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Last Updated: September 20, 2020

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Claims for Patent: 9,526,734

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Summary for Patent: 9,526,734
Title:Formulation of meloxicam
Abstract: Unit dosage forms of meloxicam containing either 5 mg or 10 mg of meloxicam that provide effective pain relief and have desirable pharmacokinetic properties are described. The unit dosage forms can provide pain relief when a single unit dose is administered to a patient and useful for treating pain such as osteoarthritis pain at a relatively low systemic exposure to meloxicam.
Inventor(s): Bosch; H. William (Bryn Mawr, PA)
Assignee: iCeutica Pty Ltd. (Balcatta WA, AU)
Application Number:14/675,410
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,526,734
Patent Claims: 1. A capsule form of a pharmaceutical composition comprising 5 mg of meloxicam having a median particle size, on a volume basis, between 100 nm and 500 nm and a D(0.9) that is between 1200 nm and 3000 nm, wherein a single capsule, upon oral administration to a population of healthy adults in the fasted state, provides a mean plasma AUC (0-.infin.) of 7500-20000 h*ng/ml and a mean plasma Cmax of 350-950 ng/ml, wherein the dissolution rate is such that, when the capsule is tested using USP Apparatus 1 (baskets) set to rotation speed of 100 RPM in 500 mL of pH 6.1 phosphate buffer with 0.1% sodium lauryl sulfate (SLS) at 37.degree. C.+0.5.degree. C., at least 80% of the meloxicam dissolves in 10 minutes or less, wherein a single capsule is effective for treating osteoarthritis pain.

2. The capsule of claim 1 wherein the dissolution rate is such that, when tested using USP Apparatus 1 (baskets) set to rotation speed of 100 RPM in 500 mL of pH 6.1 phosphate buffer with 0.1% sodium lauryl sulfate (SLS) at 37.degree. C..+-.0.5.degree. C., at least 90% of the meloxicam dissolves in a time period selected from: 8 minutes or less; 7 minutes or less; 6 minutes or less; and 5 minutes or less.

3. The capsule of claim 1, wherein a single capsule, upon oral administration to a population of healthy adults in the fasted state, provides a median plasma Tmax of 1 to 3 hrs.

4. The capsule of claim 1, wherein a single capsule, upon oral administration to a population of healthy adults in the fasted state, provides a mean plasma AUC (0-.infin.) that is 80% to 125% of 13610 ng-h/ml.

5. A capsule comprising 10 mg of meloxicam having a median particle size on a volume basis between 100 nm and 500 nm and a D(0.9) that is between 1200 nm and 3000 nm, wherein a single capsule, upon oral administration to a population of healthy adults in the fasted state, provides a mean plasma AUC (0-.infin.) of 16000-44000 h*ng/ml and a mean plasma Cmax of 700-1900 ng/ml, wherein the dissolution rate is such that, when the tablet or capsule is tested using USP Apparatus 1 (baskets) set to rotation speed of 100 RPM in 1000 mL of pH 6.1 phosphate buffer with 0.1% sodium lauryl sulfate (SLS) at 37.degree. C.+0.5.degree. C., at least 80% of the meloxicam dissolves in 15 minutes or less, wherein a single capsule is effective for treating osteoarthritis pain.

6. The capsule of claim 5 wherein the dissolution rate is such that, when tested using USP Apparatus 1 (baskets) set to rotation speed of 100 RPM in 1000 mL of pH 6.1 phosphate buffer with 0.1% sodium lauryl sulfate (SLS) at 37.degree. C..+-.0.5.degree. C., at least 90% of the meloxicam dissolves in a time period selected from: 14 minutes or less; 13 minutes or less; 12 minutes or less; 11 minutes or less; 10 minutes or less; and 5 minutes or less.

7. The capsule of claim 5, wherein a single capsule, upon oral administration to a population of healthy adults in the fasted state, provides a median plasma tmax of 1 to 3 hrs.

8. The capsule of claim 5, wherein a single dose, upon oral administration to a population of healthy adults in the fasted state, provides a mean plasma AUC (0-.infin.) that is 80% to 125% of 29,173 ng-h/ml.

9. The capsule of claim 5, wherein a single dose, upon oral administration to a population of healthy adults in the fasted state, provides a mean plasma Cmax that is 80% to 125% of 1253 ng/ml.

10. The capsule of claim 1 further comprising a binding agent, a disintegrant and a lubricant.

11. The capsule of claim 5 further comprising a binding agent, a disintegrant and a lubricant.

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