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Claims for Patent: 8,722,650

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Claims for Patent: 8,722,650

Title:Extended-release minocycline dosage forms
Abstract: An oral dosage form has the following: an amount of minocycline selected from the group consisting of 55 mg, 80 mg, and 105 mg; an amount of lactose monohydrate; an amount of hydroxypropylmethylcellulose. The hydroxypropylmethylcellulose is at least 8.3 to about 9.8% hydroxypropoxylated. The minocycline in the oral dosage form has a dissolution profile or release rates about 35% to about 50% in 1 hour, about 60% to about 75% in 2 hours, and at least about 90% in 4 hours. There is also provided a method of treating acne in a human and a method of assisting a physician in prescribing a dose of minocycline for the treatment of acne.
Inventor(s): Wortzman; Mitchell (Scottsdale, AZ), Plott; R. Todd (Scottsdale, AZ), Newhard; Steven B. (Scottsdale, AZ), Watt; David (Scottsdale, AZ)
Assignee: Medicis Pharmaceutical Corporation (Bridgewater, NJ)
Application Number:12/861,424
Patent Claims: 1. A method of treating acne in a human, comprising: administering to the human once per day an oral dosing form including: an amount of minocycline selected from the group consisting of 55 mg, 80 mg, and 105 mg; an amount of lactose monohydrate; and an amount of hydroxypropylmethylcellulose, wherein the hydroxypropylmethylcellulose is at least 8.3 to about 9.8% hydroxypropoxylated; and wherein the minocycline in the oral dosage form has a dissolution of about 35% to about 50% in 1 hour, about 60% to about 75% in 2 hours, and at least about 90% in 4 hours.

2. The method of claim 1, wherein the oral dosage form provides the patient with an amount of minocycline at about 1.1 mg/kg to about 0.9 mg/kg of body weight.

3. The method of claim 2, wherein the oral dosage form provides the patient with an amount of minocycline at 1 mg/kg of body weight.

4. The method of claim 1, wherein the hydroxypropylmethylcellulose is 8.3 to about 9.1% hydroxypropoxylated.

5. The method of claim 4, wherein the hydroxypropylmethylcellulose is 8.9 to 9.1% hydroxypropoxylated.

6. The method of claim 1, wherein the lactose monohydrate is present in an intragranular component and in an extragranular component.

7. A method of assisting a physician in prescribing a dose of minocycline for the treatment of acne, comprising: (a) determining the body weight of a patient; (b) referring to a chart or reference tool that correlates a plurality of body weight ranges with a corresponding number of dosage forms each having a different level of minocycline based on a target dosage rate of 1 mg/kg/day; (c) identifying a single dosage form corresponding to a particular weight range in which the patient's weight falls in the chart or reference tool; and (d) administering to the patient the identified single dosage form, wherein the identified single dosage form includes: an amount of minocycline selected from the group consisting of 55 mg, 80 mg, and 105 mg, an amount of lactose monohydrate, and an amount of hydroxypropylmethylcellulose, wherein the hydroxypropylmethylcellulose is at least 8.3 to about 9.8% hydroxypropoxylated, and wherein the minocycline in the oral dosage form has a dissolution of about 35% to about 50% in 1 hour, about 60% to about 75% in 2 hours, and at least about 90% in 4 hours.

8. The method of claim 7, wherein the hydroxypropylmethylcellulose is 8.3 to about 9.1% hydroxypropoxylated.

9. The method of claim 8, wherein the hydroxypropylmethylcellulose is 8.9 to 9.1% hydroxypropoxylated.

10. The method of claim 7, wherein the lactose monohydrate is present in an intragranular component and an extragranular component.
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