Formulation of meloxicam
DC CAFC
First Claim
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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-∞
- ) 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°
C.+0.5°
C., at least 80% of the meloxicam dissolves in 10 minutes or less, wherein a single capsule is effective for treating osteoarthritis pain.
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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.
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11 Claims
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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-∞
- ) 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°
C.+0.5°
C., at least 80% of the meloxicam dissolves in 10 minutes or less, wherein a single capsule is effective for treating osteoarthritis pain. - View Dependent Claims (2, 3, 4, 10)
- ) 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°
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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-∞
- ) 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°
C.+0.5°
C., at least 80% of the meloxicam dissolves in 15 minutes or less, wherein a single capsule is effective for treating osteoarthritis pain. - View Dependent Claims (6, 7, 8, 9, 11)
- ) 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°
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Litigation Data
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Current AssigneeIceutica Pty Limited (Assertio Holdings, Inc.)
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Original AssigneeIceutica Pty Limited (Assertio Holdings, Inc.)
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InventorsBosch, H. William
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Primary Examiner(s)Barham, Bethany
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Assistant Examiner(s)FRAZIER, BARBARA S
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Application NumberUS14/675,410Publication NumberTime in Patent Office637 DaysField of SearchNoneUS Class Current1/1CPC Class CodesA61K 31/00 Medicinal preparations cont...A61K 31/5415 ortho- or peri-condensed wi...A61K 9/0053 Mouth and digestive tract, ...A61K 9/14 Particulate form, e.g. powd...A61K 9/145 with organic compoundsA61K 9/1617 Organic compounds, e.g. pho...A61K 9/1623 Sugars or sugar alcohols, e...A61K 9/1652 Polysaccharides, e.g. algin...A61K 9/4858 Organic compoundsA61P 19/02 for joint disorders, e.g. a...A61P 25/04 Centrally acting analgesics...A61P 29/00 Non-central analgesic, anti...Y10T 428/2982 Particulate matter [e.g., s...
