active
ingredient. The glycerine prevents irritation from the
alcohol/salt mixture. Less than about 2.5 parts by weight is
ineffective in this purpose, but the upper limit of glycerine in
the composition is largely determined by the solution stability
and solubility of the glycerine in the chosen medium, rather
than by reasons of technical effect. Of course, glycerine
should not be used in such large amounts, even in a cream
formulation, that it effectively masks the effect of the
composition as a whole.
Whilst it is not intended that the invention should be
limited to any particular theory of operation, it is believed
that the compositions of the invention have an effect on the
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interferon secreted by the applicable body cells. The
composition, especially the ethanol, appear to stimulate
appropriate interferon secretions from the virally infected
cells, at least to assist in combatting the virus therein.
It is preferred to include an alkaline metal halide,
preferably sodium chloride, in a liquid formulation according to
the invention, so as to maintain proper saline compatibility
with the body fluids. The preferred amount of sodium chloride
is in accordance with standard medical practice in
administration of saline solutions, to produce an isotonic
solution, e.g. approximately 0.9% by weight of sodium chloride,
in the total liquid solution. A preferred formulation according
to the present invention comprises from O to 1 parts by weight
of sodium chloride, from about 3 to about 5 parts by weight of
glycerine, and from 3 to about 5 parts by weight of ethyl
alcohol, along with approximately 90-100 parts by weight water,
to make a homogeneous aqueous solution.
In making the aqueous solution formulation according to
the present invention, no special temperatures or mixing
equipment are necessary. Initially the salt and water are mixed
together, then the alcohol is added, and finally the glycerine.
Standard mixing and agitation techniques can be employed, to
obtain a homogeneous solution, storable for up to 4 weeks
without apparent loss of efficiency.
The invention is further illustrated in the following
specific, non-limiting examples.
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EXAMPLE 1
An aqueous solution according to the invention was made
up of the following ingredients:
0.9 parts by weight sodium chloride;
3 parts by weight glycerine;
4 parts by weight ethyl alcohol;
92.1 parts by weight water.
The ingredients were mixed in a standard mixing vessel,
and a homogeneous solution prepared at room temperature by
stirring agitation. The solution was then used to treat viral
infections in humans, as described in the subsequent examples.
EXAMPLE 2
An adult male suffering from a common cold, manifested
by constricted and inflamed nasal and sinus passages and other
well known symptoms of a cold, administered to himself the
composition as described in Example 1. Administration was
performed topically, by filling a dropper with about 1 cc of
formulation and depositing it into each nostril, and then
working the composition into the nasal and post-nasal passages.
This treatment, administration of 1 cc to each nostril from a
dropper, was repeated at approximately 1 hour intervals. After
a few hours, the patient noticed a significant improvement in
terms of the constriction of his nasal passages and other
painful symptoms resulting from the cold, and thereby decreased
the frequency of dosage to intervals of about 2 hours, further
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decreasing the frequency as the symptoms became alleviated.
After 48 hours the patient reported that all symptoms
and manifestations of the cold had disappeared, and he felt and
appeared completely cured.
EXAMPLE 3
An adult male human sufferer with herpes simplex type I
viral infection, manifesting itself in a lip sore, treated the
sore with the composition described in ~xample 1. Treatment
commenced at the first noticeable development of the lip sore,
when inflammation and swelling first became apparent before
bursting had occurred, by application of the composition from an
absorbent swab, at intervals of 1 hour. The pain and swelling
soon began to decrease, with the repeated hourly treatment. By
the following day, there had been a noticeable decrease in this
swelling and a considerable relief of discomfort, so that the
frequency of application of the composition was reduced to
intervals of two hours. The improvement continued and the
frequency of application was decreased therewith, until, after
72 hours from the commencement of treatment, the sore resulting
from the viral infection had totally visably disappeared and the
patient reported no residual discomfort.
EXAMPLE 4
A child of approximately 6 years of age reported for
treatment with extensive HSV I infections manifesting themselves
in a plurality of sores and blisters in the mouth area, some of
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which had burst. The sores were treated topically with the
liquid composition of Example 1, lnitially at intervals of 1
hour, and subsequently, as the sores began to dry and reduce in
size, at intervals of two hours. The patient was reported to
have made an excellent recovery, with all blisters and sores
effectively disappeared, after about 4 days of this treatment.
EXAMPLE 5
An adult female patient suffered from HSV II infection,
diagnosed as such by a gynecologist, and manifesting itself in a
sore/blister in the vicinity of the patient's hip. This was
reported to be a recurrence of a previous manifestation of HSV
II infection in its active state. The hip sore was treated with
the formulation described in Example 1, by topical application
from a soaked swab of the formulation, at hourly intervals,
gradually decreasing the frequency of application as the
condition of the sore improved. After three days of such
treatment, the patient reported that the sore was completely
cured.
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