Ointment base useful for pharmaceutical preparations

• US 5,512,278 A
• Filed: 01/11/1994
• Issued: 04/30/1996
• Est. Priority Date: 01/11/1994
• Status: Expired due to Term

• Current Assignee: Esperanza Peptide, Ltd.
• Original Assignee: PhyloMed Corporation
• Inventors: Mundschenk, David D.
• Primary Examiner(s): WU, SHEAN CHIU
• Application Number:
  US08/180,078
• Time in Patent Office: 840 Days
• Field of Search: 424/78.06, 424/616, 514/900, 514/902
• US Class Current: 424/78.06
• CPC Class Codes: A61K 2800/412 Microsized, i.e. having sizes between 0.1 and 100 microns
• CPC Class Codes: A61K 47/06 Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• 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 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/44 Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14
• CPC Class Codes: A61K 8/06 Emulsions
• CPC Class Codes: A61K 8/11 Encapsulated compositions
• CPC Class Codes: A61K 8/22 Peroxides; Oxygen; Ozone
• CPC Class Codes: A61K 8/31 Hydrocarbons
• CPC Class Codes: A61K 8/342 Alcohols having more than seven atoms in an unbroken chain
• CPC Class Codes: A61K 8/345 containing more than one hydroxy group
• CPC Class Codes: A61K 8/37 Esters of carboxylic acids
• CPC Class Codes: A61K 8/927 of insects, e.g. shellac
• 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: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
• CPC Class Codes: A61Q 15/00 Anti-perspirants or body deodorants deodorisation of air A61L9/00
• CPC Class Codes: A61Q 17/005 Antimicrobial preparations

Abstract

An ointment base useful for preparing topically applied medicament formulations. The base can be provided in the form of a stable emulsion including paraffin(s), polyol, beeswax, cetostearyl alcohol, a 4-hydroxy benzoic acid lower alkyl ester, a surface active agent and a dispersing agent. The base can be combined with large volumes containing a variety of medicaments to form stable, useful formulations.

Claims

1. An ointment base useful for preparing topically applied medicament formulations, comprising a stable emulsion of at least about 10% by weight of each of water, one or more paraffins, and a liquid polyol;

and less than about 10% by weight of each of beeswax, cetostearyl alcohol, a 4-hydroxy benzoic acid lower alkyl ester, a surface active agent, and a dispersing agent.

2. An ointment base according to claim 1 wherein the paraffin component includes both liquid paraffin and soft paraffin, the liquid polyol component is glycerol;

the beeswax component is white beeswax;

the 4-hydroxy benzoic acid lower alkyl ester component is methyl paraben, the surface active agent is polyoxyethlenesorbitan monostearate, and the dispersing agent is glyceryl monostearate.

3. An ointment base according to claim 2 having the following concentrations of ingredients, based on weight:

space="preserve" listing-type="tabular">______________________________________liquid paraffin 3 to 8%white petrolatum 5 to 15%glycerol 20 to 45%white beeswax 0.1 to 1%cetostearyl alcohol 6 to 10%methyl paraben 0.1 to 0.5%polyoxyethylenesorbitan monostearate 1 to 10%glyceryl monostearate 0.5 to 5%water to 100%.______________________________________

4. An ointment base according to claim 3 wherein the ointment base is comprised of the following ingredients, based on weight:

space="preserve" listing-type="tabular">______________________________________ Weight %______________________________________liquid paraffin 5white petrolatum 10glycerol 30white beeswax 0.4cetostearyl alcohol 8methyl paraben 0.3polyoxyethylenesorbitan monostearate 3.6glyceryl monostearate 2purified water to 100.______________________________________

5. An ointment base according to claim 1 wherein the paraffin component includes both liquid paraffin and soft paraffin.

6. An ointment base according to claim 5 wherein the liquid paraffin is present at a concentration of 3 to 8%, by weight.

7. An ointment base according to claim 1 wherein the liquid polyol component is glycerol.

8. An ointment base according to claim 7 wherein the glycerol is present at a concentration of 20 to 45% by weight.

9. An ointment base according to claim 1 wherein the beeswax component is white beeswax.

10. An ointment base according to claim 9 wherein the white beeswax is present at a concentration of 0.1 to 1% by weight.

11. An ointment base according to claim 1 wherein the 4-hydroxy benzoic acid lower alkyl ester component is methyl paraben.

12. An ointment base according to claim 11 wherein the methyl paraben is present at a concentration of 0.1 to 0.5% by weight.

13. An ointment base according to claim 1 wherein the surface active agent is polyoxyethlenesorbitan monostearate.

14. An ointment base according to claim 13 wherein the polyoxyethlenesorbitan monostearate is present at a concentration of 1 to 10% by weight.

15. An ointment base according to claim 1 wherein the dispersing agent is glyceryl monostearate.

16. An ointment base according to claim 15 wherein the glyceryl monostearate is present at a concentration of 0.5 to 5% by weight.