Compositions for the treatment of rosacea
The present invention relates to pharmaceutical compositions for topical use (including also dermatological compositions), for treating skin conditions and afflictions, such as rosacea and symptoms and conditions associated there from.
1. A composition for the topical treatment of rosacea, comprising:
a pharmaceutical acceptable topical vehicle, and as the sole pharmaceutical active agent, benzoyl peroxide in solid form,
wherein said vehicle is an oil-in-water emulsion comprising a polyoxylstearate, a glyceryl stearate, and at least one fatty alcohol, wherein the ratio of said polyoxylstearate to said glyceryl stearate is in the range of 0.1:10 to 10:0.1,
wherein said solid benzoyl peroxide is encapsulated as the core of a microcapsule having a shell comprising at least one inorganic polymer, said core consisting of said solid benzoyl peroxide, and
wherein said composition has a dissolution rate of less than 60% weight/h as measured in a medium of a mixture of water and acetonitrile at ambient temperature.
2. A composition according to claim 1 , wherein said benzoyl peroxide is at least 1.0% by weight of said composition.
3. A composition according to claim 1 , wherein said benzoyl peroxide is present in the composition in an amount of about 2.5% to about 10% by weight of said composition.
4. A composition according to claim 1 , wherein said benzoyl peroxide is in a crystalline form.
5. A composition according to according to claim 1 , further comprising at least one additive, which additive is not a pharmaceutical active agent, selected from the group consisting of at least one of chelating agents, antioxidants, sunscreens, preservatives, fillers, electrolytes, humectants, dyes, mineral or organic acids or bases, fragrances, essential oils, moisturizers, vitamins, essential fatty acids, sphingolipids, self-tanning compounds, calmatives and skin-protecting agents, and pro-penetrating agents and gelling agents.
6. The composition of claim 1 , wherein said composition further comprises a polyacrylic acid homopolymer or copolymer.
7. The composition of claim 1 , wherein said oil in said oil in water emulsion is selected from the group consisting of paraffin oil, isopropyl myristate, caprylic/capric triglyceride, squalane, squalene, almond oil, castor oil, olive oil, jojoba oil, sunflower oil, soybean oil, grape seed oil, dimethicone, cyclomethicone and mixtures thereof.
8. A composition according to claim 1 , wherein said composition is in a gel form comprising at least one non-ionic polymeric dispersant and at least one thickening agent.
9. The composition of claim 8 , wherein said at least one non-ionic polymeric dispersant is selected from the group consisting of poly vinyl pyrrolidone (PVP), poly vinyl pyrrolidone-co-vinyl acetate, polyamide, polyurethane, polyurea and mixtures thereof.
10. The composition of claim 8 , wherein said at least one thickening agent is selected from the group consisting of at least one of hydroxy propyl cellulose (HPC), hydroxyl ethyl cellulose (HEC), hydroxyl methyl cellulose (HMC), polyacrylic acid homopolymer, polyacrylic acid copolymer, fatty alcohol, silica and its derivatives, xanthan gum, arabic gum, poly vinyl alcohol, veegum, laponite, and clay.
11. The composition of claim 8 , wherein said composition further comprises glycerin.
12. A method for the topical treatment of rosacea, comprising, topically administering to a patient in need, an effective amount of the composition in accordance with claim 1 .