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Claims for Patent: 8,252,776

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Claims for Patent: 8,252,776

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:11/695,513
Patent Claims: 1. A method of distributing an oral dosage form, comprising: providing the oral dosage form, wherein the oral dosage form includes an oral minocycline and a slow continuous release vehicle for controlling release of the minocycline so that the minocycline is released in the patient, without an initial load dose, and at a release rate in gastric fluid that is either about 25% to about 52% within 1 hour, about 53% to about 89% within 2 hours, and at least 90% within about 4 hours, or about 30% to about 52% within 1 hour, about 53% to about 84% within 2 hours, and at least 85% within about 4 hours, and wherein the oral dosage form is administered, once daily, to the patient to provide the patient with about 0.70 mg/kg/day to about 1.3 mg/kg/day of the minocycline; distributing information for selection of the oral dosage form based on the body weight of the patient; and concomitantly distributing information that the oral dosage form may cause one or more adverse effects selected from pseudomembranous colitis, hepatotoxicity, vasculitis, tissue hyperpigmentation, and anaphylaxis.

2. The method of claim 1, wherein the controlled release carrier vehicle includes a fast dissolving carrier and a slow dissolving carrier.

3. The method of claim 2, wherein the fast dissolving carrier includes an intragranular fast dissolving carrier and an extragranular fast dissolving carrier.

4. The method of claim 3, wherein the extragranular fast dissolving carrier and the slow dissolving carrier are at a weight ratio of from 0.3 to 0.5 of extragranular fast dissolving carrier to slow dissolving carrier.

5. The method of claim 4, wherein the extragranular fast dissolving carrier and the slow dissolving carrier are at a weight ratio of from 0.35 to 0.45 of extragranular fast dissolving carrier to slow dissolving carrier.

6. The method of claim 5, wherein the extragranular fast dissolving carrier and the slow dissolving carrier are at a weight ratio of from about 0.36 to 0.40 of extragranular fast dissolving carrier to slow dissolving carrier.

7. The method of claim 1, wherein the adverse effect is pseudomembranous colitis.

8. The method of claim 1, wherein the adverse effect is hepatotoxicity.

9. The method of claim 1, wherein the adverse effect is vasculitis.

10. The method of claim 1, wherein the adverse effect is tissue hyperpigmentation.

11. The method of claim 1, wherein the adverse effect is anaphylaxis.

12. The method of claim 1, wherein the oral dosage form is used to treat acne.

13. The method of claim 1, wherein the oral dosage form is used to treat acne rosacea.
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