Compositions comprising S-adenosylmethionine and a gallic acid ester

• US 8,975,238 B2
• Filed: 04/07/2014
• Issued: 03/10/2015
• Est. Priority Date: 10/17/2012
• Status: Active Grant

• Current Assignee: Msi-195 Holdings LLC
• Original Assignee: Methylation Sciences International SRL (MSI Methylation Sciences, Inc.)
• Inventors: Guan, Dechi, MacDonald, I. David
• Primary Examiner(s): Barham, Bethany
• Assistant Examiner(s): FRAZIER, BARBARA S
• Application Number:
  US14/247,061
• Publication Number:
  US 20140220129A1
• Time in Patent Office: 337 Days
• Field of Search: None
• US Class Current: 514/46
• 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 31/235 having an aromatic ring attached to a carboxyl group
• CPC Class Codes: A61K 31/7076 containing purines, e.g. adenosine, adenylic acid
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2059 Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
• CPC Class Codes: A61K 9/28 Dragees; Coated pills or tablets , e.g. with film or compression coating A61K9/2072 takes precedence, e.g. partially coated tablets A61K9/2072, coated multilayer tablets A61K9/2086, tablets with drug-coated core A61K9/209
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• 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 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/18 Antioxidants, e.g. antiradicals preparations for protection against sunlight A61Q17/00
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/16 : Anti-Parkinson drugs
• 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 25/32 : Alcohol-abuse
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/14 : for RNA viruses
• CPC Class Codes: A61P 31/18 : for HIV
• CPC Class Codes: A61P 31/20 : for DNA viruses
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• 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: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Provided herein are compositions and formulations comprising S-adenosyl-L-methionine (“SAM-e” or “SAMe”) and one or more gallic acid esters. Also provided herein are methods for improving the delivery of SAMe. Compositions and formulations provided herein increase SAMe plasma concentrations and area under the curve (AUC) values. Also provided herein are methods of treating a disease or disorder in a subject by administering compositions or formulations comprising exogenous SAMe and one or more gallic acid esters.

Claims

1. A composition comprising exogenous S-adenosylmethionine and at least one gallic acid ester, wherein said gallic acid ester is selected from the group consisting of ethyl gallate, propyl gallate, and octyl gallate.

2. The composition of claim 1, wherein the ratio (weight:

weight) of gallic acid ester to exogenous S-adenosylmethionine ion is from 5;

1 to 1;

400.

3. The composition of claim 2, wherein the ratio (weight:

weight) of gallic acid ester to exogenous S-adenosylmethionine ion is from 1;

1 to 1;

100.

4. The composition of claim 3, wherein the ratio (weight:

weight) of gallic acid ester to exogenous S-adenosylmethionine ion is from 1;

2 to 1;

80.

5. The composition of claim 1, wherein said composition comprises from about 1 to about 400 mg of said gallic acid ester.

6. The composition of claim 5, wherein said composition comprises from about 5 to about 200 mg of gallic acid ester.

7. The composition of claim 6, wherein said composition comprises from about 5 to about 100 mg of gallic acid ester.

8. The composition of claim 1, wherein said composition comprises 0.1 to 40%, 0.1 to 25%, or 0.1 to 10% by weight gallic acid ester.

9. The composition of claim 1, wherein the dose of exogenous S-adenosylmethionine ion is from about 50 mg to about 1600 mg.

10. The composition of claim 1, wherein the composition comprises an oral dosage form.

11. The composition of claim 10, wherein the oral dosage form comprises a functional coating.