DESC:
FILED OF INVENTION:
The present invention relates to natural super disintegrant to enhance disintegration property in Phytopharmaceutical tablet dosage form and method of making the same. In particular, the present disclosure relates to the herbal natural super disintegrant based formulation comprising of Dehydrate Banana Powder, Saponin of Trigonella, and Dehydrated Guava powder to form tablet dosage form. Another invention relates to Tablet which is one of the most preferred dosage forms throughout oral dosage in which Disintegrants are agents integrated to tablet and encapsulated formulations to promote the breakup of the tablet and slugs into small fragments in an aqueous medium.

BACKGROUND OF INVENTION:
In Herbal, Ayurvedic and Phytoconstituents based formulation, disintegration property is very important as with solubility. In herbal industry, Disintegration time is depending on particle size, binding agent, fibers, granulation process and nature of extract. Dosage release and dissolution also depend on disintegration. If tablet disintegration is poor than it will directly affect on therapeutical effect. In Pharmaceutical industry most of tablet dosage form formulated with Superdisintegrants like sodium starch glycolate, Cross providone, Cross carmellose sodium, Ion exchange resin, Ac-di-sol and mannitol. All are chemical based excipients and some of it dangerous in different metabolic condition like diabetes, Obesity. Superdisintegrant ideal property should be like they should be disintegrated within seconds when placed in mouth. They should not require excess water to dissolve. Quick dissolution and absorption and less sensitive to environmental condition like humidity and temperature. They should be less fragile and should maintain its hardness

The present invention developed fibers blend as a Super disintegrants made up with natural ingredients for replacement of synthesized disintegrants. This Super disintegrants blend is to be added during granulation and post granulation and both depending up on formulation. This blend has also good probiotic effect helpful in gut health also.

1. Dehydrate Banana Powder - Banana is additionally called plantain. It contains vitamin A, so it is utilized in the treatment of gastric ulcer and diarrhea. It withal contains vitamin B6, which avails in reducing the stress and solicitousness. It is a very good source of energy due to high carbohydrate content, and it contains potassium, which is responsible for more preponderant brain functioning and salt for fast dissolving action, Dehydrated Banana powder proportion should be adjusted between 30-45.

2. Saponin of Trigonella (20%) - Trigonella (Fenugreek) is key herbs for digestive and metabolic imbalance. It contains saponin and soluble fibers help to lowering the surface tension of a liquid, decreasing the hydrophobicity of particles and promoting the penetration of the liquid through the pores of the tablet, breaking it into small pieces. Additionally, fibers help to improve disintegration property by improving porosity. Trigonella saponin proportion should be adjusted between 35-40.

3. Dehydrated Guava powder - Guava contains soluble, insoluble fibers and also contains gum for little binding effect. This gum is water soluble and insoluble fibers help to breakdown tablet in small piece when it comes to contact with gastric fluid. For Superdisintegrating action, Dehydrated Guava powder proportion should be adjusted between 24-30.

US20160346209A1 disclosure provides improved systems and methods utilizing colloidal/ultrafine superdisintegrant-based composite particles for dispersion and/or dissolution of active pharmaceutical agents. In general, the present disclosure utilizes a surfactant-free or near surfactant-free formulation by incorporating a wet milled SDI as a dispersant in the formulation. As such, the present disclosure provides for the preparation of surfactant-free or substantially surfactant-free formulations (e.g., nano-composite micro-particle formulations) by incorporating a wet-milled superdisintegrant (SDI) as the dispersant in the formulations. The advantageous SDI particles (e.g., colloidal/ultrafine SDI particles) of the present disclosure can be used to break-up the aggregates (e.g., nanoparticle aggregates) of the active agents (e.g. poorly water-soluble drugs) in the formulations (e.g., micro-particle formulations) and enhance the recovery of the nanoparticles of active agents during aqueous re-dispersion and their dissolution rate in vitro and in vivo.

US11253481B1 disclosure self-nanoemulsifying 3D printer ink composition and a method of using such composition to manufacture a 3D-printed tablet having compartmentalized active pharmaceutical ingredients. In particular, the 3D-printed tablet composition includes glimepiride and/or rosuvastatin in a curcuma oil based self-nanoemulsifying drug delivery system (SNEDDS).

Recent Patents on Drug Delivery & Formulation (Volume 14, Number 1) Fast Dissolving/Disintegrating Dosage Forms of Natural Active Compounds and Alternative Medicines (Singh, A., Kharb, V., & Saharan, V. A. (2020)) discloses Fast Dissolving/Disintegrating Dosage Forms (FDDFs) are a group of dosage forms which dissolve or disintegrate quickly, leading to fast distribution of active ingredients at the site of administration; thereby providing ease of oral ingestion of solid unit dosage forms and have the potential to enhance transmucosal absorption. With time, the use of FDDFs in alternative systems has significantly increased. Homeopathic systems and traditional Chinese medicine have embraced FDDFs for the delivery of active compounds. Most of the patents in this area are from China or by the Chinese innovators. In Europe and US, FDDFs have been extensively studied for the delivery of natural active compounds. It was fascinating to know that some new dosage forms and new routes of delivering active compounds are also making their way to the family of FDDFs. The dose of active compound, size of dosage forms, standardization of extracts, polyherbal mixtures, stability of active compounds, safety, efficacy and pharmacokinetics are challenging issues for developing FDDF herbal formulations or phytopharmaceuticals.

International Journal of Pharmaceutical Research (July - Sep 2021 Vol 13 Issue 3) Formulation, in-vitro evaluation and comparative study of diclofenac potassium loaded fast dissolving tablet using natural and synthetic superdisintegrants (THAPA, CHHITIJ, et al.) discloses The study aims to extract and characterize starch and mucilage from Jackfruit seeds, Banana powder, Hibiscus leaves, Fenugreek seed, Mango peel, and Lepidium sativum and using these dry extracts as a natural superdisintegrant in the formulation of fast dissolving Tablets and comparing disintegration time with a commercially available synthetic superdisintegrant, Sodium Starch Glycolate. Various phytochemical test concludes the presence of polysaccharides in the extracts of natural superdisintegrants while no indications of the presence of alkaloids, glycosides, proteins, saponins, and other phenolic compounds were observed. Thirteen different formulations of diclofenac potassium loaded FDTs were prepared by the direct compression method and were subjected for both pre-compression and post-compression studies. Flow properties depicted the formulations to be within the considerable range indicating a good flow of powders while postcompression studies including weight variation, thickness, hardness, and friability of different formulations were within the acceptable limit.

Journal of Phytomedicine and Therapeutics (Vol. 19 No. 1 (2020)) Comparative Evaluation of Fast Dissolving Tablets of Acetaminophen Using Super-disintegrant Blends and Sublimation Method (Eraga, S. O., et al.) discloses Fast disintegrating tablets (FDTs) are gaining prominence as drug delivery systems and emerging as one of the popular and widely accepted dosage forms, especially for the peadiatric and geriatric patients. This study aims to evaluate and compare the tablet properties of fast disintegrating tablets of acetaminophen prepared by super-disintegrant blends and sublimation methods. Two groups of tablets comprising various batches were prepared by wet granulation. Granules batches of one group of tablets (A-G) were prepared with different concentrations of sodium starch glycolate and croscarmellose sodium while the other group of tablets (H-N) were incorporated with varying concentrations of menthol into the batches. The granules were subjected to analysis and compressed into tablets. The post-compression parameters of the tablets such as weight uniformity, crushing strength, friability, wetting and disintegration times, as well as dissolution studies were evaluated.

OBJECTIVE OF INVENTION
A disintegrant is an additive that promotes disintegration, which is the breakage of a tablet into small fragments or small pieces when it contacts with a liquid medium. Depending on disintegration power and fast dissolving action, Super disintegrants can be classified into two categories: (1) those that promote water uptake. Example of such includes surfactants (e.g., sodium lauryl sulfate or Surfactant) that work by lowering the surface tension of a liquid, decreasing the hydrophobicity of drug particles and promoting the penetration of the liquid through the pores of the tablet, breaking it into small pieces. (2) Those that promote Swelling by water intake, example SSG, CP, CCS etc.

Natural superdisintegrant blend from Banana, Trigonella and Guava with good disintegrating property. Banana and Guava powder contains gum and fibers help to promote water intake and fibers helps tablet in to small fragments. On the other side synergy blend of Saponin derived from Trigonella promote water penetration through the core by lowering surface tension of medium leads high disintegration power. It is natural hence patients’ compliance is good and very compatible with active phytoconstituents.

SUMMERY OF THE INVENTION:
The present invention relates to natural super disintegrant to enhance disintegration property in Phytopharmaceutical tablet dosage form and method of making the same.

In particular, the present disclosure relates to the herbal natural super disintegrant based formulation comprising of Dehydrate Banana Powder, Saponin of Trigonella, and Dehydrated Guava powder to form tablet dosage form.

The present disclosure further relates to the herbal natural super disintegrant based formulation comprising Banana (30-45) and Guava powder (24-30) contains gum and fibers help to promote water intake and fibers helps tablet in to small fragments. On the other side synergy blend of Saponin derived from Trigonella (35-40) promote water penetration through the core by lowering surface tension of medium leads high disintegration power.

Another invention relates to Tablet which is one of the most preferred dosage forms throughout oral dosage. In oral dosage Disintegrants are agents integrated to tablet and encapsulated formulations to promote the breakup of the tablet and slugs into small fragments in an aqueous medium thereby incrementing the available surface area and promoting a more rapid release of the active substance.

DETAILED DESCRIPTION OF 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.
Natural polymers have more preponderant effects on fast dissolving tablets than synthetic polymers. Natural polymers incremented the release rate from the tablet and decremented the dissolution and disintegration time, and they are utilized as binder superdisintegrant and diluent. Natural polymers are preferred over synthetic polymers as they are nontoxic, facilely available at low cost, utilized in low concentration, and are naturally extracted to provide nutritional supplement compatible with active Phytochemicals or Synergy form of Phytoconstituents. The disintegrating properties of Plantago ovata, Lepidium sativum, gum karaya, Guar gum, mango peel pectin and many more have been studied in comparison to artificial super disintegrants. Thus, natural Superdisintegrants exhibit faster drug dissolution and increased bioavailability, thereby, availing in efficacious therapy and improved patient compliance.

Disintegrants are an additive used to enhance the disintegration process of tablet formulation when they make contact with GIT fluid. Their mechanism of action, such as those that amplify the action of capillary forces that encourage the absorption of water, enlarge upon contact with water, or liberate gases leading directly to the disintegration of the tablet. Starches are blended with the powder blends in the dry state because of their disintegrating effect. Starch swells when coming in contact with water; it has a great affinity toward water and thus enhances the breakdown of the matrix of the tablet. On contact with water the Superdisintegrants swell, hydrate, change volume or form and produce a disruptive change in the tablet. Effective superdisintegrants provide improved compressibility, compatibility and have no negative impact on the mechanical strength of formulations containing high-dose drugs. Precise natural superdisintegrants involve various natural substances like gums, mucilages, and other substances of natural origin which are more effective at lower concentrations with greater disintegrating efficiency and mechanical strength. They are comparatively cheaper, abundantly available, non-irritating and nontoxic in nature and compatible with Natural active.

Tablet is one of the most preferred dosage forms throughout oral dosage. In oral dosage Disintegrants are agents integrated to tablet and encapsulated formulations to promote the breakup of the tablet and slugs into small fragments in an aqueous medium thereby incrementing the available surface area and promoting a more rapid release of the active substance. They promote moisture penetration and dispersion of the tablet matrix. The disintegrants have the major function to oppose the efficiency of the tablet binder and the physical forces that act under compression to compose the tablet. The stronger the binder, the more efficacious must be the disintegrating agents in order for the tablet to release its medication. Disintegrants are an essential component to tablet formulations. The ability to interact strongly with water is essential to disintegrate function. Combination of swelling or wicking or deformation are the mechanisms of disintegrant action. The polymers obtained from the natural inchoation are more efficacious and safer. They are facilely available in natural regions around the world therefore they are preferred over synthetic polymer. Natural polymers are nontoxic; they do not have any adverse effects on the body. Natural polymers are environmentally friendly as they are biodegradable in nature, they do not cause any pollution and incompatibility during formulation. Natural polymers are mainly preferred by the patients as they are safer and more efficacious as compared to the synthetic polymers and have more patient compliance.
Table 1. Method of preparation of natural Superdisintegrants blend
Natural Superdisintegrants Proportional of Superdisintegrants
Post Granulation mixing time Concentration of Superdisintegrating action
Dehydrated Banana Powder 30-45

30-45 min

2-5 %
Trigonella
Saponin (20%) 35-40
Dehydrated
Guava Powder 24-30

Table 2. Granulation Process Parameter to produce Superdisintegrants
Granulating Solution Kneading time
(Min) Drying
(40-500 C) Pulverize
through
Distilled water
1-2 Liter in 50 kg blend 35-60 minutes 60-90 min Sieve-80-100

Table 3. Disintegration Property of 95% Curcumin Tablet
Parameters With SSG With Modified blend
Disintegration time More than 180 sec 90-120 Sec
Dissolution time 90 min 45-50 min
Friability 0.992-1.034 0.871-0.916

Table 4. Disintegration Property of 60% Boswellic acid
Parameters With SSG With Modified blend
Disintegration time 220-280 sec 90-120 Sec
Dissolution time 90-120 min 35-45 min
Friability 0.989-1.008 0.862-0.951

Table 5. Disintegration Property of 65% Hydrocytric acid
Parameters With SSG With Modified blend
Disintegration time 220-240 sec 80-110 Sec
Dissolution time 120-150 min 35-45 min
Friability 0.996-1.107 0.902-0.964

Table 6. Disintegration Property of Synergy blend of above Phytochemicals
Parameters With SSG With Modified blend
Disintegration time 260-280 sec 92-118 Sec
Dissolution time 115-135 min 50-60 min
Friability 0.981-1.017 0.922-0.960
,CLAIMS:1. An herbal natural super disintegrant based formulation to enhance disintegration property in Phytopharmaceutical tablet dosage form.
2. The herbal natural super disintegrant based formulation as claimed in claim 1, wherein herbal natural super disintegrant based formulation comprising of Dehydrate Banana Powder, Saponin of Trigonella, and Dehydrated Guava powder to form tablet dosage form.
3. The herbal natural super disintegrant based formulation as claimed in claim 1, wherein the herbal natural super disintegrant based formulation comprising Banana (30-45) and Guava powder (24-30) contains gum and fibers help to promote water intake and fibers helps tablet in to small fragments.
4. The herbal natural super disintegrant based formulation as claimed in claim 1, wherein the herbal natural super disintegrant based formulation comprising synergy blend of Saponin derived from Trigonella (35-40) promote water penetration through the core by lowering surface tension of medium leads high disintegration power.
5. The herbal natural super disintegrant based formulation as claimed in claim 1, wherein Tablet which is one of the most preferred dosage forms throughout oral dosage in which disintegrants are agents integrated to tablet and encapsulated formulations to promote the breakup of the tablet and slugs into small fragments in an aqueous medium.
6. A method of preparation of herbal natural super disintegrant based formulation comprises of;
a. Super disintegrants blend comprising of Dehydrate Banana Powder (30-45), Saponin of Trigonella (35-40), and Dehydrated Guava powder (24-30) reprocesses with granulation to improve palatability for 30-45 min.
b. Granulating solution having Distilled water 1-2 Liter in 50 kg blend for 35-60 minutes.
c. Dry all Super disintegrants blend of Phytoconstituents at 40-50 0C for 60-90 min.
d. Pulverized it in sieve number 80-100.

7. The herbal natural super disintegrant based formulation as claimed in claim 1, wherein the herbal natural super disintegrant based formulation in the form of tablet can be used for to enhance disintegration property.