METHODS FOR TREATING SKIN DISORDERS WITH A TOPICAL COMPOSITION OF BIS-(2-CHLOROETHYL)METHYLAMINE

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Patent No.: US None
App. No.: 15/804,804

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Abstract

Provided are methods for treating skin disorders comprising topically applying a highly stable pharmaceutical composition comprising bis-(2-chloroethyl)methylamine or a pharmaceutically acceptable salt thereof.

Claims (93)

1 . A method of treating a skin disorder selected from cutaneous T-cell lymphoma, psoriasis, alopecia, lymphomatoid papulosis, parapsoriasis, Langerhans cell histiocytosis and vitiligo comprising topically applying a pharmaceutical composition to a subject in need thereof, wherein the pharmaceutical composition comprises an effective amount of bis-(2-chloroethyl)methylamine, or a pharmaceutically acceptable salt thereof, and an excipient that is a compound of the formula HOCH 2 CH 2 OCH 2 CH 2 OR, wherein R represents (C 1 -C 4 )alkyl; and wherein the pharmaceutical composition is essentially stable for at least 90 days and up to 240 days when stored for up to 1 hour per day at about room temperature and for the remaining time of the day at or below 8° C.

2 . The method according to claim 1 , wherein the skin disorder is mycosis fungoides.

3 . The method according to claim 1 , wherein the bis-(2-chloroethyl)methylamine, or the pharmaceutically acceptable salt thereof, is present as bis-(2-chloroethyl)methylamine hydrochloride in an amount of about 0.01% to about 0.05% by weight of the composition.

4 . The method according to claim 2 , wherein the bis-(2-chloroethyl)methylamine, or the pharmaceutically acceptable salt thereof, is present as bis-(2-chloroethyl)methylamine hydrochloride in an amount of about 0.01% to about 0.05% by weight of the composition.

5 . The method according to claim 3 , wherein the bis-(2-chloroethyl)methylamine hydrochloride is present in an amount of about 0.02% by weight of the composition.

6 . The method according to claim 4 , wherein the bis-(2-chloroethyl)methylamine hydrochloride is present in an amount of about 0.02% by weight of the composition.

7 . The method according to claim 1 , wherein the compound of the formula HOCH 2 CH 2 OCH 2 CH 2 OR is the compound HOCH 2 CH 2 OCH 2 CH 2 OCH 2 CH 3 .

8 . The method according to claim 4 , wherein the compound of the formula HOCH 2 CH 2 OCH 2 CH 2 OR is the compound HOCH 2 CH 2 OCH 2 CH 2 OCH 2 CH 3 .

9 . The method according to claim 7 , wherein the compound HOCH 2 CH 2 OCH 2 CH 2 OCH 2 CH 3 is present in an amount of about 40% to about 60% by weight of the composition.

10 . The method according to claim 8 , wherein the compound HOCH 2 CH 2 OCH 2 CH 2 OCH 2 CH 3 is present in an amount of about 40% to about 60% by weight of the composition.

11 . The method according to claim 1 , wherein the pharmaceutical composition is essentially stable for at least 90 days and up to 240 days when stored for up to 1 hour per day at about room temperature and for the remaining time of the day between −25° and 8° C.

12 . The method according to claim 4 , wherein the pharmaceutical composition is essentially stable for at least 90 days and up to 240 days when stored for up to 1 hour per day at about room temperature and for the remaining time of the day between −25° and 8° C.

13 . The method according to claim 1 , wherein the pharmaceutical composition is essentially stable for at least 90 days and up to 240 days when stored for up to 1 hour per day at about room temperature and for the remaining time of the day between 2° and 8° C.

14 . The method according to claim 4 , wherein the pharmaceutical composition is essentially stable for at least 90 days and up to 240 days when stored for up to 1 hour per day at about room temperature and for the remaining time of the day between 2° and 8° C.

15 . The method according to claim 8 , wherein the pharmaceutical composition is essentially stable for at least 90 days and up to 240 days when stored for up to 1 hour per day at about room temperature and for the remaining time of the day between 2° and 8° C.

16 . The method according to claim 10 , wherein the pharmaceutical composition is essentially stable for at least 90 days and up to 240 days when stored for up to 1 hour per day at about room temperature and for the remaining time of the day between 2° and 8° C.

17 . The method according to claim 1 , wherein the pharmaceutical composition is essentially stable for at least 90 days and up to 180 days when stored for up to 1 hour per day at about room temperature and for the remaining time of the day at or below 8° C.

18 . The method according to claim 1 , wherein the pharmaceutical composition is essentially stable for at least 90 days and up to 168 days when stored for up to 1 hour per day at about room temperature and for the remaining time of the day at or below 8° C.

19 . The method according to claim 1 , wherein the pharmaceutical composition is essentially stable for at least 90 days and up to 112 days when stored for up to 1 hour per day at about room temperature and for the remaining time of the day at or below 8° C.

20 . The method according to claim 1 , wherein the pharmaceutical composition is essentially stable for 90 days when stored for up to 1 hour per day at about room temperature and for the remaining time of the day at or below 8° C.

21 . A method of treating a skin disorder selected from cutaneous T-cell lymphoma, psoriasis, alopecia, lymphomatoid papulosis, parapsoriasis, Langerhans cell histiocytosis and vitiligo comprising topically applying a pharmaceutical composition to a subject in need thereof, wherein the pharmaceutical composition comprises an effective amount of bis-(2-chloroethyl)methylamine, or a pharmaceutically acceptable salt thereof, and an excipient that is a compound of the formula HOCH 2 CH 2 OCH 2 CH 2 OR, wherein R represents (C 1 -C 4 )alkyl; and wherein at least 90% of the original amount of the bis-(2-chloroethyl)methylamine, or of the pharmaceutically acceptable salt thereof, is still present in the pharmaceutical composition, if the pharmaceutical composition is stored at about room temperature for up to 1 hour per day and at 8° C. or below for the remaining time of the day for a total of 90 days.

22 . The method according to claim 21 , wherein the skin disorder is mycosis fungoides and wherein the bis-(2-chloroethyl)methylamine, or the pharmaceutically acceptable salt thereof, is present as bis-(2-chloroethyl)methylamine hydrochloride in an amount of about 0.01% to about 0.05% by weight of the composition.

23 . The method according to claim 22 , wherein the compound of the formula HOCH 2 CH 2 OCH 2 CH 2 OR is the compound HOCH 2 CH 2 OCH 2 CH 2 OCH 2 CH 3 ; and wherein the compound HOCH 2 CH 2 OCH 2 CH 2 OCH 2 CH 3 is present in an amount of about 40% to about 60% by weight of the composition.

24 . The method according to claim 21 , wherein at least 90% of the original amount of the bis-(2-chloroethyl)methylamine, or of the pharmaceutically acceptable salt thereof, is still present in the pharmaceutical composition, if the pharmaceutical composition is stored at about room temperature for up to 1 hour per day and at between 2° and 8° C. for the remaining time of the day for a total of 90 days.

25 . The method according to claim 22 , wherein at least 90% of the original amount of the bis-(2-chloroethyl)methylamine hydrochloride is still present in the pharmaceutical composition, if the pharmaceutical composition is stored at about room temperature for up to 1 hour per day and at between 2° and 8° C. for the remaining time of the day for a total of 90 days.

26 . The method according to claim 23 , wherein at least 90% of the original amount of the bis-(2-chloroethyl)methylamine hydrochloride is still present in the pharmaceutical composition, if the pharmaceutical composition is stored at about room temperature for up to 1 hour per day and at between 2° and 8° C. for the remaining time of the day for a total of 90 days.

27 . The method according to claim 1 , wherein the pharmaceutical composition further comprises hydroxypropyl cellulose, butylated hydroxytoluene, isopropyl alcohol and lactic acid.

28 . The method according to claim 4 , wherein the pharmaceutical composition further comprises hydroxypropyl cellulose, butylated hydroxytoluene, isopropyl alcohol and lactic acid.

29 . The method according to claim 8 , wherein the pharmaceutical composition further comprises hydroxypropyl cellulose, butylated hydroxytoluene, isopropyl alcohol and lactic acid.

30 . The method according to claim 15 , wherein the pharmaceutical composition further comprises hydroxypropyl cellulose, butylated hydroxytoluene, isopropyl alcohol and lactic acid.

31 . The method according to claim 26 , wherein the pharmaceutical composition further comprises hydroxypropyl cellulose, butylated hydroxytoluene, isopropyl alcohol and lactic acid.

32 . The method according to claim 1 , wherein the pharmaceutical composition further comprises:

about 1% to about 3% by weight of the composition hydroxypropyl cellulose;

about 0.005% to about 0.02% by weight of the composition edetate disodium dihydrate;

about 0.01% to about 0.1% by weight of the composition menthol;

about 0.005% to about 0.02% by weight of the composition butylated hydroxytoluene;

about 10% to about 20% by weight of the composition isopropyl alcohol;

about 13% to about 23% by weight of the composition propylene glycol;

about 6% to about 16% by weight of the composition glycerin;

about 2% to about 6% by weight of the composition lactic acid; and

about 0.1% to about 0.3% by weight of the composition sodium chloride.

33 . The method according to claim 10 , wherein the pharmaceutical composition further comprises: