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Claims for Patent: 8,501,819

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Claims for Patent: 8,501,819

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 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.
Inventor(s): Alonso; Robert (Wayne, PA), Crooks; Peter A. (Little Rock, AR), Pimley; Mark A. (West Chester, PA)
Assignee: Ceptaris Therapeutics, Inc. (Malvern, PA)
Application Number:12/948,593
Patent Claims: 1. A method for treating a person with a skin disorder, comprising topically applying to the affected skin a non-aqueous 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; 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; and the skin disorder is psoriasis, mycosis fungoides, or alopecia.

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

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

4. The method 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 method 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 method of claim 2, wherein the acid-addition salt is an HCl salt.

7. The method 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).

8. The method of claim 1, wherein the skin disorder is mycosis fungoides.

9. The method of claim 1, wherein the skin disorder is psoriasis.

10. The method of claim 1, wherein the skin disorder is alopecia.
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