Chlorthalidone compositions and methods
AssigneeNivagen Pharmaceuticals, Inc.
InventorsGovind R. Jagadale, Dasaradhi Lakkaraju, Bala Tripura Sundari Chodavarapu, Niravkumar Prajapati, Anand Shukla, Jay Shukla
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Abstract
Compositions of a stabilized chlorthalidone suspension and methods for making a stabilized chlorthalidone suspension include chlorthalidone along with a solubilizing and/or wetting agent, a suspending agent, and a viscosity increasing agent and/or an anti-caking agent, wherein the stabilized chlorthalidone suspension is a uniform dispersion with consistent concentration of chlorthalidone throughout the composition and storage.
Claims20
A composition comprising a stabilized chlorthalidone suspension, the stabilized chlorthalidone suspension, comprising:
- chlorthalidone, wherein the chlorthalidone is undissolved in the suspension and wherein the undissolved chlorthalidone is present in the suspension at a concentration of between 1 to 20 mg/mL;
- a solubilizing or wetting agent;
- at least one suspending agent;
- at least one viscosity increasing agent or at least one anti-caking agent;
- and
- water;
- wherein the solubilizing or wetting agent, the at least one suspending agent, and the at least one viscosity increasing agent or at least one anti-caking agent are present in respective quantities to provide uniform dispersion of the undissolved chlorthalidone following initial stirring of the suspension so that a first chlorthalidone concentration in a first sample of the composition differs from a second sample in a second volume of the composition by no more than 5% after storage for at least 60 min without stirring.
A method for making a stabilized chlorthalidone suspension, comprising:
- forming a first mixture by
- adding a solubilizing or wetting agent to a first volume of water having a temperature of between about 25° C. to 30° C. with stirring;
- wherein the first volume of water is 50% of the stabilized chlorthalidone suspension;
- adding a suspending agent to the first volume of water with stirring and homogenizing;
- and
- adding at least one viscosity increasing agent or at least one anti-caking agent to the first volume of water with stirring and homogenizing;
- forming a second mixture by
- adding a sweetening agent to a second volume of water with stirring;
- adding a viscosity increasing agent to the second volume of water with stirring;
- and
- adding chlorthalidone at between about 5 to 20 mg/mL to the second volume of water with stirring and homogenizing;
- and
- forming the stabilized chlorthalidone suspension by
- adding the first mixture to the second mixture with stirring to form a third mixture;
- optionally adding a third volume of water to the third mixture to thereby render a final volume;
- and
- homogenizing the third mixture to form the stabilized chlorthalidone suspension.
Dependencies are inferred from the claim text.