DESC:[0019] The following is a detailed description of embodiments of the present
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
20 all modifications, equivalents, and alternatives falling within the spirit and
scope of the present disclosure as defined by the appended claims.
[0020] 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
25 “including, but not limited to.”
7
[0021] Reference throughout this specification to “one embodiment” or “an
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
5 an embodiment” in various places throughout this specification are not
necessarily all referring to the same embodiment. Furthermore, the particular
features, structures, or characteristics may be combined in any suitable manner
in one or more embodiments.
[0022] The headings and abstract of the invention provided herein are for
10 convenience only and do not interpret the scope or meaning of the
embodiments.
[0023] Various terms are used herein. To the extent a term used in a claim is
not 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
15 patents at the time of filing.
[0024] The present disclosure relates to a use of phytochemical mixture as an
alternative to the excipient in formulating the herbal tablet.
[0025] In the preferred embodiment of the present disclosure, a phytochemical
20 mixture, an alternative to excipient further comprises of powder extract of Guar
gum and Okra gum mixed with distilled water to form aqueous coating which
is used in formulating the herbal tablet.
[0026] In an embodiment of the present disclosure, disclosed herein is a
phytochemical mixture comprising powder extract of Guar gum and Okra gum
25 which itself acts as an excipient wherein the guar gum extract is used as film
former, viscosity enhancer, binder and for sustained release of a tablet and okra
8
gum extract is used as good film former with binding property in aqueous
coating during herbal tablet formulation.
[0027] In an embodiment of the present disclosure, powder extract of Guar
gum was purchased from the local market while okra pods were purchased from
5 the local market and later powdered extract was prepared.
[0028] In an embodiment of the present disclosure, powdered extract of okra
pods has been prepared by cutting the okra pods into thin slices, drying the slices
and further milling the dried slices into the powder.
10 [0029] In an embodiment of the present disclosure, a modified granulating
method has been adopted wherein, the phytochemical mixture of powder extract
of Guar gum and Okra gum is added to distilled water which is an aqueous
medium to form an aqueous coating that itself acts as a granulating agent and
excipient in formulating herbal tablet.
15 [0030] In another embodiment of the present disclosure, a modified
granulation method for formulating herbal tablet comprises of;
- mixing specific quantity of powder extract of Guar gum and Okra gum
together in a beaker and adding distilled water to the said mixture to form
aqueous medium;
20 - allowing to set the aqueous medium by keeping it aside for few hours;
- after few hours stirring the aqueous medium containing the phytochemical
mixture with 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
25 air;
9
- after 8-12 hours of continuous magnetic stirring, sieving the aqueous
coating solution of phytochemical mixture to obtain clear solution;
- spraying of the aqueous coating solution of phytochemical mixture on the
active phytoconstituent powder that is to be used in herbal formulation with
5 continuous kneading for 35 to 90 minutes;
- after kneading, pulverizing the granules and passing the same through sieve
no. 22 to 40;
- drying of aqueous solution coated granules in tray dryer at 50-600C for 60-
120 minutes;
10 [0031] pulverizing the dried granules and passing the same through sieve no.
80 to 100
[0032] In another embodiment of the present disclosure, disclosed herein is a
process wherein, spraying of the aqueous coating solution of phytochemical
mixture on the active phytoconstituent powder with continuous kneading
15 further involves stopping the spraying of the aqueous coating solution for one
minute at every interval of 5-10 minutes, until 30 to 45 mins.
[0033] In another embodiment of the present disclosure, disclosed herein in a
process wherein, drying of aqueous solution coated granules in tray dryer at 50-
600C further involves removing the tray containing the said granules from the
20 dryer for 1-2 minutes at every interval of 30 minutes, until 60-120 minutes.
[0034] In another embodiment of the present disclosure, the concentration of
gaur gum powder extract is 0.1-0.8 %, the concentration of okra powder is 0.2-
1.2 %, the concentration of active phytoconstituent used to formulate herbal
tablet is 0.1-0.3 % and distilled water is 98.8-99.5 %.
25
10
[0035] In another embodiment of the present disclosure, the aqueous
concentration of phytochemical mixture used for coating is 1–8-liter solution in
50 kg batch.
5 [0036] In yet another embodiment of the present disclosure disclosed herein is
a use of phytochemical mixture for formulating herbal tablet wherein the use of
the said mixture has advantages like; discarding use of excipients or chemicals
for formulating tablets, improves micrometric properties of the formulated
tablet, leads to sustained release of drug thereby preventing dose dumping,
10 overcomes the issues related to tablet capping, slugging and high friability and
has good patient compliance.
The following examples further describe certain specific aspects and
embodiments of the invention and a better understanding of present invention
may be obtained through the following examples and displayed process for
15 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:
a) Preparation of powder extract:
20 In the present invention, powdered extract of Guar gum was purchased from
the local market while okra pods were purchased from the local market and
later powdered extract was prepared.
Preparation of powder extract from okra pods:
Okra pods were washed sliced into about 2-3 cm thickness and dried at about 50 °C
25 in locally fabricated cabinet dryer for up to 3-4 hours. Drying okra at this
temperature gives high quality dried slices. The dried slices were milled and then
sieved through Sieve no 80 to give okra powder. The okra powder was thinly spread
11
on stainless steel trays for drying in a cabinet dryer thermostatically set at a
temperature of 60 °C until the moisture contents were below 12% (wet basis). The
dried flakes were then cooled, pulverized and packaged in sealed high-density
polythene bags and kept under a dry cool condition.
5
b) Process for preparing an aqueous coating of phytochemical mixture to
formulate the herbal tablet:
A modified granulation method for formulating herbal tablet comprises of; mixing
specific quantity of powder extract of Guar gum and Okra gum together in a beaker
10 and adding distilled water to the said mixture to form aqueous medium; allowing to
set the aqueous medium by keeping it aside for few hours; after few hours stirring
the aqueous medium containing the phytochemical mixture with 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
15 trapping of air; after 8-12 hours of continuous magnetic stirring, sieving the aqueous
coating solution to obtain clear solution; spraying of the aqueous coating solution
on the active phytoconstituent that is to be used in herbal formulation with
continuous kneading for 35 to 90 minutes; after kneading, pulverizing the drying of
aqueous solution coated granules and passing the same through sieve no. 22 to 40;
drying of drying of aqueous solution coated granules in tray dryer at 50-600
20 C for
60-120 minutes; pulverizing the dried granules and passing the same through sieve
no. 80 to 100 as indicated in Table 1, 2 and 3.
Table 1: Aqueous coating Solution mixing Parameters
Granulating agent blend Concentration
(%)
Mixing time in
aqueous phase
Aqueous
concentration of
mixture for coating
Guar Gum 0.1-0.8 % 8-12 hours
1–8-liter solution in
50 kg batch
Okra Gum 0.2-1.2 % 8-12 hours
Active Phytoconstituent 0.1-0.3 % 8-12 hours
12
Distilled Water 98.8-99.5 % 8-12 hours
Table 2: Aqueous coating solution Process Parameters
Granulating Solution Amount of Aqueous
solution
Kneading time
(Min)
Drying
(50-600 C)
Granulating blend
solution
1-8 litre in 50 kg 35-90 minutes 60-120 min
Table 3: Instrumental Parameters
Mixing Time
(30-45 Min)
Drying temp
(50-60 Min &50-600 C)
Concentration of
mixture
Stop 1 minute after each 5-
10 minutes of interval
Stop 1-2 minute after each
30 minutes of interval
1–8-liter solution in
50 kg batch
c) Evaluation of phytochemical mixture that has been used as an excipient in
5 the form for aqueous coating in formulating herbal tablets:
Herbal tablet was prepared by using mixture of 95% Curcumin, 60% Boswellic
acid,75%withanolides, 20% Bacopa as active phytoconstituent and phytochemical
mixture of gaur gum and okra gum extract in distilled water was added as excipient
to evaluate the micrometric properties. Results for micrometric properties have
10 been depicted in Table 4 and 5 below.
Table 4: Micrometric property before and after addition of phytochemical mixture
as an excipient
Micromeritics
property
Pure form of Active
Phytoconstituent
After Phytochemical mixture as
excipient is added
Angle of Repose 44.91 29.61
13
Carr’s Index 22.31 15.15
Hausner’s Ratio 1.27 1.12
Table 4: Flow Property
5 Table 4 and 5 indicates enhancement in the micrometric property of the herbal
formulation on adding phytochemical mixture which acts as binder, film forming
agent, viscosity enhancer and granulating agent.
DSC, XRPD and FTIR studies indicates no interaction between the herbal tablet
and phytochemical mixture as depicted in Fig 1, Fig 2 and Fig 3 respectively ,CLAIMS:1) A phytochemical mixture comprising powder extract of 0.1 to 0.8 % of Guar
gum and 0.2 to 1.2% Okra gum, which acts as an excipient in formulating
herbal tablet.
5 2) The phytochemical mixture as an excipient as claimed in claim 1 wherein,
0.1 to 0.8 % of Guar gum and 0.2 to 1.2% Okra gum powder extract are
mixed in 98.8-99.5 % distilled water to form an aqueous medium in
formulating herbal tablet.
3) The phytochemical mixture as an excipient as claimed in claim 1 wherein,
10 the said phytochemical mixture is added to distilled water to form an
aqueous coating solution, that acts as an excipient in formulating herbal
tablet.
4) The phytochemical mixture as an excipient as claimed in claim 1 wherein,
the guar gum extract in the said mixture acts as film former, viscosity
15 enhancer, binder and is used for sustained release of a tablet and okra gum
extract in the said mixture acts as good film former with binding property
in aqueous coating during herbal tablet formulation.
5) The phytochemical mixture as an excipient as claimed in claim 1 wherein,
the said mixture enhances the micrometric property of the formulated herbal
20 tablet.
6) The phytochemical mixture as an excipient as claimed in claim 1 wherein,
the said phytochemical mixture in formulating herbal tablet is prepared by
modified granulating method in which the said mixture itself acts as
granulating agent and excipient.
25 7) A modified granulation method for formulating herbal tablet comprises of;
- mixing specific quantity of powder extract of Guar gum and Okra gum
together in a beaker and adding distilled water to the said mixture to form
aqueous medium;
15
- allowing to set the aqueous medium by keeping it aside for few hours;
- after few hours stirring the aqueous medium containing the phytochemical
mixture with the magnetic stirrer under a constant speed and if needed,
increasing the speed accordingly for forming vortex;
5 - the stirring speed is reduced momentarily to avoid foaming and trapping of
air;
- after 8-12 hours of continuous magnetic stirring, sieving the aqueous
coating solution of phytochemical mixture to obtain clear solution;
- spraying of the aqueous coating solution of phytochemical mixture on the
10 active phytoconstituent powder that is to be used in herbal formulation with
continuous kneading for 35 to 90 minutes;
- after kneading, pulverizing the granules and passing the same through sieve
no. 22 to 40;
- drying of aqueous solution coated granules in tray dryer at 50-600C for 60-
15 120 minutes;
8) pulverizing the dried granules and passing the same through sieve no. 80 to
100
9) The modified granulation method as claimed in claim 7, wherein, spraying
of the aqueous coating solution of phytochemical mixture on the active
20 phytoconstituent powder with continuous kneading further involves
stopping the spraying of the aqueous coating solution for one minute at
every interval of 5-10 minutes, until 30 to 45 mins.
10) The modified granulation method as claimed in claim 7 wherein, drying of
aqueous solution coated granules in tray dryer at 50-600C further involves
25 removing the tray containing the said granules from the dryer for 1-2
minutes at every interval of 30 minutes, until 60-120 minutes