The present invention provides stabilized cream formulations of oxymetazoline and uses thereof. The present invention also provides a method of treating facial erythema associated with rosacea in a patient in need of such treatment, comprising topically administering once or twice daily to the site of erythema on the face of the patient a pharmaceutical composition comprising 0.5%, 1.0% or 1.5% oxymetazoline or a pharmaceutically acceptable salt thereof as the sole active ingredient.

The present invention provides stabilized cream formulations of oxymetazoline and uses thereof. The present invention also provides a method of treating facial erythema associated with rosacea in a patient in need of such treatment, comprising topically administering once or twice daily to the site of erythema on the face of the patient a pharmaceutical composition comprising 0.5%, 1.0% or 1.5% oxymetazoline or a pharmaceutically acceptable salt thereof as the sole active ingredient.

A sanitizing composition for restoring skin's natural balance of bacteria and/or increasing the production and/or activity of antimicrobial peptides is provided. The sanitizing composition includes about 0.005 wt. % to 15.0 wt. % of an active ingredient that is one or more of a probiotic, probiotic derivative, prebiotic, and a prebiotic derivative and at least one compound that delivers a sanitizing effect.

A sanitizing composition for restoring skin's natural balance of bacteria and/or increasing the production and/or activity of antimicrobial peptides is provided. The sanitizing composition includes about 0.005 wt. % to 15.0 wt. % of an active ingredient that is one or more of a probiotic, probiotic derivative, prebiotic, and a prebiotic derivative and at least one compound that delivers a sanitizing effect.

Compositions for the treatment of some orphan diseases and oral mucosal ulcers, many with similarities in terms of their anti-inflammatory and anti-oxidative activities, but also multiple differences in their observed abilities that can be combined to challenge the current, underlying pathophysiology. The orphan diseases of interest are Dupuytren's Contracture, Peyronie's Disease, Scleroderma, Raynaud's (or Renaud's) Phenomenon, chemotherapy/radiation induced oral mucosal ulceration, and aphthous ulcers; and more frequent skin issues of skin damage from cuts, abrasions, and burns; aging skin changes, and toe nail fungus. These can be treated with the disclosed compositions with the proper combination and alteration of ingredients inclusive of alpha-pinene, an aloe vera preparation, and a shea butter preparation. A process for preparation of such ingredients in a water-in-oil emulsion is described herein.

Compositions for the treatment of some orphan diseases and oral mucosal ulcers, many with similarities in terms of their anti-inflammatory and anti-oxidative activities, but also multiple differences in their observed abilities that can be combined to challenge the current, underlying pathophysiology. The orphan diseases of interest are Dupuytren's Contracture, Peyronie's Disease, Scleroderma, Raynaud's (or Renaud's) Phenomenon, chemotherapy/radiation induced oral mucosal ulceration, and aphthous ulcers; and more frequent skin issues of skin damage from cuts, abrasions, and burns; aging skin changes, and toe nail fungus. These can be treated with the disclosed compositions with the proper combination and alteration of ingredients inclusive of alpha-pinene, an aloe vera preparation, and a shea butter preparation. A process for preparation of such ingredients in a water-in-oil emulsion is described herein.

A composition for the treatment of Demodex blepharitis and/or acne containing tea tree oil (TTO), coconut oil, aloe barbadensis, decyl glucoside, sodium chloride, sodium lauroyl methyl isethionate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ethylhexylglycerin, and Hexylene Glycol in glycerin or in water or in a mixture of glycerin and water. The composition is used to treat Demodex blepharitis and/or acne by applying the composition to the eyelid margin and eyelashes or acne and scrubbing the eyelid margin, eyelashes, and eyelash roots or acne with the composition using any suitable cloth, wipe, sponge, brush, or cotton tipped applicator.

A composition for the treatment of Demodex blepharitis and/or acne containing tea tree oil (TTO), coconut oil, aloe barbadensis, decyl glucoside, sodium chloride, sodium lauroyl methyl isethionate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ethylhexylglycerin, and Hexylene Glycol in glycerin or in water or in a mixture of glycerin and water. The composition is used to treat Demodex blepharitis and/or acne by applying the composition to the eyelid margin and eyelashes or acne and scrubbing the eyelid margin, eyelashes, and eyelash roots or acne with the composition using any suitable cloth, wipe, sponge, brush, or cotton tipped applicator.

The present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one neutral diacyl lipid and/or at least one tocopherol; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent;
wherein at least one bioactive agent is dissolved or dispersed in the low viscosity mixture and wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. The preformulations are suitable for generating parenteral, non-parenteral and topical depot compositions for sustained release of active agents. The invention additionally relates to a method of delivery of an active agent comprising administration of a preformulation of the invention, a method of treatment comprising administration of a preformulation of the invention and the use of a preformulation of the invention in a method for the manufacture of a medicament.

The present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one neutral diacyl lipid and/or at least one tocopherol; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent;
wherein at least one bioactive agent is dissolved or dispersed in the low viscosity mixture and wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. The preformulations are suitable for generating parenteral, non-parenteral and topical depot compositions for sustained release of active agents. The invention additionally relates to a method of delivery of an active agent comprising administration of a preformulation of the invention, a method of treatment comprising administration of a preformulation of the invention and the use of a preformulation of the invention in a method for the manufacture of a medicament.