Delivery system
In accordance with the present disclosure, there are provided formulations comprising: (a) at least one active agent; (b) an oil, and optionally a thickener therefor; (c) an organic solvent, and a thickener therefor; and (d) an oil and/or solvent soluble skin penetration enhancer; wherein: said formulation comprises <10 wt % water; and said formulation optionally forms a thixotropic thinning gel. Also provided are gels comprising oil and organic solvent, methods for preparing same and methods for the topical delivery of an active agent to a subject in need thereof.
1. A formulation for human or veterinary use, said formulation comprising:
(a) diclofenac;
(b) oleic acid;
(c) at least one organic solvent selected from the group consisting of dimethyl isosorbide, dimethyl formamide, ethanol, ethyl acetate, 1,2-propanediol, 1,3-propanediol, and glycerin;
(d) dimethylsulfoxide; and
(e) hydroxypropyl cellulose;
wherein:
said formulation is a non-aqueous transparent gel.
2. The formulation of claim 1 wherein said formulation further comprises 2.0 wt % to 5.0 wt % of at least one compound selected from the group consisting of Dibutyl Lauroyl Glutamide, Dibutyl Ethylhexanol Glutamide, Poloxamer 124, Poloxamer 188, Poloxamer 237, Poloxamer 337, Poloxamer 408, and Polyamide 8.
3. The formulation of claim 1 wherein component (c) of the formulation comprises ethanol and the combined concentration of dimethylsulfoxide and component (c) in the formulation is 30 wt % to 60 wt %.
4. The formulation of claim 1 , further comprising propylene glycol.
5. A gel formulation, comprising:
(a) diclofenac or a salt thereof;
(b) oleic acid;
(c) ethanol
(d) hydroxypropyl cellulose;
(e) propylene glycol; and
(f) dimethylsulfoxide;
wherein:
said formulation is a nonaqueous transparent gel and comprises 2-5 wt % hydroxypropyl cellulose, 1-10 wt % diclofenac or a salt thereof, and a combined concentration of dimethylsulfoxide and ethanol of 30-60 wt %.
6. A formulation of claim 1 , wherein component (a) of the formulation comprises 1-10 wt % diclofenac or a salt thereof.