Withania somnifera composition, method for obtaining same and pharmaceutical, nutritional and personal care formulations thereof

• US 20040166184A1
• Filed: 02/26/2004
• Published: 08/26/2004
• Est. Priority Date: 12/03/2002
• Status: Active Grant

• Current Assignee: Indian Herbs Research & Supply Company Ltd., Natreon, Inc.
• Original Assignee: Indian Herbs Research & Supply Company Ltd., Natreon, Inc.
• Inventors: Ghosal, Shibnath
• Granted Patent: US 7,318,938 B2
• Time in Patent Office: Days
• US Class Current: 424/773
• CPC Class Codes: A61K 36/81 Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
• CPC Class Codes: A61K 8/9789 Magnoliopsida [dicotyledons]
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 25/08 Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: 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
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 39/06 Free radical scavengers or antioxidants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61Q 17/04 Topical preparations for affording protection against sunlight or other radiation; Topical sun tanning preparations
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin
• CPC Class Codes: A61Q 19/02 for chemically bleaching or whitening the skin
• CPC Class Codes: A61Q 19/08 Anti-ageing preparations

Abstract

This invention relates to a composition of the plant Withania Somnifera, and, more particularly to a high purity extract composition with advantageous levels of withanolide glycosides and oligosaccharides, a minimum of polysaccharides, and substantially low levels of free withaferin A and equivalents (withanolide aglycones), which composition provides enhanced cognition-enhancing effects for the user, and an extraction process for obtaining such composition, as well as pharmaceutical, nutritional and personal care use products thereof.

Claims

1. A Withania Somnifera extract composition, in the form of a stable, herbaceous powder, which comprises, by weight, (a) at least 8% of withanolide glycosides and sitoindosides, (b) about 25% of oligosaccharides, and (c) less than 2% of free withaferin A (aglycone).

2. A composition according to claim 1 wherein (a) is 8-25%, and (b) is 25-75%;

and (c) is <

1%.

3. A composition according to claim 2 wherein (b) has a mol. wt. <

2000.

4. A process of making the extract composition of claim 1 which comprises (a) providing root stock and leaves of a Withania Somnifera plant which is about 1-2 years old, (b) extracting said root stock with an aqueous-alcoholic solvent in the presence of a saccharide, (c) concentrating the extract under vacuum, (d) treating the residue with an apolar organic solvent to remove free withanolide A aglycones therefrom, (e) vacuum drying the insoluble residue of such treatment below about 60°

C. to provide a dry solid, and (f) pulverizing the solid under controlled temperature and humidity conditions, to obtain the desired powder product.

5. A pharmaceutical use product which includes the extract composition of claim 1 in a dosage form suitable for oral administration at a use dosage level of about 100 to 800 mg/day, optionally including excipients suitable for such oral administration, wherein the dosage form is a tablet, a capsule or an elixir or suspension.

6. A nutritional supplement according to claim 1 in which said extract is present therein in the form of liquids, powders, pills, tablets, capsules or confectionery bars.

7. A nutritional supplement according to claim 6 wherein the said dosage form is a nutritional drink.

8. A nutritional supplement composition of claim 6 for producing a baked, edible, high protein product comprising (a) at least 0.25% Withania somnifera extract composition, (b) a mixture of high protein components, (c) flour, (d) leavening agent, (e) sweetener, and (f) water.

9. A nutritional composition according to claim 6, further including a flavor component for imparting a characteristic taste to said nutritional composition selected from the group consisting of water soluble natural or artificial extracts that include apple, banana, cherry, cinnamon, cranberry, grape, honeydew, honey, kiwi, lemon, lime, orange, peach, peppermint, pineapple, raspberry, tangerine, watermelon, wild cherry and equivalents thereof;

being in the overall range of 0.10% to 2.0% by weight of said dry composition.

10. A nutritional composition according to claim 6, further including a colorant component for imparting a characteristic color to said nutritional composition selected from the group consisting of water soluble natural or artificial dyes of blue, green, orange, red, violet, and yellow;

iron oxide dyes, ultramarine pigments of blue, pink, red, and violet; and

equivalents thereof;

being in the overall range of 0.10% to 2.0% by weight of said dry composition.

11. A personal care formulation comprising the composition of claim 1 present therein in an amount of about 0.1 to 10% by weight.

12. A skin care or protection formulation according to claim 11 in the form of a lotion, cream, serum or gel, wherein said composition is present in an amount of about 0.1-5%.

13. A skin care or protection formulation according to claim 12 which additionally contains a cosmetically acceptable carrier and at least one cosmetic adjuvant selected from the group of sunscreens, skin lightening agents, antioxidants, preservatives, perfumes, oils, waxes, propellants, waterproofing agents, emulsifiers, thickeners, humectants and emollients.

14. A pharmaceutical use product of claim 5, which produces a cognition effect and learning facility for the user.

15. A pharmaceutical use product of claim 5, which produces a stress relief to the user.

16. A pharmaceutical anti-stress use of claim 15 arising from anxiety, depression, thermic changes, gastric ulcers, convulsions and adrenocortical activation.

17. A pharmaceutical use product of claim 5, which produces immuno-modulating effects to the user.

18. A pharmaceutical use product of claim 5, which increases antioxidant defense enzymes—

super oxide dismutase (SOD), catalase and glutathione peroxidase.

19. A process according to claim 1 wherein said extract is a standardized extract.