Controlled release formulation for poorly soluble basic drugs
AssigneeAbbott Laboratories
InventorsNeville W. Broad, Alan F. Carmody, Liam C. Feely, Brian C. Withers
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Abstract
A controlled release, oral, solid, pharmaceutical composition for a reduced daily dosage regimen is described where the therapeutic ingredient is a poorly soluble basic drug. The formulation comprises the use of a water-soluble alginate salt, a complex salt of alginic acid and an organic carboxylic acid in admixture with the therapeutic drug. A particular embodiment comprising a once a day dosage form for clarithromycin is also described.
Claims17
A controlled release, solid pharmaceutical composition adapted for oral administration comprising:
- a therapeutically effective amount of at least one basic drug having a water solubility of less than 1 part per 30 parts water;
- a water-soluble alginate salt;
- a complex salt of alginic acid, wherein the cation yielding an insoluble salt is selected from the group consisting of calcium, strontium, iron, and barium;
- and an organic carboxylic acid to facilitate dissolution of the basic drug, wherein the weight ratio of the water-soluble salt to the complex salt of alginic acid varies from 16:1 to 1:1, and the molar ratio of the carboxylic acid to the drug varies from 0.2:1 to 5:1.
A controlled release, solid pharmaceutical composition adapted for oral administration of a once a day dosage regimen comprising:
- about 500 mg of clarithromycin;
- from about 75 to 400 mg of sodium alginate;
- from about 10 to 400 mg of sodium-calcium alginate, and about 128 mg of citric acid.
Dependencies are inferred from the claim text.