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Claims for Patent: 9,192,615

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Claims for Patent: 9,192,615

Title:Method for the treatment of acne and certain dosage forms thereof
Abstract: An oral dosage form, including 65 mg of minocycline, an amount of lactose monohydrate, and an amount of hydroxypropylmethylcellulose. The hydroxypropylmethylcellulose is hydroxypropylmethylcellulose that is about 8.9+/-0.2% hydroxypropoxylated. An oral dosage form, including 115 mg of minocycline, an amount of lactose monohydrate, and an amount of hydroxypropylmethylcellulose. The hydroxypropylmethylcellulose is hydroxypropylmethylcellulose that is about 8.9+/-0.2% hydroxypropoxylated.
Inventor(s): Wortzman; Mitchell (Scottsdale, AZ), Plott; R. Todd (Dallas, TX), Newhard; Steven B. (Scottsdale, AZ), Watt; David (Pickering, CA)
Assignee: Medicis Pharmaceutical Corporation (Bridgewater, NJ)
Application Number:12/536,359
Patent Claims: 1. An oral dosage form, comprising: 65 mg of minocycline; a first amount of lactose monohydrate present as an extragranular fast dissolving carrier and a second amount of lactose monohydrate present as an intragranular fast dissolving carrier; an amount of hydroxypropylmethylcellulose present as an intragranular slow dissolving carrier, wherein the hydroxypropylmethylcellulose is selected from the group consisting of hydroxypropylmethylcellulose that is 8.9%+/-0.2% hydroxypropoxylated and hydroxypropylmethylcellulose that is about 9.1% hydroxypropoxylated, wherein the hydroxypropylmethylcellulose has a viscosity of 40 cps to 60 cps; wherein the ratio of the extragranular fast dissolving carrier to intragranular slow dissolving carrier is from 0.30 to 0.50; wherein the minocycline has a release rate, as measured in 0.1 N HCl, of about 37% within 1 hour, about 61% within 2 hours, and 90% within 3 hours when the hydroxypropylmethylcellulose is 8.9+/-0.2% hydroxypropoxylated, and wherein the minocycline has a release rate, as measured in 0.1 N HCl, of about 41% within 1 hour, about 68% within 2 hours, about 90% within 3 hours and about 100% within 4 hours when the hydroxypropylmethylcellulose is about 9.1% hydroxypropoxylated.

2. The oral dosage form of claim 1, further comprising a coating in an amount of 3.5% to 4.0% of the weight of the oral dosage form.

3. An oral dosage form, comprising: 115 mg of minocycline; a first amount of lactose monohydrate present as an extragranular fast dissolving carrier and a second amount of lactose monohydrate present as an intragranular fast dissolving carrier; an amount of hydroxypropylmethylcellulose present as an intragranular slow dissolving carrier, wherein the hydroxypropylmethylcellulose is selected from the group consisting of hydroxypropylmethylcellulose that is 8.9%+/-0.2% hydroxypropoxylated and hydroxypropylmethylcellulose that is about 9.1% hydroxypropoxylated, wherein the hydroxypropylmethylcellulose has a viscosity of 40 cps to 60 cps; wherein the ratio of the extragranular fast dissolving carrier to intragranular slow dissolving carrier is from 0.30 to 0.50; wherein the minocycline has a release rate, as measured in 0.1 N HCl, of about 37% within 1 hour, about 61% within 2 hours, and 90% within 3 hours when the hydroxypropylmethylcellulose is 8.9+/-0.2% hydroxypropoxylated, and wherein the minocycline has a release rate, as measured in 0.1 N HCl, of about 41% within 1 hour, about 68% within 2 hours, about 90% within 3 hours and about 100% within 4 hours when the hydroxypropylmethylcellulose is about 9.1% hydroxypropoxylated.

4. The oral dosage form of claim 3, further comprising a coating in an amount of 3.0% to 3.3% of the weight of the oral dosage form.
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