Filled gelatin capsules
AssigneeNovartis Finance Corporation
InventorsAdedotun Tony Adesunloye, Paul Edward Stach
Life of this patent
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Abstract
Disclosed is a method of reducing crosslinking in gelatin capsules wherein an amino acid and a carboxylic acid are incorporated into the capsule fill, as well as filled gelatin capsules that utilize the disclosed method. The inventive method is especially useful for pharmaceutical formulations which include hydrochlorothiazide, triamterene, gemfibrozil, chloramphenicol, etodolac, piroxicam, nifedipine, tetracycline, diphenhydramine, hydroflumethiazide and rifampin, or a combination thereof as active ingredient.
Claims18
A method of preparing a filled gelatin capsule wherein the dissolution profile at 45 minutes of capsules maintained at about 40.degree. C. and 85 percent relative humidity for four weeks remains within .+-.10 percent of the initial dissolition of the capsules at 45 minutes and/or the dissolution profile at 45 minutes of capsules maintained at about 40.degree. C. and 85 percent relative humidity for twelve weeks remains within .+-.20 percent of the initial dissolution of the capsules at 45 minutes, which comprises incorporating into the filled gelatin capsule a material which promotes crosslinking in the gelatin capsule and from 0.1 to 25 percent by weight of at least one monomeric amino acid, or salt thereof, and from 0.01 to about 10 percent by weight of at least one monomeric carboxylic acid, or salt thereof, which is different from the amino acid and which is in addition to any stearic acid or salt thereof present in the filling.
Dependencies are inferred from the claim text.