DESC:FIELD OF THE INVENTION
The present invention relates to develop bilayer tablets derived from botanical synergy phytoconstituents blend that is characterized by initial burst release and then followed by intestinal target uniform release for overall gut health. In particular, the present disclosure shows for Gut Health, a Bi-layer tablet is suitable for sequential the release of two different synergistic blends of phytochemical/Phytoconstituent combination in a single tablet, one is for immediate release in gastric PH, and the second one is for intestinal target uniform release. In particular, the present disclosure further relates bilayer tablet is constructed with two layers with the three blends to the target upper GIT and followed by the colon (Intestine). Invention design according to disease causality and various factor connected with Gut health. For overall digestive health, this bilayer tablet prepared with synergy phytoconstituents includes alkaline herbs, Fibers, Gum, and Natural Probiotics with no or minimal use of excipients. Another invention relates to bilayer tablet is suitable for the sequential release of two or more different synergy forms in combination, separating two incompatible ingredients, and also for sustained release, intestinal target, control release tablet in which one layer is immediate release as initial target dose and the second layer is maintenance dose with a different target.

BACKGROUND OF THE INVENTION
Bowel disorders are often characterized by bloating and constipation and are thought to affect at least 20% of the population. Yet, to date no effective therapy is available. Such bowel disorders include irritable bowel syndrome, functional constipation, chronic pseudo-obstruction, and chronic abdominal bloating syndrome. Symptoms include abdominal pain, constipation, bloating, acid reflux, flatulence, nausea and vomiting, chronic lethargy, and sleep disorders. IBS is a gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits with either constipation, diarrhoea, or both. It is normal to have a bowel movement anywhere from three times a day to three times a week, as long as the stool is soft and comfortable to pass. A person experiencing constipation has a hard or lumpy stool, which is difficult to pass. Chronic constipation affects 15-30% of globally Gut issues especially constipation commonly found in young children and the elderly, occurring more frequently in females than in males. Hence long-term medicine is not safe for gut health because some medicine’s side effects are there related to gut health. Some science is also behind gastric empty time and bowel moment is there as per biological rhythm.
Transit time is the duration between when food enters the mouth and when leftover is finally passes out as stool. A meal could take anywhere from 12-72 hours to travel through the digestive tract. Each person is unique; a normal bowel movement pattern for one person may be very different from those of family members or friends. Some individuals have irregular patterns, never knowing what to expect. Usually, before food enters the colon, most of the nutrients have been absorbed into the body and the colon’s role is to remove water. If someone has a long transit time, meaning food passes slowly through the colon, then too much water is absorbed, hardening the stool. Lots of factors that can contribute to constipation, often by altering transit time, include: medication side effects (e.g., some narcotics, antidepressants, codeine, calcium or iron supplements, and medications that affect the nervous system), diseases in which there is a physiological change to some tissue or organ of the body (e.g., radiation therapy, inflammatory bowel disease, colon cancer, diabetes, stroke, hypothyroidism, or Parkinson’s disease), functional disorders, such as irritable bowel syndrome, intestinal obstructions or strictures resulting from surgery, and diets and lifestyle choices, such as consuming a diet too low in fibre, and fluid, insufficient physical activity, and chronic use of laxatives, suppositories, or enemas.
For overall gut health bilayer tablet concept is precise for target action. Bi-layer tablet is a new era for the successful development of controlled-release formulation along with various features to provide successful drug delivery. Bilayer layer tablets have consisted of two layers which is the slow-release, and immediate- release layer. As well as improved beneficial technology to overcome the shortcoming of single-layer tablets. For Gut Health, a Bi-layer tablet is suitable for sequential the release of two different synergistic blends of phytochemical/ Phytoconstituent combination in a single tablet, one is for immediate release in gastric PH, and the second one is for intestinal target uniform release. Both blends are designed with no or minimal use of excipients to avoid long- term side effects of chemical additives. Natural dosage modifying and causality target additives are used to incorporate Bi layer tablet dosage form. Gut problems like acid reflux, constipation, indigestion, and intestinal motility are associated with different gastric issues like acidity, gas, acid reflux, indigestion, nausea, vomiting, etc. for proper digestion and metabolism, role of enzymes and microbiota homeostasis is very important. Hence this invention comprises bilayer tablet design as per disease causality for multiple digestive treatments.

US8765197B2 discloses the extract of herbal and composition containing the same discloses to herbal extracts of Sinapis Semen, Corydalis Tuber, Pharbitidis Seed, and Strychni Ignatii Semen, and a composition containing the same for treating and preventing gastrointestinal motility disorder. The extracts of the present invention have a remarkable effect of promoting gastrointestinal motility through HT3 receptor antagonism and/or HT4 receptor antagonism.

CN104940633A relates to Miao ethnomedicine for treating gastric ulcer The invention discloses Miao ethnomedicine for treating gastric ulcer and belongs to medicine preparations. The Miao ethnomedicine is prepared with, by mass, 20-25 parts of bletilla striata, 20-25 parts of fructus aurantii, 15-20 parts of Paris polyphylla, 30-35 parts of cuttlebone and 20-25 parts of tofieldia thibetica. A preparation method comprises the steps of cleaning, drying and disinfecting the five types of medicine, firstly taking and immersing the bletilla striata, the fructus aurantii and the tofieldia thibetica in prescriptive proportion with clear water, conducting heating with steam, extracting active ingredients, and fabricating the active ingredients into extract; conducting the drying, mixing the extract with the Paris polyphylla and the cuttlebone in prescriptive proportion, conducting the pulverization till the mixture becomes powder, conducting the mixing, obtaining mixed powder, then conducting pressing according to the conventional pharmaceutical preparation technology for obtaining tablets, or conducting encapsulation, maintaining each tablet or each granule 1 gram, and obtaining the Miao ethnomedicine. Accordign to the Miao ethnomedicine for treating the gastric ulcer, the prescription is simple, medicinal materials are easy to obtain, the curative effect is obvious, and the effective rate is as high as 90%; the processing is convenient, the application is simple, and the Miao ethnomedicine is applicable to treatment of gastric ulcer patients.

US20050287235A1 provides a novel herbal synergistic formulation for treatment of acute and chronic ulcers in stomach. Formulation(s) comprises of plant extracts together with the conventional additives to form the oral dosage forms which include tablets, capsules and powders ready for suspension. Utleria solicifolia along with this plants used traditionally like Asparagus racemosus, Foeniculum vulgare, and Ficus glomerata are added which are used in intestinal discomforts and as an galactogogue.

International Journal of Pharmacy and Pharmaceutical Sciences (Vol 6, Issue 3, 2014) formulation and evaluation of bilayer matrix tablets of amoxicillin and esomeprazole as an oral modified release dosage form for treatment of peptic ulcer (Majeed, Saad M., and Yehia I. Khalil.) discloses to formulate a dual therapy of peptic ulcer containing antimicrobial agent amoxicillin and anti-secretory agent esomeprazole, utilizing the concept of bilayer tablet system for the effective treatment of H. pylori associated gastric/duodenal ulcer, in an attempt to improve bioavailability and to get maximum therapeutic benefits and patient compliance about the treatment.

Frontiers in Pharmacology (Volume 6 - 2015) Formulation and evaluation of bilayer tablet for bimodal release of venlafaxine hydrochloride (Momin, Munira M., and Snehal Kane.) The aim of the present research was to develop a bilayer tablet of venlafaxine hydrochloride for bimodal drug release. In the present investigation authors have tried to explore fenugreek mucilage (FNM) for bioadhesive sustained release layer. The attempt has been made to combine FNM with well studied bioadhesive polymers like hydroxy propyl methyl cellulose (HPMC), Carbopol, and Xanthan Gum. The formulations were evaluated for swelling Index, ex vivo bioadhesion, water uptake studies, in vitro drug release and dissolution kinetics was studied.

None of the above mention prior art discloses bilayer tablets derived from botanical synergy phytoconstituents blend that is characterized by initial burst release and then followed by intestinal target uniform release for overall gut health

OBJECTIVE OF INVENTION
Chronic digestion problems including acidity, constipation, and indigestion increase day by day due to junk food, lifestyle, and long consumption of medicines. For overall gut problems Enzymes, Gut microbiota, intestinal and motility, and Digestive juice are key factors. Once it starts to imbalance, it to turns into disease. Every chronic disease connected with Gut health and Gut is called the second brain. The Brain and Gut continue to monitor signals through the Vagus nerve and for obesity, Diabetes, Alzheimer’s, and Microbiota play an important role.

The purpose of this study is to develop and evaluate bilayer tablets for multiple digestive problems. The Bilayer tablet is constructed with two layers with the three blends to the target upper GIT and followed by the colon (Intestine). Invention design according to disease causality and various factor connected with Gut health. For overall digestive health, this bilayer tablet prepared with synergy phytoconstituents includes alkaline herbs, Fibers, Gum, and Natural Probiotics with no or minimal use of excipients.

SUMMARY OF THE INVENTION
The present invention relates to develop bilayer tablets derived from botanical synergy phytoconstituents blend that is characterized by initial burst release and then followed by intestinal target uniform release for overall gut health.

In particular, the present disclosure shows for Gut Health, a Bi-layer tablet is suitable for sequential the release of two different synergistic blends of phytochemical/ Phytoconstituent combination in a single tablet, one is for immediate release in gastric PH, and the second one is for intestinal target uniform release.

In particular, the present disclosure further relates bilayer tablet is constructed with two layers with the three blends to the target upper GIT and followed by the colon (Intestine). Invention design according to disease causality and various factor connected with Gut health. For overall digestive health, this bilayer tablet prepared with synergy phytoconstituents includes alkaline herbs, Fibers, Gum, and Natural Probiotics with no or minimal use of excipients.

Another invention relates to bilayer tablet is suitable for the sequential release of two or more different synergy forms in combination, separating two incompatible ingredients, and also for sustained release, intestinal target, control release tablet in which one Layer is immediate release as initial target dose and the second layer is maintenance dose with a different target.

In the present Bilayer tablet, Blend-1 Fast Dissolve Consist of Synergy Extract of Phyllanthus emblica extract, Trachyspermum Ammi extract, Rosa extract, Mentha extract, Spinacia oleracea extract, and Zingiber officinale extract;
Blend-2 Intestinal pH Consist Synergy Extract of Terminalia chebula extract, Operculina Turpethum extract, Plantago ovata extract, Rheum rhabarbarum extract and Glycyrrhiza Glabra extract;
Blend-3 Colon target Consist Synergy Extract of Abelmoschus esculentus gum & Senna alexandrina extract

Following are the scientific benefits of individual phytoconstituent.
1. Phyllanthus emblica is gastroprotective, prevent gastric reflux, and aid in indigestion.
2. Active enzymes in Trachyspermum Ammi improve the flow of stomach acids, which can help to relieve indigestion, bloating, and gas. The plant can also help to treat peptic ulcers as well as sores in the esophagus, stomach, and intestines.
3. One of the most common traditional uses of rose tea is to treat stomach issues. Modern research suggests that this may be due to rose tea's ability to increase our liver's bile production. This helps your body digest food easier, prevents constipation, and can improve nutrient absorption.
4. Mentha leaves are anti-inflammatory in nature which helps in reducing any inflammation in your stomach. Mint leaves also helps relieve indigestion. Mint leaves are rich in phosphorus, calcium, and vitamins like C, D, E, and A which improve the body's immune systems Spinacia oleracea make stool more porous through proper digestion and digestive enzyme. This may help prevent gas, and nausea.
5. Spinach is low in carbs but high in insoluble fiber. This type of fiber may benefit your digestion.
6. Zingiber officinale has multiple benefits individually and with synergy form such as constipation, dyspepsia, belching, bloating, gastritis, epigastric discomfort, gastric ulcerations, indigestion, nausea, and vomiting.
Steps -
a. Blend-1 design for fast release at Gastric PH with Guava dehydrated powder as natural super disintegrant.
b. Blend-1 granulation dry at 50-55 degree Celsius for 45-90 minutes in tray dryer and then pulverized by sieve no-80.
c. Then add require amount of talc for lubricating effect.
d. Blend evaluated for physical evaluation, micromeritics property and characterization for optimization of final bilayer tablet.
e. This fast release synergy blend of phytoconstituents improves digestive process, gastric imbalance and maintain gastric juice.
f. At low concentration of guava gives the best disintegration property in fast dissolving blend as compare to SSG and Mannitol.
g. In 60 minutes, blend-1 single layer release completely without dose dumping and fluctuation.
h. Blend-2 design for uniform release at intestinal PH with blend-3 with guar gum granulation over blend-2.
i. It is then dry at 50-55 degree Celsius for 45-90 minutes in a tray dryer and then pulverized by sieve no-80.
j. Then add require amount of talc for lubricating effect. Optimized Blend evaluated for physical evaluation, micromeritics property and characterization.
k. This uniform- release synergy blend of phytoconstituents improves intestinal motility, makes stool more porous by fibers, and regulates indigestion and constipation by balance microbiota.
l. Probiotic blend improves overall gut health. This blend release uniformly within 3 hour up to 100 % of dose release.

Blend -1 is for first layer with fast acting (30% dose release in 60 min) and blend-2 and blend-3 combine in second layer with uniform release (70% in 3 hrs.) at intestinal PH.
Pre compression parameter of Blend such as Bulk Density, Tapped density, Hasusner’s ratio, Carr's Index, Angle of repose. Physical evaluation of Bilayer tablet such as Weight variation, Hardness of uncoated Tablet, Hardness of Coated tablet, Friability, Density.

DETAILED DESCRIPTION OF THE INVENTION
Detailed Description of the Invention While this specification concludes with claims particularly pointing out and distinctly claiming that, which is regarded as the invention, it is anticipated that the invention can be more readily understood through reading the following detailed description of the invention and study of the included examples.
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 all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

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.”

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 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.

The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
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 patents at the time of.
In GUT health, Constipation may be defined as infrequent or hard stools or difficulty passing stools. There is wide variability is what is considered normal patterns of bowel evacuation. While some healthy people may have consistently soft or near runny stools others may have consistently hard firm stools, but no difficulty in passing them. When the stool is hard, infrequent, and requires significant effort to pass, the person has constipation. Once afflicted with constipation, persons may suffer from complications such as headache or skin rash, in serious cases, piles, and in the worst case, rectal cancer. Constipation can be caused by changes in diet, decrease in physical activity, lack of toilet facilities, behavior and psychological problems, dehydration, diseases of the bowel, neurological diseases, congenital diseases, medications, and many other causes. Dysbiosis, which is an imbalanced gut microbiota, contributes to constipation. Individuals with constipation often have significantly different gut bacteria composition than non-constipated healthy people, with higher levels of methane- producing bacteria in their intestines, which slows intestinal transit time.

Table 1. Optimization of Synergy Phytoconstituents blend for Digestive support
Sr.no Ingredients F1
(mg) F2
(mg) F3
(mg) F4
(mg) F5
(mg) Target
1 Terminalia chebula extract 230 220 180 150 200 Blend-2 Intestinal PH
2 Operculina Turpethum extract 150 180 220 230 200
3 Plantago ovata extract 80 80 120 140 100
4 Rheum rhabarbarum extract 50 120 80 50 100
5 Glycyrrhiza Glabra extract 140 50 30 80 50
6 Phyllanthus emblica extract 50 40 30 50 50
Blend-1
Fast Dissolve

7 Trachyspermum Ammi extract 50 60 40 30 50
8 Rosa extract 50 30 60 40 50
9 Mentha extract 60 40 40 50 50
10 Spinacia oleracea extract 40 60 50 60 40
11 Zingiber officinale extract 30 50 60 40 40
12 Abelmoschus esculentus gum 35 30 20 50 40 Blend-3
Colon target
13 Senna alexandrina extract 35 40 50 20 30

Various phytochemical and botanical ingredients includes tannins, sennosides, glycyrrhizin acid, gingerol, Plantago ovata etc. used in digestive and gut health since long and historical proven but it’s not safe for long consumption because it creates habits once it will not convert according to disease causality and target at specific site with proper concentration. Hence optimization of dose and synergistic combination incompatibility is needed before formulation. Formulation F-5 selected for blend concentration according to case study in different volunteer and invitro analysis.
Our invention comprises phytoconstituent blend according to GUT disease causality and symptoms. Three blends selected for bilayer tablet. Blend -1 is for first layer with fast acting (30% dose release in 60 min) and blend-2 and blend-3 combine in second layer with uniform release (70% in 3 hrs.) at intestinal PH. Optimization of batch are as following.

Table 2. Optimization of Bilayer tablet comprise Synergy blend of Digestive support
Sr.no Ingredients F1 F2 F3 F4 F5 F6 F7 F8 F9
Mg mg Mg mg Mg mg mg Mg mg
Fast dissolving (Immediate release)
1 Blend-1 270 270 270 270 270 270 270 270 270
2 Guava dehydrated powder 5 10 15 - - - - - -
3 SSG - - - 5 10 15 - - -
4 Mannitol - - - - - - 5 10 15
5 Blend-1 in distilled water 5 5 5 5 5 5 5 5 5
6 Talc (IP Grade) 5 5 5 5 5 5 5 5 5
Intestinal Target (Uniform release)
1 Blend-2 650 650 650 650 650 650 650 650 650
2 Blend-3 in Distilled water 70 70 70 70 70 70 70 70 70
3 Guar gum in blend-3 5 10 15 5 10 15 5 10 15
6 Talc (IP Grade) 15 15 15 15 15 15 15 15 15
Total 1030 1035 1040 1030 1035 1040 1030 1035 1040

Pre compression parameter
Precompression parameter of Blend-1 and Blend-2 is studied are as under. Formulation -1 optimized for Bilayer tablet physical evaluation & compliance with pharmacopeial limits.
Table 3. Pre compression parameter of Blend-1
Formulation Bulk
Density (g/ml) Tapped density (g/ml)
Hasusner’s ratio Carr's Index (%) Angle of repose
F1 0.614±0.002 0.730±0.001 1.16±0.01 14.32±0.65 26.3°±0.98
F2 0.623±0.001 0.754±0.003 1.29±0.01 17.37±0.87 29.8 °± 1.17
F3 0.528±0.002 0.752±0.004 1.22±0.03 19.94± 1.11 28.8 °±0.75
F4 0.545±0.004 0.751±0.002 1.24±0.01 21.20±0.87 28.6 °±0.88
F5 0.585±0.001 0.767±0.002 1.23±0.02 20.08±0.45 28.4 °± 1.24
F6 0.616±0.003 0.766±0 .001 1.24±0.02 19.73±0.72 29.4 °± 1.32
F7 0.594±0.002 0.725 ±0.004 1.22±0.03 19.87±0.42 28.9 °± 1.52
F8 0.603±0.001 0.798±0.003 1.29±0.01 20.08±0.32 27.1 °± 1.11
F9 0.601±0.002 0.741±0.004 1.25±0.02 17.34±0.51 27.5 °± 1.90
Table 4. Pre compression parameter of Blend-2
Formulation Bulk
Density (g/ml) Tapped Density
(g/ml) Hausner's Ratio Carr's Index
(%) Angle of repose (0)
F1 0.471±0.002 0.606±0.002 1.07±0.01 18.39±0.89 26.4 °± 1.40
F2 0.474±0.003 0.614±0.006 1.15±0.01 20.60± 1.12 31.7 °± 1.23
F3 0.481±0.001 0.617±0.00 I 1.22±0.03 20.89± 1.45 32.5 °±0.95
F4 0.481±0.002 0.622±0.002 1.23±0.01 20.41± 1.23 3 1.8 °±0.89
F5 0.492±0.007 0.599±0.002 1.09±0.02 18.19± 1.16 26.2 °± 1.15
F6 0.509±0.008 0.615±0.00 I 1.26±0.01 20.82± 1.31 29.9 °± 1.63
F7 0.486±0.009 0.609±0.003 1.25±0.02 20.32±0.93 29.4 °± 1.34
F8 0.477±0.005 0.600±0.004 1.25±0.02 20.51±0.96 30.3 °±0.90
F9 0.461±0.005 0.610±0.004 1.25±0.01 20.53±0.36 30.1 °±0.20

Table 5. Disintegration time of Tablet in different PH-1.2 & PH-7.4
Formula DT in pH 1.2 (Min) DT in pH 7.4 (Min)
F1 2.12+0.165 3.31+0.49
F2 3.21+0.26 8.33+0.27
F3 3.14+0.66 7.26+0.14
F4 3.13+0.15 3.72+0.24
F5 4.03+0.31 4.07+0.19

Table 6. Optimization & Physical evaluation of Bilayer tablet
Formulation Weight variation Hardness of uncoated Tablet Hardness of Coated tablet Friability Density
F1 1001 ±1.03 5.1±0.2 5.2±0.2 0.703±0.12 29.92±0.41
F2 1002±2.49 4.3±0.2 5.2±0.2 0.761±0.05 27.45±0.34
F3 1001.2±1.9 4.6±0.3 5.1±0.3 0.632±0.25 27.27±0.56
F4 1000 ±1.78 4.6±0.2 5.2±0.3 0.604±0.13 28.13±0.81
F5 1000±1.18 4.6±0.1 5.4±0.3 0.731±0.25 28.15±0.28
F6 1001.4±2.1 4.7±0.1 5.3±0.3 0.634±0.20 29.34±0.24
F7 1002.3±3.1 4.9±0.2 5.3±0.1 0.635±0.23 28.91±0.44
F8 1000±2.0 4.9±0.3 5.3±0.2 0.562±0.14 28.34±0.49
F9 999.6±1.64 4.2±0.4 5.2±0.3 0.401±0.29 28.12±0.17

Table 7. % Cumulative release of Bilayer tablet in 0.1 N HCL and PH - 7.4
Time (Min) Fl F2 F3 F4 F5
0.1 N HCL (PH1.2)
0 0 0 0 0 0
30 15.76 21.32 29.15 32.31 13.23
60 30.1 36.57 42.51 53.21 24.52
(INTESTINAL PH -7.4)
90 30.12 43.49 46.27 65.17 26.57
120 50.12 51.52 60.54 75.69 40.40
150 67.45 60.17 70.13 87.95 52.87
180 84.34 79.18 88.12 97.97 67.10
210 99.98 99.99 89.67 100.03 81.09
240 99.99 99.99 99.09 100.03 92.05

% Cumulative release of Optimized batch- F1
Immediate release Intestinal uniform release
Table 8. Stability Study of Optimized batch
S.N Parameters Conditions
Initial 40°C & 75%RH 40°C & 75%RH 40°C & 75%RH
0 Day 1 month 2 months 3 months
1 Average weight 1030±5mg 1030±5mg 1031±5mg 1031±5mg
2 Dissolution (60min) 30.1±0.014 30.1±0.014 30.1±0.014 30.3±0.011
3 Friability
0.703±0.12 0.703±0.12 0.703±0.12 0.701±0.09

,CLAIMS:1. A synergistic blend of phytoconstituent combination to form bi-layer tablet.
2. The polyherbal blend of bi-layer tablet composition as claimed in claim 1, wherein for Gut Health, a Bi-layer tablet is suitable for sequential the release of two different synergistic blends of phytochemical/ Phytoconstituent combination in a single tablet, one is for immediate release in gastric PH, and the second one is for intestinal target uniform release.
3. The polyherbal blend of bi-layer tablet composition as claimed in claim 1, wherein bilayer tablet is constructed with two layers with the three blends to the target upper GIT and followed by the colon (Intestine).
4. A method of preparation of polyherbal blend of bilayer tablet composition comprises of;
a. Blend-1 Fast Dissolve Consist of Synergy Extract of Phyllanthus emblica extract, Trachyspermum Ammi extract, Rosa extract, Mentha extract, Spinacia oleracea extract, and Zingiber officinale extract;
b. Blend-2 Intestinal pH Consist Synergy Extract of Terminalia chebula extract, Operculina Turpethum extract, Plantago ovata extract, Rheum rhabarbarum extract and Glycyrrhiza Glabra extract;
c. Blend-3 Colon target Consist Synergy Extract of Abelmoschus esculentus gum & Senna alexandrina extract
5. The polyherbal blend of bi-layer tablet composition as claimed in claim 1, wherein for overall digestive health, this bilayer tablet prepared with synergy phytoconstituents includes alkaline herbs, Fibers, Gum, and Natural Probiotics with no or minimal use of excipients.
6. The polyherbal blend of bi-layer tablet composition as claimed in claim 1, wherein bilayer tablet is suitable for the sequential release of two or more different synergy forms in combination, separating two incompatible ingredients, and also for sustained release, intestinal target, control release tablet in which one Layer is immediate release as initial target dose and the second layer is maintenance dose with a different target.
7. The polyherbal blend of bi-layer tablet composition as claimed in claim 1, wherein Blend -1 is for first layer with fast acting (30% dose release in 60 min) and blend-2 and blend-3 combine in second layer with uniform release (70% in 3 hrs.) at intestinal ph.
8. A method of preparation of polyherbal blend of bilayer tablet composition comprises of;
a. Blend-1 design for fast release at Gastric PH with Guava dehydrated powder as natural super disintegrant.
b. Blend-1 granulation dry at 50-55 degree Celsius for 45-90 minutes in tray dryer and then pulverized by sieve no-80.
c. Then add require amount of talc for lubricating effect.
d. Blend evaluated for physical evaluation, micromeritics property and characterization for optimization of final bilayer tablet.
e. This fast release synergy blend of phytoconstituents improves digestive process, gastric imbalance and maintain gastric juice.
f. At low concentration of guava gives the best disintegration property in fast dissolving blend as compare to SSG and Mannitol.
g. In 60 minutes, blend-1 single layer release completely without dose dumping and fluctuation.
h. Blend-2 design for uniform release at intestinal PH with blend-3 with guar gum granulation over blend-2.
i. It is then dry at 50-55 degree Celsius for 45-90 minutes in a tray dryer and then pulverized by sieve no-80.
9. The polyherbal blend of bi-layer tablet composition as claimed in claim 1, wherein uniform- release synergy blend of phytoconstituents improves intestinal motility, makes stool more porous by fibers, and regulates indigestion and constipation by balance microbiota.
10. The polyherbal blend of bi-layer tablet composition as claimed in claim 1, wherein Probiotic blend improves overall gut health. This blend release uniformly within 3 hour up to 100 % of dose release.