Novel Formulation of Meloxicam
First Claim
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1. A tablet or capsule form of a pharmaceutical composition comprising 5 mg of meloxicam, wherein a single dose, 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, 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 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 a time period selected from;
10 minutes or less;
8 minutes or less;
7 minutes or less;
6 minutes or less; and
5 minutes or less.
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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.
0 Citations
30 Claims
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1. A tablet or capsule form of a pharmaceutical composition comprising 5 mg of meloxicam, wherein a single dose, 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, 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 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 a time period selected from;
10 minutes or less;
8 minutes or less;
7 minutes or less;
6 minutes or less; and
5 minutes or less. - View Dependent Claims (2, 3, 4, 5, 6, 8, 9, 10, 11, 12)
- ) of 7500-20000 h*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 500 mL of pH 6.1 phosphate buffer with 0.1% sodium lauryl sulfate (SLS) at 37°
-
7. (canceled)
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13. A tablet or capsule comprising 10 mg of meloxicam, wherein a single dose, 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, 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 a time period selected from;
15 minutes or less;
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. - View Dependent Claims (14, 15, 16, 17, 18, 20, 21, 22, 23, 24, 25)
- ) of 16000-44000 h*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°
-
19. (canceled)
- 26. A tablet or capsule of a pharmaceutical composition comprising 10 mg of meloxicam, wherein a single dose, upon oral administration to a population of healthy adults in the fed state, provides a mean plasma Cmax of 525-1500 ng/ml.
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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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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current1/1
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CPC 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...
