Methods and compositions for reducing sympathomimetic-induced side effects

• US 20020168428A1
• Filed: 01/10/2002
• Published: 11/14/2002
• Est. Priority Date: 09/27/1999
• Status: Active Grant

• Current Assignee: Northern Innovations Holding Corp.
• Original Assignee: Anthony L. Almada
• Inventors: Almada, Anthony L.
• Granted Patent: US 6,759,063 B2
• Time in Patent Office: Days
• US Class Current: 424/727
• 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 36/752 Citrus, e.g. lime, orange or lemon
• CPC Class Codes: A61K 36/889 Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto

Abstract

Provided are compositions including Serenoa repens and extracts thereof, in combination with a sympathomimetic agent, which may be used to control a variety of physical conditions, including obesity, appetite suppression, decongestion, asthma and energy stimulation. Serenoa repens, or extracts thereof, when added to dosage forms of pharmacologic agents with sympathomimetic activity, or when administered in combination with sympathomimetic agents, decreases side effects. Thus, debilitating side effects associated with use of pharmacologic agents that stimulate adrenergic receptors and display sympathomimetic effects can be reduced.

Claims

1. A composition comprising Serenoa repens or an extract thereof and a sympathomimetic agent.

2. The composition of claim 1, wherein the Serenoa repens or extract thereof has anti-adrenergic activity.

3. The composition of claim 2, where the anti-adrenergic activity is inhibition of agonist binding to the alpha-adrenergic receptor.

4. The composition of claim 1, wherein the composition is in pharmaceutically acceptable form.

5. The composition of claim 1, comprising an extract of Serenoa repens comprising a compound isolated from Serenoa repens selected from the group consisting of fatty acids, fatty acid esters, alcohols and sterols.

6. The composition of claim 1, where the sympathomimetic agent is comprises ephedrine or an ephedrine related alkaloid.

7. The composition of claim 1, wherein the sympathomimetic agent comprises a mixture of ephedrine or ephedrine related alkaloid and caffeine.

8. The composition of claim 1, wherein the sympathomimetic agent is selected from the group consisting of synephrine, pseudoephedrine, and phenylpropanolamine.

9. The composition of claim 1, wherein the sympathomimetic agent is ma huang or other natural sources of ephedrine or related alkaloids, or Citrus aurantium or other natural source of synephrine.

10. A method of alleviating the side effects of a sympathomimetic agent, the method comprising administering Serenoa repens or extract thereof, and the sympathomimetic agent, to a human or animal in need thereof;

wherein the Serenoa repens or extract thereof is administered in an amount effective to reduce side effects of the sympathomimetic agent.

11. The method of claim 10, wherein the Serenoa repens or extract thereof has anti-adrenergic activity.

12. The method of claim 11, where the anti-adrenergic activity is inhibition of agonist binding to the alpha-adrenergic receptor.

13. The method of claim 10, wherein the Serenoa repens or extract thereof is administered in a pharmaceutically acceptable form.

14. The method of claim 10, comprising administering an extract of Serenoa repens comprising a compound isolated from Serenoa repens selected from the group consisting of fatty acids, fatty acid esters, sterols and alcohols.

15. The method of claim 10, where the sympathomimetic agent comprises ephedrine or an ephedrine related alkaloid.

16. The method of claim 10, wherein the sympathomimetic agent comprises a mixture of ephedrine or ephedrine related alkaloid and caffeine.

17. The method of claim 10, wherein the sympathomimetic agent is selected from the group consisting of synephrine, pseudoephedrine, and phenylpropanolamine.

18. The method of claim 10, wherein the sympathomimetic agent is ma huang or other natural sources of ephedrine or related alkaloids, or Citrus aurantium or other natural source of synephrine.

19. The method of claim 10, wherein the Serenoa repens or extract thereof is administered at least about 24 hours prior to administration of the sympathomimetic agent.