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Details for Patent: 7,404,965

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Details for Patent: 7,404,965

Title:Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels
Abstract: A pharmaceutical composition in the form of a solution, cream, lotion, spray, ointment, gel, aerosol, tablet, suppository or patch device for transdermal or transmucosal administration of alprazolam to a subject, which includes as a permeation enhancing mixture a fatty component in an amount of 0.1% to 20% by weight which is one of (a) a saturated fatty alcohol of formula CH.sub.3--(CH.sub.2).sub.n--CH.sub.2OH, a saturated fatty acid of formula CH.sub.3--(CH.sub.2).sub.n--CH.sub.2COOH, (b) an unsaturated fatty alcohol of formula CH.sub.3(C.sub.nH.sub.2(n-1))--OH, or (c) a fatty acid of formula CH.sub.3(C.sub.nH.sub.2(n-1))--COOH, wherein n is an integer of between 8 and 22; and a vehicle that includes a C.sub.1-C.sub.4 alkanol, a polyalcohol, and water.
Inventor(s): Carrara; Dario (Buenos Aires, AR), Porto; Gabriel (Basel, CH), Rodriguez; Jorge (Buenos Aires, AR)
Assignee: Antares Pharma IPL AG (Zug, CH)
Filing Date:Dec 04, 2006
Application Number:11/634,005
Claims:1. A pharmaceutical composition in the form of a solution, cream, lotion, spray, ointment, gel, aerosol, tablet, suppository or patch device for transdermal or transmucosal administration of alprazolam to a subject, comprising as a permeation enhancing mixture: a fatty component in an amount of 0.1% to 20% by weight and comprising a saturated fatty alcohol of formula CH.sub.3--(CH.sub.2).sub.n--CH.sub.2OH, or an unsaturated fatty alcohol of formula CH.sub.3(C.sub.nH.sub.2(n-1))--OH, wherein n is an integer of between 8 and 22; and a vehicle comprising a monoalkylether of diethyleneglycol, a C.sub.1-C.sub.4 alkanol, a polyalcohol, and water.

2. The pharmaceutical composition of claim 1, wherein the polyalcohol is a glycol, the alkanol is ethanol, and the monoalkylether of diethyleneglycol is diethylene glycol monoethylether.

3. The pharmaceutical composition of claim 1 wherein the vehicle comprises 5% to 75% by weight of a C.sub.1-C.sub.4 alkanol, 0.5% to 50% of a polyalcohol, water, and up to 40% by weight of a monoalkylether of diethyleneglycol, with all weights calculated based on the total weight of the composition and provided that the total weights of the components does not exceed 100%.

4. The pharmaceutical composition of claim 3, wherein the fatty component is present in an amount of 0.1% to 10%, the alkanol is present in an amount of 15% to 65%, the polyalcohol is present in an amount of 3% to 20%, and the monoalkylether of diethyleneglycol is present in an amount of 0.2% to 25%.

5. The pharmaceutical composition of claim 4, wherein the fatty component is present in an amount of 0.2% to 3%, the alkanol is present in an amount of 20% to 55%, the polyalcohol is present in an amount of 4% to 10%, and the monoalkylether of diethyleneglycol is present in an amount of 2% to 8%.

6. The pharmaceutical composition of claim 1, which further comprises a gelling agent in an amount of 0.2 to 3% by weight so that the composition is in the form of a gel.

7. The pharmaceutical composition of claim 6, wherein the gelling agent is a polyacrylic acid or a cellulose compound.

8. The pharmaceutical composition of claim 7, wherein the gelling agent is carbopol, hydroxypropylmethylcellulose, carboxymethylcellulose, ethylhydroxyethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, polyvinylpyrrolidone, a polyoxyethylene/polyoxypropylene copolymer, polyvinylalcohol, a natural gum, an alginate, or a pectin.

9. The pharmaceutical composition of claim 6, which further comprises a pH regulator in an amount of 0.05% to 2% by weight.

10. The pharmaceutical composition of claim 9, wherein the pH regulator is a tertiary amine or sodium hydroxide.

11. The pharmaceutical composition of claim 1, wherein the fatty component is a saturated or unsaturated fatty alcohol where n is an integer of between 8 and 12, the polyalcohol is a glycol, the alkanol is ethanol, and the monoalkylether of diethyleneglycol is diethylene glycol monoethylether.

12. The pharmaceutical composition of claim 11, wherein the fatty component is dodecanol, the polyalcohol is propylene glycol and the pH regulator is triethanolamine or tromethamine.

13. The pharmaceutical composition of claim 1, which further comprises one or more of a flavor agent, saborizant, sweetener or solubilizant in an amount sufficient to impart desired properties to the composition.
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