Instructional presentation kopi manual.ppt

pharmaceutical

1. Se-cure
Pharmaceuticals

2. -The Tofupill Line of products is based on a unique
therapeutic raw materialthat serves as a selective
substitute for the female hormone -Estrogen.
-The Tofupill Line of products includes 3 products:
-Tofupill-For the relief of menopausal symptoms.
-Tofupill30+-Detains and prevents the
development of Osteoporosis.
-TofupillPMS-Relieves pre-menstrual emotional
and physical symptoms.

3. -All the products in the Tofupill Line are defined as
Food Supplements
-All the products in the Tofupill Line are produced in
a pharmaceutical manufacturing plant with GMP
and ISO 9002 Certificates.
-All the products have gone through extensive R&D
and have proved their effectiveness through clinical
studies done by doctors in a number of hospitals.

4. Unique Characteristics of the Raw
Material
-RawMaterial:UniqueTofuRichinPhytoestrogen
clearfromnon-activeingredients
-Scientific Name: DT56A
-Chemical characteristics:
-A concentrated format of the organic structure of
the 56 components in the Phytoestrogen.
-Does not contain any genetically modified
components
-Shelf Life-28 months from manufacturing date

5. The Raw Material Standard
Specification of DT56A Amino Acids:
Compound % Compound % Compound %
Aspartic 5.618 Glycine1.963 Isoleucine 2.294
Threonine 1.894 Alanine1.765 Leucine4.085
Serine2.494 Valine 2.137 Tyrosine2.202
Glutamic8.095 Methionine 0.758 Phenalanine 2.517
Proline2.118 Isoleucine 2.294 Histidine1.33
Lysine3.006 Arginine3.640

6. Manufacturing Procedure of DT56A
The Unique Tofu

7. The Uniqueness of the Raw
Material –DT56A
•DT56Ais the only material that has all 56 components
that constitute the Phytoestrogen.
•DT56Aacts like a Selective Substitute to the
Conventional HRT.
-It acts like the female Hormone, Estrogen, in the
woman’s body and relieves menopausal symptoms such
as:
-Hot Flashes
-Vaginal Dryness
-Concentration Problems
-Sleep Disturbances…

8. -Doesn’t cause cell proliferation
-Safe for long-term use
-Doesn’t lead to Breast, Ovary and Uterus Cancer.
-Acts like the Female Hormone Estrogen in
protecting the body from the bone depletion process
-Each capsule contains the equivalence of
Phytoestrogen as in 110 g. of regular Tofu.
The Tofupill line takes advantage of the most progressive
modern Biotechnology. For the first time it is possible to
use the advantage of the complete structure of
Phytoestrogen in all its natural form, being able to give
women the safest solution for Menopausal Symptoms and
Osteoporosis.

9. What is Menopause?
–Menopause represents the end of menstruation.
–The majority of women experience a natural
menopause between the ages of 45 and 55.
–Menopause is considered to be "premature" when it
occurs either naturally or is induced before age 40.
–Menopause is not a disease, but a natural event, the
end of fertility, resulting from the ovaries slowing
down production of two sex hormones: estrogen and
progesterone.

10. Menopausal Symptoms
–Hot flashes-Sudden waves of heat that can start in
the waist or chest and work their way to the neck and
face and sometimes the rest of the body.
•More common in the evening and during hot weather.
•They can hit as often as every 90 minutes. Each one
can last from 15 seconds to 30 minutes -five minutes is
average.
•75-80% percent of women going through menopause
experience hot flashes , some more bothered by them
than others.
–Sometimes heart palpitationsaccompany hot flashes.
–Irregular periods

11. -vaginal dryness
-headaches
-dizziness
-skin and hair changes
-mood changes
-lack of concentration
-difficulty with memory
-tension
-anxiety
-depression
-insomnia and many more.

12. What are Phytoestrogens?
-A group of substances that function in a similar way to
the female hormone (estrogen, estradiol).
-Contains all 56 components of the Phytoestrogen
structure (Daidzein, Genistein, Glycitein, Isoflavone and many
more.)
-It bonds with the receptors that react mostly to estrogen
bonds.
-terminating menopausal symptoms -
-inducing the bone rebuilding process
-preventing estrogen bondage in places where such a
bonding leads to an accelerated growth of cells (cancer).

13. Isoflavone vs. Phytoestrogen
-Isoflavone is 1 of the 56 components that compose the
Phytoestrogen.
The structure of Isoflavone vs. Estradiol (Female Hormone)
-Isoflavone does not have even the slightest similarity to
the female hormone.
Estradiol
OH
OH
Isoflavone

14. -The Isoflavone is extracted through the use of violent
chemicals (solvents) such as acetate and alcohol taking
apart the molecular structure of the natural material
creating a completely new substance.
-The effect of the single material is very low
-Large quantities of Isoflavones are needed in order to
actually feel an elevation of menopausal symptoms.
-Isoflavone “overdose” leads to the excessive
encouragement of cell growth in the breast tissue and the
ovaries, just like with HRT.

15. Tofupill-Product Information
Purpose:Balancing the woman’s Hormonal System during menopause.
Composition:-Tofu (DT56A) 322 mg.
-Flaxseed 108 mg.
Indications: For menopausal symptoms.
Dosage: 2 capsules a day.
Therapeutic effects:Relief is felt within the 3-5 days.
Effectiveness of Treatment: 72% feel an alleviation of menopausal
symptoms
-Recommended for women as long as menopausal symptoms persist.
-There are no dangers with long-term use.
-Tofupill is the ultimate and safest solution for menopausal symptoms.

16. TheTofupill Line -Clinical Studies
1995-Study done on female menopausal mice. The
results showed a significant improvement on hot
flashesdue to Tofupill.
1995-1997-Clinical study of Tofupillon 152 women
suffering from menopausal symptoms. The results
clearly showed a great improvement in the relief of hot
flashes, similar to the relief found from the
conventional HRT, in 72% of the womenparticipating
in the study. Furthermore there was no change in the
Endometrial wall thickness compared to the control
group.

17. The effect of a daily dietary supplementation of TOFUPILL on menopausal
symptoms, specifically hot flashes, in post-menopausal women

18. 1998-1999-Study of Tofupill30+on 24 women
suffering from Osteoporosis. After 12 months the
results showed a complete standstill in the development
of the diseasein 21 of the participating women. In 18 of
the participants there was a nominal increase of more
than 3% of the bone’s density.
2000-(2001)-Controlled clinical study headed by Dr.
Boris Kaplan, approved by the Helsinki committee. 130
women suffering from Osteoporosis are being tested to
prove the effectiveness of Tofupill30+in preventing the
development of the disease. The study is being
conducted in 5 hospitals in Israel and in the beginning
of 2001, we are planning to add additional doctors
from different countries across the world.

19. 2000-(2001)-Controlled clinical study, headed by Prof.
Scerovsky, approved by the Helsinki committee, will be
done on Tofupill.
The study is looking at the effect of Tofupillon the
heart palpitations suffered by 28% of the women
reaching menopause.
The preliminary study has shown the direct influence of
Tofupill in easing the heart palpitations of women. 160
women will participate in this study for the duration of
9 months.

20. There are two kinds of products in the market today on two
competing fronts.
Pharmacological Solutions Food Supplements
“Conventional Therapies” “Alternative Therapies”
The most common treatment today is hormone replacement
therapy (HRT)
-Highly effective in preventing most of the disorders.
-Prolonged HRT, however, leads to an increased risk in the
development of breast and uterus cancer.
-Approximately 80% of women refuse this therapy.
Competing Products found in the
market

21. Conventional Therapies
ERT (estrogen) & HRT (estrogen & progestin)
Name of Product: Premarin (ERT)or Prempro/Premphase(HRT)
(Wyeth-Ayerst Laboratories)
Main Component: Conjugated Estrogen or
Estrogen/Progesterone tablets
Prescribed for: relieving hot flashes, night sweats and vaginal
dryness (Most widely prescribed by Doctors).
Dangers: Increases the risk of breast and uterus Cancer, worsens
diabetic condition, blood clots, nausea, vomiting, breast
tenderness, abdominal pain, vaginal bleeding.
-Cannot be taken by women that have a heart disease, stroke or
liver disease

22. Alternative Treatments
Name of Product: Promensil (Novogen-Australia)
Main Component: Isoflavone extraction from Red Clover.
Extraction: through organic solvents-acetate & alcohol.
Dangers: Chemical changes of the natural structure derived
from the extraction & Isoflavone overdose.
-40 mg. Isoflavones -10 times the Isoflavone content that is
found in nature
Contains Biochanin and Formononetin -these materials have a
full estrogenic effect, rise in FSH levels in the blood
Result:a thriving of the tissue in the breasts, ovaries and uterus
-Development of Hormonal Cancer.
Clinical Studies: conflicting results

23. Name of Product: Remifemin
(Schaper and Brummer-Germany)
Main Component: Extraction of the Black Cohosh root
Time of felt relief: 6-8 weeks
Known Side Effects: Nausea, vomiting, uterine contractions,
dizziness, diarrhea, abdominal pain, visual dimness, headache,
tremors, joint pains and depressed heart rate.
Side Effects are known to occur after prolonged use-3 months
and more or when taking large doses.
-Not recommended for women with a history of breast cancer.
-Warning in scientific material: German Commission
recommends that treatment be limited to 6 months.

24. Name of Product: Meno-Menopause Formula (ehn-Canada)
Main Components: Black Cohosh, Red Clover and Dong Quai
* Net weight of capsule as written on label: 1,900 mg.
Actual Gross Weight: 480 mg. (including capsule).
Main Ingredient: Dong Quai (1,250 mg.)-a popular component
in Ancient Asian Medicine.
Side Effects: excessive bleeding, occasional fever, increased
sensitivity to sunlight and interacts with blood thinning
medication.
Result: Mix of every material known to have an effect on the
woman’s hormonal system including all side effects.
* No substantiating evidence of any positive effect for short or long
term.

25. Advantage of Tofupill vs. Other
Alternatives
-Preserves the complete biological molecule of the
Phytoestrogen as found in nature
-Natural extraction of the unnecessary parts through
enzymes
-No use of violent chemicals throughout the process.
-Substantiated by clinical studies.
-Safe for long-term use

26. Tofupill 30+
Introduction
-Women go through a gradual bone loss process from the
age of 30, which continues steadily until fractures
suddenly appear at the age of 55+.
-The decrease of the Estrogen level in the woman's body
accelerates the bone loss process in women
-Fractures are caused by the loss of the Density in the
Bone Mass, which leads to the development of
Osteoporosis.

27. -Tofupill30+uses the technological advantage that
enables to isolate complete natural structure of the
Phytoestrogen (DT56A)-balancing the hormonal
system.
-Tofupill30+is based on a holistic approach, treating all
the factors that lead the bone loss process it:
-maintains a steady hormonal balance of the woman's
body-inducing bone formation
-decreases the blood's acidity levels that are the result of
a deficient diet based of processed food, meat and
carbonated drinks
-adds calcium phosphate to strengthen the bone.

28. What is Osteoporosis?
-Osteoporosis is a disease in which the density and
quality of bone are reduced, leading to weakness of the
skeleton and increased risk of fractures.
-Bone loss is gradual and without symptoms or warning
signs until the disease is advanced.
-Osteoporosis is not an “old woman’s disease”, the bone
depletion process starts at the age of 30 and gradually
deteriorates with a sharp acceleration from the time
women reach menopause (or “premature” menopause)
to the sudden painful clinical breaks.
-Osteoporosis is often called the "silent disease" because
bone loss occurs without symptoms-a sudden strain,
bump, or fall causes a fracture or a vertebra to collapse.

29. Factors Involved in the
Development of Osteoporosis
The most recent studies show a combination of factors
that contribute to the development of Osteoporosis.
These factors can be divided in two categories.
1. Genetic factors
2. Environmental and behavioral factors.
Both factors if modified will slow the development of the
disease and may even prevent it completely depending on
the commencement and duration of the preventive
treatment.

30. Family History:
-Women with a family history of Osteoporosis are at a
higher risk of developing the disease.
Lack of Physical Activity:
-Daily exercising from puberty until old age is the key to
the amount of calcium that determines the bone's density.
-The bodily effort on the bone fortifies the bone to the
extent that it can afford to lose calcium and still keep the
amount that is needed for bone density.
Unbalanced diet:
-Our diet in the last decades increases the pH level in our
blood to levels exceeding all norms. These high acidity
levels require the blood to absorb a neutralizing agent, in
order to lower the acidity. The blood absorbs anti oxidants
from food sources but more readily it absorbs calcium
from the bones, as a regulatory and counteractive measure
to the blood's acidity.

31. Who is at Risk?
-Osteoporosis is a disease that puts almost all women at
risk of suffering.
-While osteoporosis is often thought of as an older
person's disease, it can strike at any age.
-Every year in the U.S. alone according to the National
Osteoporosis Foundation one in two women are at risk
of suffering a fracture due to Osteoporosis.
-Osteoporosis affects more than 20 million Americans.
About 40,000 women die each year from complications
attributable to osteoporotic fractures
-A woman's risk of hip fracture is equal to the combined
risk of developing breast, uterine and ovarian cancer.

32. Tofupill 30+ Product Information
Purpose:Delay and prevent the development of Osteoporosis
Composition:each capsule contains:
Calcium Phosphate 250 mg.
Tofu (DT56A) 172 mg.
Vitamin E 8 mg.
Indications: For the prevention of bone loss.
Dosage: 1-2 capsules a day.
Therapeutic effects: Increase in Bone Mass Density (BMD).
-Recommended for women from the age of 30.
-Especially recommended for women reaching menopause
-Can be taken with HRT.

33. Competing Products found in the market
Conventional Therapies
Name of Product: Evista(Raloxifene)(Eli Lilly-U.S.A.)
Main Component: Synthetic Estrogen Raloxifene
Prescribed for: Osteoporosis prevention.
New class drug: Selective Estrogen Receptor Modulators
(SERMs)
Dangers: Most women experience hot flashes and leg cramps
furthermore there are serious side effects of blood clots in the
veins.
-In Eli Lilly own laboratory studies designed to prove the
drug’s safety have shown that Evista induces ovarian cancer
in both mice and rats at dosages below the therapeutic.

34. Name of Product: Fosamax (Merck-U.S.A.)
Function: Its function is to specifically inhibit the
resorption of bone, improving bone density. It is a "non
hormonal" drug.
Problem: It is poorly absorbed and is best taken on an
empty stomach with water only about 10% of the drug is
usually absorbed. It works pretty well if it gets absorbed.
If not, it is pretty worthless.
Major side effects: The most common side effects are
abdominal and skeletal pain, nausea, constipation and
headache.
*The time duration of this drug is currently relatively short
and other drugs have found severe side effects when used
with larger population groups for longer periods of time.

35. Alternative Therapies
Name of group of products: Calcium Supplements (such as
Caltrate…)
Main components: Calcium Carbonate or Calcium Citrate
Philosophy of such supplements: Following the great scientific
difficulty to develop calcium with the organic format present
in the bone and with a high absorbency capacity, the general
solution created was supplying the body with calcium in
different formats in extremely high amounts of up to 8 times,
the amount of the naturally needed measure. The massive
presence of calcium in the blood was for the possibility that
this will allow some chemical bonds with free phosphates
found in the blood and subsequently this bondage will lead to
the composition of the material composing our bones, which is
calcium phosphate.

36. Disadvantages:
-The presence of phosphates in the blood system is very
low.
-Utter dependency on the blood as a factor to make
those chemical connections.
-Up to date we have no knowledge as to what impact such
massive presence of calcium have on the different body
systems such as the liver, kidneys and to the different glands.
-Calcium carbonate composes 10% of the bone composition,
and calcium citrate only 2%, even if they would have a high
availability to the body, they still would be able to contribute
to the strengthening of the bone only in those amounts since
the bone won’t change its natural composition.

37. Bone Inorganic Composition
Compound Chemical Formula% of bone Ash
Calcium phosphate Ca3(PO4)2 84
Calcium carbonate CaCO3 10
Calcium citrate Ca3(citrate)2 2
Magnesium phosphate Mg3(PO4)2 1
Magnesium carbonate MgCO3 1
Sodium phosphate Na2HPO4 2

38. Name of group of products:Calcium +Vitamin D Supplements
(Caltrate 600+D…)
Main component: Vitamin D or a combination of vitamin D
and calcium
Function: Vitamin D helps the process of calcium deposition
in the bones.
General Information:
-The body produces enough Vitamin D through exposure to
sunlight
-In countries that have an extreme deficiency in sunlight, there
is a need for a supplement of this vitamin in the form of a
food supplement.
-The presence of excessive amounts of vitamins can lead to
physiological problems.

39. Advantage of Tofupill vs. Other Alternatives
The components that form Tofupill30+have the exact
requirements that are needed to fight Osteoporosis on all its
fronts.
-250 mg. of Calcium Phosphate-GIVOCAL (France)
-Calcium Phosphate is the most abundant mineral in the
body, comprising 84% of our bone composition
-Extremely high capacity of absorbency
-Same chemical structure as found in the bone
-Highest availability to the bone organic composition.

40. -172 mg. Tofu (D756A)-
-Unique Tofu, extremely rich in Phytoestrogen
-Helps the body to maintain its steady hormonal balance
throughout the month which influences bone
formation.
8 mg. of Vitamin E (Tocopheryl)-
-A major anti-oxidant nutrient
-Specific dosage balances the pH level in our blood.
-Enables our system to balance itself
-Vitamin E stimulates the body in the formation of new
bone tissue, rejuvenating the cells.

41. The Advantages of the Tofupill Line
Tofupill
-A Unique variety of Non Genetically Modified Soybeans -
Unique Raw Material, DT56A-The complete organic
molecular structure of the Phytoestrogen –all 56
components
-Extremely rich in Phytoestrogen
-Completely naturally derived through the use of enzymes
-Backed by clinical studies
-Recommended for women as long as menopausal
symptoms persist.
-There are no dangers with long-term use.
Tofupill, the ultimate and safest solution for
menopausal symptoms.

42. Tofupill 30+
-Supplements the bones with Calcium phosphatein the
organic structure just like in the bone
-High absorbency of calcium
-Highest availability to the largest compound of the bone 84%
-Tofu (DT56A),Balances the Woman’s Hormonal System
-Induces bone formation
-Vitamin E,supplies a solution for our Deficient Diet
-Fights the high acidity levels in our blood
-Recommended for women from the age of 30.
-Especially recommended for women reaching menopause
-Can be taken with HRT.
Tofupill30+, the Strength to Fight Bone Loss

43. Thank you!