Synergistic composition for the treatment of diabetes mellitus

• US 7,674,485 B2
• Filed: 02/15/2006
• Issued: 03/09/2010
• Est. Priority Date: 05/14/2003
• Status: Active Grant

• Current Assignee: Indus Biotech Pvt., Ltd.
• Original Assignee: Indus Biotech Pvt., Ltd.
• Inventors: Bhaskaran, Sunil, Mohan, Vishwaraman
• Primary Examiner(s): FLOOD, MICHELE C
• Application Number:
  US11/355,868
• Publication Number:
  US 20060134242A1
• Time in Patent Office: 1,483 Days
• Field of Search: None
• US Class Current: 424/757
• 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 31/195 having an amino group
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/205 Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 36/48 Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/50 for increasing or potentiating the activity of insulin
• CPC Class Codes: A61P 7/12 Antidiuretics, e.g. drugs for diabetes insipidus ADH A61P5/10

Abstract

A composition for the treatment of diabetes in a subject in need thereof, said composition—comprising Trigonelline of concentration ranging between 20 to 30%, amino acids of concentration ranging between 20 to 60%, and soluble fiber of concentration ranging between 10 to 60%, optionally along with pharmaceutically acceptable additives, a process thereof and also, a method of treating diabetes.

Claims

1. A process for preparing a composition, the composition comprising:

trigonelline of concentration ranging between 20 to 30% weight/weight (w/w), amino acids of concentration ranging between 20 to 60% w/w, and soluble fiber of concentration ranging between 10 to 60% w/w, optionally along with pharmaceutically acceptable additives,

the process consisting steps of;

a. flaking fenugreek (Trigonella foenum-graecum) seeds to obtain flaked seeds,

b. extracting the flaked seeds with hydro-alcohol to obtain an extract,

c. concentrating the extract under vacuum to remove alcohol to obtain a concentrate,

d. extracting the concentrate with n-hexane to remove fats and lipids to obtain a defatted concentrate,

e. diluting the defatted concentrate to obtain a diluted extract,

f. filtering of the diluted extract to remove insolubles to obtain a resultant,

g. subjecting the resultant to column chromatography wherein amino-acids, and trigonelline are eluted, and

h. adding fiber of fenugreek into the amino acids and trigonelline to obtain the composition.

2. A process as claimed in claim 1, wherein the flaked seeds are extracted at a temperature ranging between 20 to 70°

C.

3. A process as claimed in claim 1, wherein the flaked seeds are of size of about 15 millimeter(mm).

4. A process as claimed in claim 1, wherein the hydro-alcohol is isopropyl alcohol and water in equal ratio.

5. A process as claimed in claim 1, wherein the flaked seeds are extracted for a time duration ranging between 3 to 24 hours.

6. A process as claimed in claim 1, wherein the amino acids are selected from the group consisting of 1-arginine, leucine, isoleucine, and 4-hydroxyisoleucine.

7. A process as claimed in claim 1, wherein the column chromatography is ion exchange chromatography.

8. A process as claimed in claim 1, wherein the fiber is galactomannan.

9. A process as claimed in claim 2, wherein the flaked seeds are extracted at a temperature of 35°

C.

10. A process as claimed in claim 5, wherein the flaked seeds are extracted for a time duration of 12 hours.