US 7,507,769 B2
	Treatment and prevention of benign breast disease with 4-hydroxy tamoxifen
Elisabeth Le Nestour, Paris (France)
Assigned to Laboratoires Besins International, Montrouge (France)
Filed on Mar. 22, 2004, as Appl. No. 10/805,528.
Prior Publication US 2005/0209340 A1, Sep. 22, 2005
Int. Cl. A01N 33/02 (2006.01); A61K 31/35 (2006.01)

U.S. Cl. 514—651  [514/344; 514/971; 424/449; 424/444]

19 Claims

1. A method of treatment, comprising percutaneously administering an effective amount of 4-hydroxy tamoxifen to a female patient having benign breast disease, wherein said 4-hydroxy tamoxifen is in a vehicle containing an effective amount of isopropyl myristate as a fatty acid ester penetration enhancer, wherein said benign breast disease is selected from the group consisting of adenosis, cysts, duct ectasia, fibroadenoma, fibrocystic disease, fibrosis, hyperplasia and metaplasia and wherein said vehicle is a hydroalcoholic gel or hydroalcoholic solution that comprises (a) about 0.001 % to 1.0 % by weight of 4-hydroxy tamoxifen, (b) about 0.5% to 2% by weight of isopropyl myristate, (c) about 60% to 75% by weight of absolute alcohol, (d) about 25% to 40% by weight of aqueous vehicle, and (e) about 0.5% to 5% by weight of gelling agent, wherein the percentage of components are weight to weight of the gel or solution.