DESC:[0020] The following is a detailed description of embodiments of the present
disclosure. The embodiments are in such detail as to clearly communicate the
7
disclosure. However, the amount of detail offered is not intended to limit the
anticipated variations of embodiments; on the contrary, the intention is to cover all
modifications, equivalents, and alternatives falling within the spirit and scope of the
present disclosure as defined by the appended claims.
5 [0021] Unless the context requires otherwise, throughout the specification which
follow, the word “comprise” and variations thereof, such as, “comprises” and
“comprising” are to be construed in an open, inclusive sense that is as “including,
but not limited to.”
[0022] Reference throughout this specification to “one embodiment” or “an
10 embodiment” means that a particular feature, structure or characteristic described
in connection with the embodiment is included in at least one embodiment. Thus,
the appearances of the phrases “in one embodiment” or “in an embodiment” in
various places throughout this specification are not necessarily all referring to the
same embodiment. Furthermore, the particular features, structures, or
15 characteristics may be combined in any suitable manner in one or more
embodiments.
[0023] The headings and abstract of the invention provided herein are for
convenience only and do not interpret the scope or meaning of the embodiments.
[0024] Various terms are used herein. To the extent a term used in a claim is not
20 defined below, it should be given the broadest definition persons in the pertinent art
have given that term as reflected in printed publications and issued patents at the
time of filing.
[0025] The present disclosure relates to a method for masking of maltodextrin by
using mixture of phytochemicals in the form of aqueous transparent coating.
25
[0026] In the preferred embodiment of the present disclosure, a method for masking
of maltodextrin by using phytochemical mixtures further comprises of
8
phytochemical mixtures like Gymnema Silverstein, Karaya Gum and Guar Gum in
distilled water as the aqueous medium.
[0027] In an embodiment of the present disclosure, powdered extract of Gymnema
Silverstein, Karaya Gum and Guar Gum was purchased from the local market.
5 [0028] In an embodiment of the present disclosure, masking of maltodextrin has
been done by wet granulation method.
[0029] In an embodiment of the present disclosure, a method for masking
maltodextrin by using phytochemical mixtures;
10 - taking the powdered extract of Gymnema Silverstein, Karaya Gum and
Guar Gum in a magnetic stirrer and adding distilled water to the said extract
to form aqueous medium;
- stirring the aqueous medium in the magnetic stirrer under a constant speed
and if needed, increasing the speed accordingly for forming vortex;
15 - the stirring speed is reduced momentarily to avoid foaming and trapping of
air;
- after 24 hours of continuous magnetic stirring, sieving the aqueous
transparent coating solution to obtain clear solution;
- aqueous transparent solution is further sprayed on maltodextrin powder for
20 30 to 45 minutes;
- after spraying of aqueous transparent solution on maltodextrin powder, the
same is kneaded to form dough mass for 45 to 90 mins for making uniform
synergy granules;
- drying the kneaded dough mass in a tray dryer at 40-650C for 90 -120 mins
25 to form masked maltodextrin granules.
9
[0030] In another embodiment of the present disclosure, disclosed herein is a
method wherein, spraying of the aqueous transparent coating solution on
maltodextrin for masking for 30 to 45 mins further involves stopping of spraying
the said solution for one minute at the interval of 5-10 minutes until 30 to 45 mins.
5 [0031] In another embodiment of the present disclosure, disclosed herein in a
method wherein, drying of kneaded dough mass in a tray dryer at 40-650C for 30 to
45 mins further involves removing the aqueous transparent coated maltodextrin
granules for one minute from tray dryer at the interval of 10-12 mins until 30 to 45
mins.
10 [0032] In another embodiment of the present disclosure, a method for masking of
maltodextrin by using phytochemical mixture further comprises of 1-4% Gymnema
Silverstein powder extract, 0.2-0.8% Karaya Gum powder extract, 0.2-0.4% Guar
Gum powder extract and 95-98% of distilled water.
15 [0033] In another embodiment of the present disclosure, the total amount of
aqueous transparent coating solution is 1 to 3 litre in 50 kg of maltodextrin powder.
[0034] In another embodiment of the present disclosure, disclosed herein is a
method for masking maltodextrin by using phytochemical mixtures wherein the
20 masked granules of maltodextrin have been evaluated further with respect to
parameters like, Hausner's ratio, Carr's Index, Angle of repose, flow property,
disintegration time, dissolution time, average weight, friability and stability.
[0035] In yet another embodiment of the present disclosure, the said method for
25 masking maltodextrin has few advantages over the prior art like consumption of
phytochemical mixture masked maltodextrin do not elevate blood sugar level and
cholesterol levels and obesity, the said method uses the mixture that has been
10
derived from the natural source and hence is not harmful and the masked
maltodextrin can be consumed by diabetic, heart patients and obese patients.
[0036] In yet another embodiment of the present disclosure, the blood sugar and
5 cholesterol levels do not elevate, on oral administration of the masked maltodextrin
due to the synergistic effect of Gymnema Silverstein, Karaya Gum and Guar Gum
extract (phytochemical extract).
The following examples further describe certain specific aspects and embodiments
10 of the invention and a better understanding of present invention may be obtained
through the following examples and displayed process for manufacturing and it
demonstrates the practice and advantages thereof. It is to be understood that the
examples are given by way of illustration only and are not intended to limit the
scope of invention in any manner.
15 EXAMPLES:
a) Method for masking of maltodextrin:
A method for masking maltodextrin by using phytochemical mixtures comprises
of; taking 1-4% Gymnema Silverstein powder extract, 0.2-0.8% Karaya Gum
powder extract, 0.2-0.4% Guar Gum powder extract and adding 95-98% of distilled
20 water to the said extract to form aqueous medium as indicated in Table 1; stirring
the aqueous medium in the magnetic stirrer under a constant speed and if needed,
increasing the speed accordingly for forming vortex; the stirring speed is reduced
momentarily to avoid foaming and trapping of air; after 24 hours of continuous
magnetic stirring, sieving the aqueous transparent coating solution to obtain clear
25 solution; aqueous transparent solution is further sprayed on maltodextrin powder
for 30 to 45 minutes; after spraying of aqueous transparent solution on maltodextrin
powder, the same is kneaded to form dough mass for 45 to 90 mins for making
uniform synergy granules; drying the kneaded dough mass in a tray dryer at 40-
11
650C for 90 -120 mins to form masked maltodextrin granules.as indicated in Table
2 and Table 3.
Table 1: Concentration of Phytochemical mixture
Aqueous transparent Coating
ingredients
Concentration
(%)
Gymnema 1-4 %
Guar gum 0.2-0.8 %
Karaya Gum 0.2-0.4 %
Distilled Water 95-98 %
5 Table 2: Aqueous transparent Coating Parameters
Coating
solution
Spraying Time
(30-45 Min)
Drying temp
(90-120 Mins & 40-65 0
C)
Concentration of
Blend
Aqueous
Coating
mixture from
phytochemicals
Stop 1 minute after
each 5-10 minutes
of interval
Stop 1 minute after each
10-12 minutes of interval
1–3-liter
solution in 50 kg
batch
Table 3: Granulating Solution Parameters for wet granulation
Granulating Solution Amount of
Aqueous solution
Kneading time Drying (40-65
0 C)
12
Aqueous
Granulating mixture
solution (1-5%)
1-3 liter in 50 kg 45-90 minutes 90-120 min
b) Evaluation of masked maltodextrin:
Table 4: Comparison of Phytochemical mixture coating before and
5 after granulation & masking for pre-formulation parameters
Ingredients
Pre-formulation Parameter
Standard (before
granulation & masking)
Modified (after
granulation & masking) Marketed Product
Hausner's
ratio
Carr's
Index
Angle
of
repose
Hausner's
ratio
Carr's
Index
Angle
of
repose
Hausner's
ratio
Carr's
Index
Angle
of
repose
Mixture:
1.36 27.34 34.23 1.16 13.52 1.33 1.56 23.45 40.21
Gymnema
Silverstein
Karaya
Gum
Guar Gum
Table 5: Flow Property of Phytochemical mixture coating before and after
granulation & masking
10
Ingredients
Flow Property
Standard (before
granulation &
masking)
Modified (after
granulation &
masking)
Marketed
Product
Mixture:
(Gymnema
Silverstein,
Karaya Gum,
Guar Gum)
Poor Excellent Poor
13
Table 6: Stability and other parameters
Sr.
No. Parameters
Conditions
Initial 40°C &
75% RH
40°C & 75%
RH
40°C & 75%
RH
0 Day 1 Month 2 Months 3 Months
1
Disintegration
Time
200-240
sec
200-240sec 200-240sec 200-242 sec
2
Dissolution
Time
45
minutes 45min 45min ±
0.01min
45 min ± 0.01
min
3 Average Weight 670 ± 5
mg
670 ± 5 mg 670 ± 5 mg 671 ± 5 mg
4 Friability 0.8981 0.8981 0.898 0.8979
After stability study as indicated in Table 6 conducted till 3 months with varying
5 conditions indicates that no worthy disturbance is reported leading to
decomposition or toxicity of synergic phytochemical mixture after aqueous coating
and masking maltodextrin. Hence, it is compatible for oral administration.
DSC, XRPD and FTIR studies indicates no interaction between the maltodextrin
and aqueous transparent coating of synergistic phytochemical mixture as depicted
10 in Fig 1, Fig 2 and Fig 3 respectively.
,CLAIMS:1) A method for masking maltodextrin by using phytochemical mixtures
comprises of following steps;
- taking the powdered extract of Gymnema Silverstein, Karaya Gum and
5 Guar Gum in a magnetic stirrer and adding distilled water to the said extract
to form aqueous medium;
- stirring the aqueous medium in the magnetic stirrer under a constant speed
and if needed, increasing the speed accordingly for forming vortex;
- the stirring speed is reduced momentarily to avoid foaming and trapping of
10 air;
- after 24 hours of continuous magnetic stirring, sieving the aqueous
transparent coating solution to obtain clear solution;
- aqueous transparent solution is further sprayed on maltodextrin powder for
30 to 45 minutes;
15 - after spraying of aqueous transparent solution on maltodextrin powder, the
same is kneaded to form dough mass for 45 to 90 mins for making uniform
synergy granules;
- drying the kneaded dough mass in a tray dryer at 40-650C for 90 -120 mins
to form masked maltodextrin granules.
20 2) The method for masking maltodextrin by using phytochemical mixtures as
claimed in claim 1 wherein, wet granulation method has been adopted for
masking of maltodextrin.
3) The method for masking maltodextrin by using phytochemical mixtures as
claimed in claim 1 wherein, the concentration of phytochemical mixtures in
25 aqueous medium is 1-4% Gymnema Silverstein powder extract, 0.2-0.8%
15
Karaya Gum powder extract, 0.2-0.4% Guar Gum powder extract and 95-
98% of distilled water.
4) The method for masking maltodextrin by using phytochemical mixtures as
claimed in claim 1 wherein, the total amount of aqueous transparent coating
5 solution is 1 to 3 litre in 50 kg of maltodextrin powder.
5) The method for masking maltodextrin by using phytochemical mixtures as
claimed in claim 1 wherein, in the said method, spraying of the aqueous
transparent coating solution on the maltodextrin powder for masking for 30
to 45 mins further involves stopping of spraying the said solution for one
10 minute at the interval of 5-10 minutes until 30 to 45 mins.
6) The method for masking maltodextrin by using phytochemical mixtures as
claimed in claim 1 wherein, in the said method, drying of kneaded dough
mass in a tray dryer at 40-650C for 30 to 45 mins further involves removing
15 the aqueous transparent coated maltodextrin granules for one minute from
tray dryer at the interval of 10-12 mins until 30 to 45 mins.
7) The method for masking maltodextrin by using phytochemical mixtures as
claimed in claim 1 wherein, the masked maltodextrin prepared by the said
method, prevents elevation of blood sugar levels and cholesterol levels.
20 8) The method for masking maltodextrin by using phytochemical mixtures as
claimed in claim 1 wherein, the masked maltodextrin prepared by the said
method can be administered orally by diabetic, heart patients and obese
people.