U.S. patent application number 10/639585 was filed with the patent office on 2004-06-24 for composition.
This patent application is currently assigned to MEDIHONEY PTY LTD.. Invention is credited to Moloney, Anthony Peter.
Application Number | 20040121020 10/639585 |
Document ID | / |
Family ID | 27809831 |
Filed Date | 2004-06-24 |
United States Patent
Application |
20040121020 |
Kind Code |
A1 |
Moloney, Anthony Peter |
June 24, 2004 |
Composition
Abstract
A therapeutic composition is described comprising honey or a
honey derivative, a fatty ester wax or wax-like compound and a
surfactant. The honey or derivative may comprise a single type of
honey or may be a mixture of two or more different types of honey.
The fatty ester, wax or wax-like compound preferably has a melting
point around 45.degree. C. or less and most preferably between 40
and 43.degree. C. The wax may be myristyl myristate. The surfactant
is preferably ethoxylated sweet almond oil but may also comprise
ethoxylated caster oil and ethoxylated evening primrose oil. The
preferred embodiment comprises honey or honey derivative 80%,
myristyl myristate 15% and ethoxylated sweet almond oil 5%. The
invention extends to a method of producing a therapeutic honey
composition by heating the honey to a temperature that will not
cause degradation of one or more functional enzymes of the honey,
combining wax and surfactant by heating and mixing and cooling the
mixture before mixing it with honey. The maximum temperature of
honey in this method is preferably 45.degree. C. or less while the
wax and surfactant may be mixed in the temperature range of
50-60.degree. C.
Inventors: |
Moloney, Anthony Peter;
(Queensland, AU) |
Correspondence
Address: |
SUGHRUE MION, PLLC
2100 PENNSYLVANIA AVENUE, N.W.
SUITE 800
WASHINGTON
DC
20037
US
|
Assignee: |
MEDIHONEY PTY LTD.
|
Family ID: |
27809831 |
Appl. No.: |
10/639585 |
Filed: |
August 13, 2003 |
Current U.S.
Class: |
424/539 ;
514/23 |
Current CPC
Class: |
A61L 15/40 20130101;
A61K 35/644 20130101; A61P 31/02 20180101; A61L 15/34 20130101;
A61L 15/48 20130101; A61K 35/644 20130101; A61K 2300/00
20130101 |
Class at
Publication: |
424/539 ;
514/023 |
International
Class: |
A61K 031/70; A61K
035/64 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 13, 2002 |
AU |
2002950744 |
Claims
1. A composition for treating a patient, said composition
comprising: honey or a honey derivative; a fatty ester, wax or
wax-like compound; and a surfactant.
2. The composition of claim 1 comprising honey of a single type
substantially derived from one floral species.
3. The composition of claim 1 comprising honey selected from two or
more of different types of honey each substantially derived from
different floral species.
4. The composition of claim 3 wherein at least one type of honey
has peroxide associated activity and at least one other honey has
non-peroxide associated activity.
5. The composition of claim 1 wherein the honey or honey derivative
is present as at least 50% of the composition.
6. The composition of claim 5 wherein the honey or honey derivative
is present in the range of 70-90% of the composition.
7. The composition of claim 6 wherein the honey or honey derivative
is present in a concentration of around 80% of the composition.
8. The composition of claim 1 wherein the fatty ester, wax or
wax-like compound has a melting point around 45.degree.C or
less.
9. The composition of claim 9 wherein the fatty ester, wax or
wax-like compound has a melting point around 40.degree. C.
10. The composition of claim 1 wherein the fatty ester, wax or
wax-like compound is myristyl myristate.
11. The composition of claim 1 wherein the fatty ester, wax or
wax-like compound is an emollient fatty ester or fatty alcohol.
12. The composition of claim 1 wherein the surfactant is a
non-ionic surfactant.
13. The composition of claim 12 wherein the surfactant comprises or
includes ethoxylated sweet almond oil.
14. The composition of claim 12 wherein the surfactant comprises or
includes ethoxylated caster oil and/or ethoxylated evening primrose
oil.
15. The composition of claim 1 wherein the surfactant is present in
the range of 2-10% of the composition.
16. The composition of claim 15 wherein the surfactant is present
in the range of 2-7% of the composition.
17. The composition of claim 16 wherein the surfactant is present
at around 5% of the composition.
18. The composition of claim 1 wherein the fatty ester, wax or
wax-like compound is present in the range of 1-50% of the
composition.
19. The composition of claim 17 wherein the fatty ester, wax or
wax-like compound is present in the range of 10-30%.
20. The composition of claim 19 wherein the fatty ester, wax or
wax-like compound is present at around 15% of the composition.
21. A composition for treatment of a patient, said composition
comprising 80% honey, 15% myristyl myristate and 5% ethoxylated
sweet almond oil.
22. A method of producing a therapeutic honey composition or
ointment, said method comprising the steps of: heating honey to a
temperature which is below a temperature that will cause
degradation, complete or partial, of one or more functional enzymes
in the honey; combining a wax and a surfactant by heating and
mixing; cooling the mixture of wax and surfactant until the mixture
has a temperature similar to the temperature of the honey;
combining the honey with the wax and surfactant.
23. The method of claim 22 wherein the one or more functional
enzymes in the honey is glucose oxidase.
24. The method of claim 22 wherein the maximum temperature of the
heated honey is 45.degree. C.
25. The method of claim 22 wherein the wax and surfactant mixture
is heated to a temperature in the range of 50-60.degree. C.
26. The method of claim 25 wherein the wax and surfactant mixture
is mixed through the honey with high shear mixing until
substantially homogenous.
27. The method of claim 22 wherein the wax is myristyl
myristate.
28. The method of claim 22 wherein the surfactant is ethoxylated
sweet almond oil.
29. The method of claim 22 further including the step of
sterilising the composition or ointment.
30. The method of claim 29 wherein the ointment is sterilised by
applying one or more dosages of gamma irradiation.
31. The method of claim 30 wherein the gamma irradiation is applied
at levels between 25-35 kGy.
32. The method of either one of claim 22 or claim 31 further
including the step of impregnating a bandage or dressing with the
composition or ointment.
33. A method of treating a subject, human or animal, comprising
applying the composition of claim 1 in a therapeutically effective
dose to the human or animal subject.
34. A wound dressing comprising a material dressing and the
composition of claim 1.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to therapeutic compositions
and in particular compositions including honey or honey
derivatives.
BACKGROUND OF THE INVENTION
[0002] Honey has been used as a natural remedy and therapeutic aid
since ancient times. The anti-microbial properties of honey have
long formed part of both folk and scientific knowledge.
Applications for honey have included topical application for
wounds, ulcers, burns and similar conditions. Honey has also been
known to be used as a demulcent for use in the gastrointestinal
tract for soothing or allaying irritation of inflamed or abraded
surfaces. Therapeutic benefits of honey use are manifested by a
reduction in inflammation, swelling and pain; prevention and
control of infection in a wound; reduction in malodour and exudate;
assisted debriding of wounds and improved granulation and
epilthelialisation of new tissue. These advantages help promote the
rapid healing of a wound with minimal scarring.
[0003] Whilst these properties encourage the use of honey as a
wound healing agent and provide a moist wound environment, regarded
as beneficial to the healing of wounds, use has been mainly
restricted to unadulterated honey which has been applied in various
forms of wound dressings and treatments. Application of honey
directly presents difficulties arising from some inherent
properties of the material. Due to its relatively low viscosity and
fluid nature, plus natural "stickiness", honey tends to contaminate
the local environment around a treatment region. The disadvantage
of direct honey use is accentuated by the fact that honey at body
temperature becomes reasonably fluid and migrates from a treatment
site to further increase the chance of transfer to unintended
areas. Use of honey can be time consuming, messy and
impractical.
[0004] Attempts have been made to address at least some of these
problems by the use of wound dressings which may form a physical
barrier to honey migration and which may also be impregnated with
honey. The use of these methods has added an extra layer of expense
to treatment with honey and has provided variable success.
[0005] In using honey, the presence of wound fluid or exudate also
dilutes the therapeutic agent exacerbating the problem of
diminished contact time with the wound and diminished therapeutic
efficacy. Attempts have also been made to address at least some of
these problems by combination with other ingredients. Again the
outcome has been variable in success rate. It is preferred, and in
some cases, essential, that any combination be sterilised prior to
use or commercial distribution. One common form of sterilisation
requires gamma irradiation at a dose level that is toxic to
microorganisms. Such a process is known to cause breakdown or
undesirable changes in the matrix of a honey admixture.
[0006] While the therapeutic properties of honey are recognised and
appreciated, there remain problems with the practicality of using
honey on wounds.
SUMMARY OF THE INVENTION
[0007] Throughout this specification, unless the context requires
otherwise, the word "comprise", or variations such as "comprises"
or "comprising", will be understood to imply the inclusion of a
stated element or integer or group of elements or integers but not
the exclusion of any other element or integer or group of elements
or integers.
[0008] In one form although it need not be the only or indeed the
broadest form the invention resides in a composition
comprising:
[0009] honey or a honey derivative;
[0010] a fatty ester, wax or wax-like compound; and
[0011] a surfactant.
[0012] The honey may be a single type of honey or may be a
combination of one or more honeys. The one or more honeys may be
selected for therapeutic properties which may include anti
microbial activities. The honeys may be substantially derived from
the flowers of one or more Leptospermum species. In one embodiment,
a honey derivative may be used. A honey derivative may be a
modified form of honey formed by any one of various processes known
to a skilled addressee. The honey derivative may include a modified
honey where one or more components have been fully or partially
removed. The honey or modified honey may have components added to
it or treated in a manner to improve its functionality. It may be a
composition of compounds formulated in a manner to have a similar
functionality as honey yet contain little or no honey. In the
International Honey Industry, honey derivative is often applied to
a product that is totally or substantially artificial honey and is
sold as a honey substitute. These substances are known to a person
skilled in the art.
[0013] Combinations of honey may include at least one honey with
peroxide associated antibacterial activity and at least one other
honey with non peroxide associated antibacterial activity. The
honey or honeys may be selected on the basis of natural sugar
levels to regulate natural crystal formation. The honeys may also
be selected on the levels of physiologically active compounds
including but not limited to flavonoids, alkaloids, growth
regulators and compounds that cause stimulation of TNF-alpha
release.
[0014] Honey is preferably present as at least 50% of the
composition. Preferably the honey is present in the range of 70-90%
of the composition and most preferably is present in a
concentration at or around 80% of the composition. The percentage
compositions in this specification are calculated on percentage
weight/weight (% wt/wt).
[0015] The fatty ester, wax or wax-like compound preferably has a
narrow melting point range around 40.degree. C. Preferably the wax
or wax like material has a melting point of 45.degree. C. or less.
The wax like material may be Myristyl Myristate. Alternatively or
additionally, the wax or wax like material may be an emollient
fatty ester or fatty alcohol. The Myristyl Myristate may be
Crodamol MM.
[0016] The fatty ester, wax or wax-like compound may be present in
the range of 1-50% of the composition. Most preferably the fatty
ester or wax or wax-like compound is present in the range of
10-30%. In a preferred embodiment the fatty ester, wax or wax-like
compound is present at or around 15% of the ointment.
[0017] The surfactant may be a low irritant, mild non ionic
surfactant. The surfactant may be ethoxylated almond oil,
preferably ethoxylated sweet almond oil. The surfactant may
alternatively comprise or include ethoxylated caster oil or
ethoxylated evening primrose oil. The surfactant may be Crovol A70.
The surfactant may be present in the range of 2-10%. Preferably the
surfactant is present in the range of 2-7%. Most preferably the
surfactant is present at or around 5% of the composition.
[0018] In a further aspect the invention resides in a method of
producing a therapeutic honey ointment, the method comprising the
steps of:
[0019] heating honey to a temperature which is below a temperature
that will cause degradation, complete or partial, of one or more
functional enzymes in honey;
[0020] combining a wax and a surfactant by heating and mixing;
[0021] cooling the mixture of wax and surfactant until the mixture
has a temperature similar to the temperature of the honey; and
[0022] combining the honey with the wax and surfactant.
[0023] "Wax" in this context includes fatty esters and wax-like
compounds.
[0024] The one or more functional enzymes in honey may be glucose
oxidase. The maximum temperature of the heated honey may be
45.degree. C.
[0025] The wax and surfactant mixture may be heated to a
temperature in the range of 50-60.degree. C.
[0026] The wax and surfactant mixture may be mixed through the
honey with high shear mixing until homogeneous, preferably avoiding
overheating of the mixture.
[0027] The method may include the step of sterilising the ointment.
The ointment can be sterilised by applying one or more doses of
gamma irradiation. The gamma irradiation may be provided at levels
between 25-35 kGy.
[0028] The expression "ointment" in this specification may be
understood to extend to any suitable physical state including, but
not restricted to a gel, a paste, a cream, a lotion, a balm and a
salve.
[0029] The method may further include the step of impregnating a
bandage or dressing with the ointment for use on a subject.
[0030] The method may further include the step of packaging the
ointment for distribution.
[0031] In a further aspect the invention extends to a method of
treating a subject by applying one or more doses of an ointment
made according to the above method or comprising the above
described ingredients.
DETAILED DESCRIPTION OF THE INVENTION
[0032] The present invention is directed to an easy to use,
effective and stable honey based composition preferably presented
as an ointment. The ointment may be formed from a combination of
honey or honey derivative, a surfactant and a wax or wax-like
component or fatty ester.
[0033] The honey component of the ointment may include a
combination of one or more honeys selected for their therapeutic
properties. The honeys may be derived from the Australian or New
Zealand Leptospermum species. The honeys may include a combination
of two or more honeys selected for differing but preferably
complementary physiological/therapeutic action including those with
peroxide and non peroxide antibacterial activity. This combination
may ensure a broad spectrum of antibacterial activity. There are
many known types of honey. Many are identified in publications such
as Honey and Pollen Flora, Clemson A, INKATA PRESS Pty Ltd,
Melbourne, 1985 and similar reference works. Honeys may be selected
on the basis of the presence of flavonoids which may act as an
anti-oxidant resulting in inflammation reduction. Honeys may also
be selected for the presence of growth factors which can assist
with granulation, epithelialisation and the growth of new tissue to
ensure a progressive and satisfactory healing process. The honeys
may also be selected on the presence of or levels of
physiologically active compounds including but not limited to
flavonoids, alkaloids, growth regulators and compounds that cause
stimulation of TNF-alpha release.
[0034] The surfactant is preferably a low irritant, mild chemical.
Preferably the surfactant is non ionic as, in general, this class
of compounds is milder than ionic surfactants. A preferred
surfactant is an ethoxylated triglyceride and in particular sweet
almond oil or a derivative thereof. Alternatively it is possible to
substitute ethoxylated castor oil or ethoxylated evening primrose
oil, preferably in non ionic form.
[0035] An example of a commercially available product is CROVOL A70
which is derived from sweet almond oil in an ethoxylated form. The
international nomenclature for cosmetic ingredients has allotted
the name of PEG-60 almond glycerides to CROVOL A70. This product is
a long chain ethoxylate and has been shown to have a very low
tendency to irritation. CROVOL A70 has a chemical description as
ethoxylated (70% by weight) sweet almond oil (CAS 124046-50-0) and
may be obtained from Croda Australia, Villawood, Sydney.
[0036] An additional ingredient is a fatty ester, wax or wax-like
compound. Preferably the fatty ester or wax has a relatively narrow
melting range around 40.degree. C. and preferably in the range of
3743.degree. C. The preferred melting point is selected so that the
ointment is substantially non-running at the body temperature of a
patient which is usually around 37.degree. C. in a person but may
be higher in domestic animals. In general however, the invention is
suitable for both veterinary and human use. One means of assessing
whether the ointment is non-running is to place a sample on a
slope, preferably at 45.degree., and demonstrate that the sample
does not freely flow down the incline at 25.degree. C.
[0037] A preferred wax is Myristyl Myristate (CAS 3234-85-3). This
is a wax with a low melting point, usually in the range of
3743.degree. C. It has good skin softening and lubricating
properties. Alternative ingredients may include any emollient fatty
ester or fatty alcohol that satisfies the condition of having a
relatively narrow melting range around 40.degree. C. This
temperature is above normal body temperature but it is also below
the denaturing temperature of functional enzymes in honey which is
generally accepted to be around 45.degree. C. Most fatty esters
have long hydro-carbon chains that are very stable. The ester group
at the end of the molecule also provides a stable and non-reactive
aspect to the compound, making it safe to use for this
application.
[0038] An example of a commercially available source of Myristyl
Myristate is Crodamol MM which is available from Croda Australia,
Villawood, Sydney.
[0039] In a preferred method of manufacture, honey is heated to a
temperature that will not degrade the functional enzymes, such as
glucose oxidase, which occur in honey. Preferably this temperature
is a maximum of 45.degree. C. Separately, the wax and surfactant
are heated while being mixed until both are fully melted. The
temperature in this process may reach between 50-60.degree. C. The
wax/surfactant mixture is allowed to cool to the temperature of the
honey at which time it is added to the honey with high shear mixing
until homogenous. The mixing period may be relatively brief. It is
preferred to avoid heating honey above the upper identified
temperature as such a process may lead to degradation of functional
enzymes with resulting diminution of therapeutic effect.
[0040] The mixed ointment may then be allowed to cool and be
packaged for distribution.
[0041] Preferably the ointment is also sterilised particularly to
remove or reduce Clostridium sp spores and to provide an associated
reduction in bioburden levels. The preferred method of
sterilisation is through the use of gamma irradiation, preferably
at levels between 25-35 kGy. One of the benefits of the present
ointment is that it remains substantially stable and homogenous
after irradiation at these levels. The current formulation may be
described as a fine wax dispersion in a honey matrix. Without
wishing to be tied to any one theory, it appears the surfactant
acts to keep the wax particles small and enables them to be
suspended and dispersed throughout the honey. It has been found
that some emulsifiers including lanolin are prone to denaturing or
breakdown under irradiation making them unsuitable for use in the
present composition.
[0042] The ointment may be formulated according to the following
proportions:
1 Ingredient Range (% wt/wt) Honey or honey derivative 50-97%
Myristyl Myristate 1-50% Ethoxylated sweet almond oil 2-15%
[0043] Preferably honey is present in the range of 75-84%. Myristyl
Myristate may be the range of 15-20% and ethoxylated sweet almond
oil may be present in the range of 1-7%.
[0044] The preferred embodiment has a composition of honey 80%,
Myristyl Myristate 15% and ethoxylated sweet almond oil 5%.
[0045] It is envisaged that the present ointment may also be used
for cosmetic rather than therapeutic purposes. In this case,
selection of honeys with therapeutic characteristics is not
essential. Honeys may be selected for cosmetic benefits such as
providing a general moisturising action. Clearly, honeys may also
be selected for the treatment of essentially aesthetic problems
such as comedones or pimples. Selected honeys in these cases may be
bacteriostatic.
[0046] Once produced, the ointment may be packaged and distributed
in any suitable fashion. It may be dispensed into tubes.
Alternatively it may be formed as part of a wound dressing by
impregnation into a wound dressing material. The ointment may be
packed into individual screw top containers or it may be delivered
in sealed capsules or sachets for single use dispensing and
treatment.
[0047] The ointment of the present invention may be applied in a
wide range of situations and as already noted may be used in both
human and veterinary medicine, as well as for human cosmetics. In
its simplest form, the ointment may be applied topically to a
lesion. The frequency of application may be varied to reflect the
severity of the condition and the efficacy of the treatment. It is
envisaged that an application rate of up to two to three times
daily may be of benefit in some circumstances while application
every 2-14 days may be suitable in other circumstances where the
contact time is prolonged. The ointment is preferably of suitable
viscosity that it may be dispensed or molded or pressed into shape
using finger pressure to adopt a configuration suitable for a
lesion. That shape may be retained while the ointment is fixed in
position by a support bandage or similar.
[0048] The ointment may be beneficially utilised in post surgical
wounds, sinus wounds, fistulae, burns, donor sites, infected
wounds, pressure ulcers, venous ulcers, diabetic ulcers, trauma
injuries, catheter exit sites, dental extraction sockets,
fungating/malignant wounds, lesions, ophthalmology and surgical
procedures. This list is not comprehensive. Viscosity may be
selected so that the ointment is suitable for filling wound
cavities. Some advantages of the composition will be demonstrated
in the following non-limiting Examples.
EXAMPLE 1
[0049] Honey ointment according to the present invention was used
to treat burns in paediatric patients. The ointment demonstrated an
ability to deslough the wound, reduce the bacterial load and assist
healing. One child had a deep partial thickness burn to the scalp
that had become infected and a hard crusty eschar had formed over
the wound. The honey ointment desloughed the wound, cleared the
infection and the wound healed without the need for surgical
debridement within five days. Another case involved a deep partial
thickness burn on a child, that had become infected with bacteria
that were resistant to other topical antibacterial products and
oral antibiotics. After application of the honey ointment to the
burn, the bacterial load was reduced within five days, allowing for
successful skin grafting. The honey ointment was easy to apply to
gauze dressings, which were then applied to the wounds. The honey
ointment washed off easily in a shower. Dressings were changed
daily over the period of treatment.
EXAMPLE 2
[0050] The honey ointment was tested in a microbiological
laboratory against various bacterial organisms, including
Pseudomonas sp isolated from wounds and resistant to antibiotics
and other antibacterial products including silver sulfadiazine and
povidone-iodine. The honey ointment proved very effective against
all tested organisms.
EXAMPLE 3
[0051] Malodour associated with fungating tumours was reduced with
the use of the honey ointment. The honey ointment was applied
directly to a melolin dressing which was then applied to a
fungating tumour external to the mouth cavity, which had become
malodorous. Malodour was reduced within two days. The honey
ointment was easy to apply and stayed in place on the wound.
EXAMPLE 4
[0052] Leg ulcers and skin tears are well suited to application of
the honey ointment. One male patient with poor circulation and a
difficult-to-heal leg ulcer infected with Pseudomonas sp and
Staphylococcus sp was treated with honey ointment of the present
invention. He had previously been on antibiotics, but as these had
not helped clear the infection, he was taken off his oral
antibiotics and the honey ointment was used. The honey ointment was
applied directly to the wound then covered with either plain gauze
or paraffin-impregnated gauze. The dressings were changed daily
initially then when the wound was clean, dressings were changed
every second day. The honey ointment cleared the infection and the
wound was rendered clean and healing. Another male patient had a
skin tear that was progressing towards an ulcerous condition and
was treated with the honey ointment as described above. The wound
healed within two weeks. Other ulcers and skin tears have also been
treated successfully with the honey ointment.
EXAMPLE 5
[0053] A sacral area ulcer and an infected stump wound resulting
from surgery were healed with the use of the honey ointment applied
to a dry dressing (Combine.TM.).
EXAMPLE 6
[0054] The honey ointment was applied directly to a partial
amputation of the foot using a sterile tongue depressor and covered
with a dry dressing (Combine.TM.). The wound had been treated with
pure honey but the patient had been complaining of leakage from the
dressing. The treatment was changed to daily honey ointment
dressings and the patient had no further complaints. Healing of the
wound was subsequently uneventful.
[0055] A small and deep arterial leg ulcer infected with
Methicillin-resistant Staphylococcus aureus (MRSA) was healed with
the use of the honey ointment Daily dressings of the honey ointment
applied to a dry dressing (Combine.TM.) helped clear the infection
and heal the wound.
[0056] As a result of prior wound management, a sacral wound on a
patient had macerated edges and no granulation at the base of
wound. A zinc-based cream was applied around the edges of the wound
and the honey ointment was applied to the wound and covered with
dry dressings (Combine.TM.) and paraffin-based dressing
(Adaptic.TM.) and followed by a film dressing (Opsite.TM.).
Dressings were changed daily. Improved granulation of the wound bed
was observed, the wound edges improved and the wound size decreased
until the patient was sent to another clinical site.
EXAMPLE 7
[0057] The honey ointment has also been used to help reduce
caesarean section scars. The honey ointment was applied directly to
the week-old scar with no dressings required.
EXAMPLE 8
[0058] Diabetic wounds have also healed with the use of the honey
ointment. The honey ointment was found to be easier to apply to
these wounds than pure honey and the healing response was the same
as or better than pure honey dressings.
[0059] The present ointment may be applied to mucous membranes and
may be dispensed into bodily cavities for the treatment of mucous
membranes. The ointment may be ingested for beneficial results in
some circumstances. The composition of the ointment may be such
that at body temperature, compared to room or storage temperature,
it will soften and conform to a wound and surface to which it is
applied and will remain in place for temperatures up to 37.degree.
and preferably up to 40.degree..
[0060] The present invention provides real benefits in the
therapeutic use of honey. The use of 100% honey is, as noted above,
somewhat problematic. Additionally the use of honey in known
methods can be quite irritating particularly to sensitive wounds.
The present invention incorporates ingredients which may be of
natural origin and which do not have marked side effects such as
may arise with mineral based products. The viscosity of the
invention is such that it can be easily applied to a wide range of
wounds some of which are painful to touch. As the surfactant can be
a water soluble, vegetable derived emollient, the ointment can be
easily washed off the body and can be irrigated out of body
cavities. This advantage is of considerable significance as it
provides easy clean-up of both patient and surrounding
environments.
[0061] Manufacture of the ointment as described provides a product
which can slowly dissolve over time in body fluid rather than be
subject to immediate dilution and displacement by wound exudate.
Additionally the ointment may be suitable for internal use and for
effective gamma irradiation sterilisation. The nature of the
product makes it practical for bulk manufacture and relatively easy
dispensing into packages and containers.
[0062] The ingredients of the combination are known to be stable,
inert, non irritating and safe to use in therapeutic applications.
Further the composition is such that a stable and homogenous mix of
ingredients is achieved within the manufacturing temperature
restrictions. The present invention reduces the problems associated
with raw honey used in the treatment of wounds which may cause
stinging and sometimes painful sensations when applied to the
wounds of patients. The ointment may be used for cosmetic
purposes.
[0063] The honey ointment is preferably formulated with natural
waxes and oils to provide a high viscosity gel that is easy to
apply with good wash off characteristics when dressings are
changed.
[0064] The honey ointment can be applied either directly to the
wound or to the dressing. A thin absorbent dressing with a non/low
adhering surface can be used to cover the honey ointment with
additional absorbent secondary dressings applied as required.
[0065] The frequency of dressing changes required will depend on
how rapidly the honey ointment is being diluted by exudate. Daily
dressing changes are usual during the initial stages of wound
healing. More frequent changes may be needed if the honey ointment
is being diluted by a heavily exudating wound. When exudation is
reduced, dressing changes can be less regular (2 to 3 days).
[0066] The honey present in the honey ointment will be gradually
diluted by exudate and absorbed by the dressing. Waxes contained in
the honey ointment will remain leaving a protective layer. These
waxes can be washed away at each dressing change by rinsing with
normal saline or similar products.
[0067] The honey ointment provides natural debridement of the wound
through autolysis so the wound may appear deeper after the initial
dressing changes.
[0068] It is within the scope of the invention to add other
ingredients known to a skilled addressee for various additional
characteristics.
[0069] Throughout the specification the aim has been to describe
the preferred embodiments of the invention without limiting the
invention to any one embodiment or specific collection of features.
Those of skill in the art will therefore appreciate that, in light
of the instant disclosure, various modifications and changes can be
made in the particular embodiments exemplified without departing
from the scope of the present invention. All such modifications and
changes are intended to be included within the scope of the
disclosure.
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