Valerian Composition and Related Methods
AssigneePhysician's Seal, LLC
InventorsSyed M. Shah, Christopher Diorio, Daniel Hassan, Fred Hassan
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Abstract
A valerian composition includes a therapeutically effective pharmaceutical dosage form having a solid core including a polymer in which valerian and a valerian stability improving amount of an acidifying agent are contained. The valerian stability improving amount of acidifying agent being sufficient to impart a pH of 2 to 5 to the polymer.
Claims32
A composition comprising a therapeutically effective pharmaceutical dosage form having a solid core including a polymer in which valerian and an amount of acidifying agent are contained, the amount of acidifying agent being sufficient to impart a pH of 2 to 5 to the polymer.
A composition comprising a therapeutically effective pharmaceutical dosage form having:
- a solid core including valerian within an acidified polymer matrix;
- an expedited release portion including a first fraction of the valerian, the expedited release portion being effective to release the first fraction within about 2 hours from placement in a 0.1 N HCl solution;
- and
- a sustained release portion including a second fraction of the valerian, the sustained release portion being effective to release the second fraction within about 10 hours from placement in a phosphate buffer with a pH of 6.8.
A method of making a storage stable valerian pharmaceutical dosage form, the method comprising:
- forming an acidified polymer matrix by combining valerian, a hydrogel forming polymer, an amount of acidifying agent acidifying agent, and water;
- and
- making a solid pharmaceutical dosage including the acidified polymer matrix;
- wherein the amount of acidifying agent makes the solid pharmaceutical dosage form storage stable by preventing degradation of the valerian when the pharmaceutical dosage form is stored at 25 degrees C. and 60% relative humidity.
A method of treatment comprising administering to a patient in need thereof a therapeutically effective amount of a pharmaceutical dosage form having a solid core including a polymer in which valerian and an amount of acidifying agent are contained, the amount of acidifying agent being sufficient to impart a pH of 2 to 5 to the polymer.
Dependencies are inferred from the claim text.