# US 11,433,111 B2 · Composition for treatment and management of dementia and cognitive dysfunction and method of preparation thereof

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- Number: US 11,433,111 B2
- Document ID: US11433111B2
- Status: Granted
- Kind: B2
- Application number: 16/808,726
- Filed: 2020-03-04
- Published: 2020-06-25
- Granted: 2022-09-06
- Earliest claimed: 2019-03-06
- Assignees: Muniyal Ayurvedic Research Centre
- Applicants: Muniyal Ayurvedic Research Centre
- Inventors: M Vijayabhanu Shetty
- Web page: https://patentgrep.com/patent/US11433111B2

## CPC

- A61K 36/81: Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K 33/14: Alkali metal chlorides; Alkaline earth metal chlorides
- A61K 33/24: Heavy metals; Compounds thereof
- A61K 33/26: Iron; Compounds thereof
- A61K 33/28: Mercury; Compounds thereof
- A61K 33/30: Zinc; Compounds thereof
- A61K 33/34: Copper; Compounds thereof
- A61K 33/38: Silver; Compounds thereof
- A61K 35/02: from inanimate materials (carbon A61K33/44)
- A61K 35/04: Tars; Bitumens; Mineral oils; Ammonium bituminosulfonate
- A61K 35/614: Cnidaria, e.g. sea anemones, corals, coral animals or jellyfish
- A61K 35/618: Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
- A61K 36/185: Magnoliopsida (dicotyledons)
- A61K 36/24: Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
- A61K 36/35: Caprifoliaceae (Honeysuckle family)
- A61K 36/39: Convolvulaceae (Morning-glory family), e.g. bindweed
- A61K 36/48: Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K 36/577: {Malvaceae (Mallow family)}
- A61K 36/68: Plantaginaceae (Plantain Family)
- A61K 36/882: Acoraceae (Calamus family), e.g. sweetflag or Acorus calamus
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention relates to a composition for treatment and management of Dementia. The composition is a combination of herbs and bhasmas. It includes herbs such as Bacopa monnieri, Convolvulus pluricaulis, Mucuna pruriens, Nardostachys jatamansi, Rauwolfia serpentina, Withania somnifera, Acorus calamus, Sida cordifolia and Emblica officinalis. It further includes Shilajit, Rasa sindura and bhasmas. The composition is useful in treating Cognitive dysfunction, Dementia and other cognitive impairments associated with neuro-degenerative disorders. Further, the composition is also useful in restoring and improving cognitive function.

## Claims

### Claim 1

An oral composition for treatment and management of dementia and cognitive dysfunction, comprising
therapeutically effective amounts of Bacopa monnieri or extracts thereof, Convolvulus pluricaulis or extracts thereof, Mucuna pruriens or extracts thereof, Nardostachys jatamansi or extracts thereof, Rauwolfia serpentina or extracts thereof, Withania somnifera or extracts thereof, Acorus calamus or extracts thereof, Sida cordifolia or extracts thereof, Emblica officinalis or extracts thereof, Shilajit, Rasa sindura and at least one bhasma, wherein said Bacopa monnieri is present in an amount in the range of 4 to 8 wt. % of the total weight of the composition, Convolvulus pluricaulis is present in an amount in the range of 2 to 4 wt. % of the total weight of the composition, Mucuna pruriens is present in an amount in the range of 2 to 4 wt. % of the total weight of the composition, Nardostachys jatamansi is present in an amount in the range of 2 to 4 wt. % of the total weight of the composition, Rauwolfia serpentina is present in an amount in the range of 2 to 4 wt. % of the total weight of the composition, Withania somnifera is present in an amount in the range of 3 to 7 wt. % of the total weight of the composition, Acorus calamus is present in an amount in the range of 2 to 4 wt. % of the total weight of the composition, Sida cordifolia is present in an amount in the range of 2 to 4 wt. % of the total weight of the composition, Emblica officinalis is present in an amount in the range of 3 to 7 wt. % of the total weight of the composition; and
at least one ingredient selected from the group consisting of Santalum album, Pterocarpus santalinus, Glycyrrhiza glabra, Terminalia chebula, Terminalia bellerica, Zingiber officinale, Piper nigrum, Piper longum, Curcuma longa, Inula racemosa, Cinnamomum zeylanica, Elettaria cardamomum, Syzygium aromaticum, Ocimum sanctum, Tinospora cordifolia, Hemidesmus indicus, Vetiveria zizanioides, Alpinia galangal, Cassia fistula, Embelia ribes, Prunus cerasoides, Rubia cordifolia, Ricinus communis, Boerhavia diffusa, Terminalia arjuna, Commiphora mukul, Picrorhiza kurroa, Plumbago zeylanica, and Mesua ferrea, or extracts thereof;
wherein said composition is in at least one form selected from the group consisting of tablet, pellet, lozenge, granule, suspension and capsule.

### Claim 2 (depends on 1)

The composition as claimed in claim 1, wherein said bhasma is selected from the group consisting of Swarna makshika bhasma, Loha Bhasma, Abhraka bhasma, Rajata Bhasma, Muktashukti Bhasma, Pravala Bhasma, Shringa Bhasma, Vanga Bhasma, Yashada Bhasma, Shankha Bhasma and Mandura Bhasma.

### Claim 3 (depends on 1)

The composition as claimed in claim 1, wherein said Shilajit is present in an amount of ≤2 wt. % of the total weight of the composition; Rasa sindura is present in an amount of ≤2 wt. % of the total weight of the composition; and at least one bhasma is present in an amount of ≤2 wt. % of the total weight of the composition.

### Claim 4 (depends on 2)

The composition as claimed in claim 2, wherein said Swarna makshika bhasma is present in an amount of ≤2 wt. % of the total weight of the composition; Loha Bhasma is present in an amount of ≤2 wt. % of the total weight of the composition; Abhraka bhasma is present in an amount of ≤2 wt. % of the total weight of the composition; Rajata Bhasma is present in an amount of ≤2 wt. % of the total weight of the composition; Muktashukti Bhasma is present in an amount of ≤2 wt. % of the total weight of the composition; Pravala Bhasma is present in an amount of ≤2 wt. % of the total weight of the composition; Shringa Bhasma is present in an amount of ≤2 wt. % of the total weight of the composition; Vanga Bhasma is present in an amount of ≤2 wt. % of the total weight of the composition; Yashada Bhasma is present in an amount of ≤2 wt. % of the total weight of the composition; Shankha Bhasma is present in an amount of ≤2 wt. % of the total weight of the composition; and Mandura Bhasma is present in an amount of ≤2 wt. % of the total weight of the composition.

### Claim 5 (depends on 1)

The composition as claimed in claim 1, wherein said Santalum album is present in an amount of ≤2 wt % of the total weight of the composition; Pterocarpus santalinus is present in an amount of ≤2 wt % of the total weight of the composition; Glycyrrhiza glabra is present in an amount of ≤2 wt % of the total weight of the composition; Terminalia chebula is present in an amount of ≤2 wt % of the total weight of the composition; Terminalia bellerica is present in an amount of ≤2 wt % of the total weight of the composition; Zingiber officinale is present in an amount of ≤2 wt % of the total weight of the composition; Piper nigrum is present in an amount of ≤2 wt % of the total weight of the composition; Piper longum is present in an amount of ≤2 wt % of the total weight of the composition; Curcuma longa is present in an amount of ≤2 wt % of the total weight of the composition; Inula racemosa is present in an amount of ≤2 wt % of the total weight of the composition; Cinnamomum zeylanica is present in an amount of ≤2 wt % of the total weight of the composition; Elettaria cardamomum is present in an amount of ≤2 wt % of the total weight of the composition; Syzygium aromaticum is present in an amount of ≤2 wt % of the total weight of the composition; Ocimum sanctum is present in an amount of ≤2 wt % of the total weight of the composition; Tinospora cordifolia is present in an amount in the range of 1 to 3 wt. % of the total weight of the composition; Hemidesmus indicus is present in an amount of ≤2 wt % of the total weight of the composition; Vetiveria zizanioides is present in an amount of ≤2 wt % of the total weight of the composition; Alpinia galangal is present in an amount in the range of 1 to 3 wt. % of the total weight of the composition; Cassia fistula is present in an amount in the range of 1 to 3 wt. % of the total weight of the composition; Embelia ribes is present in an amount of ≤2 wt % of the total weight of the composition; Prunus cerasoides is present in an amount of ≤2 wt % of the total weight of the composition; Rubia cordifolia is present in an amount of ≤2 wt % of the total weight of the composition; Ricinus communis is present in an amount of ≤2 wt % of the total weight of the composition; Boerhavia diffusa is present in an amount of ≤2 wt % of the total weight of the composition; Terminalia arjuna is present in an amount of ≤2 wt % of the total weight of the composition; Commiphora mukul is present in an amount of ≤2 wt % of the total weight of the composition; Picrorhiza kurroa is present in an amount of ≤2 wt % of the total weight of the composition; Plumbago zeylanica is present in an amount of ≤2 wt % of the total weight of the composition; and Mesua ferrea is present in an amount of ≤2 wt % of the total weight of the composition.

### Claim 6 (depends on 1)

The composition as claimed in claim 1, further comprising Gum acacia.

### Claim 7 (depends on 4)

The composition as claimed in claim 4, wherein Gum acacia is present in an amount in the range of 8 to 12 wt. % of the total composition.

### Claim 8 (depends on 1)

The composition as claimed in claim 1, said composition comprising Bacopa monnieri, Convolvulus pluricaulis, Mucuna pruriens, Nardostachys jatamansi, Rauwolfia serpentina, Withania somnifera, Acorus calamus, Sida cordifolia, Emblica officinalis, Santalum album, Pterocarpus santalinus, Glycyrrhiza glabra, Terminalia chebula, Terminalia bellerica, Zingiber officinale, Piper nigrum, Piper longum, Curcuma longa, Inula racemosa, Cinnamomum zeylanica, Elettaria cardamomum, Syzygium aromaticum, Ocimum sanctum, Tinospora cordifolia, Hemidesmus indicus, Vetiveria zizanioides, Alpinia galangal, Cassia fistula, Embelia ribes, Prunus cerasoides, Rubia cordifolia, Ricinus communis, Boerhavia diffusa, Terminalia arjuna, Commiphora mukul, Picrorhiza kurroa, Plumbago zeylanica, Mesua ferrea, Shilajit, Rasa sindura, Swarna makshika bhasma, Loha Bhasma, Abhraka bhasma, Raj ata Bhasma, Muktashukti Bhasma, Pravala Bhasma, Shringa Bhasma, Vanga Bhasma, Yashada Bhasma, Shankha Bhasma and Mandura Bhasma.

### Claim 9 (depends on 1)

A process for the preparation of a composition claimed in claim 1, comprising:
preparing a grinding decoction comprising Stereospermum suaveolens by soaking dry root of Stereospermum suaveolens in 16 parts of water and boiling at a temperature in the range of 80° C. to 85° C. for a period until the amount of water is reduced to ⅛th of the initial volume;
levigating at least one bhasma, Rasa sindura, Guggulu and Shilajit with a first portion of said grinding decoction in a grinder; and
adding powdered herbs comprising whole plant of Bacopa monnieri and Convolvulus pluricaulis; seeds of Mucuna pruriens; rhizome of Nardostachys jatamansi; roots of Rauwolfia serpentina, Withania somnifera, Sida cordifolia and Acorus calamus; and fruits of Emblica officinalis into said grinder and grinding with a second portion of said grinding decoction, to obtain a homogenous mass.

### Claim 10 (depends on 9)

The process as claimed in claim 9, wherein said powdered herbs further comprises seeds of Elettaria cardamomum; roots of Picrorhiza kurroa, Plumbago zeylanica, Rubia cordifolia, Hemidesmus indicus, Vetiveria zizanioides, Alpinia galangal, Glycyrrhiza glabra and Inula racemosa; fruits of Terminalia chebula, Terminalia bellerica, Piper nigrum and Piper longum; heartwood of Santalum album and Pterocarpus santalinus; rhizome of Zingiber officinale and Curcuma longa; bark of Cinnamomum zeylanica; floral bud of Syzygium aromaticum; leaves of Ocimum sanctum, stem of Tinospora cordifolia; bark of Cassia fistula; fruit of Embelia ribes; heartwood of Prunus cerasoides; leaves of Ricinus communis; roots of Boerhavia diffusa; stem bark of Terminalia arjuna; and stamen of Mesua ferrea.

### Claim 11 (depends on 9)

The process as claimed in claim 9, wherein said bhasma is selected from a group consisting of Swarna makshika bhasma, Loha Bhasma, Abhraka bhasma, Rajata Bhasma, Muktashukti Bhasma, Pravala Bhasma, Shringa Bhasma, Vanga Bhasma, Yashada Bhasma, Shankha Bhasma and Mandura Bhasma.

### Claim 12 (depends on 9)

The process as claimed in claim 9, wherein said grinding decoction further comprises Aloe vera, Centella asiatica, Premna mucronata, Gmelina arborea, Aegle marmelos, Oroxylum indicum, Desmodium gangeticum, Uraria picta, Solanum indicum, Solanum xanthocarpum, Tribulus terrestris, Acorus calamus, Celastrus paniculatus, Nardostachys jatamansi, Rauwolfia serpentina, Alpinia galanga, Asparagus racemosus, Triticum aestivum, Cuminum cyminum, Coriandrum sativum, Apium graveolens, Yavakshara alkali, Sarjikshara alkali and Cissus quadrangularis.

### Claim 13 (depends on 12)

The process as claimed in claim 12, wherein preparing said grinding decoction comprises soaking 3 parts of fresh leaves of Aloe vera, 3 parts of fresh leaves of Centella asiatica, ½ part of dry root of Stereospermum suaveolens, ½ part of dry root of Premna mucronate, ½ part of dry root of Gmelina arborea, ½ part of dry root of Aegle marmelos, ½ part of dry root of Oroxylum indicum, ½ part of dry plant of Desmodium gangeticum, ½ part of dry plant of Uraria picta, ½ part of dry root of Solanum indicum, ½ part of dry plant of Solanum xanthocarpum, ½ part of dry fruit of Tribulus terrestris, 2 part of Acorus calamus, 2 part of Celastrus paniculatus, 2 part of Nardostachys jatamansi, 3 part of Rauwolfia serpentina, 2 part of Alpinia galanga, 1 part fresh roots of Asparagus racemosus, 1 part of fresh leves of Triticum aestivum, 0.4 part of dry seeds of Cuminum cyminum, 0.4 part of dry fruits of Coriandrum sativum, 0.4 part of dry seeds of Apium graveolens, 0.3 part of Yavakshara alkali (Alkali of Hordeum vulgare), 0.3 part of Sarjikshara alkali (Barilla) and 0.8 part of fresh stem of Cissus quadrangularis in 427.2 parts of water; and boiling until the amount of water is reduced to ⅛th of the initial volume.

### Claim 14 (depends on 9)

The process as claimed in claim 9, further comprising adding Gum acacia to said homogenous mass and grinding to obtain a semisolid mass; drying; granulating by wet granulation; and punching to obtain tablets.

### Claim 15 (depends on 1)

A method for manufacturing a medicament, comprising combining a suitable excipient and the composition claimed in claim 1.

### Claim 16 (depends on 15)

The method as claimed in claim 15, wherein said composition is present in an amount effective for treatment of Dementia.

### Claim 17 (depends on 1)

A method for treatment and management of Dementia, said method comprising administering, to a patient in need thereof, a therapeutically effective amount of the composition claimed in claim 1.

### Claim 18 (depends on 1)

A method for treatment and management of neurodegenerative disorder, said method comprising administering, to a patient in need thereof, a therapeutically effective amount of the composition claimed in claim 1.

### Claim 19 (depends on 1)

A method for improving memory in an individual, said method comprising administering, to said individual, the composition claimed in claim 1.