Withania somnifera composition

• US 6,153,198 A
• Filed: 07/13/1999
• Issued: 11/28/2000
• Est. Priority Date: 07/13/1999
• 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): Prats, Francisco
• Assistant Examiner(s): HOFFMAN, SUSAN COE
• Application Number:
  US09/351,890
• Time in Patent Office: 504 Days
• Field of Search: 424/195.1
• US Class Current: 424/773
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 36/81 Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed

Abstract

A high purity Withania somnifera extract composition in the form of a high purity, stable, free-flowing, light yellow-to-brown herbaceous powder, for producing an enhanced cognition effect for the user and to augment the learning facility in the geriatric population when taken in a dosage of 200-800 mg/day. This extract contains, by weight, (a) at least 3% of withanolide glycosides and sitoindosides, preferably 3-8%, (b) at least 3% of oligosaccharides, preferably 3-8%, preferably a molecular weight of <2000, and (c) less than 0.5% of free cytotoxic withaferin A (aglycone), wherein the ratio of (a):(c) is 75-95:25-5, and the ratio of (a):(b) is 40-60:60-40. An extraction process for obtaining such extract composition, and pharmaceutical and nutritional use products thereof, also are described.

Claims

1. A Withania somnifera extract composition, in the form of a stable, herbaceous powder, which produces a cognition effect and learning facility for the user, when taken in a dosage of about 200-800 mg/day, which comprises, by weight, (a) at least 3% of withanolide glycosides and sitoindosides, (b) at least 3% of oligosaccharides, and (c) less than 0.5% of free withaferin A (aglycone), wherein the weight ratio of (a):

(c) is 75-95;

25-5, and the weight ratio of (a);

(b) is 40-60;

60-40.

2. A composition according to claim 1 wherein the oligosaccharides have a molecular weight of less than 2,000.

3. A composition according to claim 2 including ash wherein said extract composition is at least 90% water soluble, the ash content is a maximum of 8%, and its moisture content is maximum of 5% (w/w).

4. A composition according to claim 1 wherein (a) is 3-8%, and (b) is 3-8%.

5. A process of making the extract composition of claim 1 which comprises (a) providing root stock of a Withania somnifera plant which is about 1-2 years old, (b) extracting said root stock with an aqueous-alcoholic solvent, (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.

6. A process according to claim 5 wherein said aqueous-alcoholic solvent is water-methanol or water-ethanol, and said organic solvent is chloroform or ethyl acetate.

7. A pharmaceutical or nutritional product which includes the extract composition of claim 1.

8. A product according to claim 7 in which said extract is present in a dosage form suitable for oral administration.

9. A product according to claim 8 wherein said dosage level is about 200 to 800 mg/day.

10. A product according to claim 8 which includes excipients suitable for such oral administration.

11. A product according to claim 8 wherein the dosage form is a tablet.

12. A product according to claim 8 wherein said dosage form is a capsule.

13. A product according to claim 8 wherein said dosage form is an elixir or suspension.