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Claims for Patent: 8,268,804

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Claims for Patent: 8,268,804

Title:Minocycline oral dosage forms for the treatment of acne
Abstract: Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.
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:12/875,876
Patent Claims: 1. A method for the treatment of acne in a person using an oral dosage form, comprising: determining the body weight of the person; and selecting the dosage form based on the body weight of the person so that the dosage form provides the person, without an initial load dose, 0.7 mg/kg/day to 1.3 mg/kg/day of the minocycline or a pharmaceutically acceptable salt thereof by a once daily administration, wherein the dosage form comprises: minocycline or the pharmaceutically acceptable salt thereof; and an amount of a carrier, said carrier being a controlled-release carrier that provides a release rate in gastric fluid of the minocycline or a pharmaceutically acceptable salt thereof that is either 25% to 52% within 1 hour, 53% to 89% within 2 hours, and at least 90% at 4 hours, or 30% to 52% within 1 hour, 53% to 84% within 2 hours, and at least 85% at 4 hours.

2. The method of claim 1, wherein said carrier comprises at least one ingredient selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylcellulose, and polyvinylpyrrolidone.

3. The method of claim 1, wherein said carrier is present in the range of 20% to 30%, by weight based on the total weight of the dosage form.

4. The method of claim 1, wherein the pharmaceutically acceptable salt comprises minocycline hydrochloride.

5. The method of claim 1, wherein the 0.7 mg/kg/day to 1.3 mg/kg/day of the minocycline or the pharmaceutically acceptable salt thereof is about 1 mg/kg/day.

6. The method of claim 5, wherein the minocycline is present in an amount selected from the group consisting of 45 mg, 90 mg and 135 mg.

7. The method of claim 6, wherein said carrier further includes a slow dissolving carrier.

8. The method of claim 1, wherein said carrier includes a slow dissolving carrier.

9. The method of claim 7, wherein when the minocycline is present in an amount of 45 mg or 90 mg, said slow dissolving carrier is 26% to 28% by weight based on the total weight of the dosage form.

10. The method of claim 7, wherein when the minocycline is 135 mg, said slow dissolving carrier is 22% to less than 25% by weight based on the total weight of the dosage form.

11. The method of claim 8, wherein said carrier further includes a fast dissolving carrier.

12. The method of claim 11, wherein said fast dissolving carrier includes an intragranular fast dissolving carrier and an extragranular fast dissolving carrier.

13. The method of claim 12, wherein said intragranular fast dissolving carrier and said slow dissolving carrier are each in an amount greater than said extragranular fast dissolving carrier.

14. The method of claim 1, further comprising a film coat of 2 to 3% of the total weight of the dosage form with coating.
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