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Claims for Patent: 7,838,564

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Claims for Patent: 7,838,564

Title:Stabilized compositions of volatile alkylating agents and methods of using thereof
Abstract: A composition and method for treatment of cancer. The composition for treating a skin disorder, comprising: a Nitrogen Mustard or an HX salt of the Nitrogen Mustard, wherein the Nitrogen Mustard or the HX salt of the Nitrogen Mustard is in a non-aqueous vehicle or carrier that does not include petrolatum or ethanol, wherein the non-aqueous vehicle or carrier that does not include petrolatum or ethanol does not include petrolatum or ethanol. The method comprises topically applying the composition of a Nitrogen Mustard or a HX salt of the Nitrogen Mustard to the affected skin, wherein the Nitrogen Mustard or the HX salt of the Nitrogen Mustard is in a non-aqueous vehicle or carrier that does not include petrolatum or ethanol, wherein the non-aqueous vehicle or carrier does not include petrolatum or ethanol.
Inventor(s): Alonso; Robert (Rye, NH), Crooks; Peter A. (Nicolasville, KY), Pimley; Mark A. (Westchester, PA), Al-Ghananeem; Abeer M. (Lexington, KY)
Assignee: Yaupon Therapeutics Inc. (Radnor, PA)
Application Number:12/549,258
Patent Claims: 1. A composition comprising: (a) bis-(2-chloroethyl)methylamine or a pharmaceutically acceptable salt thereof; and (b) a pharmaceutically acceptable excipient, wherein the bis-(2-chloroethyl)methylamine or pharmaceutically acceptable salt thereof is present in an amount of about 0.001% to about 2.0% by weight of the composition; and the pharmaceutically acceptable excipient is a compound of the formula HOCH.sub.2CH.sub.2OCH.sub.2CH.sub.2OR.sub.79, wherein R.sub.79 is a linear alkyl group having 1-6 carbon atoms.

2. The composition of claim 1, wherein the bis-(2-chloroethyl)methylamine is in the form of an acid-addition or base-addition salt.

3. The composition of claim 2, wherein the acid-addition salt is an HCl, HBr, H.sub.1, H.sub.2SO.sub.4, or HNO.sub.3 salt.

4. The composition of claim 1, wherein the pharmaceutically acceptable excipient is a compound of the formula HOCH.sub.2CH.sub.2OCH.sub.2CH.sub.2OR.sub.79, wherein R.sub.79 is a linear alkyl group having 2 carbon atoms (ethoxy diglycol reagent).

5. The composition of claim 1, wherein the bis-(2-chloroethyl)methylamine or pharmaceutically acceptable salt thereof is present in an amount of about 0.01% to about 0.04% by weight of the composition.

6. The composition of claim 3, wherein the acid-addition salt is an HCl salt.

7. The composition of claim 6, wherein the pharmaceutically acceptable excipient is a compound of the formula HOCH.sub.2CH.sub.2OCH.sub.2CH.sub.2OR.sub.79, wherein R.sub.79 is a linear alkyl group having 2 carbon atoms (ethoxy diglycol reagent).
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