Pharmaceutical Composition Comprising an Immunosuppressant for Use in the Treatment of Skin Diseases

• US 20070276004A1
• Filed: 04/02/2004
• Published: 11/29/2007
• Est. Priority Date: 04/04/2003
• Status: Abandoned Application

• Current Assignee: Novartis Ag
• Original Assignee: Novartis Ag
• Inventors: Hirsch, Stefan, Mayer, Friedrich, Paul, Carle, Sekkat, Nabila, Weiss, Carl-Martin
• Application Number:
  US10/550,357
• Publication Number:
  US 20070276004A1
• Time in Patent Office: Days
• US Class Current: 514/330
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/435 having six-membered rings with one nitrogen as the only ring hetero atom
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 47/02 Inorganic compounds
• 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 47/44 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 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 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Synergistic combinations of a macrolide T-cell immunomodulator or immunosuppressant such as 33-epichloro-33-desoxyascomycin and an emollient such as dimethicone, glycerol or isostearyl isostearate are provided, which are useful in particular in the treatment of dermatological or mucosal diseases such as dry skin or atopic or contact dermatitis.

Claims

1. A pharmaceutical composition comprsing 33-epichloro-33-desoxyascomycin in combination or association with an emollient selected from the group consisting of dimethicone, glycerol and isostearylstearate together with at least one pharmaceutically acceptable diluent or carrier.

2. A pharmaceutical composition of claim 1 wherein the emollient is present in an amount from about 10% to about 5000% w/w of the amount of 33-epichloro-33-desoxyascomycin.

3. A method of treatment of a dermatological or mucosal disease in a subject suffering from such a disease comprising co-administering synergistically effective amounts of a composition of claim 1.

4. A process for the preparation of a composition of claims 1 comprising mixing 33-epichloro-33-desoxyascomycin and an emollient selected from the group consisting of dimethicone, glycerol and isostearylstearate in combination or association with at least one pharmaceutically acceptable diluent or carrier.

5. A kit of parts comprising 33-epichloro-33-desoxyascomycin and an emollient selected from the group consisting of dimethicone, glycerol and isostearylstearate in separate unit dosage forms, together with instructions for use.