Pharmaceutical cream compositions and methods of use

Abstract

Embodiments relating to cream formulations as well as oxymetazoline creams and methods for treating rosacea and symptoms associated with rosacea, including, for example, papules, pustules, phymas (skin thickening), telangiectasias or erythema associated with rosacea, other skin erythemas, telangiectasias, purpura or the like, and other manifestations associated therewith; other inflammatory conditions of the skin including, but not limited to, keratosis pilaris, lupus miliaris dissemniatus faciei, eczema, dermatitis, such as contact dermatitis, atopic dermatitis, seborrheic dermatitis, nummular dermatitis, generalized exfoliative dermatitis, statis dermatitis, neurodermatitis, lichen simplex chronicus, xerosis and xerotic dermatitis, dyshidrosis and dyshidrotic dermatitis, asteototic dermatitis or other conditions characterized by sensitive skin or a disturbance of the epidermal barrier; disorders characterized by rough, dry, cracked or fissured skin, disorders characterized by hyperkeratotic skin such as keratodermas and ichthyosisis and ichthyosiform dermatoses; disorders of hair follicles and sebaceous glands, such as acne, perioral dermatitis, and pseudofolliculitis barbae; disorders of sweat glands, such as miliaria, including, but not limited to, miliaria crystallina, miliaria rubra, miliaria profunda, miliaria pustulosa; sunburn, chronic actinic damage, poikiloderma, radiation dermatitis, actinic purpura (“solar purpura”); other inflammatory dermatoses, reactions and conditions of the skin, including, but not limited to, psoriasis, drug eruptions, erythema multiforme, erythema nodosum, and granuloma annulare; diseases and conditions characterized by bleeding or bruising such as petechiae, ecchymosis, purpura and the like including any accumulation of blood in the skin due to vascular extravasation, irrespective of size or cause, bleeding or bruising due to any skin injury which may include any trauma including surgical or procedural trauma; infection, inflammatory dermatoses or inflammation due to any cause using such creams are described herein.

1 - 17 . (canceled) 
     
     
         18 . A pharmaceutical composition comprising about 1% oxymetazoline hydrochloride, greater than 10% of an emulsifier, an emollient, and a buffering agent, wherein the composition is a cream and has a pH of 4.3 to 4.7. 
     
     
         19 . The pharmaceutical composition of  claim 18 , wherein the buffering agent is selected from citric acid, sodium citrate, sodium lactate, ammonium hydroxide, tris(hydroxymethyl)aminomethane acetate salt, sodium borate, acetic acid, sodium acetate, phosphoric acid, sodium phosphate, sodium citrate dihydrate, and any combination of the foregoing. 
     
     
         20 . The pharmaceutical composition of  claim 18 , wherein the buffering agent comprises citric acid and sodium citrate. 
     
     
         21 . The pharmaceutical composition of  claim 19 , wherein the buffer capacity of the buffering agent ranges from about 5 mM to about 600 mM. 
     
     
         22 . The pharmaceutical composition of  claim 20 , wherein the emollient comprises medium chain triglycerides, diisopropyl adipate, oleyl alcohol, and lanolin. 
     
     
         23 . The pharmaceutical composition of  claim 22 , wherein the sole oils in the emollient are the medium chain triglycerides, diisopropyl adipate, oleyl alcohol, and lanolin. 
     
     
         24 . The pharmaceutical composition of  claim 18 , wherein the emulsifier comprises cetostearyl alcohol. 
     
     
         24 . The pharmaceutical composition of  claim 18 , wherein the composition, when packaged in a tube, maintains a pH of 4.3 to 4.7 after about 4 weeks of storage at about 25° C. and 60% relative humidity. 
     
     
         25 . The pharmaceutical composition of  claim 18 , further comprising a preservative, a chelating agent and an antioxidant. 
     
     
         26 . A pharmaceutical composition comprising:
 (a) about 1% oxymetazoline hydrochloride,   (b) one or more ceteareth in combination with a fatty acid alcohol selected from stearyl alcohol, cetyl alcohol, and a combination thereof,   (c) an emollient, and   (d) a buffering agent,   
       wherein the composition is a cream and has a pH of 4.3 to 4.7. 
     
     
         27 . A pharmaceutical composition comprising:
 (a) about 1% oxymetazoline hydrochloride,   (b) one or more ceteareth in combination with a fatty acid alcohol selected from stearyl alcohol, cetyl alcohol, and a combination thereof,   (c) an emollient comprising medium chain triglycerides, diisopropyl adipate, oleyl alcohol, and lanolin, and   (d) a buffering agent,   
       wherein the composition is a cream and has a pH of 4.3 to 4.7.