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US 12,667,554 B1Granted
Oral solid chlorthalidone compositions
AssigneeIngenus Pharmaceuticals, LLC
InventorsMukteeshwar Gande, Praveen Reddy Billa, Jagatpal Reddy Surikanti
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Abstract
Described herein are solid oral compositions comprising chlorthalidone, or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable excipient, wherein the chlorthalidone has a Sauter mean diameter ranging from about 8 μm to about 14 μm. Methods of making and using these compositions are also described herein.
Claims12
A solid oral composition comprising:
- chlorthalidone, or a pharmaceutically acceptable salt thereof, having:
- a Sauter's mean diameter (D3,2) of from 8 μm to 14 μm;
- and
- a specific surface area of from 0.25 m2/gram to 0.5 m2/gram;
- and
- a pharmaceutically acceptable carrier;
- wherein the pharmaceutically acceptable carrier comprises:
- about 40% w/w of microcrystalline cellulose;
- about 7% w/w sodium starch glycolate;
- about 15% w/w pregelatinized starch;
- about 1% w/w of colloidal silicon dioxide;
- and
- about 0.9% w/w of calcium stearate;
- wherein the solid oral composition releases not less than 58% of chlorthalidone within 15 minutes in dissolution media having a pH of 1.2, 4.5, or 6.8;
- and
- wherein the dissolution testing is conducted in a USP Type I basket apparatus at 100 rpm in 500 ml of dissolution media maintained at 37±0.5° C.
13 more elements
Dependencies are inferred from the claim text.