U.S. patent application number 14/452405 was filed with the patent office on 2015-01-29 for compositions comprising extracts or materials derived from palm oil vegetation liquor for inhibition of vision loss due to angiogenesis and method of preparation there.
This patent application is currently assigned to Malaysian Palm Oil Board. The applicant listed for this patent is Kenneth C. HAYES, Kalyana Sundram P. MANICKAM, Ali Hafezi MOGHADAM, Ravigadevi SAMBANTHAMURTHI, Zandi SOUSKA, Yew Ai TAN. Invention is credited to Kenneth C. HAYES, Kalyana Sundram P. MANICKAM, Ali Hafezi MOGHADAM, Ravigadevi SAMBANTHAMURTHI, Zandi SOUSKA, Yew Ai TAN.
Application Number | 20150030710 14/452405 |
Document ID | / |
Family ID | 52390711 |
Filed Date | 2015-01-29 |
United States Patent
Application |
20150030710 |
Kind Code |
A1 |
MOGHADAM; Ali Hafezi ; et
al. |
January 29, 2015 |
COMPOSITIONS COMPRISING EXTRACTS OR MATERIALS DERIVED FROM PALM OIL
VEGETATION LIQUOR FOR INHIBITION OF VISION LOSS DUE TO ANGIOGENESIS
AND METHOD OF PREPARATION THERE
Abstract
The present invention relates generally to a composition
comprising palm fruit juice for use in a method of preventing and
inhibiting vision loss due to angiogenesis related diseases. The
composition of the present invention aids to decrease in CNV size
using confocal microscopy, in addition to reduction in macrophage
infiltration using immune staining; decrease in VEGF-A-induced
angiogenesis using established cornea pocket assay, inhibition of
IKB-D phosphorylation in laser treated choroidal tissues and
reduction in macrophage recruitment to CNV lesions.
Inventors: |
MOGHADAM; Ali Hafezi;
(Jamaica Plain, MA) ; SAMBANTHAMURTHI; Ravigadevi;
(Selangor, MY) ; TAN; Yew Ai; (Selangor, MY)
; MANICKAM; Kalyana Sundram P.; (Selangor, MY) ;
HAYES; Kenneth C.; (Waltham, MA) ; SOUSKA; Zandi;
(Berlin, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MOGHADAM; Ali Hafezi
SAMBANTHAMURTHI; Ravigadevi
TAN; Yew Ai
MANICKAM; Kalyana Sundram P.
HAYES; Kenneth C.
SOUSKA; Zandi |
Jamaica Plain
Selangor
Selangor
Selangor
Waltham
Berlin |
MA
MA |
US
MY
MY
MY
US
DE |
|
|
Assignee: |
Malaysian Palm Oil Board
|
Family ID: |
52390711 |
Appl. No.: |
14/452405 |
Filed: |
August 5, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14118209 |
|
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PCT/MY2012/000102 |
May 18, 2012 |
|
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14452405 |
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Current U.S.
Class: |
424/777 |
Current CPC
Class: |
A23L 2/02 20130101; A23L
33/105 20160801; A61K 36/889 20130101 |
Class at
Publication: |
424/777 |
International
Class: |
A61K 36/889 20060101
A61K036/889; A23L 2/02 20060101 A23L002/02 |
Foreign Application Data
Date |
Code |
Application Number |
May 18, 2011 |
MY |
PI 2011002220 |
Claims
1. A composition comprising an effective amount of an extract
derived from palm oil vegetation liquor so as to prevent or inhibit
vision loss due to angiogenesis associated disease.
2. The composition as claimed in claim 1 wherein the extract is a
water soluble component derived from palm oil vegetation
liquor.
3. The composition as claimed in claim 1 wherein the extract
contains phenolics.
4. The composition as claimed in claim 1 wherein the extract is
palm fruit juice.
5. The composition according to claim 1, wherein the angiogenesis
associated disease is an ocular angiogenesis associated
disease.
6. The composition according to claim 1, wherein the angiogenesis
associated disease is macular degeneration.
7. The composition according to claim 5, wherein the ocular
angiogenesis associated disease is age-related macular degeneration
(AMD).
8. The composition according to claim 7, wherein an effective
amount of the composition is used to reduce the size of choroidal
neovascularization (CNV) lesions in AMD.
9. The composition according to claim 7, wherein an effective
amount of the composition is used to reduce macrophage infiltration
in AMD.
10. The composition according to claim 1, wherein an effective
amount of the composition is used to suppress VEGF-A-induced
angiogenesis.
11. The composition according to claim 7, wherein an effective
amount of the composition is used to suppress pro-inflammatory
signaling in AMD.
12. The composition according to claim 2, wherein an effective
amount of the composition is used to inhibit IKB-.alpha.
phosphorylation in choroidal tissues.
13. The composition according to claim 7, wherein an effective
amount of the composition is used to reduce macrophage recruitment
to CNV lesions in AMD.
14. The composition according to claim 1, wherein an effective
amount of the composition is used to inhibit vision loss due to
diseases associated with VEGF receptor phosphorylation.
15. The composition according to claim 1, wherein an effective
amount of the composition is used to inhibit vision loss due to
ocular neovascularization.
16. A method for the prevention of vision loss due to angiogenesis
related disease, said method comprising administering the
composition of claim 1 to a patient in need thereof.
17. The method as claimed in claim 16, wherein the angiogenesis
related disease is associated with macular degeneration.
18. The method as claimed in claim 16, wherein the disease is
age-related macular degeneration (AMD).
19. The method as claimed in claim 16, wherein an effective amount
of the composition is used to provide protective effects against
glaucoma, diseases associated with glaucoma, or corneal
transplants.
20. The method as claimed in claim 16, wherein an effective amount
of the composition is used to provide protective effects against
diabetic retinopathy and diseases associated thereto.
21.-25. (canceled)
Description
FIELD OF INVENTION
[0001] The present invention relates generally to compositions
based on oil palm plant and more particularly to compositions
comprising materials obtained from palm oil vegetation liquor for
the treatment and prevention of ocular inflammatory and vascular
diseases, such as Age-Related Macular Degeneration (AMD).
BACKGROUND
[0002] Reference to any prior art in this specification is not, and
should not be taken as, an acknowledgement or any form of
suggestion that this prior art forms part of the common general
knowledge in Malaysia or any other countries.
[0003] Angiogenesis relates to the formation or sprouting of new
blood vessels from preexisting vessels. Under normal circumstances,
angiogenesis is observed as the formation of blood vessels during,
but not limiting to, wound healing and embryonal development. For
the past few years, great efforts have been expended by researchers
to understanding the regulation of angiogenesis, identifying
pathways to angiogenesis and much has been written about the
mechanisms as well as its pathologic and physiologic conditions.
There are three major processes or stages involved in the formation
of blood vessels; whereby the first stage is angiogenic activation
of endothelial cells and degradation of basement membrane, the
second stage is endothelial proliferation and migration, and the
third stage is new vessel formation.
[0004] Stages of maturation and stabilization of the newly formed
blood vessels occur by means of recruitment of pericytes which may
involve angiogenic factors such as vascular endothelial growth
factor (VEGF). Accordingly, vascular endothelial growth factor
(VEGF) plays a major role in all these three main stages. It
facilitates in inducing angiogenic activated state of endothelial
cells for the blood vessel, proliferation and migration of stimulus
from the preexisting blood vessel and expression of integrins in
new vessel formation.
[0005] One of the major causes of human blindness or adult vision
loss is age-related maculopathy, especially in industrialized
countries. Generally, such cause is associated to interference of
normal physiological process of angiogenesis as described earlier,
particularly due to local expansion of blood vessels, or
uncontrolled angiogenesis.
[0006] An example of a leading cause of adult vision loss is
age-related macular degeneration (AMD). Recent studies have
demonstrated that AMD is caused by an assortment of clinically
ocular findings that leads to vision impairment and blindness.
Generally, AMD occurs in two forms, dry and wet. In wet AMD,
choroidal vessels pathologically grow through the retinal pigmented
epithelial (RPE) cell layer into the subretinal space, a process
known as choroidal neovascularization (CNV). According to
scientific reports, CNV and ensuing leakage damage to the RPE and
retinal cells would lead to permanent vision loss.
[0007] Because VEGF is an important biomarker in angiongenesis
(Zahir K Otrock, 2010) in many cases, VEGF has been identified as
the key molecule responsible for the growth and leakiness of CNV,
and the primary regulatory factor of neovascularization of
angiogenic diseases. It can be concluded that VEGF, is one of the
most significant factors affecting endothelial cell (EC)
proliferation, among others, its motility and vascular
permeability.
[0008] Macrophages are a major source of VEGF and tumor necrosis
factor (TNF)-.quadrature., thereby it is implicated in the
pathogenesis of AMD due to their spatiotemporal distribution in the
proximity of the CNV lesions particularly in experimental models
and humans.
[0009] In US 2007203211 A1, there is disclosed a drug for use in
preventing or treating angiogenic eye diseases, in which the method
involves administering to a mammal in need thereof pharmaceutically
effective amount of angiotesin II receptor antagonist. It is
further disclosed that angiotensin II receptor antagonist is highly
effective in the prevention or treatment of intraocular angiogenic
diseases such as proliferative retinopathy or retinal vein
occlusion. There is no explicit disclosure on using plant based
materials as VEGF inhibitors.
[0010] A great majority of treatments and medications are chemical
based or surgical based treatments which may not be favorable for
patients at advanced ages. Further, it has been shown that
treatment for AMD is effective for only a small proportion of
patients, particularly patients who have well-defined choroidal
neovascular membrane (CNVM) (Bressler et al, 2004).
[0011] Therefore, there is a need to identify a solution and
effective treatment for ocular angiogenesis and thus inhibits human
blindness derived from highly abundant sources, such as plant based
materials.
[0012] It is primary object of the present invention to provide a
composition and method thereof for use in the prevention and
inhibition of vision loss due to angiogenesis associated
diseases.
[0013] Still other objects of the present invention will become
readily apparent to those skilled in the art from the following
detailed description.
SUMMARY OF INVENTION
[0014] The present invention relates to the prevention and
inhibition of vision loss due to ocular angiogenesis by a
composition comprising palm fruit juice.
[0015] In accordance with the present invention there is provided a
composition comprising materials obtained from palm oil vegetation
liquor, used for prevention and inhibition of vision loss due to
ocular angiogenesis diseases.
[0016] In accordance with the present invention, the composition
may be used in a method for inhibiting vision loss due to
angiogenesis mediated or associated diseases, for instance but not
limiting to ocular neovascularization, macular degeneration or any
diseases where inhibition of angiogenesis is required.
[0017] In an additional aspect, the composition of the present
invention may be used in a method for prevention of vision loss due
to diseases associated with angiogenesis and VEGF receptor
phosphorylation.
BRIEF DESCRIPTION OF DRAWINGS
[0018] Some figures contain color representations or entities in
order to elucidate the results of experiments for the purpose of
the present invention.
[0019] FIGS. 1(a) and (b) shows the effect of palm fruit juice
(PFJ) of the present invention on CNV formation;
[0020] FIGS. 2(a) and (b) shows the macrophage infiltration in CNV
in accordance with a preferred method of the present invention;
[0021] FIGS. 3(a) and (b) shows the leucocyte activation in
experimental AMD;
[0022] FIGS. 4(a) and (b) shows tissues areas of angiogenesis in
corneas;
[0023] FIG. 5 shows the western blot of pIK.beta.-.quadrature.,
IKB-.quadrature., pNFKB and NFKB in experimental AMD with and
without palm fruit juice treatment.
DETAILED DESCRIPTION
[0024] 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.
[0025] Embodiments of the invention are described by way of
illustration. As will be realized, the invention is capable of
other and different embodiments and its several details are capable
modifications in various respects, all without departing from the
spirit and/the scope of the present invention.
[0026] In accordance with the present invention, the composition
comprises materials or extracts obtained from palm oil vegetation
liquors, whereby said vegetation liquors maybe obtainable either
directly from plants or as waste streams or aqueous streams in the
processing of plant material. The vegetation liquors may be
obtained based on wastes from any processing stages of oil palm at
a palm oil mill.
[0027] Further in accordance with the present invention, the
materials or extracts obtained from palm oil vegetation liquor of
palm oil milling process are water soluble.
[0028] The materials or extracts obtained from palm oil vegetation
liquor of the present invention contains phenolics.
[0029] The present invention provides a composition and method
thereof for use in the treatment of ocular angiogenesis, and in
particular age-related macular degeneration (AMD), whereby said
composition is based on oil palm plants of the species Elaeis.
[0030] The present invention thereby introduces a novel composition
and a novel method of medical treatment.
[0031] A particular aspect of the present invention contemplates a
method for preparing a medicament based on a composition comprising
materials obtained from vegetation liquors, for instance, palm
fruit juice, in the treatment of an ocular angiogenesis.
[0032] Yet another aspect of the present invention provides a
composition comprising extracts, more particularly palm fruit juice
obtained from vegetation liquor for the treatment of an ocular
angiogenesis, and more particularly, a macular degeneration
associated diseases, such as, but not limiting to age-related
macular degeneration (AMD).
[0033] Throughout the specification, the term "Elaeis sp" which may
be used includes Elaeis guineensis and Elaeis oleifera.
[0034] As a preliminary example, it is described below the effects
of extracts derived from oil palm vegetation liquor against CNV;
more particularly said extract is palm fruit juice.
Materials and Methods
[0035] In order to examine the effects of PFJ against vision loss,
several experiments will be elucidated as examples were carried out
and the results obtained will be described herein.
[0036] The palm fruit juice (PFJ) may be obtained by conventional
means, from pure palm nut. The juice for use in the purpose of the
present invention may contain other components however not to
disrupt the nutritional content of fruit juice.
[0037] According to the present invention, the Palm Fruit Juice
(PFJ) provides significant decrease in VEGF-A-induced angiogenesis.
Such effect can be examined with a standard method of corneal
micropocket assay as provided in EXAMPLE 1 below.
EXAMPLE 1
Corneal Micropocket Assay
[0038] Balb/C mice were anesthetized with an intraperitoneal
injection of ketamine (100 mg/kg) and xylazine (10 mg/kg). Hydron
pellets (0.3 .mu.l) containing 25, 100, 200, 400 or 1600 ng human
VEGF-A (293-VE; R&D Systems), 200 ng mouse VEGF-A (493-MV;
R&D systems), were prepared and implanted into the corneas.
Pellets were positioned in around 1.0.+-.0.2 mm distance to the
corneal limbus. After implantation, bacitracin ophthalmic ointment
(E. Fougera & Co) was applied to each eye to prevent an
infection. On the indicated days after the implantation, digital
images of the corneal vessels were obtained and recorded using
OpenLab software version 2.2.5 (Improvision Inc) with standardized
illumination and contrast.
EXAMPLE 2
Quantification of Angiogenesis in Whole-Mount
[0039] The mice were perfused with rhodamin-ConA and the eyes were
taken out, radial cuts were then made in the peripheral cornea to
allow flat mounting on a glass slide using a mounting medium
(TA-030-FM, Mountant Permaflour; Lab Vision Corporation). The
flat-mounted tissues were examined by fluorescence microscopy and
recorded using OpenLab software version 2.2.5 (Improvision Inc)
with standardized illumination and contrast. The results obtained
were recorded.
EXAMPLE 3
Laser-Induced CNV
[0040] To induce CNV, C57BL/6 mice were anesthetized and pupils
were dilated with 5% phenylephrine and 0.8% tropicamide. Using a
532-nm laser (Oculight GLx, Iridex, Mountain View, Calif.), a
slit-lamp delivery system, and a cover glass as a contact lens,
four spots (100 mW, 50 .mu.m, 100 ms) were placed in each eye. The
lesions were located at 3, 6, 9 and 12 o'clock meridians centered
on the optic nerve head and located .about.2 to 3 disk diameter
from the optic nerve head. Development of a bubble under laser
confirmed the rupture of the Bruch's membrane. Eyes showing
haemorrhage were excluded from experiments. The results obtained
for this step were recorded.
[0041] In accordance with another preferred embodiment of the
present invention, PFJ decreases the CNV size, whereby an analysis
to evaluate this effect is shown in EXAMPLE 4 below:
EXAMPLE 4
Evaluation of CNV
[0042] Seven days after laser injury, the size of the CNV lesions
was measured in choroidal flat mounts. Briefly, mice were
anesthetized and perfused through the left ventricle with PBS,
followed by 5 ml of fluorescein-labeled dextran (5 mg/ml,
fluorescein isothiocyanate-dextran; Sigma Aldrich) in 1% gelatin.
Anterior segment and retina were removed from the eyecup. The
remaining RPE-choroid-sclera complex was flat mounted after
relaxing radial incisions using Mounting Medium (TA-030-FM,
Mountant Permafluor; Lab Vision Corporation) and coverslips.
Micrographs of the choroidal complex were taken using a Confocal
Microscope (Leica, Wetzlar, Germay). The magnitude of the CNV
lesions was determined by measuring the hyperfluorescent area using
Openlab Software (Improvision, Boston, Mass.). The results obtained
for this step were accordingly recorded.
[0043] According to another preferred embodiment of the present
invention, the PFJ decreases macrophage infiltration, whereby a
standard method can be used to examine such effect, as elucidated
in EXAMPLE 5 below.
EXAMPLE 5
Immune Histochemistry
[0044] On day 3 after laser injury 10 .mu.m frozen sections of the
posterior segment were prepared. The sections were incubated with a
mouse anti-F4/80 mAb (10 .mu.g/ml), and subsequently with the
secondary antibody. Photomicrographs of the CNV lesions were taken
and the number of F4/80 positive macrophages was counted.
EXAMPLE 6
Western Blot
[0045] To obtain tissues, animals were perfused with PBS and eyes
were enucleated immediately after perfusion. Choroid was
microsurgically isolated and placed into 100 .mu.l of lysis buffer
(mammalian cell lysis kit MCL 1, Sigma Chemical Co, St. Louis,
Mo.), supplemented with protease and phosphatase inhibitors
(Sigma), and sonicated. The lysate was centrifuged (12000 rpm, 15
min, 4.degree. C.) and the supernatant was collected. Each sample
containing equal amount of total protein, quantified by protein
assay (Bio-Rad Laboratories, Inc, CA) was separated by SDS-PAGE
(sodium dodecyl sulfate-polyacrylamide gel electrophoresis), and
electroblotted to PVDF (polyvinylidene fluoride) membranes
(Invitrogen, Carlsbad, Calif.). To block the nonspecific binding
the membranes were washed with 5% skim milk and subsequently
incubated with a rabbit polyclonal antibody against (1 .mu.g/ml,
Santa Cruz Biotechnology, Santa Cruz, Calif.) or a mAb against
.beta.-tubulin (1.5 .mu.g/ml; Abcam, Cambridge, Mass.) at 4.degree.
C. overnight, followed by incubation with a horseradish
peroxidase-conjugated donkey or sheep antibody against rabbit or
mouse IgG (1:2000; GE Healthcare UK limited Buckinghamshire, UK).
The signals were visualized with chemiluminescence (ECL kit; GE
Healthcare UK limited, Buckinghamshire, UK) according to the
manufacturer's protocol.
Statistics
[0046] All values are expressed as mean.+-.SEM. Data were analyzed
by t-test and differences between the experimental groups were
considered statistically significant or highly significant, when
the probability value, p, was <0.05 or <0.01,
respectively.
Results
[0047] Results obtained from each experiment were suitably recorded
and analyzed via conventional means.
I. Reduction of CNV Size in Experimental AMD using PFJ
[0048] To examine the potential of PFJ in reducing CNV, mice were
fed PFJ for two weeks prior to laser injury. On day seven after CNV
induction, CNV Volume was measured using confocal microscopy.
[0049] FIGS. 1(a) and (b) shows the representative micrographs of
CNV lesions in choroidal flat mounts from animals treated with
vehicle or PFJ orally. Red dashed lines show the amount of CNV
lesions filled with FITC-dextran. FIG. 1(b) shows the quantitative
analysis of CNV volume. As evident in FIG. 1, it is observed that
the CNV volume was reduced significantly compared to vehicle-fed
controls.
II. Reduction of Microphage Infiltration Experimental AMD using
PFJ
[0050] To investigate the effect of PFJ on macrophage infiltration
in AMD, immune staining for the macrophage-specific marker, F4/80,
and quantified the number of F4/80 positive cells in CNV lesion
were performed. It is found and shown in FIGS. 2(a) and (b) that
macrophages were recruited to the CNV lesion one week after laser
injury. In comparison, the number of accumulated macrophages at
this time point was significantly reduced.
[0051] FIG. 2(a) shows fluorescent micrograph of a laser induced
CNV lesion, vehicle and treated with PFJ, immunostained with F4/80.
The green shade shows the amount of macrophage infiltration with
CNV lesion. FIG. 2(b) shows the quantitative analysis of macrophage
infiltration. Bars show the average of macrophages number, n=3,
P.quadrature.0.05.
[0052] In order to investigate macrophage activation in the CNV
lesion, immune staining was performed for CD11b, a leukocyte
activation marker, and quantified the number of CD11b positive
cells in CNV lesion. One week after laser injury it is observed
that a significant number of activated immune cells accumulated in
CNV lesions of vehicle fed animals. In contrast, it is observed
that the number of activated leukocytes was significantly reduced
in PFJ-fed animals. The results obtained based on this experiment
were tabled and plotted as FIGS. 3(a) and (b).
[0053] FIG. 4(a) shows the tissue areas of angiogenesis in corneas
based on a preferred embodiment of the present invention. Digital
images of the corneal vessels on 3.sup.rd and 6.sup.th day of
VEGF-A implantation: Images in FIG. 4(b) shows the fluorescence
microscopy of flat mounted cornea tissues, whereby on the 6.sup.th
day the mice were perfused with rhodamin-ConA.
[0054] FIG. 4(c) shows a plotted graph based on the quantitative
analysis of the angiogenesis area. Based on this experiment, it is
shown that the average of area (n=3), P.quadrature.0.05.
III. Suppression of Pro-Inflammatory Signaling Experimental AMD
using PFJ
[0055] Investigation on the effect of PFJ on angiogenesis on a
molecular level was performed based on implanted hVEGF-A (200 ng)
in corneas of mice that were fed vehicle or PFJ. To examine,
whether PFJ reduces angiogenesis, on 3.sup.rd and 6.sup.th day
after the implantation, digital images of the corneal vessels were
obtained and subsequently quantified. Results based on this
experiment are shown in FIG. 5, wherein a western blot of
pIKB-.quadrature., IKB-.quadrature., pNFKB and NFKB in experimental
AMD with and without Palm Fruit Juice (PFJ) treatment, three days
after laser injury, while the control are unlasered eyes.
[0056] From the above, as it is widely known that immune cells and
more particularly macrophages play a significant role in AMD
pathology, disruption of monocyte recruitment and infiltration into
ocular tissues may aid in preventing disease development and
progression.
[0057] According to the present invention, it is shown in the
experimental results that subjects fed or treated with Palm Fruit
Juice (PFJ), exhibited: [0058] a) Significant decrease in CNV size
using confocal microscopy, in addition to reduction in macrophage
infiltration using immune staining; [0059] b) Significant decrease
in VEGF-A-induced angiogenesis using established cornea pocket
assay; [0060] c) Inhibition of IKB-.quadrature. phosphorylation in
laser treated choroidal tissues with PFJ; [0061] d) Reduction in
macrophage recruitment to CNV lesions.
[0062] As briefly mentioned in earlier sections, in accordance with
the present invention, the composition may be used in a method, for
inhibiting vision loss due to angiogenesis mediated or associated
diseases, for instance but not limiting to ocular
neovascularization, macular degeneration or any diseases where
inhibition of angiogenesis is required.
[0063] In another aspect of the present invention, the composition
may be used for providing protective effect in diabetic retinopathy
or damages to the eye's retina, various types of glaucoma which may
lead to blindness or eyes disorders and corneal transplants.
[0064] Further, the composition of the present invention may be
used in a method for prevention of vision loss due to diseases
associated with angiogenesis and VEGF receptor phosphorylation.
[0065] Generally, the composition comprising palm fruit juice (PFJ)
may be prepared in various suitable forms for direct or oral
administration for the purpose of preventing adult vision loss.
[0066] According to the present invention, the PFJ of the present
invention may be used to make supplements, or contained in drinks,
edible products, tonics, health supplements, cosmetics. It is clear
that PFJ may be prepared in concentrated form or extract.
[0067] Compositions suitable for oral administration may be
presented in discrete units, such as capsules, sachets, lozenges,
or tablets, each containing a pre-determined amount of the extract:
as a powder or granules; as a solution or a suspension in an
aqueous or non-aqueous liquid. Such compositions may be prepared by
any suitable method of pharmacy which includes the step of bringing
into association the extract of the present invention and one or
more suitable carriers (which may contain one or more accessory
ingredients as noted below). In general, the compositions of the
invention are prepared by uniformly and intimately admixing the
extract or any form of the palm fruit juice (PFJ) with a liquid or
finely divided solid carrier, or both, and then, if necessary,
shaping the resulting mixture. For example, a tablet may be
prepared by compressing or moulding a powder or granules containing
the extract or any form of the palm fruit juice (PFJ), optionally
with one or more accessory ingredients.
[0068] Compressed tablets may be prepared by compressing in a
suitable machine, the extracts in the form of a powder or granules,
optionally mixed with a binder, lubricant, inert diluents, and/or
surface active/dispersing agent(s). Moulded tablets may be made by
moulding, in a suitable machine, the powdered compound moistened
with an inert liquid binder.
[0069] Compositions may be prepared in a manner, and in a
form/amount as is conveniently practiced.
[0070] As mentioned, the compositions of the invention may also be
administered to a human in a dietary supplement form. Dietary
supplements incorporating the active composition can be prepared by
adding the composition to a food in the process of preparing the
food. Any food may be used including, but not limited thereto,
meats such as ground meats, emulsified meats and marinated meats;
beverages such as nutritional beverages, sports beverages, protein
fortified beverages, juices, milk, milk alternatives, and weight
loss beverages; cheeses such as hard and soft cheeses, cream
cheese, and cottage cheese; frozen desserts such as ice cream, ice
milk, low fat frozen deserts, and non dairy frozen deserts;
yoghurts; soaps; puddings; bakery products; salad dressings; and
dips and spreads such as mayonnaise, butter, butter substitute, and
other fat containing spreads. The composition is added to the food
in an amount selected to deliver a desired dose of the composition
to the consumer of the food.
[0071] Further, an effective amount of the compositions of the
present invention is administered to a human subject. The actual
dosage levels will depend upon a number of factors, such as
specific mode of administration, the condition being treated, the
condition of the patient and the judgement of the health care
giver.
[0072] The composition comprising any form of the present invention
may be prepared for use in a pharmaceutically effective or
nutraceutically effective amount, solely on its own or in
combination with other agents or compounds deemed appropriate by a
person skilled in the art.
[0073] It is noted that the term `pharmaceutically effective` and
`nutraceutically effective` amount includes a quantification that
is acceptable for improving or prevention of vision loss, due to
macular degeneration associated diseases.
[0074] Those skilled in the art will appreciate that the invention
described herein is susceptible to variations and modifications
other than those specifically described. It is to be understood
that the invention includes all such variations and modifications.
The invention also includes all of the steps, features,
compositions and compounds referred to or indicated in this
specification, individually or collectively, and any and all
combinations of any two or more of said steps or features.
* * * * *