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Current
Issues - Newsletter
June 2008
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Phytonutrients to Phytopharmaceuticals:
An Eventful Journey
Message from Dr.Muhammed Majeed, Founder & Chairman |
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Sabinsa Corporation turning twenty
in 2008, remains committed to its
founding principles of "Innovating for
the Future from the Past". Over the
years we adapted phytonutrients with
a history of food and medicinal use to
applications in dietary supplements,
functional foods and cosmetics, for
preventive health maintenance.
With our expertise in phytochemistry,
medicinal chemistry and organic synthesis,
we embarked on developing
innovative molecules and compositions
from nature, for use as therapeutics
in the treatment of chronic disease
conditions
A milestone in Sabinsa Corporation's
pioneering efforts in the field of phytonutrients
for health and well being,
was achieved in 2006, with the approval
of Ocufors, a branded and patented
composition of forskolin eye drops as
a natural drug for the management of
glaucoma, by the Drugs Control General
of India.
Forskolin is the active ingredient in
ForsLean®, Sabinsa's award winning,
and patented, standardized natural
extract, used in dietary supplements
for weight management support.
ForsLean® efficiently
and safely enhances lean
body mass at the expense
of body fat, improving
body composition, and
body mass index (BMI).
The major stumbling
block in the commercialization
of forskolin as an ophthalmic
drug has been its poor water
solubility. For example, the forskolin
eye drops used in clinical trials by
Hoescht Pharmaceuticals was a suspension
of varying concentration of
forskolin which induced side effects
like reddening, itching, lacrimation
and an initial increase in intraocular
pressure (IOP). Currently available
therapeutics for the management
of glaucoma (a leading cause of blindness
globally), offer benefits, but are
associated with side effects and tolerance
development. Research efforts by
Sabinsa Corporation enabled preparing
aqueous solutions of diterpenes such
as Forskolin and its derivatives, using
suitably substituted cyclodextrins as
solubilizing agents improving the
water solubility of forskolin 6,000
fold (US Patent #6,960,300).
| The composition effectively
addresses formulation challenges
that have limited the use of forskolin
as a therapeutic, functional food,
or cosmetic active agent in the past.
Aqueous preparations of forskolin and
related diterpenes are preferable in dermatological,
gynecological, otological,
rhinological and in mucous membrane
applications, and especially useful in
ophthalmic preparations
for the management of
ocular hypertension and
glaucoma. The soluble
forskolin composition is
potentially a first-line natural
therapy in reducing
IOP, based on its safety
in terms of side effect
profile, and its efficacy
in lowering IOP. Drug registration efforts are
underway globally. |
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In 1994, Sabinsa
Corporation introduced
and patented BioPerine®
(black pepper fruit extract)
for use as a bioavailability
enhancer for nutrients.
Tetrahydropiperine, derived
from this extract, improves
the uptake and utilization
of topically applied active
molecules, and received the
Thomas Alva Edison patent
award in 2005. This invention
is relevant to cosmetics,
as well as dermatological
compositions, and topical
drug delivery, wherein it
reduces dose requirements
of potentially toxic actives,
in the treatment of chronic
disease conditions.
Sabinsa Corporation
is now developing natural
molecules and compositions
for the treatment of socially
debilitating conditions such
as psoriasis, and precancerous
conditions such as oral
leukoplakia.
As always, we remain
caring and committed to
the spirit of innovation
in healthcare, and will
continue to provide the
quality ingredients that
you have come to expect
from SABINSA, this year
and in the years to come. |
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Sabinsa Hires Jeff Lind As
Chief Executive Officer |
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Sabinsa Corporation
has announced the
appointment of Jeff Lind
as the company's chief
executive officer, overseeing
all operational
aspects including supply
chain and purchasing
management, as well as
financial expenditures.
As a key member of
Sabinsa's leadership
team, Lind will help to
develop strategic direction
and determine optimal
business practices for the company.
| With a successful executive track
record and comprehensive expertise in
the nutraceutical industry, Lind’s more
than 17 years of business experience
includes leadership roles in sales and
marketing, corporate finance, supply
chain and risk management. Most
recently, he served as
the director of marketing
and sales for a leading
nutritional company,
further cementing his vast
experience in the industry’s
retail and manufacturing
sector. Lind holds a
J.D. degree fromWestern
New England College
School of Law and has
previously practiced
taxation and general
corporate law. |
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"We are excited to
have Mr. Lind join our team of professionals,"
said Muhammed Majeed, Ph.D.
and founder of Sabinsa Corporation. "As
CEO, Jeff brings rich experience and
expertise that will be a tremendous asset
as the company begins a phase of substantial
growth to meet the future needs
of the industry." |
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Jim Cudahy joins Sabinsa Corporation as President and COO |
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| Jim Cudahy graduated from Manhattan
College with a B.S. in Chemical
Engineering. Jim has over 26 years of
experience in the CPG industry, including
two Fortune 100 companies (Kraft and
Kellogg), focused on food and dietary supplements
(Nellson Nutraceuticals). With his
strong experiences in manufacturing, supply
chain, quality, engineering, contract manufacturing
and sales, Jim will provide Sabinsa with
a comprehensive business experience base
upon which we will move into the future. |
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Sabinsa Announces Capability as
Full-Service ContractManufacturer
Utah Site Provides Complete Range of Manufacturing Services in
Addition to Raw Material Offerings |
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Sabinsa Corporation's Payson, Utah contract manufacturing
facility is now fully operational. The additional
17,000-square-foot center provides cutting-edge capabilities
for the development of capsules, tablets, bulk custom
pre-mixes, drum-to-hopper blends, stick packs, and
powdered drinks. |
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Sabinsa's contract manufacturing services include:
Blending - 10,000 kg/shift
Roll compaction - 1,400 kg/shift
Fluid-bed granulation - 3,500 kg/shift
High sheer granulation - 1,400 kg/shift
Comill particle size reduction - 5,000 kg/shift
Tablet compression - 1 MM tabs/shift
Tablet coating - 250 kg/shift
Encapsulation - 1.2 MM caps/shift
Stick Packs - 1.2 MM/shift
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"As a proven supplier of quality raw materials for
nearly two decades, we felt it a natural transition to
extend our offerings to include state-of-the-art manufacturing
services," said Muhammed Majeed, Ph.D.,
founder and CEO of Sabinsa Corporation. "Now, our
customers not only have access to our scientificallybacked
raw materials offerings, but also to valueadded
manufacturing capabilities that meet all of their
formulation needs. This provides finished goods
manufacturers with added convenience, substantial cost
savings and a decreased time to market for products."
Additionally, Sabinsa is working to secureAustralian
TGAand other international regulatory certifications for
this facility to better serve its domestic clients with international
distribution, as well as international clients
presently serviced through other Sabinsa offices globally.
Sabinsa's global network of scientists, expertise in
the development of custom extracts and ingredients, and
ability to provide resources from product inception to
completion results in unparalleled service to its qualityoriented
customers.
For more information visit www.sabinsa.com/
manufacturing. |
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Sabinsa Corporation Awarded Gras
Status for Selenium SeLECT®
Bioavailable and Safe Selenium Ingredient
Confirmed Safe for Use in Foods and Beverages |
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Sabinsa Corporation announced Selenium SeLECT®, the
company's branded L-(+)-Selenomethionine compound
and the most bioavailable, pure and safe form of selenium,
received GRAS (Generally RecognizedAs Safe) designation
after an intensive review of safety and toxicology data
by an independent panel of respected scientists assembled
by Soni &Associates, Inc. This GRAS status allows for
Selenium SeLECT® to be used in a variety of food and
beverage applications including yogurt, flavored milk,
pudding, bread, cookies, pasta, cereal, oils, candies, water,
beverages, tea, herbs and other natural blends.
"As consumers continue to embrace functional foods
and beverages as a major component of a healthy lifestyle,
manufacturers are searching for safe and efficacious ingredients
to improve the nutritional profile of their finished
products," stated Muhammed Majeed, Ph.D., Managing
Director and CEO, Sabinsa Corporation. "Given the
increasing number of ineffective and sometimes dangerous
products on the market today, the proven safety and efficacy
of Selenium SeLECT®, as exemplified by its clinical
research and GRAS status, makes it ideal for inclusion in
a full-array of food and beverage offerings."
Selenium is a trace mineral that is found naturally in soil
and has been shown to have several positive health benefits.
When consumed, selenium enters the body to form
selenoproteins and glutathione, the body's antioxidant
immune system detoxifier. Selenium SeLECT®'s superior
quality as a selenium ingredient is additionally supported
by the following:
The worldwide quality standard or United States
Pharmacopeia (USP) monograph for selenomethionine is
based on Selenium SeLECT®
Selenium SeLECT® is registered and approved by the
European Union as a safe form of selenium supplementation
The National Cancer Institute (NCI) is using Selenium SeLECT® for its Selenium and Vitamin E Cancer Prevention
Trial (SELECT), a 12-year study focused on the role of
selenium and vitamin E, both separately and together, in
the prevention of prostate cancer. Additionally, NCI is
conducting the Prevention of Alzheimer's by Selenium SeLECT® and Vitamin E (PREADVISE) trial, researching
the role of selenium and vitamin E in preventing memory
damage with age, including Alzheimer's and other diseases
that can affect the brain. Selenium SeLECT® was chosen
for these NCI studies because of its high quality.
Selenium SeLECT® has been certified by NSF
International
Selenium SeLECT® is manufactured at Sabinsa's stateof-
the-art facility in India
For more information visit www.seleniumselect.com. |
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Sabinsa's Manufacturing Facilities Receive Funding,
Recognition From Government of India
Grant Aids Sami Labs to Complete Two Novel Research Projects |
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Sabinsa Corporation announced that Sami Labs, its
research and manufacturing arm in Bangalore, India,
received funding from the Government of India's
Department of Scientific and Industrial Research (DSIR)
to perform pilot trials on two novel research projects.
Sami Labs was awarded $185,000 under the
Department's Technology Development and Demonstration
Programme, designed to help promote India's research,
development and technology advancements. The grant will
be used in part to develop and test a plant-derived cosmetic
active, with expected market availability in late 2008. In
addition, the grant will assist Sami Labs in developing a
novel method to manufacture Resveratrol utilizing Sami
Labs' patented synthetic Demethylation strategy.
Additionally, India's National Accreditation Board
for Testing & Calibration Laboratories successfully
audited Sami Labs research & development and quality
control labs. The accreditation certificate provides further
validation of Sami Labs' equipment, analytical
methods, data systems and regulation compliance. |
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PATENT NEWS
SABINSA SECURES PATENT FOR
ForsLean® IN CANADA |
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Sabinsa has secured a patent in Canada for its branded
ingredient ForsLean®, a standardized extract of
Coleus forskohlii roots, the only known plant source of
forskolin, a natural compound that has been shown to
increase lean body mass and help optimize body composition
through cAMP activation. Patent #2281562 protects
the use and preparation of Coleus forskohlii extract
and affirms that ForsLean® is the only such extract that
can legally be used in nutritional supplements for the
purpose of increasing lean body mass in Canada. |
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SABINSA SECURES U.S. PATENT FOR
COCOCIN™ INGREDIENT |
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Sabinsa has secured a U.S. patent for its branded
ingredient Cococin™, a freeze-dried powder form of
green coconut water. In addition to Sabinsa's derivation
process, U.S. patent #7,300,682 secures exclusive
rights to the resulting vitamin-rich composition and
its intended uses in cosmetics, supplements and foods
and beverages to support healthy cell growth and
improve overall dermal health, among others.
Sabinsa's process extracts green coconut water, a
liquid endosperm of maturing coconut, at optimal maturity
when high levels of RNA, critical for amino acid
transport and respiratory metabolism of living cells, are
present. Long considered a refreshing beverage and even
a natural sports drink in SoutheastAsia, CentralAmerica
and other tropical regions, green coconut water has been
valued for its regenerative benefits.
In addition to Cococin™'s U.S. protection, the
branded ingredient was also granted European Patent
#EP1341547 for process, composition and use in the
European Market. |
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SABINSA JAPAN SECURES TWO NEW
PATENTS: BioPerine® &
COSMOPERINE® |
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Sabinsa Corporation has secured patents in
Japan for its branded ingredients BioPerine® and
Cosmoperine®, standardized piperine compositions
derived from black pepper extract.
Patent # JP 3953513 protects the use of piperine
in increasing the bioavailability of the nutrients and
pharmaceuticals. It affirms that BioPerine® is the only
black pepper extract that can legally be used in nutritional
supplements for the purpose of enhancing the
bioavailability of nutrients in Japan.
Patent # JP 4098985 protects the use of tetrahydropiperine
obtained from black pepper using
proprietary process. When included in formulations
with other biological actives, it enhances their
bioavailability and utilization. |
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OTHER NEWS: Evonik Extends Partnership with Sabinsa |
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Evonik Industries and Sabinsa have elevated
their exclusive marketing partnership with the
Personal Care product line of Evonik on a new
level. Evonik will now offer two more specialized,
standardized botanical actives and extracts from
Sabinsa, all specifically developed for cosmeceutical
use, to the personal care industry worldwide.
Evonik will introduce a standardized extract derived
from the seeds of the Horse Chestnut tree for the
cosmetic market. Horse chestnut extract is clinically
proven to benefit people suffering for example from
varicose or spider veins. The second "new entry" is
Xymenynic Acid, obtained from Santalum album
seeds. The standardized powder extract adds an
anti-inflammatory effect to personal care products.
These products are produced at Sami Labs Ltd.,
Sabinsa's national award-winning research &
manufacturing facilities in Bangalore, India and
have been tested for safety and efficacy in their
biological research laboratory by advanced in
vitro systems i.e., cell lines and bioassays. |
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Study Confirms Sabinsa's LeanGard®
Effectively BoostsWeight Loss and
Cuts Body Fat |
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Results of a randomized, double-blind, placebocontrolled
study of 46 overweight men and women
revealed that participants receiving LeanGard® - a
proprietary blend of three of Sabinsa's patented, clinically
researched ingredients, ForsLean®, Garcitrin®
and BioPerine® - had greater overall weight loss and
reduction in body fat, as well as significant increases
in lean body mass, than the placebo group.
The 12-week study, which was conducted at the
Shifaa Hospital in Banglore, India, evaluated the efficacy
and safety of LeanGard® as a dietary intervention
for weight management support against a neutral
placebo. Study participants were given either 500 mg
of LeanGard® or a placebo twice daily and screening
visits were conducted on day zero, as well as at weeks
three, six, nine and 12, to measure Total Body Water
(TBW), Basal Metabolic Rate (BMR), Body Mass
Index (BMI), Waist to Hip Ratio (WHR), Body Fat
Percentage (BF%) and Lean Body Mass (LBM).
Nineteen of the 21 LeanGard® receiving participants
achieved more than a 5 percent reduction in body
weight at the end of 12 weeks. Additionally, the
LeanGard® group showed a mean reduction in BMI of
7.45 percent from the baseline compared to 1.09 percent
for the placebo group, as well as a decrease in body
fat of 8.15 percent compared to 1.18 percent for the
placebo group. A 4.36 percent increase in lean body
mass was also seen in the LeanGard® group versus a 0.67
percent increase from baseline in the placebo group. No
clinically significant changes were observed in blood
pressure or heart rate, hematological liver function,
renal function, thyroid function, plasma lipid levels
or other biochemical parameters.
"With nearly two-thirds of the world's population
overweight, the need for effective products with extensive
scientific validation is more important than ever,"
noted Dr. Lakshmi Prakash, vice president of innovation
and business development, Sabinsa Corporation. "These
study results indicate that LeanGard® helps improve
body composition and mitigate weight gain in overweight
men and women with no apparent side effects."
LeanGard® consists of a proprietary ratio of
ForsLean®, Garcitrin® and BioPerine®. ForsLean® is an
extract derived from Coleus forskohlii roots, and the
only known plant source of forskolin, a natural compound
that has been shown to increase lean body mass
and help optimize body composition through cAMP
activation. Garcitrin® is a composition of calcium salt
hydroxycitric acid (HCA) with garcinol, a polyisoprenylated
benzophenone isolated from Garcinia
cambogia and Garcinia indica fruits, which reduces
fatty acid and lipid synthesis and improves lean body
mass. BioPerine® is a standardized piperine composition
derived from black pepper extract that has been shown
to increase the absorption of nutrients in nutritional
supplement formulations. All ingredients listed above
are patented by Sabinsa for their use. |
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OTHER NEWS: SabinsaWelcomes Benoit Le Gall as
Quality Assurance and Quality Control Manager |
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| Sabinsa Corporation announces the
appointment of Benoit Le Gall, Ph.D. as
quality assurance and quality control manager
for its Payson, Utah facility. Le Gall
will be responsible for upholding TGA
certifications, maintaining FDAcGMP
compliance and managing laboratories,
air handling, water purification systems
and other quality system requirements.
Le Gall comes to Sabinsa with over eight
years of experience as a chemist with a
strong background in quality control and
laboratory practices. His management
background includes a master of business
administration from the Paris Graduate
School of Management. |
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Cosmetic Corner: |
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New cosmeceutical product
launches from Sabinsa
MONOLAURIN |
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Monolaurin is a wide spectrum anti-viral,
anti-fungal and anti-bacterial ingredient.
Monolaurin is the glycerol ester of lauric acid,
a 12-carbon chain fatty acid found naturally in breast
milk and certain vegetable oils like coconut oil.
Monolaurin lends itself useful in formulations
requiring antimicrobial activity. It has an MIC of
40/ml i.e., at 0.004% as such against p. acnes and
hence useful in anti-acne preparations. It also has a
potential role as component of a natural preservative
blend. Being a non-ionic surfactant, it can also be
used in anti-microbial soaps and shampoos. |
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GLYCYRRHIZINIC ACID
& MONOAMMONIUM
GLYCYRRHIZINIC ACID |
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Glycyrrhizin, glycyrrhizinic acid or glycyrrhizic
acid, is the active principle of licorice root. It is
a powerful sweetener, 30-50 times as potent as
sucrose. Monoammonium Glycyrrhizinic acid (MAG)
is the water soluble delivery form of Glycyrrhizinic
acid. It is used as an anti-inflammatory and antiallergic
remedy for the treatment of bronchial asthma
and other diseases. It finds applications as a flavor
enhancer and flavoring agents in various food
categories. Topically, MAG can be used in the
form of creams or water based gels in the
management of eczema and other skin disorders. |
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OXYRESVENOX™ |
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OxyResvenox™ is the registered trade mark of
Oxyresveratrol from Sabinsa. Oxyresveratrol is an
analog of Resveratrol and is of synthetic origin.
US Patent 7,253,324, granted to Sabinsa specifically
protects the process for the synthesis of biologically
active polyphenolic compounds like Pterostilbene,
Resveratrol and Oxyresveratrol by novel dealkylation.
OxyResvenox finds potential applications as
an anti-tyrosinase, anti-oxidant and anti-inflammatory
ingredient. In view of skin lightening, de-pigmentation
and anti-inflammatory potential it can also be used in
cosmetic formulations as an anti-aging ingredient. |
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Introducing Natural Colors from
Sabinsa for Nutraceutical and
Cosmeceutical Applications |
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1) Red Sandalwood (Pterocarpus santalinus)
Cosmeceutical Applications
:: To impart glow and shine to the skin in cosmetic
creams, gels, lipsticks and lotions
:: To help wound healing
Nutraceutical Applications
:: Add color and nutrient value to processed food
beverages, candies etc.,
:: Impart red color to alcoholic beverages |
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2) Sappanwood (Caesalpinia sappan)
Cosmeceutical Applications
:: Sappanwood Extract can be incorporated into
cosmetic creams, gels and lotions
:: Its antibacterial property can be utilized effectively
in aftershave lotions
:: It can give bright color and add aesthetic value
to bath soaps
Nutraceutical Applications
:: Add color and nutritional value to citrus drinks
:: Impart color to alcoholic beverages
:: Add nutrient value and aesthetic appeal to
processed foods |
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