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

• US 7,318,938 B2
• Filed: 02/26/2004
• Issued: 01/15/2008
• Est. Priority Date: 12/03/2002
• Status: Expired due to Term

• Current Assignee: Indian Herbs Research & Supply Company Ltd., Natreon, Inc.
• Original Assignee: Indian Herbs Research & Supply Company Ltd., Natreon, Inc.
• Inventors: Ghosal, Shibnath
• Primary Examiner(s): Hoffman; Susan Coe
• Application Number:
  US10/788,130
• Publication Number:
  US 20040166184A1
• Time in Patent Office: 1,419 Days
• Field of Search: 424/725, 424/773, 424/774
• US Class Current: 424/725
• 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) at least 25% of oligosaccharides, (c) less than 10% polysaccharides and (d) 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%.

3. A composition according to claim 2 wherein said oligosaccharides of (b) have a mol. wt. <

2000.

4. 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.

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

6. A nutritional supplement according to claim 5 wherein the said dosage form is a nutritional drink.

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

8. A skin care or protection formulation according to claim 7 in the form of a lotion, cream, serum or gel, wherein said composition is present in an amount of about 0.1-5%.

9. A skin care or protection formulation according to claim 8 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.

10. A pharmaceutical use product of claim 4, which produces enhanced cognition and memory-improving effects for the user.

11. A pharmaceutical use product of claim 4, which produces a stress relief to the user.

12. The pharmaceutical use product of claim 11, wherein said product attenuates stress-induced syndrome selected from the group consisting of anxiety, depression, thermic changes, gastric ulcers, convulsions and adrenocortical activation.

13. A pharmaceutical use product of claim 4, which produces immuno-modulating effects to the user.

14. A pharmaceutical use product of claim 4, which increases antioxidant defense enzymes—

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

15. A composition according to claim 1 wherein said extract is a standardized extract.

16. A composition obtained by extracting the roots and leaves of a Withania Somnifera plant with an aqueous-alcoholic solvent in the presence of an exogenous saccharide, followed by concentrating the extract under vacuum, treating the residue with an apolar organic solvent to remove free withanolide A aglycones therefrom, vacuum drying the insoluble residue to provide a dry solid, and pulverizing the solid to a powder.

17. A Withania Somnifera extract composition of claim 16 wherein vacuum drying is carried out below about 60°

C.

18. The composition of claim 16 comprising, by weight, at least 8% of withanolide glycosides and sitoindosides, at least 25% of oligosaccharides, less than 10% polysaccharides and less than 2% free withaferin A (aglycone).

19. A composition of claim 18 wherein said withanolide glycosides and sitoindoside comprise 8-25% of the composition.

20. A composition of claim 18 wherein said oligosaccharides comprise 25-75% of said composition.

21. A composition of claim 20 wherein said oligosaccharides have a mol. wt. <

2000.