DESC:FIELD OF THE INVENTION-
The present invention relates to the process to formulate Colon target Phytosomes for Piles and Hemorrhoids comprises a synergy form of Phytoconstituents containing a blend of alkaline herbs, Gum, Fibers and Natural Probiotics accordingly causality for target action. This invention relates to an oral delivery system made by phytoconstituents for delivering a precise amount of a tablet dosage for colon target without premature delivery of the product to the upper gastrointestinal (GI) tract. The present disclosure further relates to enteric-coated tablet for Piles and Gut health is developed with 3 active causality target blends for the specific site of action and uniformity release at the target site for quick therapeutical action

BACKGROUND OF THE INVENTION
Colonic drug delivery is getting important not only for the treatment of local diseases related to the colon but also for the delivery of ingredients that contains more release in intestinal PH than gastric for high therapeutical effect. The delivery system is a tablet comprised of three parts. First an enteric coating to prevent penetration of gastric fluid into the delivery system, thereby preventing any drug release in the stomach. Second an erodible polymer layer which is exposed and gradually erodes during transit through the upper intestinal tract for intestinal motility, and at last a core, in conventional tablet containing an active ingredient that readily disintegrates and swells subsequently releases the constituents supported by fibres to the target site, the colon, after erosion of the erodible polymer layer. The erodible polymer layer prevents release in the upper portion of the intestinal tract for 4-6 hours after gastric emptying, representing the amount of time needed for the delivery system to reach the colon.

AU2020200966A1, Theacrine-based supplement and method of use thereof discloses A human dietary supplement comprises theacrine and optionally other compounds that modulate the effects of theacrine. Uses for the theacrine-containing supplement include improvement of at least one of mood, energy, focus, concentration or sexual desire or a reduction of at least one of anxiety or fatigue.

US11207388B2, Multi-supplement compositions provides dietary supplement compositions. For example, multi-supplement compositions having combinations of dietary supplement formulations useful for human or animal consumption are provided.

US20210024565A1, Modified 2' and 3'-nucleoside prodrugs for treating flaviviridae infections discloses 2' and/or 3' prodrugs of 1', 2', 3' or 4'-branched nucleosides, and their pharmaceutically acceptable salts and derivatives are described. These prodrugs are useful in the prevention and treatment of Flaviviridae infections, including HCV infection, and other related conditions. Compounds and compositions of the prodrugs of the present invention are described. Methods and uses are also provided that include the administration of an effective amount of the prodrugs of the present invention, or their pharmaceutically acceptable salts or derivatives. These drugs may optionally be administered in combination or alteration with further anti-viral agents to prevent or treat Flaviviridae infections and other related conditions.

Asian journal of pharmaceutical research and development (volume 2nd issue 3rd may-june 2014) Phytosome: Recent Advance Research for Novel Drug Delivery System (Singh, R. P., et al.) discloses Phytosome is a patented technology that was introduced and developed by a leading herbal drug manufacturer and nutraceuticals. In phytosomes, incorporated the standardized extracts of plant or water soluble phytoconstituents was improved into phospholipids to form a lipid compatible molecular complex. These phytosomes improve the absorption and bioavailability of drug. This novel formulation has remarkable advantages over conventional formulations of plant actives and extracts which includes enhancement of solubility, bioavailability, ability to cross the cell membranes, protection from toxicity, enhancement of stability, sustained delivery, and protection from physical and chemical degradation.

Journal of cellular physiology, Phytosomal curcumin inhibits tumor growth in colitis-associated colorectal cancer (Marjaneh, Reyhaneh Moradi, et al.) The aim of current study was explored the therapeutic-potential of novel phytosomal curcumin as well as its application in combination with 5-Flurouracil (5-FU) in a mouse-model of colitis-associated colon-cancer. The anti-proliferative-activity of phytosomal curcumin was assessed in 2- and 3-dimensional cell-culture-models as well as in a mouse-model of colitis-associated colon-cancer.

OBJECTIVE OF INVENTION
In phytopharmaceutical, some active phytochemical/ phytoconstituent have poor solubility, poor absorption, and poor bioavailability due to high concentration and method of extraction by the aqueous phase. Some evidence there in the botanical extract that improves absorption and bioavailability through gut target by the enteric coating, microencapsulation, eudragit coating. Gastric empty time is important for the distribution of active blend from gastric phase to intestinal phase.

An oral delivery system that can precisely target drugs to the colon without prematurely delivering active ingredients to the upper GI tract is important and advantageous in a number of ways. Such a delivery system can be used to more effectively treat local bowel disease such as ulcerative colitis, Piles, Hemorrhoids because it minimizes systemic absorption through the upper GI tract and by so doing, maximizes the amount of active delivered to the colon. Also, by using such delivery system, enema dosage forms, which are often impractical, and are ineffective for delivering drug to the ascending colon, may be avoided. Hence enteric-coated tablet for Piles and Gut health is developed with 3 active causality target blends for the specific site of action and uniformity release at the target site for quick therapeutical action.

SUMMARY OF THE INVENTION
The present invention relates to the process to formulate Colon target Phytosomes for Piles and Hemorrhoids comprises a synergy form of Phytoconstituents containing a blend of alkaline herbs, Gum, Fibers and Natural Probiotics accordingly causality for target action. This invention relates to an oral delivery system made by phytoconstituents for delivering a precise amount of a tablet dosage for colon target without premature delivery of the product to the upper gastrointestinal (GI) tract. The present disclosure further relates to enteric-coated tablet for Piles and Gut health is developed with 3 active causality target blends for the specific site of action and uniformity release at the target site for quick therapeutical action.
In particular, the present disclosure relates with phytochemistry science, enteric-coated tablet is developed by using 10 phytoconstituents combined in 3 blends to form tablet for Piles and Hemorrhoids.
In particular, the present disclosure relates to the polyherbal composition comprising of;
a. Blend-1 (Colon target matrix- Immediate release at intestinal PH)
b. Blend-2 (Colon target matrix- Sustain release at intestinal PH)
c. Blend-3 (Colon target Fibre’s blend to solve constipation)

In particular, the present disclosure relates to the polyherbal composition comprising of;
a. Mesua ferrea extract, Mimosa Pudika extract, Plumbago indica extract, Boswelia serrata extract, Terminalia Arjuna extract, having 75-85% concentration combined to form blend 1.
b. Saraca asoca extract, Terminalia bellirica extract, Azadirachta Indica extract, having 12-18% concentration combined to form blend 2.
c. Operculina turpethum extract, Senna alexandrina extract, having 5-9% concentration combined to form blend 3.

The present disclosure further relates to the method of preparing the said polyherbal mixture comprising of,
a. Mixed all blend uniformly, add talcum as a lubricant (1-2%) & compressed into a tablet without any diluent, binder, or chemicals.
b. Standard extract synergy mixture without process mixed for 45-60 min.
c. Modified synergy blend after process for piles and hemorrhoids.
d. Dry all blend of Phytoconstituents in tray dryer or fluidized bed dryer.
e. Pulverized it.
f. Blended with inulin and talc.

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.
Targeting of active by causality target such colon through oral administration of active ingredients is attractive and important for two reasons: 1. Colon disease like piles, hemorrhoids, constipation, large bowel diseases, such as ulcerative colitis or Crohn's Disease, can be treated locally, thus avoiding enema, suppositories dosage forms and minimizing systemic absorption; and 2. Phytochemical drugs, Phytoconstituents that may be absorbed in the colon but which are degraded in the upper digestive tract can be made available orally, since the colonic site minimizes the exposure of these compounds to the multitude of degradative digestive and proteolytic enzymes present in the upper digestive tract. Enteric coated tablet for Piles and Gut health developed with 3 active causality target blends for specific site of action and uniformity release at target release for quick intestinal absorption.

The present invention relates to the process to formulate Colon target Phytosomes for Piles and Hemorrhoids comprises a synergy form of Phytoconstituents containing a blend of alkaline herbs, Gum, Fibers and Natural Probiotics accordingly causality for target action. This invention relates to an oral delivery system made by phytoconstituents for delivering a precise amount of a tablet dosage for colon target without premature delivery of the product to the upper gastrointestinal (GI) tract. The present disclosure further relates to enteric-coated tablet for Piles and Gut health is developed with 3 active causality target blends for the specific site of action and uniformity release at the target site for quick therapeutical action.
In particular, the present disclosure relates with phytochemistry science, enteric-coated tablet is developed by using 10 phytoconstituents combined in 3 blends to form tablet for Piles and Hemorrhoids.
In particular, the present disclosure relates to the polyherbal composition comprising of;
a. Blend-1 (Colon target matrix- Immediate release at intestinal PH)
b. Blend-2 (Colon target matrix- Sustain release at intestinal PH)
c. Blend-3 (Colon target Fibre’s blend to solve constipation)

In particular, the present disclosure relates to the polyherbal composition comprising of;
a. Mesua ferrea extract, Mimosa Pudika extract, Plumbago indica extract, Boswelia serrata extract, Terminalia Arjuna extract, having 75-85% concentration combined to form blend 1.
b. Saraca asoca extract, Terminalia bellirica extract, Azadirachta Indica extract, having 12-18% concentration combined to form blend 2.
c. Operculina turpethum extract, Senna alexandrina extract, having 5-9% concentration combined to form blend 3.

The present disclosure further relates to the method of preparing the said polyherbal mixture comprising of,
a. Mixed all blend uniformly, add talcum as a lubricant (1-2%) & compressed into a tablet without any diluent, binder, or chemicals.
b. Standard extract synergy mixture without process mixed for 45-60 min.
c. Modified synergy blend after process for piles and hemorrhoids.
d. Dry all blend of Phytoconstituents in tray dryer or fluidized bed dryer.
e. Pulverized it.
f. Blended with inulin and talc.
Now a day’s world health organization encourages, recommends and promotes traditional, herbal remedies in health care science, because these drugs are easily available at low cost and are safe but herbal medicines are not a simple task since many factors influence biological efficacy and reproducible therapeutic effect. These days colonic diseases are commonly seen and need lifelong medical attention. Because of safety, herbal medicines can play a vital role in the treatment of colonic diseases. Various natural therapies, are available for the treatment of colonic diseases like piles, hemorrhoids, ulcerative colitis, Intestinal bowel syndrome, colon cancer, etc. It is possible to improve the effectiveness of these herbal medicines by targeting the colon. This invention comprises novel approaches used for colon targeting herbal dosage for piles and hemorrhoids. Effects of different processes and formulation parameters on colon targeted delivery system are mentioned following.

Table 1. Process to formulate Enteric coated Phytosomes
Blend Ingredients Conc.
(%) Active Causality Target
Enteric coated
Blend-1 Mesua ferrea extract 75-85%

Colon targeted immediate release, Gut microbiota support, Synergy tannins for anti-inflammatory & haemorrhoids support, natural gum for Intestinal motility support
Mimosa Pudika extract
Plumbago indica extract
Boswelia serrata extract
Terminalia Arjuna extract
Blend-2 Saraca asoca extract 12-18%
Erodible layer sustained releases, Wound Healing with anti-infective phytoconstituent’s blend
Terminalia bellirica extract
Azadirachta Indica extract
Blend-3 Operculina turpethum extract 5-9% Colon target Fibre’s blend to solve constipation
Senna alexandrina extract
Talc Lubricant 1-3% Lubricating effect for Compression

Preparation:
A. Preparation of Blend-1 (Colon target matrix- Immediate release at intestinal PH)
1. Dry extract of Asparagus dissolve in distilled water (0.5-2 % w/v) and mixed it for 15 minutes in mechanical stirrer at low speed.
2. Aqueous solution from Step 1 is granulated with blend-1 containing tannins phytoconstituents till optimum granulation is obtained.
3. The granulation from Step 2 is dried in a tray dryer at 50° C for 1-3 hours.
4. The granulation from Step 3 is passed through a #60 mesh screen.
5. The granulation from Step 4 is blended with inulin (0.5-1.5%) & Talc (0.5-1%)
B. Preparation of Blend-2 (Colon target matrix- Sustain release at intestinal PH)
a)
1. Dry form of Soya Lecithin heated and dissolve in neem oil (0.2-1 % w/v) and knead for 15 minutes with low-speed continuous stirring.
2. Step 1 is granulated with blend-2 gradually and then uniformly add distilled water till optimum dough mass granulation is obtained.
3. The granulation from Step 2 is dried in a tray dryer at 55° C for 1-3 hours.
4. The granulation from Step 3 is passed through a #45-60 mesh screen.
5. The granulation from Step 4 is blended with Talc (0.5-1%)
b)
1. Dry extract of Asparagus dissolve in distilled water (0.2-0.5 % w/v) and mixed it for 15 minutes in mechanical stirrer at low speed.
2. Step 1 is granulated with blend-3 gradually and then uniformly add distilled water till optimum granulation is obtained.
3. The granulation from Step 2 is dried in tray dryer at 50-55° C for 1-3 hours.
4. The granulation from Step 3 is passed through a #60-85 mesh screen.
5. The granulation from Step 4 is blended with Talc (0.5-1%)

Table 2. Micromeritic property Enhancement of Colon targeted blend
Micromeritics properties Boswellic acid 65% Soya Lecithin Asparagus saponin BA-Phytosomes
Angle of Repose 41.25 32-33 33-35 31-33
Carr’s index 18.54 16-18 16-18 14-16
Hausner Ratio 1.26 1.20-1.23 1.21-1.24 1.18-1.20

Table 3. Stability study and Physical evaluation of Optimized batch
Physical evaluation Optimized Tablet
(0 Day) Optimized Tablet
(3 months) Pharmacopeial Standards
% Gastric Release in 45 min 10.21% 10.19% Compliance
% Friability Less than 1 % Less than 1 % Compliance
Hardness 4-5 4-514-16 Compliance
% Intestinal Release in 45 min 90.05 % 90.05 % Compliance

Table 4. Case study
Piles and Hemorrhoids recovery (in days)
Product Patients
(30) Piles Inflammation Piles Pain Constipation Hemorrhoids
Gplife’s Piles Colon Target tablet Male (21) 7-10 days 3-4 days 3-5 days 2-4 days
Female (9) 7-10 days 3-4 days 3-5 days 2-4 days

,CLAIMS:1. A polyherbal blend of enteric coated tablet composition comprises a synergy form of Phytoconstituents containing a blend of alkaline herbs, Gum, Fibers and Natural Probiotics accordingly causality for target action.
2. The polyherbal blend of enteric coated tablet composition as claimed in claim 1, wherein oral delivery system made by phytoconstituents for delivering a precise amount of a tablet dosage for colon target without premature delivery of the product to the upper gastrointestinal (GI) tract.
3. The polyherbal blend of enteric coated tablet composition as claimed in claim 1, wherein enteric-coated tablet for Piles and Gut health is developed with 3 active causality target blends for the specific site of action and uniformity release at the target site for quick therapeutical action.
4. The polyherbal blend of enteric coated tablet composition as claimed in claim 1, wherein enteric-coated tablet is developed by using 10 phytoconstituents combined in 3 blends to form tablet for Piles and Hemorrhoids.
5. The polyherbal blend of enteric coated tablet composition as claimed in claim 4, wherein enteric-coated tablet is developed by using 10 phytoconstituents combined in 3 blends comprising of;
a. Blend-1 (Colon target matrix- Immediate release at intestinal PH)
b. Blend-2 (Colon target matrix- Sustain release at intestinal PH)
c. Blend-3 (Colon target Fibre’s blend to solve constipation)
6. The polyherbal blend of enteric coated tablet composition as claimed in claim 5, wherein enteric-coated tablet is developed by using 10 phytoconstituents combined in 3 blends comprising of;
a. Mesua ferrea extract, Mimosa Pudika extract, Plumbago indica extract, Boswelia serrata extract, Terminalia Arjuna extract, having 75-85% concentration combined to form blend 1.
b. Saraca asoca extract, Terminalia bellirica extract, Azadirachta Indica extract, having 12-18% concentration combined to form blend 2.
c. Operculina turpethum extract, Senna alexandrina extract, having 5-9% concentration combined to form blend 3.
7. The polyherbal blend of enteric coated tablet composition as claimed in claim 6, wherein the method of preparing the polyherbal mixture comprising of,
a. Mixed all blend uniformly, add talcum as a lubricant (1-2%) & compressed into a tablet without any diluent, binder, or chemicals.
b. Standard extract synergy mixture without process mixed for 45-60 min.
c. Modified synergy blend after process for piles and hemorrhoids.
d. Dry all blend of Phytoconstituents in tray dryer or fluidized bed dryer.
e. Pulverized it.
f. Blended with inulin and talc