Topical nsaid compositions having sensate component

A topically administrable pharmaceutical composition for the relief of pain or inflammation in a patient in need thereof comprising a topically active non-steroidal anti-inflammatory agent and at least one sensate agent, and optionally a self-warming system, in a topically administrable vehicle comprising:

• (a) from approximately 5 to approximately 50% by weight of a water-soluble, volatile lower alkanol having from 2 up to and including 4 carbon atoms,
• (b) from approximately 1 to approximately 20% by weight of a polyhydric alcohol or a poly-lower alkylene glycol having a chain length of from approximately 200 to approximately 6000 units as co-solvent,
• (c) from approximately 20 to approximately 80% by weight of water,
• (d) from approximately 3 to approximately 15% by weight of a liquid, semi-solid or solid hydrocarbon;
• a fatty alcohol having 1 or 2 hydroxy functions and approximately from 6 to 34 carbon atoms;
• a fatty acid ester with glycerine, the fatty acid having from 6 to 24 carbon atoms;
• a fatty acid ester of a lower alcohol, having from 1 up to and including 12 carbon atoms or of a higher even-numbered aliphatic alcohol having from 16 to 36 carbon atoms, the fatty acid having from 6 to 34 carbon atoms;
• or a fatty alcohol of approximately from 6 to 34 carbon atoms etherified by a lower alkanol or a lower alkoxy-lower alkanol;
• as a lipid;
• or a silicon compound selected from dimethyl silicone, methylphenyl silicone, methyl hydrogen silicone, fully methylated linear siloxane polymers end-blocked with trimethylsiloxy units, polydimethylsiloxanes, dimethicone copolyols, dimethicone copolyol and the acetate, adipate, almondate, amine, butyl ether, laurate, and stearate derivatives thereof;
• dimethicone silylate, dimethicone propylethylenediamine behenate, dimethiconol, octamethyltrisiloxane, polyalkyl siloxane, polyalkylaryl siloxane, alkylmethyl silicone polyglycols and cyclomethicones;
• or mixtures thereof,
• (e) in the presence or absence of from approximately 0.5 to approximately 5% by weight of a readily or sparingly soluble fatty acid salt;
• a salt of a fluorinated fatty acid, of an alkoxy-carboxylic acid, of a sulphonamido carboxylic acid, of a fatty acid lactate, or of an alkylmalonic or alkylsuccinic acid;
• a sparingly soluble alkyl sulphonate;
• a sulphonated fatty acid alkyl ester;
• a fatty acid sulphonate;
• a fatty acid ester sulphonate;
• a perfluorinated alkyl sulphonate;
• a readily or sparingly soluble alkylbenzene sulphonate;
• a sulphated primary or secondary fatty alcohol;
• a soap, sulphated ester, amide, alkanolamide, mono- or polyglyceride or polyglycol ether, of a fatty alcohol or alkylphenol;
• a fatty acid ester with a mono- or poly-hydric alcohol;
• a fatty acid ester with an oligo-hydroxy compound or with a polyhydroxy compound;
• a polyethylene or polypropylene glycol ether having approximately from 2 to 23 ethylene glycol or ethylene oxide units of a fatty alcohol, of a fatty acid ester or of fatty amines derived from fatty alcohols;
• ethylene oxide or propylene oxide block copolymers having hydrophilic polyhydroxyethylene groups or hydrophobic polyhydroxypropylene groups having a molecular weight of from approximately 1000 to approximately 11000, the fatty acid each having from 6 to 34 carbon atoms and the fatty alcohol having approximately from 6 to 34 carbon atoms;
• as emulsifier, and present if the lipid phase is not self-emulsifying, and
• (f) from approximately 0.5 to approximately 3% by weight of a synthetic gel-forming macromolecule, the units of which are vinyl alcohol, vinyl pyrrolidine, acrylic or methacrylic acid or their salts as gel structure former, and