SELF-PRESERVING TOPICAL PHARMACEUTICAL COMPOSITIONS COMPRISING DIETHYLENE GLYCOL MONOETHYL ETHER
Self-preserving topical pharmaceutical compositions comprising diethylene glycol monoethyl ether (DEGEE) maintained at an acidic pH. The pH of the formulation can be maintained at a pH of less than 6.3, or alternatively less than 6.0. The topical pharmaceutical compositions disclosed herein are self-preserving and can satisfy European Pharmacopeia Efficacy of Antimicrobial Preservation Criteria A without the addition of a traditional antimicrobial preservative. Certain pharmaceutical composition further comprise an emulsifier blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate, which is manufactured by Croda under the tradename Crodafos™ CES.
1 . A topical pharmaceutical composition comprising:
a pharmaceutically effective amount of an active ingredient;
diethylene glycol monoethyl ether; and
water, and
wherein the topical pharmaceutical composition has a pH that is less than or equal to 6.3,
wherein the pharmaceutical composition satisfies European Pharmacopeia Efficacy of Antimicrobial Preservation Criteria A, and
wherein the pharmaceutical composition does not comprise an antimicrobial preservative.
2 . The topical pharmaceutical composition of claim 1 , wherein the topical pharmaceutical composition has a pH that is less than or equal to 6.0.
3 . The topical pharmaceutical composition of claim 1 , wherein the pharmaceutical composition has a pH between 5.0 and 6.3.
4 . The topical pharmaceutical composition of claim 1 , wherein the pharmaceutical composition has a pH between 5.0 and 6.0.
5 . The topical pharmaceutical composition of claim 1 , wherein the pharmaceutical composition satisfies United States Pharmacopeia Criteria for Category 2 (Topical) Products.
6 . The topical pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is a cream.
7 . The topical pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is a gel.
8 . The topical pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises between about 25% and about 40% w/w of diethylene glycol monoethyl ether.
9 . The topical pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises between about 25% and about 35% w/w of diethylene glycol monoethyl ether.
10 . The topical pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further comprises an emulsifier blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate.
11 . The topical pharmaceutical composition of claim 13 , wherein the pharmaceutical composition comprises between about 8% and about 15% w/w of the emulsifier blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate.
12 . The topical pharmaceutical composition of claim 1 , wherein the active ingredient has a water solubility of 60 mg/l or less.
13 . A topical pharmaceutical composition comprising:
a pharmaceutically effective amount of an active ingredient;
diethylene glycol monoethyl ether;
an emulsifier blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate; and
water, and
wherein the pharmaceutical composition satisfies European Pharmacopeia Efficacy of Antimicrobial Preservation Criteria A.
14 . The topical pharmaceutical composition of claim 13 , wherein the pharmaceutical composition satisfies United States Pharmacopeia Criteria for Category 2 (Topical) Products.
15 . The topical pharmaceutical composition of claim 13 , wherein the pharmaceutical composition is a cream.
16 . The topical pharmaceutical composition of claim 13 , wherein the pharmaceutical composition is a gel.
17 . The topical pharmaceutical composition of claim 13 , wherein the pharmaceutical composition does not comprise an antimicrobial preservative.
18 . The topical pharmaceutical composition of claim 13 , wherein the pharmaceutical composition has a pH less than or equal to 6.3.
19 . The topical pharmaceutical composition of claim 13 , wherein the pharmaceutical composition has a pH between about 5.0 and about 6.3.
20 . The topical pharmaceutical composition of claim 13 , wherein the pharmaceutical composition comprises between about 25% and about 40% w/w of diethylene glycol monoethyl ether.
21 . The topical pharmaceutical composition of claim 20 , wherein the pharmaceutical composition comprises between about 25% and about 35% w/w of diethylene glycol monoethyl ether.
22 . The topical pharmaceutical composition of claim 13 , wherein the pharmaceutical composition comprises between about 8% and about 15% w/w of the emulsifier blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate.
23 . The topical pharmaceutical composition of claim 13 , wherein the active ingredient has a water solubility of 60 mg/l or less.
24 . A topical pharmaceutical composition comprising:
roflumilast;
diethylene glycol monoethyl ether;
an emulsifier blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate; and
water,
wherein the topical pharmaceutical composition has a pH that is less than or equal to 6.3, and
wherein the pharmaceutical composition satisfies European Pharmacopeia Efficacy of Antimicrobial Preservation Criteria A.
25 . The topical pharmaceutical composition of claim 24 , wherein the pharmaceutical composition satisfies United States Pharmacopeia Criteria for Category 2 (Topical) Products.
26 . The topical pharmaceutical composition of claim 24 , wherein the pharmaceutical composition does not comprise a paraben.
27 . The topical pharmaceutical composition of claim 24 , wherein the pharmaceutical composition does not comprise propylene glycol.
28 . The topical pharmaceutical composition of claim 24 , wherein the pharmaceutical composition does not comprise an antimicrobial preservative.
29 . The topical pharmaceutical composition of claim 24 , wherein the pharmaceutical composition has a pH between about 5.0 and about 6.3.
30 . The topical pharmaceutical composition of claim 24 , wherein the pharmaceutical composition comprises between about 25% and about 40% w/w of diethylene glycol monoethyl ether.
31 . The topical pharmaceutical composition of claim 24 , wherein the pharmaceutical composition comprises between about 8% and about 15% w/w of the emulsifier blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate.