DESC:[0021] The following is a detailed description of embodiments of the present
15 disclosure. The embodiments are in such detail as to clearly communicate the
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.
20 [0022] 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.”
[0023] Reference throughout this specification to “one embodiment” or “an
25 embodiment” means that a particular feature, structure or characteristic described
7
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
5 characteristics may be combined in any suitable manner in one or more
embodiments.
[0024] The headings and abstract of the invention provided herein are for
convenience only and do not interpret the scope or meaning of the embodiments.
[0025] Various terms are used herein. To the extent a term used in a claim is not
10 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.
[0026] In the preferred embodiment of the present disclosure, disclosed herein is a
plant extract-based diluent, wherein the said diluent is prepared by using extract of
15 Punica granatum, Moringa oleifera and Glycyrrhiza glabra, that is used in tablet
formulation.
[0027] In an embodiment of the present disclosure, mention which part of the plant
was taken for preparing extract. Also mention the source of each extract i.e. whether
readymade powder was purchased or it was obtained from a particular geographical
20 location.
[0028] In an embodiment of the present disclosure, diluent is prepared from the
said plant extracts and formulated into the tablet by dry granulation method.
[0029] In an embodiment of the present disclosure, disclosed herein is the plant
25 extract-based diluent wherein Moringa oleifera extract and Glycyrrhiza glabra
extract contains fibres that promotes water intake and tablet’s disintegration while
8
Punica granatum extract acts as binder that gives good micromeritics property with
improvement in tablet compaction, hardness and compressibility.
[0030] In an embodiment of the present disclosure, the synergistic mixture of
Punica granatum, Moringa oleifera and Glycyrrhiza glabra extract solves tablet
5 capping, tablet slugging, and friability problem.
[0031] In an exemplary embodiment of the present disclosure, a method for
preparing plant extract-based diluent to formulate tablet comprising;
- mixing Punica granatum, Moringa oleifera and Glycyrrhiza glabra extract
10 in equal proportion and processing it for granulation;
- adding minor amount of granulating agent (starch syrup) during ongoing
granulation as the said plant extract mixture itself also acts as granulating
solution to avoid agglomeration of granules formed;
- kneading of the said granulating plant extract mixture for 30-45 minutes;
15 - adding active phytoconstituent slowly to the said granulating plant extract
mixture uniformly under constant agitation till the formation of perfect
knead;
- the granulated mixture of active phytoconstituent and plant extract mixture
is pulverized through sieve 80-100 to a mean particle size of the granule in
20 the range of about 80-100 µm;
- the granulated mixture is dried by fluidized bed dryer or tray dryer at 40-
55? for 60-90 minutes till complete moisture is removed;
- dried granulated mixture is converted to table by direct compression
method.
9
- evaluation of both granulated mixture and tablet with respect to parameters
like, Hausner's ratio, Carr's Index, Angle of repose, flow property,
disintegration time, dissolution time, friability and stability.
[0032] In another embodiment of the present disclosure, the said extract of Punica
5 granatum, Moringa oleifera and Glycyrrhiza glabra are mixed in the ratio of 1:1:1.
[0033] In another embodiment of the present disclosure, 8-12% total concentration
of plant extract-based diluent can be used to formulate the tablet.
[0034] In yet another embodiment of the present disclosure, the said plant extractbased diluent used in tablet formulation significantly improves pre and post10 formulation parameters after tablet formulation.
[0035] In yet another embodiment of the present disclosure, the said plant extractbased diluent used in tablet formulation is chemical free, has good patient
compliance and can be consumed by all types of patients including diabetic, heart
and obese patients.
15 [0036] In yet another embodiment of the present disclosure, the said plant extractbased diluent used in tablet formulation has probiotic effect that helps in
maintaining good gut health.
The following examples further describe certain specific aspects and embodiments
of the invention and a better understanding of present invention may be obtained
20 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.
EXAMPLES:
25 a) A method for preparing plant extract-based diluent to formulate tablet:
10
A method includes mixing Punica granatum, Moringa oleifera and Glycyrrhiza
glabra extract in equal proportion of 1:1:1 and processing for granulation;
adding minor amount of granulating agent (starch syrup) during ongoing
granulation as the said plant extract mixture itself also acts as granulating
5 solution to avoid agglomeration of granules formed; kneading of the said
granulating plant extract mixture and for 30-45 minutes; adding active
phytoconstituent slowly to the said granulating plant extract mixture uniformly
under constant agitation till perfect knead; the granulated mixture of active
phytoconstituent and plant extract mixture is pulverized through sieve no 80-
10 100 to a mean particle size of the granule in the range of about 80-100 µm; the
granulated mixture is dried by fluidized bed dryer or tray dryer at 40-55? for
60-90 minutes till complete moisture is removed as indicated in Table 1 and
dried granulated mixture is converted to table by direct compression method.
Table 1: Parameters defined for Granulation method
Kneading time
(Min)
Drying
(40-500 C)
Pulverize
Through
35-60 minutes 60-90 min Sieve-80-100
15
Excipient’s category and range
The quantity of the natural plant extract-based diluent in solid (dry) and liquid
form and the total concentration that is to be used is indicated in Table 2 below:
Natural Diluent Dry diluent (%)
concentration
Liquid Diluent
concentration (%)
Total % Concentration
plants extract based
Diluent (%)
11
Punica granatum 30-32
Moringa Oleifera 30-32 1-3 8-12
Glycyrrhiza glabra 30-32
b) Preparation of Table Formulation by using plant extract-based Diluent
Initially three formulations F1, F2 and F3 were prepared that comprised of active
phytoconstituent, individual plant extract-based diluent, banana powder as
5 Superdisintegrants and talc as indicated in Table 3.1 below. Further Formulation F4
was prepared by adding of active phytoconstituent, mixture of three plants extract
Punica granatum, Moringa oleifera and Glycyrrhiza glabra, banana powder as
Superdisintegrants and talc as indicated in Table 3.2 below.
Table 3.1: Formulation of Tablet using individual plant extract-based Diluent
Sr. NO Ingredients F1 F2 F3
1 Active Phytoconstituent 820 820 820
2 Diluent 1-Punica granatum 100 - -
3 Diluent-2 Moringa oleifera - 100 -
4 Diluent-3 Glycyrrhiza glabra - - 100
5 Superdisintegrant (Banana Powder) 50 50 50
6 Talc 30 30 30
10
Table 3.2: Formulation of Tablet using mixture of plant extract-based Diluent
Sr. NO Ingredients F4
1 Active Phytoconstituent 820
2 Diluent blend (Punica granatumMoringa oleifera
Glycyrrhiza glabra) (1:1:1)
100
5 Superdisintegrant (Banana Powder) 50
6 Talc 30
12
c) Evaluation of the Tablet formulation containing plants extract-based
Diluent
Table 4.1: Pre-formulation Characteristic of Granules
Parameters
Formulation
F1 F2 F3 F4
Hausner’s ratio 1.19 1.18 1.18 1.15
Carr's index (%) 18.91 19.14 17.41 15.51
Angle of Repose 32.24 34.71 33.61 29.82
5 Table 4.2: Flow Property synergistic mixture of diluent before and after granulation
The plants extract-based diluent was used in 3 different herbal tablets and evaluated
for the parameters with respect to disintegration time, dissolution time and
friability. The same 3 herbal tablets were prepared by using lactose-based diluent.
10 Comparative analysis for the disintegration time, dissolution time and friability
were done for plants extract-based diluent and lactose-based diluent as indicated in
Table 5, 6 and 7 respectively.
Table 5: Post formulation Evaluation parameters of 65% Garcinia Cambogia
Tablet
Parameters Lactose based diluent plants extract-based diluent
Disintegration time 230-280 sec 90-120 Sec
Dissolution time 90 min 45-50 min
13
Friability 1.031 0.891
Table 6: Post formulation Evaluation parameters of Green Coffee bean extract
Tablet
Parameters Lactose based diluent plants extract-based diluent
Disintegration time 220-280 sec 90-120 Sec
Dissolution time 90-120 min 35-45 min
Friability 0.995 0.892
5 Table 7: Post formulation Evaluation parameters of Green tea extract Tablet
Parameters Lactose based diluent plants extract-based diluent
Disintegration time 240-290 sec 80-120 Sec
Dissolution time 120-150 min 45-60 min
Friability 0.996-1.107 0.902-0.964
The post formulation evaluation parameters and comparative analysis of plants
extract-based diluent with Lactose based diluent for the three herbal tablets
indicates that plants extract-based diluent has improved disintegration time,
10 dissolution time and friability as compared to Lactose based diluent.
Stability Study
Table 8: Stability Study of plants extract based diluent used in tablet formulation
Parameters Conditions
14
Sr.
No.
Initial 40°C & 75%
RH
40°C & 75%
RH
40°C & 75%
RH
0 Day 1 Month 2 Months 3 Months
1
Disintegration
Time 90-120sec 90-120sec 90-120sec 90-120sec
2 Dissolution time 40-60 min 40-60 min 40-60 min 40-60 min
3 Friability 0.972 0.971 0.970 0.970
Table 8 above concludes that no significant changes were notified while stability
study up-to 3 months.
DSC, XRPD and FTIR studies of plants extract based diluent used in tablet
5 formulation have been depicted in Fig 1, Fig 2 and Fig 3 respectively. ,CLAIMS:1) A plants extract-based diluent used in tablet formulation wherein, the
diluent comprises of mixture of Punica granatum, Moringa oleifera and
Glycyrrhiza glabra extract.
5 2) The plants extract-based diluent used in tablet formulation as claimed in
claim 1, wherein, in the said diluent the proportion of Punica granatum,
Moringa oleifera and Glycyrrhiza glabra extract is 1:1:1.
3) The plants extract-based diluent used in tablet formulation as claimed in
claim 1, wherein, Moringa oleifera extract and Glycyrrhiza glabra extract
10 contains fibres that promotes water intake and tablet’s disintegration while
Punica granatum extract acts as binder that gives good micromeritics
property with improvement in tablet compaction, hardness and
compressibility.
4) The plants extract-based diluent used in tablet formulation as claimed in
15 claim 1, wherein the total concentration of the said diluent that can be used
in tablet formulation is 8-10%.
5) The plants extract-based diluent used in tablet formulation as claimed in
claim 1, the said diluent used in tablet formulation is chemical free and the
tablet formulation containing the said diluent can be consumed by all types
20 of patients including diabetic, heart and obese patients.
6) The plants extract-based diluent used in tablet formulation as claimed in
claim 1, the said diluent used in tablet formulation has probiotic effect for
maintaining gut health.
7) The plants extract-based diluent used in tablet formulation as claimed in
25 claim 1 wherein, the said diluent is prepared by dry granulation method.
8) A method for preparing plant extract-based diluent to formulate tablet
comprising;
- mixing Punica granatum, Moringa oleifera and Glycyrrhiza glabra extract
in equal proportion and processing it for dry granulation;
16
- adding minor amount of granulating agent (starch syrup) during ongoing
granulation as the said plant extract mixture itself also acts as granulating
solution to avoid agglomeration of granules formed;
- kneading of the said granulating plant extract mixture for 30-45 minutes;
5 - adding active phytoconstituent slowly to the said granulating plant extract
mixture uniformly under constant agitation till the formation of perfect
knead;
- the granulated mixture of active phytoconstituent and plant extract mixture
is pulverized through sieve 80-100 to a mean particle size of the granule in
10 the range of about 80-100 µm;
- the granulated mixture is dried by fluidized bed dryer or tray dryer at 40-
55? for 60-90 minutes till complete moisture is removed;
- dried granulated mixture is converted to table by direct compression
method.
15 - evaluation of both granulated mixture and tablet with respect to parameters
like, Hausner's ratio, Carr's Index, Angle of repose, flow property,
disintegration time, dissolution time, friability and stability.
9) The method for preparing plant extract-based diluent to formulate tablet as
claimed in claim 8 wherein, the quantity of starch syrup, acting as
20 granulating agent added during ongoing granulation.