Topical pharmaceutical formulations and methods of treatment
AssigneePharmakodex Limited
InventorsJohn Nicholas Staniforth, Michael John Tobyn
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Abstract
In certain embodiments, the present invention is directed to a pharmaceutical formulation for topical administration on a mammal, comprising a unit dose of a therapeutically effective amount of a therapeutic agent and a pharmaceutically acceptable carrier medium therefor, said formulation being solid at ambient temperature and having a softening point of not higher than 35° C., such that when the formulation is placed in continuous contact with the skin of a mammalian patient, it is softened to a consistency to effect substantial application of the unit dose of said therapeutic agent onto a desired skin area of the mammalian patient within a time period of less than 10 minutes.
Claims46
A method of treating a mammalian patient comprising applying to the skin of said patient a pharmaceutical formulation;
- wherein the formulation is a solid substantially unitary dosage form comprising a unit dose of a therapeutically effective amount of one or more therapeutic agents and a pharmaceutically acceptable carrier medium, wherein the carrier medium comprises cocoa butter or one or more glycerides, where the glycerides can be mono-glycerides, di-glycerides or tri-glycerides;
- and thereafter rubbing said dosage form against the skin of said patient at an application pressure which does not cause substantial irritation to said area;
- wherein the formulation is solid at ambient temperature and has a softening point from 30° C. to not higher than 35° C., such that upon being placed in continuous contact with an area of the skin of the patient and rubbed against the skin, it is softened or melted to effect administration of the unit dose of said therapeutic agent to the mammalian patient within a time period of less than 5 minutes.
A method according to claim 43, wherein the therapeutic agent is selected from the group consisting of salbutamol, salmeterol, formoterol, clenbuterol, ipratropium, glycotropium, tiotropium, oxytropium, beclomethasone, betamethasone, fluticasone, budesonide, montelukast, cromolyn sodium, nedocromil and pharmaceutically acceptable salts prodrugs and metabolites thereof and a therapeutically effective combination thereof.
A method of treating a skin condition in a patient in need thereof comprising applying to the affected skin area of said patient, a pharmaceutical formulation consisting of a matrix comprising at least one topically active agent and a pharmaceutically acceptable carrier, wherein the carrier comprises cocoa butter or one or more glycerides;
- and thereafter rubbing said formulation against the skin of the patient at an application pressure which does not cause substantial irritation to said area;
- wherein the formulation is a substantially unitary dosage form which is solid at ambient temperature and has a softening point from 30° C. to not higher than 35° C., such that upon being placed in continuous contact with an area of the skin of the patient and rubbed against the skin, it is softened or melted to effect administration of the unit dose of said therapeutic agent to the mammalian patient within a time period of less than 5 minutes.
Dependencies are inferred from the claim text.