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Claims for Patent: 7,919,483

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Claims for Patent: 7,919,483

Title:Method for the treatment of acne
Abstract: A method for treatment of acne with tetracyclines is provided. A lower sustained dose and no loading dose is employed, with an optional once-a-day dosing regimen.
Inventor(s): Wortzman; Mitchell (Scottsdale, AZ), Plott; R. Todd (Briscoe, TX), Bhatia; Kuljit (Nesconset, NY), Patel; Bhiku (Chandler, AZ)
Assignee: Medicis Pharmaceutical Corporation (Scottsdale, AZ)
Application Number:11/166,817
Patent Claims: 1. A method of treating acne vulgaris, comprising administering to a patient suffering from acne vulgaris an amount of a continuous slow release oral dosage form based on body weight of the patient, said continuous slow release oral dosage form comprising: an amount of an oral minocycline antibiotic that provides the patient, upon administration once daily without a loading dose, with 0.7 mg/kg/day to 1.3 mg/kg/day of said oral minocycline antibiotic; and a delivery vehicle having a first lactose monohydrate, a second lactose monohydrate, and a slow dissolving carrier, wherein said first lactose monohydrate is encapsulated by said slow dissolving carrier, wherein said second lactose monohydrate and said slow dissolving carrier are present at a weight ratio of about 0.3 to about 0.5, wherein said delivery vehicle releases said oral minocycline antibiotic at a release rate of: A) about 25 to about 52% within about 1 hour about 53 to about 89% within about 2 hours, and at least about 90% within about 4 hours; or B) about 30 to about 52% within about 1 hour about 53 to about 84% within about 2 hours, and at least about 85% within about 4 hours, wherein said release rate is measured in an aqueous physiological medium.

2. The method of claim 1, wherein said amount of 0.7 mg/kg/day to 1.3 mg/kg/day of said oral minocycline antibiotic is about 1 mg/kg/day.

3. The method of claim 1, wherein said delivery vehicle releases said oral minocycline antibiotic in such a manner that said oral minocycline antibiotic reaches the C.sub.max in the person's blood from about 3.5 hours after administration.

4. The method of claim 1, wherein said second lactose monohydrate and said slow dissolving carrier are present at a weight ratio of about 0.36 to about 0.40.

5. A method of treating acne vulgaris, comprising administering to a patient suffering from acne vulgaris an amount of a continuous slow release oral dosage form based on body weight of the patient, the continuous slow release dosage form comprising: an amount of an oral minocycline antibiotic that provides the patient, upon administration once daily without a loading dose, with 0.7 mg/kg/day to 1.3 mg/kg/day of said oral minocycline antibiotic; and a delivery vehicle having a fast dissolving carrier and a slow dissolving carrier, wherein the fast dissolving carrier has a first portion thereof that is encapsulated by the slow dissolving carrier and a second portion thereof that is not encapsulated by the slow dissolving carrier, and wherein the second portion of the fast dissolving carrier and the slow dissolving carrier are present at a weight ratio of 0.3 to 0.5, wherein the delivery vehicle releases said oral minocycline antibiotic at a release rate of: A) about 25 to about 52% within about 1 hour about 53to about 89% within about 2 hours, and at leastabout 90% within about 4 hours; or B) about 30 to about 52% within about 1 hour about 53 to about 84% within about 2 hours, and at leastabout 85% within about 4 hours, wherein the release rate is measured in an aqueous physiological medium.

6. The method of claim 1, wherein said slow dissolving carrier is hydroxypropyl methylcellulose.
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