Phase stable lecithin organogel composition

• US 20090017120A1
• Filed: 03/13/2008
• Published: 01/15/2009
• Est. Priority Date: 03/23/2007
• Status: Abandoned Application

• Current Assignee: Humco Holding Group, Inc. (Fagron NV)
• Original Assignee: Humco Holding Group, Inc. (Fagron NV)
• Inventors: Trimble, John Olin, Brisco, Christopher Michael
• Application Number:
  US12/075,653
• Publication Number:
  US 20090017120A1
• Time in Patent Office: Days
• US Class Current: 424/485
• CPC Class Codes: A61K 47/24 containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A lecithin organogel composition used to deliver pharmaceutical products transdermally as well as a method for producing the lecithin organogel composition, which may contain up to 40% additive ingredients. Preferred embodiments of the invention may include lecithin organogel compositions which provide high penetrating power, which are ready-to-use, which have improved stability, which have a high uptake capacity for active drugs, and which do not grow mold if the gel becomes contaminated.

Claims

1. A lecithin organogel composition comprising:

a non-ionic emulsifying agent having a hydrophile-lipophile balance number of between about 8 to about 18;

a thickening agent;

a polyoxyethylene polyoxypropylene block copolymer; and

a lecithin.

2. The lecithin organogel composition of claim 1, wherein the non-ionic emulsifying agent comprises an oil-in-water emulsifier.

3. The lecithin organogel composition of claim 1, wherein the non-ionic emulsifying agent comprises a mono alkyl phosphate, a sorbitan ester, a polyethylene glycol oil/wax, a poly(ortho-ester)-fatty alcohol, a polyethylene glycol-stearate, a polysorbate, or a mixture thereof.

4. The lecithin organogel composition of claim 1, wherein said non-ionic emulsifying agent is in an amount ranging from about 0.1 to about 2.5 weight percent.

5. The lecithin organogel composition of claim 1, wherein the thickening polymer comprises an aqueous-alcoholic soluble thickener and has solubility in from about 1 percent to about 30 percent of alcohol.

6. The lecithin organogel composition of claim 1, wherein the thickening polymer comprises xanthan gum, acrylate/C₁₀-C₃₀ alkyl acrylate crosspolymer, hydroxypropylcellulose, acrylamide/sodium acryloyldimethyltaurate copolymer, isohexadecane and polysorbate 80, or a mixture thereof.

7. The lecithin organogel composition of claim 1, wherein said thickening agent is in an amount ranging from about 0.2 to about 5 weight percent.

10. A method for producing a transdermal delivery system for therapeutic agents comprising:

dissolving active therapeutic agents in the lecithin organogel composition of claim 1.

11. A method of dissolving an active drug into the lecithin organogel composition of claim 1 comprising:

using an electronic pestle and mortar to mix the active drug into the lecithin organogel composition.

8. A lecithin organogel composition comprising:

a non-ionic emulsifying agent having a hydrophile-lipophile balance number of between about 8 to about 18;

a thickening agent;

from about 1 weight percent to about 25 weight percent of a polyoxyethylene polyoxypropylene block copolymer; and

from about 1 weight percent to about 20 weight percent of a lecithin.

9. A lecithin organogel composition comprising:

a non-ionic emulsifying agent having a hydrophile-lipophile balance number of between about 8 to about 18;

a thickening agent;

from about 1 weight percent to about 25 weight percent of a polyoxyethylene polyoxypropylene block copolymer; and

from about 1 weight percent to about 20 weight percent of a lecithin.

wherein the content of the non-ionic emulsifying agent and the thickening polymer are included at a non-ionic emulsifying agent;

thickening polymer ratio of from about 1;

2 to 1;

50.