Isotretinoin formulations and uses and methods thereof

Abstract

Provided herein are novel isotretinoin formulations that provide an enhanced targeted dermal delivery system for the drug isotretinoin with improved thermodynamic activity using no to a small level of ethanol relative to existing isotretinoin gel products, and methods for treatment of ichthyosis and other skin conditions using the same.

1 . A pharmaceutical composition comprising about 0.01% w/w to about 0.6% w/w isotretinoin, about 67% w/w to about 70% w/w PEG 400, about 14% w/w to about 30% w/w PEG 3350, about 15% w/w PEG 1450, wherein the pharmaceutical composition has 0% w/w of ethanol and 0% w/w of water, and is formulated as a gel, ointment, lotion, emulsion, or cream. 
     
     
         2 . The pharmaceutical composition according to  claim 1 , further comprising about 0.2% w/w methyl paraben and about 0.02% w/w propyl paraben. 
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutical composition has about 15% w/w PEG 3350. 
     
     
         4 . The pharmaceutical composition according to  claim 1 , further comprising about 0.1% w/w BHT. 
     
     
         5 . A pharmaceutical composition comprising about 0.01% w/w to about 0.2% w/w isotretinoin, about 67% w/w to about 70% w/w PEG 400, about 14% w/w to about 30% w/w PEG 3350, about 15% w/w PEG 1450, wherein the pharmaceutical composition has 0% w/w of ethanol and 0% w/w of water, and is formulated as a gel, ointment, lotion, emulsion, or cream. 
     
     
         6 . The pharmaceutical composition according to  claim 5 , wherein the pharmaceutical composition has about 15% w/w PEG 3350. 
     
     
         7 . The pharmaceutical composition according to  claim 5 , further comprising about 0.2% w/w methyl paraben and about 0.02% w/w propyl paraben. 
     
     
         8 . The pharmaceutical composition according to  claim 5 , further comprising about 0.1% w/w BHT. 
     
     
         9 . A pharmaceutical composition comprising 0.01% w/w to 0.6% w/w isotretinoin, 69% w/w to 70% w/w PEG 400, 14% w/w to 30% w/w PEG 3350, and 15% w/w PEG 1450, wherein the pharmaceutical composition has 0% w/w of ethanol and 0% w/w of water, and is formulated as a gel, ointment, lotion, emulsion, or cream. 
     
     
         10 . The pharmaceutical composition according to  claim 9 , wherein the pharmaceutical composition has 14.78% w/w PEG 3350. 
     
     
         11 . The pharmaceutical composition according to  claim 9 , further comprising 0.2% w/w methyl paraben and 0.02% w/w propyl paraben. 
     
     
         12 . The pharmaceutical composition according to  claim 9 , further comprising 0.1% w/w BHT. 
     
     
         13 . The pharmaceutical composition according to  claim 9 , wherein the pharmaceutical composition has 0.01% w/w to 0.2% w/w isotretinoin. 
     
     
         14 . A pharmaceutical composition comprising about 0.01% w/w to about 0.2% w/w isotretinoin, about 69% w/w to about 70% w/w PEG 400, about 15% w/w PEG 3350, about 15% w/w PEG 1450, about 0.1% w/w BHT, about 0.2% w/w methyl paraben, and about 0.02% w/w propyl paraben, wherein the pharmaceutical composition has 0% w/w of ethanol and 0% w/w of water, and is formulated as a gel, ointment, lotion, emulsion, or cream. 
     
     
         15 . The pharmaceutical composition of  claim 14 , wherein the pharmaceutical composition has 0.01% w/w, 0.025% w/w, 0.05% w/w, 0.1% w/w, 0.15% w/w, or 0.2% w/w isotretinoin. 
     
     
         16 . A pharmaceutical composition comprising 0.01% w/w to 0.2% w/w isotretinoin, 69% w/w to 70% w/w PEG 400, 14.78% w/w PEG 3350, 15% w/w PEG 1450, 0.1% w/w BHT, 0.2% w/w methyl paraben, and 0.02% w/w propyl paraben, wherein the pharmaceutical composition has 0% w/w of ethanol and 0% w/w of water, and is formulated as a gel, ointment, lotion, emulsion, or cream. 
     
     
         17 . The pharmaceutical composition of  claim 16 , wherein the pharmaceutical composition has 0.01% w/w, 0.025% w/w, 0.05% w/w, 0.1% w/w, 0.15% w/w, or 0.2% w/w isotretinoin.