CA2730533A1

CA2730533A1 - Process for preparing a herbal solid formulation

Info

Publication number: CA2730533A1
Application number: CA2730533A
Authority: CA
Inventors: Shankar Kumar Mitra; Uddagiri Venkanna Babu; Ekta Saxena; Anu Vrat Sharma
Original assignee: Himalaya Global Holdings Ltd
Current assignee: Himalaya Global Holdings Ltd
Priority date: 2008-07-09
Filing date: 2008-07-09
Publication date: 2010-01-14
Also published as: EP2328597A2; WO2010004356A2

Description

PROCESS FOR PREPARING A HERBAL SOLID FORMULATION
Field of the Invention This invention, in general relates to a process for preparing a herbal solid formulation. In particular, the present invention provides a novel process for preparing herbal solid formulation without using any excipients and preservatives.
Background of the Invention Pharmaceutical industry has witnessed lot of revolution in the development of excipients and dosage forms, especially for herbal extracts. Generally, the manufacturing of tablets comprising active molecules of the herbal extracts requires a lot of excipients such as binders, lubricants and diluents to achieve the desired properties of tablets.
It is very important to achieve certain properties of tablets such as hardness, disintegration and friability for better storage, stability and delivery of the drug to give the required therapeutic benefits to the patient.
In recent times, there is much concern in the consumer fraternity with respect to side effects and toxicity of synthetic excipients and preservatives used in pharmaceutical and personal care products. It is therefore a challenging task to manufacture herbal tablets without using any excipients and preservatives.
Related Art US Patent 6,207,189 by Mercati et al disclose a process for the production of tablets and capsules of natural substances of vegetable origin wherein dry extracts and micronized powders of one or more medicinal herbs in appropriate proportions are blended and subjected to steam pressure followed by drying, preparation of granules and compression to tablets.
US Patent 6,468,563 by Schmidt et al. discloses a process for producing rapidly disintegrating pharmaceutical formulation containing an extract and lubricant and compressing the blend to form the pharmaceutical formulation.
Summary of the Invention It is a principal object of the invention to provide a process for preparing a herbal solid formulation essentially free of additives/excipients and preservatives and providing required quantity of active constituents per dose.
It is another object of the invention to provide a herbal solid formulation having reduced side effects and toxicity.

.1 It is yet another object of the invention to provide a herbal solid formulation essentially free of excipients/additives and preservatives and having desired friability, disintegration time and hardness.
It is still another object of the invention to provide a method for preparing extract of one or more herbs used to prepare the solid formulation.
The above and other objects of the present invention are attained according to following preferred embodiments of the present invention. However the scope of the invention is not restricted to the particular embodiments discussed herein after.
In accordance with a preferred embodiment of the invention there is provided a process for preparing a herbal solid formulation essentially free of additives/excipients comprising granulating a mixture of extract and powder of one or more herbs, autoclaving the resultant granular mixture and further lubricating the granulated mixture by adding the powder of the one or more herbs and preparing the solid formulation. The solid formulation is preferably granules, tablet or capsule.
In accordance with another preferred embodiment of the invention said extract and said powder are mixed in a predetermined ratio, preferably about 1:0.5 to about 1:3.
In accordance with yet another preferred embodiment of the invention, the powder of one or more herbs is obtained by pulverizing the one or more herbs to a powder having mesh size preferably between about 10 to about 100, more preferably between 40 to 60.
In accordance with still another embodiment of the present invention, the process of granulating the mixture of extract and powder of the one or more herbs employs a solvent, preferably water and grain alcohol or combination thereof.
In accordance with yet another embodiment of the present invention, there is provided a process for preparing the extract of one or more herbs by percolation, hot soxhalation or refluxing followed by filtration and concentration to dryness at optimum temperature.
In accordance with one another embodiment of the present invention, there is provided a process for sterilization of herbal powders by autoclaving the granular mixture, wherein autoclaving prevents microbial growth.
In accordance with still one another embodiment of the invention, there is provided a herbal solid formulation for oral administration without adding any

2 excipients/additives and preservatives, wherein the solid formulation prepared by granulating a mixture of extract and powder of one or more herbs, autoclaving the granular mixture, lubricating the granular mixture by adding the powder of one or more herbs and preparing the solid formulation. The solid formulation can be granules, tablet or capsules.
In accordance with yet one another embodiment of the invention, the solid formulation has desired hardness preferably between about 3 to about 4 kg/cm2, friability less than about 1% and disintegration time less than about 30 min.
The solid formulation complies with USFDA guidelines.
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 present invention provides a herbal solid formulation essentially free of excipients/additives or preservatives from a mixture of extract and powder of one or more herbs (plant) and a process for preparing the same. The herbal solid formulation can be granules, tablet or capsule. The invention further discloses a process for preparing the extract of the one or more herbs.
The process of preparing the herbal solid formulation involves granulation of the mixture of extract and powder of the one or more herbs using a solvent system and autoclaving the granules. The solvent system employed for granulating the mixture includes grain alcohol, water or combination thereof. Autoclaving helps in microbial control of the solid formulation as it does not contain any preservatives.
The autoclaved granules are further lubricated using the powder of the one or more herbs and compressed or encapsulated into tablets or capsules.
The extract of the herbs is prepared by percolation, hot soxhalation or refluxing method employing a solvent, followed by filtration and concentration on a rotatory evaporator on steam bath at optimum temperature and under reduced pressure. The solvent employed includes organic grain alcohol, ethanol or water or combinations thereof, preferably grain alcohol.
The powder (herb powder) of the one or more herbs is prepared by pulverizing the one or more herbs to a powder of different mesh sizes based on the requirement,

3 preferably between about 10 to about 100, more preferably between 40 to 60.
The extract and the powder of the one or more herbs are mixed in a predetermined ratio preferably between about 1:0.5 to about 1:3 for optimum granulation.
All extracts, granules and tablets are subjected to standardization by High Performance Thin Layer Chromatography (HPTLC) and High Performance Liquid Chromatography (HPLC) for identification and quantitative estimation of active marker compounds. The extracts were evaluated for toxicity studies in rats and tablets for safety studies in healthy human volunteers.
The invention provides a general process for the preparation of a stable solid formulation of one or more herbs from a blend of the extract and the powder of the one or more herbs and is not limited to the herbs disclosed in the examples herein.
The following non-limiting examples illustrate specific embodiments of the present invention. They are, not intended to be limiting the scope of present invention in any way.
Example-1 Preparation of extract from the fruits of Organic Emblica ofcinalis by percolation method The shade dried fruits of Organic Emblica officinalis were pulverized to coarse powder and about 10 Kg each of the coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 litres (Its) of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for about 24 to about 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-2 Preparation of extract from the fruits of Organic Emblica oficinalis by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of fruits of Organic Emblica officinalis was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at about 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.

4 Example-3 Preparation of extract from the bark of Organic Terminalia arjuna by percolation method The shade dried bark of Organic Terminalia arjuna was pulverized to a coarse powder and about 10 Kg each of the coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol and water for about 24 to about 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure .
Example-4 Preparation of extract from the bark of Organic Terminalia ar/una by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of bark of Organic Terminalia arjuna was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol and water at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C under vaccum to a dried mass and milled to a powder of required mesh size.
Example-5 Preparation of extract from the roots of Organic Withania somnifera by percolation method The shade dried roots of Organic Withania somnifera were pulverized to coarse powder and about. 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol and water for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-6 Preparation of extract from the roots of Organic Withania somni era by hot-soxhalation/refluxing method The. coarse powdered material of 10 Kg each of roots of Organic Withania somnifera was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol,

5

6 PCT/IB2008/001797 organic grain alcohol and water -at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C under vaccum to a' dried mass and milled to a powder of required mesh size.
Example-7 Preparation of extract from the fruit rind of Organic Aegle marmelos by percolation method The shade dried fruit rind of Organic Aegle marmelos was pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol and water for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-8 Preparation of extract from the fruit rind of Organic Aegle marmelos by ot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of fruit rind of Organic Aegle marmelos was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol and water at optimum temperature and recycled. until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C under vaccum to a dried mass and milled to a powder of required mesh size.
Example-9 Preparation of extract from the whole plant of Organic Bacopa monnieri by percolation method The shade dried whole plant of Organic Bacopa monnieri was pulverized to coarse powder. and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol and water for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example-10 Preparation of extract from the whole plant of Organic Bacopa monnieri by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of whole plant of Organic Bacopa monnieri was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol and water at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C under vaccum to a dried mass and milled to a powder of required mesh size.

Example-11 Preparation of extract from the fruits of Organic Tibulus terrestris by percolation method The shade dried fruits of Organic Tribulus terrestris were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-12 Preparation of extract from the fruits of Organic Tribulus terrestris by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of fruits of Organic Tribulus terrestris was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-13 Preparation of extract from the stems of Organic Tinospora cordifolia by percolation method

7 The shade dried stems of Organic Tinospora cordifolia were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl' alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example-14 Preparation of extract from the stems of Organic Tinospora cordifolia by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of stems of Organic Tinospora cordifolia was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-15 Preparation of extract from the rhizomes of Organic Curcuma longa by percolation method The shade dried rhizomes of Organic Curcuma longa was pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol and organic grain alcohol for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example-16 Preparation of extract from the rhizomes of Organic Curcuma longa by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of rhizomes of Organic Curcuma longa was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, and organic grain alcohol at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus

8 obtained were washed with distilled water to remove oily matter and then dried at 50-60 C under vaccum to a dried mass and milled to a powder of required mesh size.
Example-17 Preparation of extract from the fruits of Organic Terminalia chebula by percolation method The shade dried fruits of Organic Terminalia chebula were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-18 Preparation of extract from the fruits of Organic Terminalia chebula by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of fruits of Organic Terminalia chebula was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant. extracts were then filtered and concentrated to dryness- on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-19 Preparation of extract from the seeds of Organic Mucuna pruriens by percolation method The shade dried seeds of Organic Mucuna pruriens were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48. hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-20 Preparation of extract from the seeds of Organic Mucuna pruriens by hot-soxhalation/refluxing method

9 The -coarse powdered material of 10 Kg each of seeds of Organic Mucuna pruriens was subjected to hot-soxhalation/refluxing using )solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-21 Preparation of extract from the fruits of Organic Momordica charantia by percolation method The shade dried fruits of Organic Momordica charantia were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example-22 Preparation of extract from the fruits of Organic Momordica charantia by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of fruits of Organic, Momordica charantia was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.

Example-23 Preparation of freeze dried flakes from the bulbs of Organic Allium sativum by percolation method The fresh bulbs of Organic Allium sativum was subjected to freeze drying at optimum temperature and pressure and followed by crushing into small flakes.

Example-24 Preparation of extract from the whole plant of Organic Centella asiatica by percolation method The shade dried whole plant of Organic Centella asiatica was pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-25 Preparation of extract from the whole plant of Organic Centella asiatica by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of whole plant of Organic Centella asiatica was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-26 Preparation of extract from the roots of Organic Rubia cordifolia by percolation method The shade dried roots of Organic Rubia cordifolia was pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-27 Preparation of extract from the roots of Organic Rubia cordifolia by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of roots of Organic Rubia cordifolia was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-28 Preparation of extract from the leaves of Organic Gvmnema sylvestre by percolation method The shade dried leaves of Organic Gymnema sylvestre were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl,alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-29 Preparation of extract from the leaves of Organic Gymnema sylvestre by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of leaves of Organic Gymnema sylvestre was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-30 Preparation of extract from the leaves of Organic Azadirachta indica by percolation method The shade dried leaves of Organic Azadirachta indica were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example-31 Preparation of extract from the leaves of Organic Azadirachta indica by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of leaves of Organic Azhadirachta indica was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until, extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-32 -Preparation of extract from the stems of Organic Boerhaavia diffusa by percolation method The shade dried stems of Organic Boerhaavia diffusa were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-33 Preparation of extract from the stems of Organic Boerhaavia diffusa by hot-soxhalation/refluxing method - The coarse powdered material of 10 Kg each of stems of Organic Boerhaavia diffusa was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-34 Preparation of extract from the resins of Organic Boswellia serrata by percolation method The shade dried resins of Organic Boswellia serrata were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol and organic grain alcohol for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example-35 Preparation of extract from the resins of Organic Boswellia serrata by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of resins of Organic Boswellia serrata was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol and organic grain alcohol at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C under vaccum to a dried mass and milled into a powder of required mesh size.

Example-36 Preparation of extract from the rhizomes of Organic Asparagus racemosus by percolation method The shade dried rhizomes of Organic Asparagus racemosus were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-37 Preparation of extract from the rhizomes of Organic Asparagus racemosus by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of rhizomes of Organic Asparagus racemosus was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-38 Preparation of extract from the fruits of Organic Moringa oleifera by percolation method The shade dried fruits of Organic Moringa oleifera were pulverized to coarse powder. and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-39 Preparation of extract from the rhizomes of Organic Morineifera by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of rhizomes of Organic Moringa oleifera was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-40 Preparation of extract from the resins of Organic Commiphora mukul by percolation method The shade dried resins of Organic Commiphora mukul were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant, extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example-41 Preparation of extract from the resins of Organic Commiphora mukul by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of resins of Organic Commiphora mukul was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extract thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-42 Preparation of extract from the rhizomes of Organic Zingiber officinalis by percolation method The shade dried rhizomes of Organic Zingiber officinalis were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-43 Preparation of extract from the rhizomes of Organic Zingiber offlicinalis by hot-soxhalation/Refluxing method The coarse powdered material of 10 Kg each of rhizomes of Organic Zingiber officinalis was subjected to hot-soxhalationlrefluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-44 Preparation of extract from the rhizomes of Organic Valerians wallichi by percolation method The shade dried rhizomes of Organic Valeriana wallichi were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol and organic grain alcohol for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-45 Preparation of extract from the rhizomes of Organic Valerians wallichi by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of rhizomes of Organic Valeriana wallichi was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C
under vaccum to a dried mass and milled to a powder of required mesh size.
Example-46 Preparation of extract from Organic Trikatu by percolation method The shade dried herbal blend of fruits of Organic Piper nigrum, Organic Piper longum and rhizomes of Organic Zingiber officinalis in equal parts was pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-47 Preparation of extract from Organic Trikatu by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of herbal blend of fruits of Organic Piper longum, Organic Piper nigrum and rhizomes of Organic Zingiber officinalis in equal parts was subjected to, hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C under vaccum to a dried mass and milled to a powder of required mesh size.

Example-48 Preparation of extract from Organic Triphala by percolation method The shade dried fruits of Organic Terminalia chebula, Terminalia bellerica and Emblica officinalis in equal ratio were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol, water, organic grain alcohol and water (70:30) for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-49 . Preparation of extract from Organic Triphala by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of blend of fruits of Organic Terminalia chebula, Terminalia bellerica and Emblica officinalis was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol, water and organic grain alcohol and water (70:30) at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C under vaccum to a dried mass and milled to a powder of required mesh size powder.

Example-50 Preparation of extract from the aerial parts of Organic Ocimum sanctum by percolation method The shade dried aerial parts of Organic Ocimum sanctum were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its 'of ethyl alcohol and organic grain alcohol for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example-51 Preparation of extract from the aerial parts of Organic Ocimum sanctum by hot-soxhalation/Refluxing method The coarse powdered material of 10 Kg each of aerial parts of Organic Ocimum sanctum was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol and organic grain alcohol at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were washed with distilled water and then dried at 50-under vaccum to a dried mass and milled to a powder of required mesh size.
Example-52 Preparation of extract from the leaves of Organic Adhatoda vasica by percolation method The shade dried leaves of Organic Adhatoda vasica were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol and organic grain alcohol for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.
Example-53 Preparation of extract from the leaves of Organic Adhatoda vasica by soxhalation/refluxing method The coarse powdered material of 10 Kg each of leaves of Organic Adhatoda vasica was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol and organic grain alcohol at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C under vaccum to a dried mass and milled to a powder of required mesh size.
Example-54 Preparation of extract from the fruits of Organic Garcinia combo ig a by percolation method The shade dried fruits of Organic Garcinia combogia were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a ,separate stainless steel vessel and soaked in 50 Its of ethyl alcohol and organic grain alcohol for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example-55 Preparation of extract from the fruits of Organic Garcinia combogia by hot-. 5 soxhalation/refluxing method The coarse powdered material of 10 Kg each of fruit of Organic Garcinia combogia was subjected to hot-soxlation/refluxing using solvents ethyl alcohol and organic grain alcohol at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C under vaccum to a dried mass and milled to a powder of required mesh size.

Example-56 Preparation of extract from the rhizomes of Organic Glyc rrhiza glabra by percolation method The shade dried rhizomes of Organic Glycyrrhiza glabra was pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol, organic grain alcohol and water for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example-57 Preparation of extract from the rhizomes of Organic Glvcyrrhiza glabra by hot-soxhalation/refluxing method - The coarse powdered material of 10 Kg each of rhizomes of Organic Glycyrrhiza glabra was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol, organic grain alcohol and water at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C under vaccum to a dried mass and milled to a powder of required mesh size.

Example-58 Preparation of extract from the aerial parts of Organic Androzraphis paniculata by percolation method.

The shade dried aerial parts of Organic Andrographis paniculata were pulverized to coarse powder and about 10 Kg each of coarse powdered material was placed in a separate stainless steel vessel and soaked in 50 Its of ethyl alcohol and organic grain alcohol for 24 to 48 hrs. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example-59 Preparation of extract from the aerial parts of Organic Andro&aphis paniculata by hot-soxhalation/refluxing method The coarse powdered material of 10 Kg each of aerial parts of Organic Andrographis paniculata was subjected to hot-soxhalation/refluxing using solvents ethyl alcohol and organic grain alcohol at optimum temperature and recycled until extraction is completed. The plant extracts were then filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The soft extracts thus obtained were dried at 50-60 C under vaccum to a dried mass and milled to a powder of required mesh size.

Example-60 General Manufacturing Procedure for Organic Herbal Tablets A predetermined quantity of extract powder, preferably grain alcohol extract powder and herb powder is taken in a suitable vessel and mixed properly to get a homogenous blend. The blend is granulated with required quantity of solvent or solvent system, passed through a suitable mesh screen and allowed to dry till the desired moisture content is achieved. The dried granules are passed through a suitable mesh screen and blended with the required quantity of herb powder of suitable size to get the final granules.

Compression of granules into tablets The granules obtained by the above process are compressed using suitable punch toolings on a rotary tablet compression machine to achieve desirable tablet weight and including 250 mg of active extract in each tablet. During compression, the parameters like, average weight, thickness, hardness, friability and disintegration time are monitored. The compressed tablets are then put in to suitable packaging.
Extract and powder of any of the known herb can be compressed using this general manufacturing procedure and a few of these trials are mentioned below but the examples do not limit the scope of the invention.
Example-61 Manufacturing of Organic Turmeric (Curcuma Tonga) Tablets Trial 1: The Turmeric extract and Turmeric powder (10 to 12 mesh) in the ratio of 0.25:1 were blended, granulated with ethanol and dried. The dried granules with LOD of about 2% were autoclaved, lubricated with 20% Turmeric powder and compressed in to tablets. The tablets showed poor hardness and friability.
Trial 2: The Turmeric extract and Turmeric powder (10 to 12 mesh) in the ratio of 0.25:1 were blended, granulated with grain alcohol and dried. The dried granules with LOD of about 2% were autoclaved, lubricated with 20% Turmeric powder and compressed in to tablets. The tablets showed'poor hardness and friability.
Trail 3: The Turmeric extract and Turmeric powder (30 to 40 mesh) in the ratio of 1:1 were blended, granulated with water/ethanol (3 0/70) and dried.
The dried granules with LOD of about 1% were autoclaved, lubricated with 20% Turmeric powder and compressed in to tablets. The tablets showed hardness of 2-3 kg, disintegration time (DT) of about 5 min and friability below 1%.
Trail 4: The Turmeric extract and Turmeric powder (30 to 40 mesh) in the ratio of 1:1 were blended, granulated with water/grain alcohol (3 0/70) and dried. The dried granules with LOD of about 1% were autoclaved, lubricated with 20%
Turmeric powder and compressed in to tablets. The tablets showed hardness of 2-3 kg, DT
of about 5 min and friability below 1%.
Trail 5: The Turmeric extract and Turmeric powder (20 to 30 mesh) in the ratio of 1:2 were blended, granulated with water/ethanol (10/90) and dried.
The dried granules with LOD of about 2% were autoclaved,lubricated with 20% Turmeric powder and compressed in to tablets. The tablets showed hardness of 1 kg, DT
of about 5 min and unsatisfactory friability results.
Trail 6: The Turmeric extract and Turmeric powder (10 to 12 mesh) in the ratio of 0.5:1 were blended, granulated with water/ethanol (50/50) and dried.
The dried granules with LOD of about 4% were autoclaved, lubricated with 20%
Turmeric powder and compressed in to tablets. The tablets showed poor hardness and friability but satisfactory DT.

Example-62 Manufacturing of Organic Gokhshura (Tribulus terrestris) Tablets Trail 1: The Tribulus extract and Tribulus powder (12 to 14 mesh) in the ratio of 0.5:1 were blended, granulated with water/ethanol (50/50) and dried. The dried granules with LOD of about 4% were autoclaved, lubricated with 20% Tribulus powder and compressed in to tablets. The tablets showed poor hardness and friability but satisfactory DT.

Trail 2: The Tribulus extract and Tribulus powder (30 to 40 mesh) in the ratio of 1:1 were blended, granulated with water/ethanol (30/70) and dried. The dried granules with LOD of about 1% were autoclaved, lubricated with 20% Tribulus powder and compressed in to tablets. The tablets showed poor hardness, DT of about

10 min and unsatisfactory friability results.
Trail 3: The Tribulus extract and Tribulus powder (10 to 12 mesh) in the ratio of 1:1 were blended, granulated with water/ethanol (80/20) and dried. The dried granules with LOD of about 4% were autoclaved, lubricated with 20% Tribulus powder and compressed in to tablets. The tablets showed poor hardness and friability but satisfactory DT.

Trail 4: The Tribulus extract and Tribulus powder (30-40 mesh) in the ratio of 1:2 were blended, granulated with water and dried. The dried granules with LOD
of about 1% were autoclaved, lubricated with 10% Tribulus powder and compressed in to tablets. The tablets showed satisfactory hardness of 2-3 kg, friability below 1% and DT about 20 mins.

Example-63 Manufacturin of Organic Tulasi (Ocimum sanctum) tablets Trail 1: The Tulasi extract and Tulasi powder (10 to 12 mesh) in the ratio of 0.5:1 were blended, granulated with ethanol and dried. The dried granules with LOD
of about 2% were autoclaved,lubricated with 20% Tulasi powder and compressed in to tablets. The tablets showed poor hardness and friability.
Trail 2: The Tulasi extract and Tulasi powder (30 to 40 mesh) in the ratio of 1:1 were blended, granulated with water/ethanol (10/90) and dried. The dried granules with LOD of about 4% were autoclaved, lubricated with 25% Tulasi powder and compressed in to tablets. The tablets showed satisfactory hardness of about 3-4 kg, DT of about 20 min and friability of less than I%.
Trail 3: The Tulasi extract and Tulasi powder (30 to 40 mesh) in the ratio of 1:1 were blended, granulated with water/grain alcohol (10/90) and dried. The dried granules with LOD of about 4% were autoclaved, lubricated with 25% Tulasi powder and compressed in to tablets. The tablets showed satisfactory hardness of about 3-4 kg, DT of about 20 min and friability of less than 1%.
Trail 4: The Tulasi extract and Tulasi powder (20 to 30 mesh) in the ratio of 1:2 were blended, granulated with water/ethanol (30/70) and dried. The dried granules with LOD of about 2% were autoclaved, lubricated with 20% Tulasi powder and compressed in to tablets. The tablets showed less hardness of about 1 kg and unsatisfactory friability results.
Trail 5: The Tulasi extract and Tulasi powder (10 to 12 mesh) in the ratio of 1:1 were blended, granulated with water/ethanol (40/60) and dried. The dried granules with LOD of about 4% were autoclaved, lubricated with 20% Tulasi powder and compressed in to tablets. The tablets showed poor hardness and friability.
Example-64 Manufacturing of Organic Bacopa (Bacopa monnieri) tablets Trail 1: The Bacopa extract and Bacopa powder (10 to 12 mesh) in the ratio of 0.5:1 were blended, granulated with ethanol and dried. The dried granules with LOD of about 2% were autoclaved, lubricated with 20 % Bacopa powder and compressed in to tablets. The tablets showed poor hardness and friability.
Trail 2: The Bacopa extract and Bacopa powder (30 to 40 mesh) in the ratio of 1:1 were blended, granulated with water and dried. The dried granules with LOD of about 3% were autoclaved, lubricated with 20 % Bacopa powder and compressed in to tablets. The tablets showed satisfactory hardness of about 3-4 kg, DT of about 15 min and satisfactory friability of less than 1%.
Trail 3: The Bacopa extract and Bacopa powder (20 to 30 mesh) in the ratio of 1:2 were blended, granulated with water/ethanol (30/70) and dried. The dried granules with LOD of about 2% were autoclaved, lubricated with 20 % Bacopa powder and compressed in to tablets. The tablets showed poor hardness of about 1 kg and un satisfactory friability results.

Trail 4: The Bacopa extract and Bacopa powder (30 to 40 mesh) in the ratio of 1:1 were blended, granulated with water/ethanol (50/50) and dried. The dried granules with LOD of about 4% were autoclaved, lubricated with 20 % Bacopa powder and compressed in to tablets. The tablets showed poor hardness and friability.
Example-65 Manufacturing of Organic Punarnava (Boerhaavia diffusa) tablets Trail 1: The Punarnava extract and Punarnava powder (20 to 30 mesh) in the ratio of 1:1 were blended, granulated with ethanol and dried. The dried granules with LOD of about 2% were autoclaved, lubricated with 20 % Punarnava powder and compressed in to tablets. The tablets showed poor unsatisfactory friability and hardness.
Trail 2: The Punarnava extract and Punarnava powder (30 to 40 mesh) in the ratio of 1:1 were blended, granulated with water and dried. The dried granules with LOD of about 3% were autoclaved, lubricated with 20 % Punarnava powder and compressed in to tablets. The tablets showed. satisfactory hardness, poor DT
and unsatisfactory friability results.
Trail 3: The Punarnava extract and Punarnava powder (30 to 40 mesh) in the ratio of 1:1 were blended, granulated with water and dried. The dried granules with LOD of about 1% were autoclaved, lubricated with 20 % Punarnava powder and compressed in to tablets. The tablets showed satisfactory hardness of about 3-4 kg, DT of about 15 min. and friability of less than I%.
Trail 4: The Punarnava extract and Punarnava powder (30 to 40 mesh) in the ratio of 1:2 were blended, granulated with water and dried. The dried granules with LOD of about 4% were autoclaved, lubricated with 20 % Punarnava powder and compressed in to tablets. The tablets showed poor hardness and friability.
Example-66 Manufacturing of Organic Garcinia (Garcinia compogia) tablets Trail 1: The Garcinia extract and Garcinia leaf powder (12 to 14 mesh) in the ratio of 0.5:1 were blended, granulated with water/ethanol(50/50) and dried.
The dried granules with LOD of about 4 % were autoclaved, lubricated with 20% Garcinia leaf powder and compressed in to tablets. The tablets showed poor hardness, friability and prolonged DT.

Trail 2: The Garcinia extract (40 mesh) and Garcinia leaf powder (20 mesh) in the ratio of 1:1 were blended, granulated with water and dried. The dried granules with LOD of about 3% were autoclaved, lubricated with 25 % Garcinia leaf powder and compressed in to tablets. The tablets showed satisfactory hardness, DT and friability results.
Trail 3: The Garcinia extract and Garcinia leaf powder (10 to 12 mesh) in the ratio of 1:1 were blended, granulated with water/ethanol (80/20) and dried.
The dried granules with LOD of about 4% were autoclaved, lubricated with 20% Garcinia leaf powder and compressed in to tablets. The tablets showed poor hardness and friability but satisfactory DT.
Trail 4: The Garcinia extract and Garcinia leaf powder (30 mesh) in the ratio of 1:2 were blended, granulated with water and dried. The dried granules with LOD of about 1% were autoclaved, lubricated with 10 % Garcinia leaf powder and compressed in to tablets. The tablets showed satisfactory hardness of 2-3 kg but poor friability (more than 2%) and higher DT.
Example-67 Manufacturing of Organic Arriuna (Terminalia ariuna) tablets Trail 1: The Arjuna extract and Arjuna leaf powder (12 mesh) in the ratio of 0.5:1 were blended, granulated with water/ethanol (50/50) and dried. The dried granules with LOD of about 4% were autoclaved, lubricated with 20% Arjuna leaf powder and compressed in to tablets. The tablets showed good hardness, friability but unsatisfactory DT results.
Trial 2: The Arjuna extract (40 mesh) and Arjuna leaf powder (20 mesh) in the ratio of 1:1 were blended, granulated with water and dried. The dried granules with LOD of about 3% were autoclaved, lubricated with 25% Arjuna leaf powder and compressed in to tablets. The tablets showed poor hardness, DT and friability results.
Trial 3: The Arjuna extract and Arjuna leaf powder (40 mesh) in the ratio of 1:1 were blended, granulated with water and dried. The dried granules with LOD
of about 3% were autoclaved and lubricated with 20% Arjuna leaf powder and compressed in to tablets. The tablets showed good hardness, friability and DT.
Trial 4: The Arjuna extract and Arjuna leaf powder (30 mesh) in the ratio of 1:2 were blended, granulated with water and dried. The dried granules with LOD
of about 1% were autoclaved and lubricated with 10% Arjuna .leaf powder and compressed in to tablets. The tablets showed satisfactory hardness-of 2-3 kg but poor friability (more than 2%) and higher DT.

Example-68 Manufacturing of Organic Triphala (Terminalia chebula (Tchebula), Terminalia bellerica and Emblica o icinalis tablets Trial 1: The Triphala extract and T. chebula leaf powder (14 mesh) in the ratio of .1:1 were blended, granulated with water/ethanol (50/50) and dried: The dried granules with LOD of about 4% were autoclaved, lubricated with 20% T chebula leaf powder and compressed in to tablets. The tablets showed good hardness, friability but unsatisfactory DT results.

Trial 2: The Triphala extract (40 mesh) and Tchebula leaf powder (20 mesh) in the ratio of 1:1 were blended, granulated with water and dried. The dried granules with LOD of about 3% were autoclaved, lubricated with 30% T chebula leaf powder and compressed into tablets. The tablets showed good hardness, DT and friability results.

Trail 3: The Triphala extract and T. chebula leaf powder (30 mesh) in the ratio of 1:1 were blended, granulated with water/ethanol (30:70) and dried. The dried granules with LOD of about 3 % were autoclaved, lubricated with 20% T. chebula leaf powder and compressed in to tablets. The tablets showed good hardness, friability but unsatisfactory DT results (more than 40 min).

Trail 4: The Triphala extract and T. chebula leaf powder (40 mesh) in the ratio of 1:2 were blended, granulated with water and dried. The dried granules with LOD of about 1% were autoclaved, lubricated with 10% T. chebula leaf powder and compressed in to tablets. The tablets showed satisfactory hardness of 3-4 kg but poor friability (more than 1%) and higher DT.

Example-69 Manufacturing of Organic Bitter melon (Momordica charantia) tablets Trail 1: The Bitter melon extract and stem powder (12 mesh) in the ratio of 1:1.5 were blended, granulated with water/ethanol (60/40) and dried. The dried granules with LOD of about 4 % were autoclaved, lubricated with 20 % Bitter melon stem powder and compressed in to tablets. The tablets showed poor hardness, friability but satisfactory DT results.

Trail 2: The Bitter melon extract (40 mesh) and stem powder (40 mesh) in the ratio of 1:1 were blended, granulated with water and dried. The dried granules with LOD of about 2% were autoclaved, lubricated with 20% Bitter melon stem powder and compressed in to tablets. The tablets showed poor hardness, DT and friability results.
Trail 3: The Bitter melon extract and stem powder (60 mesh) in the ratio of 1:1 were blended, granulated with water and dried. The dried granules with LOD
of about 5% were autoclaved, lubricated with 20 % Bitter melon stem powder and compressed in to tablets. The tablets showed good hardness, friability and satisfactory DT results.
Trail 4: The Bitter melon extract and stem powder (30 mesh) in the ratio of 1:2 were blended, granulated with water and dried. The dried granules with LOD
of about 2% were autoclaved, lubricated with 20 % Bitter melon stem powder and compressed in to tablets. The tablets showed poor hardness, friability (more than I%) and higher DT.
Example-70 Manufacturing of Organic Valeriana (Valerians wallichi) tablets Trail 1: The Valeriana extract and Valeriana powder (14 mesh) in the ratio of 1:2 were blended, granulated with water/ethanol (60/40) and dried. The dried granules with LOD of about 4% were autoclaved, lubricated with 20% Valeriana powder and compressed in to tablets. The tablets showed poor hardness, friability and DT
results.
. Trail 2: The Valeriana extract (30 mesh) and Valeriana powder (30 mesh) in the ratio of 1:1 were blended, granulated with water and dried. The dried granules with LOD of about 2% were autoclaved, lubricated with 20% Valeriana powder and compressed in to tablets. The tablets showed poor hardness and friability results but satisfactory DT results.
Trail 3: The Valeriana extract and Valeriana powder (40 mesh) in the ratio of 1:2 were blended, granulated with water and dried. The dried granules with LOD
of about 4% were autoclaved, lubricated with 10% Valeriana powder and compressed in to tablets. The tablets showed good hardness, friability and satisfactory DT
results.
Trail 4: The Valeriana extract and Valeriana powder (30 mesh) in the ratio of 1:1 were blended, granulated with water and dried. The dried granules with LOD
of about 2% were autoclaved, lubricated with 20% Valeriana powder and compressed in to tablets. The tablets showed poor hardness, friability (more than 1%) and higher DT.
Example-71 Sterilization and microbial control of herbal raw materials/granules by Autoclave The sterilization/reduction of microbial load of herbal raw material powders, herbal extracts, and extract granules was carried out using horizontal double door steam sterilizer (Horizontal Autoclave).
Procedure:
The herbal material including extract, granules, powder to be sterilized was placed in wide mouth stainless steel container or filled in paper bags. To ensure adequate penetration of steam, the containers were closed with porous muslin cloth and the paper bags sealed loosely. A piece of autoclave label (Signaloc) was sticked on the materials to indicate the completion of sterilization by change of its colour from light blue to dark grey/black. After completion of sterilization, the steam supply to chamber was stopped and the steam exhausted slowly till the pressure is nullified.
Following sterilization, the materials/granules were subjected to drying with the help of externally fitted vacuum pump and vacuum valve and filtered air is circulated in to the chamber. Drying time was adjusted to around 30 mins. The sterilized and dried materials were unloaded from the door present in the clean area.
Conditions The superheated steam was introduced in to the jacket to build-up the pressure upto 1.2 kg/cm2 or 15 PSI and temperature to 121 C. The standard sterilization time was 20 minutes for all the materials (in some cases it was reduced to 10 min.
for some thermo labile substances for reducing microbial load). After completion of sterilization time, the steam supply to chamber is stopped and it is exhausted slowly till the pressure is nullified.

Example-72 Standardization of herbal extracts/herbal powders/granules/tablets All herbal extracts/granules/tablets were subjected to standardization for active marker compounds by gravimetry, HPTLC and HPLC using in-house analytical procedures. The marker compounds of each extracts were identified and are given in Table-1.

Table-1 S.No. Product Botanical Name Specifications 1 Amalaki Emblica officinalis Tannins and Vitamin C

2 Arjuna Terminalia arjuna Tannins and Arjunolic acid 3 Ashwagandha Withania somnifera Withanolides + Alkaloids 4 Bael Fruit Aegle marmelos Marmelosin Bacopa Bacopa monnieri Bacosides A+B
6 Gokhshura Tribulus terrestris Saponins 7 Guduchi Tinospora cordifolia Tinosporasides 8 Turmeric Curcuma longa Curcuminoids 9 Haritaki Terminalia chebula Tannins and Chebulinic acid Mucuna Mucuna pruriens L-Dopa

11 Bitter Melon Momordica charantia Momordosides and Charantin

12 Garlic Allium sativum Allicin and Alliin

13 Gotukula Centella asiatica Triterpenoids and Asiaticosides

14 Manjishtha Rubia cordifolia Manjistin and Glycosides Gymnema Gymnema sylvestre Gymnemicacids+ Gym. acid IV
and Gurmarin 16 Neem Azhadirachta indica Bitters and Nimbidin 17 Boerrhaavia Boerhaavia diffusa Punarnavosides and Alkaloids 18 Boswellia Boswellia serrata Boswellic acids and Acetyl Keto Boswellic acid 19 Shatavari Asparagus racemosus Saponins and Shatavarin Shigru Moringa oleifera Moringine (Alkaloids) 21 Guggul Commiphora mukul Guggulsterones 22 Ginger Zingiber officinalis Gingerols 23 Valerian Valerian wallichi Valepotriates 24 Trikatu Piper longum, Piper Gingerols and Piperine nigurm and Zingiber officinalis Triphala Terminalia chebula, Tannins and Chebulinic acid Terminalia bellerica Emblica officinalis 26 Holy Basil Ocimum sanctum Ursolic acid 27 Vasaka Adhatoda vasaca Vasicine 28 Garcinia Garcinia combogia Hydroxy citric acid 29 Licorice Glycyrrhiza glabra Glycyrrhizinic acid and Saponins 30 Andrographis Andrographis Andrographolide paniculata While this invention has been described in detail with reference to certain preferred embodiments, it should be appreciated that the present invention is not limited to those precise embodiments. Rather, in view of the present disclosure, which describes the current best mode for practicing the invention, many modifications and variations would present themselves to those skilled in the art without departing from the scope and spirit of this invention.

Claims

1. A process for preparing a herbal solid formulation essentially free of excipients and preservatives, said process comprising the steps of:
a) granulating a mixture comprising extract and powder of one or more herbs;

b) autoclaving the resultant granulated mixture;
c) further lubricating the granulated mixture by adding the powder of one or more herbs; and d) preparing the solid formulation.

2. The process of claim 1, wherein said solid formulation is preferably granules, tablet or capsule.

3. The process of claim 1, wherein said solid formulation is preferably a tablet.

4. The process of claim 3, wherein said tablet is having hardness of about 3 to about 4 kg/cm2, a friability of less than about 1% and disintegration time is preferably less than about 30 min, more preferably less than about 10 min.

5. The process of claim 1, wherein said extract and said powder of one or more herbs are mixed in a predetermined ratio, preferably about 1:0.5 to about 1:3.

6. The process of claim 1, wherein the extract of one or more herbs is obtained by a method selected from percolation, hot soxhalation or reflux.

7. The process of claim 6, wherein the extraction is performed in presence of a solvent selected from water, grain alcohol or combinations thereof.

8. The process of claim 1, wherein the powder of one or more herbs is obtained by pulversing the one or more herbs to a powder having mesh size preferably between about 10 to about 100, more preferably between 40 to 60.

9. The process of claim 1, wherein the granulation is carried out by employing a solvent system selected from water, grain alcohol or combinations thereof.

10. An herbal solid formulation essentially free of excipients and preservatives for oral administration, wherein the formulation is prepared by a process comprising:

a) granulating a mixture of extract and powder of one or more herbs;
b) autoclaving the granular mixture;

c) further lubricating the granular mixture by adding the powder of one or more herbs; and d) preparing the solid formulation.

11. The herbal solid formulation of claim 10, wherein said solid formulation is preferably granules, tablet or capsule.

12. The herbal solid formulation of claim 10, wherein said solid formulation is preferably a tablet.

13. The herbal solid formulation of claim 12, wherein the tablet is having hardness of about 3 to about 4 kg/cm2, a friability of less than about 1% and disintegration time is preferably less than about 30 min, more preferably less than about 10 min.

14. The herbal solid formulation of claim 10, wherein said extract and said powder of one or more herbs are mixed in a predetermined ratio, preferably about 1:0.5 to about 1:3.

15. The herbal solid formulation of claim 10, wherein the granulation is carried out by employing a solvent system selected from water, grain alcohol or combinations thereof.

16. The process of claim 10, wherein the powder of one or more herbs is obtained by pulversing the one or more herbs to a powder having mesh size preferably between about 10 to about 100, more preferably between 40 to 60.

17. The process of claim 10, wherein the extract of one or more herbs is obtained by a method selected from percolation, hot soxhalation or reflux.

18. The process of claim 17, wherein the extraction is performed in presence of a solvent selected from water, grain alcohol or combinations thereof.