DESCRIPTION:
The following specification particularly describes the invention and the manner in which it is
to be performed:
TITLE: PROCESS FOR PREPARATION OF FOOD SUPPLEMENT
FIELD OF INVENTION:
This invention relates to a process for preparation of different food supplement and other
health improvement and in particular to a food supplements formulation containing
phytonutrients form the herbs whose combination useful in relation to, but not limited to
nutrition but also provides right amounts of all the vitamins, minerals and antioxidants which
are critical in the management of different diseases.
BACKGROUND AND PRIOR ART
With very few good supplements available in the market that cater to the requirements of
people suffering from chronic diseases. The products available in the market often use
inadequate methods or do not use the combination mentioned by us in this method, so that all
the right phytonutrients are extracted from the herbs and then blend with the right vitamins,
minerals and antioxidants for the given condition.
The products in the market either have:
• Solvent based extracts OR
• Old traditional Ayurvedic method
• Just C02 extracts filled in soft gel capsules, mostly single herbs
• Herbal extracts in combination with vitamins and minerals.
Following is the example of a diabetic supplement. The available carbohydrates of any food,
namely sugars, dextrins and starch undergo digestion and absorption mainly in the form of
glucose in human gastrointestinal tract which subsequently enters the blood stream. In
response to glucose assimilation in the blood, the pancreas releases insulin and helps in
metabolizing glucose. This results in maintaining proper level of glucose in blood in a
specified range. In healthy humans, the insulin response is adequate to maintain blood
glucose levels in normal limits but any aberration in the insulin response results in excess
(hyperglycemia) or low (hypoglycemia) glucose levels in blood.
Toady diabetes has become an epidemic; more than 400 million are suffering worldwide.
India is home to at least 50 million diabetics and an equal number don't even know that they
are suffering from it. To manage diabetes people are resorting to Pharma intervention,
Ayurveda, naturopathy, homeopathy and food supplements.
As diabetes is a lifestyle disease it requires lifestyle modification which consists of right
exercise, right eating habits, supplementation of vitamins, minerals and antioxidants, healing
herbs, stress management, blood sugar monitoring, motivation and healthy joints and muscles
apart from oral hypoglycemics and in advanced cases injectable forms like insulin.
Pharma management of DM is revolving around the drugs that lower the BS levels using
sulphonylureas, biguanides, thiazolidinediones and alpha glucosidase inhibitors: primarily
through 3 ways:
1. Agents that increase the amount of insulin secreted by the pancreas
2. Agents that increase the sensitivity of target organs to insulin
3. Agents that decrease the rate at which glucose is absorbed from the gastrointestinal
tract.
Other injectable drugs are also used like insulin, exenetide and pramlintide.
The products available in the market are of questionable quality and there are doubts in the
minds of consumers and Physicians. Following are the points make you think twice while
using the available Ayurvedic products in the market:
1. Presence of pesticides and herbicides.
2. Presence of Fertilizers.
3. Presence of Heavy metals.
4. Infested with bacteria, fungus, protozoa and viruses.
5. Usage of bhasmas and other possible toxic elements.
6. Fears of the Presence of corticosteroids.
7. Improper extraction methods destroying the active phytonutrients.
8. Too little active nutrients so as to make the production cheap for higher profits.
9. Too slow in getting the desired result.
10. Large quantities used to get the desired results, from teaspoons to tablespoons
11. Issues with taste and odor.
12. Inconvenient ways of consumption of medication like pudiya.
13. Lack of standardization and testing so as to provide consistency in the product and
hence the efficacy.
14. Limited or no clinical testing for the products.
15. Non reliable composition
16. Substitution of herbs is encouraged to non availability of genuine herbs.
17. Not all the phytonutrients are extracted, e.g. non polar are not extracted.
18. Faulty procedure of manufacturing.
Homeopathy and naturopathy are too weak to even consider.
Homeopathy has very few options for diabetes, which are limited to alcoholic drops of single
herbs like, Gymnema Syivestre. There are a lot of Ayurvedic products in the market, but
there are a lot of issues with the processing and manufacturing of the products, besides a lack
of the right combination of herbs.
Recently, it has been suggested that certain amino acids, when used as supplements to a
normal diet in relatively large doses. The doses are sufficiently large that one would need to
take a large number of pills or a large volume of powder to achieve the desired therapeutic
dosage level. Unfortunately, amino acids have an undesirable flavor and can readily react
with a variety of other chemicals found in foods, particularly when combined at elevated
temperatures.
There are hardly any good supplements for diabetes in the market, if they are present they
only contain some vitamins, minerals and antioxidants but do not contain the herbs with it(in
the Indian Market). Ayurvedic products do not contain the above mentioned vitamins,
minerals and antioxidants.
As the market for supplements is not well regularized, most of the manufacturers do not put
the right amount of vitamins, minerals and antioxidants or sometimes of cheap quality, so as
to increase profits.
Accordingly, thus there is a need of an food supplement formulation for diabetics, having a
proper combination extract of all the phytonutrients form the given herbs in right proportion
with all the vhamins, minerals and antioxidants to provide optimum nutrhion, health
protective, promotive and disease preventive benefits for diabetic patients.
Our invention lies in the process to solve the problem from which the best results can be obtained by
extracting all the right phytonutrients from the herbs both polar and non-polar by not the traditional
solvent based (for oils and oleoresins) but with supercritical CO2 extraction and (not water soluble
filtration), but with spray drying at the right temperature (under vacuum) so that the phytonutrients
stay intact and there is no fiber in the extract. Then blending of the phytonutrients is done in the right
proportion so that they give a synergistic effect. When the two types of extracts are mixed they give
all the phytonutrients in the herbs (which were not extracted or get destroyed by the traditional
methods of extraction). The product should have the right amount and the right types of vitamins,
minerals and antioxidants, so we have blended them in .the supplement. This makes this supplement
exceptional and this combination of technology with the given vitamins, minerals, antioxidants and
herbs is not available in art.
OBJECTS OF THE INVENTION:
The principal object of the present invention is this invention relates to a process for
preparation of food supplement and in particular to a food supplements formulation
containing phytonutrients form the given herbs in right proportion with all the vitamins,
minerals and antioxidants to provide optimum nutrition, health protective, promotive and
disease preventive benefits for patients.
Another objective is to provide process for preparation of food supplements containing all the
vital phytonutrients, vitamins, minerals and antioxidants that are critical for that chronic
disease/condition.
Still another object of the invention is to provide a food supplement formulation that has
good stability.
STATEMENT OF INVENTION
The present invention relates to a process for preparation of food supplement and in particular
to a food supplements containing phytonutrients food supplement formulation, having a
proper combination extract of all the phytonutrients form the given herbs in right proportion
with all the vitamins, minerals and antioxidants to provide optimum nutrition, health
protective, promotive and disease preventive benefits for diabetic patients.
DETAILED DESCRIPTION OF THE INVENTION:
Accordingly, the present invention is to develop a process of manufacturing health protective,
promotive and disease preventive composition(s) useful as food supplement to the general
health of people having diabetics with optimum nutrients and also help to control the blood
sugar level. Following is the example for a process for preparation of food supplement for
diabetics: The process comprising the selected herbs to prepare food supplement for
diabetics. This invention relates to a food supplement formulation for diabetics and in
particular to a food supplements formulation containing phytonutrients form the herbs and
antioxidants comprising Gymnema Sylvestre, Momordica Charantia, Pterocarpus
Marsupium, Trigonella Foenum Graecum, Cinnamomom Zeylicum, Syzgium Cumini, Alpha
Lipoic Acid, Benfothiamine, Tinospora Cordifolia, Coccinia Indica, Lutein, Myristica
Fragrans, Azadirachta Indica, Zingiber Officinalae, Piper Longum, Ocimum Sanctum,
Emblica Officinalis, Cassia Fistula, Lagerstroemia Speciosa, Curcuma Tonga, Astaxanthin,
Moringa Oleifera, Commiphora Mukul, Lawsonia Inermis, Zeaxanthin with Minerals(Zinc,
Chromium, Vanadium, Selenium) and vitamins(B3,.B6, B12, Biotin, Folic acid and D3).
Similarly different herbs, vitamins, mineral and antioxidants would change but the process
would remain the same for different food supplements.
The herbs are taken through processes, where the herbs which have mostly water soluble
phytonutrients go through the extraction with spray drying and the ones which contain both
polar and non-polar first go through the supercritical CO2 extraction and then through the
spray drying, the processes are mentioned briefly below:
The Extraction process begins with the careful selection of raw materials. The raw materials
once received are first subjected to sample inspection to determine the quality in terms of
physical appearance, contamination of any extraneous material etc. Once the raw material is
accepted the same is. taken for pulverizing. For materials which are heat sensitive the
pulverizing is carried out at extremely low temperatures. The pulverized material is then
stored in plastic bins which are kept closed until they are taken for the extraction process.
-7
The supercritical extraction process comprises of flowing the required quantity of CO2 at the
desired process conditions. The typical process conditions are pressures in the range of 80 to
400 bar and temperatures in the range of 20 to 80 deg C. These process conditions are
standardized based on the extensive research and analysis of the extracts for the required
active ingredients and the concentration within the total extract. This way aromatic oils, fixed
oils resin and oleoresins are separated out without disturbing its natural composition.
The extract usually contains some amount of water which is coextracted. This water is
carefully removed using gravity column of centrifuging. The finished extract is then
subjected to physical examination and then packed in air tight containers which are typically
plastic jars or aluminium bottles. After the complete extraction of the herb the extractors are
depressurized and the exhausted raw material is taken out. The fresh material is then
recharged and the process is repeated.
The extracted raw material is now completely devoid of non polar substances and is subjected
to water extraction. Here the herb powder is mixed with demineralised and distilled water and
the mixture is stirred and kept in the reactor for few hours. The process temperature is
carefully controlled to ensure that the thermal damage to the active molecules is kept to a
bare minimum. After the required batch time the mixture is filtered in a pressure filter to
separate the insoluble herb powder and solution. The solution is further micro filtered and
then taken for spray drying process.
In the spray dryer the solution is sprayed in a form of fine mist and the water is instantly
evaporated which gives rise to fine powder which represents all the water soluble active
ingredients within the herb powder.
The dried water extract is then packed in the inert packaging.
The residue which is primarily fiber would be used in making fiber sachets, biscuits,
namkeens, feed for birds and cattle from the edible fiber and cardboard material, fire ball for
cooking and making of incense sticks, filter pads, water cooler pads, worm culture manure
and from the non-edible fiber. So it is a completely eco-friendly process where no harm is
done to the nature and its balance.
According to the product different spray dried extracts are mixed to make the blend, then CO2
extracts are mixed together with ethanol, then different vitamins minerals and antioxidants
are mixed(except for the temperature sensitive ones like vitamin D, which is mixed at a later
stage.
The best results can be obtained when we extract all the right phytonutrients from the herbs
both polar and non-polar by not the traditional solvent based (for oils and oleoresins) but with
supercrticicalC02 extraction and (not water soluble filtration), but with spray drying at the
right temperature (under vacuum) so that the phytonutrients stay intact and there is no fiber in
the extract. Then we blend the phytonutrients in the right proportion so that they give a
synergistic effect. When the two types of extracts are mixed they give all the phytonutrients
in the herbs (which were not extracted or get destroyed by the traditional methods of
extraction). Three types of blends are used in process of manufacturing of food supplement
a) Dry Powder blend- spray dried
b) Vitamin/Minerals/antioxidants blend
c) Oily blend- CO2 extract
a) Dry powder proprietary blend which is basically a compound of herbal extract, which
is hygroscopic in nature and cannot stand exposure to high humid environment. This
compound has to be properly mixed in powder mixer for Ihr.
b) The material is required to be sieved through 60 mesh shifter.
c) Vitamin/mineral/antioxidants powder in material is required to be sieved througli 60
mesh shifter and then mixed for Ihr. The material is required to be granulated
separately as per procedure for Vitamin handling procedure in the schedule M of the
Drugs & Cosmetic Acts & Rules.
d) Oily proprietary blend has to be mixed with required quantity of Ethanol and there
after Dry Powder compound (Blend) & Oily blend was to be mixed in R.M.C. for 40
minutes and simultaneously granules to be made & dried in Fluid bed dryer (optimum
temperature SO'c)
e) Granules of Dry Powder & oil blend will be mixed with granules of Vitamin blend
granules along with lubricant as per required but no starch will be used.
f) These granules mix will be filled in double Zero Capsule (Hard Gelatin) each fill
would be 730-735mg. through automatic/ semiautomatic capsule fill up machine. The
entire process would be done at environmental control of temperature below 25° and
RH below 50. There should not be variation of capsule fill of more than 1.5-2% and
inbuih moisture should not be above 3%.
g) By combining both the extracts it makes a nice granule which is perfect for filling in
hard gelatin capsules, soft gels and making of tablets or any other form .
Numerous modifications and adaptations of the system of the present invention will be
apparent to those skilled in the art, and thus it is intended by the appended claims to cover all
such modifications and adaptations which fall within the true spirit and scope of this
invention.
The advantage of this process is that all the phytonutrients are intact and the best of nature is utilized.
By combining both the extracts it makes a nice granule which is perfect for filling in hard gelatin
capsules, soft gels and making of tablets or any other form .
MANUFACTURING PROCESS FLOW CHART
Inward Entry of all Ingredients (C02 extracts+ spray
dried extracts and antioxidants)
I
Unloading of the materials in Store
i
Storage in Conditioned room [RH-50- Sampling for Microbial assessment and other physico-
55%; Temp 20°C] for 24 to 48 hours ~* chemical test, if required
i i
,, .f Z 't . . , - , , 4 Verification of weight of Mat er,i„a,ls„ recei•v edI I I Exceeded microbia.l grouw* t•h ma-.yu -r eqru~i-r.e specific treatment ^ to obtain within limit.
i
Individual Sifting using 60# mesh Sieve or as per
requirement '
i
R.M.G. [Rapid Mixer & Granulator] mc
i
F.B.D. till LOD remains <1% I I Mixing of Vitamins & Minerals
i
Multimill [LOD test] Grinding of Vit to fine powder, if so
i • i
Sifting [mesh # as per requirement] Sifting of Vit using 80# mesh
i i
Weighing as per formulation sheet
i I
Loading in IPC Containers Then Blend whole vitamins with Minerals
i i
Lubrication using Octagonal/Ribbon Blender <- Mix whole content in herbal blend
i
Loading in IPC Containers I Sampling for Final Test in QC Labs***
i ^ r
Final Weight of blend tarring Containers*
i
u
Filling of Blends in Capsules using Automatic capsule
filling m/c*
i
Batch coding on Label*
i
Labeling on bottles by Shrinking*
i
Automatic Capsule Counter & Filling in Bottle m/c*
i
Bottle Capping m/c* ->
1^

I/We Claims :
1. A process for the preparation of the food supplement containing phytonutrients form
the given herbs in right proportion with all the vitamins, minerals and antioxidants
comprises step of
a) C02 extraction of herbs(for oils and oleoresins, followed by spray drying of the herb
for the water soluble phytonutrients and then the blending of both the extracts in the
right proportion which will be method separately in the patents to be filed in future.
b) Sieving material through 60 mesh shifter.
c) Addition of Vitamin/mineral/antioxidants powder in material after sieving through 80
mesh shifter and then mixed for Ihr. Granulation of the material is for Vitamin
handling.
d) Oily proprietary blending (supercritical extraction process comprises of flowing the
required quantity of CO2 at the desired process conditions) has to be mixed with
required quantity of Ethanol (in some cases) and there after Dry Powder compound
(Blend) & Oily blend was to be mixed in R.M.G. for 40 minutes and simultaneously
granules to be made & dried in Fluid bed dryer (optimum temperature 50°c).
e) Granulation (or liquid blend- in the case of soft gel capsules) of dry Powder & oil
blend and mixed with granules of Vitamin blend granules along with lubricant
without using starch.
f) Filling granules mix in hard gelatin or soft gelatin Capsules.
2. A process for the preparation of the food supplement as claimed in claim 1 wherein
extraction of all the phytonutrients from the herbs both polar and non-polar by
supercrticicalCOa extraction and spray drying, and (not water soluble filtration).
3. A process for the preparation of the food supplement as claimed in claim 1 wherein
each capsule fill up by machine between having 675-725mg of ingredients(in the case
of hard gelatin) and up to lOOOmg in the case of soft gelatin capsules.
4. A process for the preparation of the food supplement as claimed in claim 1 wherein the
supercritical C02 extraction process would be done at environmental control of
temperature in the range of 20 to 80 deg C below 25° and RH below 50 and pressures
in the range of 80 to 400 bar.
5. A process for the preparation of the food supplement as claimed in claim 1 wherein the
spray drying of the herbs has to be at a temperature not going higher than 70 degrees
centigrade.
6. A process for the preparation of the food supplement as claimed in claim 1 wherein
blending done the process dry Powder blend- spray dried, Vitamin/ Minerals/
antioxidants blend and Oily blend- CO2 extract.
7. A process for the preparation of the food supplement as claimed in claim 1 wherein
spray dried extracts are mixed to make the blend, CO2 extracts are mixed together
with ethanol and different vitamins minerals and antioxidants are mixed except for the
temperature sensitive ones like vitamin D, which is mixed at a later stage.
Date: 28'" October, 2011
TARUN JAIN
Patent Agent
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