Controlled release potassium dosage form

A - Human Necessities – 61 – K

Patent

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Details

A61K 33/14 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01)

Patent

CA 2172624

A pharmaceutical composition for oral administration of potassium salt in a form not irritating to the gastrointestinal mucosa comprises tablets or capsules of micropellets of a potassium salt, such as potassium chloride. The micropellets are coated with a permeable polymer comprising a low viscosity (10cp,) ethylcellulose in combination with triacetin. This coating provides a strong film resistant to breakage during formation of tablets and filling of capsules. The protective coating of the micropellets prevents the early release of potassium ions, while the tablet or capsule disintegrates and the micropellets are dispersed within the lumen of the gastrointestinal tract. As water passes through the permeable but insoluble coating, potassium ions are gradually eluted into the fluid of the tract over a period of many hours, thereby allowing time for the ions to be absorbed from the tract before high, irritating ion concentrations can form.

Une composition pharmaceutique permettant l'administration par voie orale de sel de potassium sous une forme n'irritant pas la muqueuse gastro-intestinale consiste en comprimés ou gélules de microbilles d'un sel de potassium tel que du chlorure de potassium. Lesdites microbilles sont enrobées de polymère perméable comprenant une éthylcellulose de faible viscosité (10 cp) combinée avec de la triacétine. Cet enrobage constitue une pellicule résistant à la rupture pendant le formage des comprimés et le remplissage des gélules. L'enrobage de protection des microbilles empêche la libération précoce d'ions de potassium lorsque le comprimé ou la gélule se désintègrent et que ces dernières se dispersent dans la lumière du tractus gastro-intestinal. A mesure que l'eau traverse l'enrobage perméable mais insoluble, les ions de potassium sont élués dans le liquide du tractus sur une période de plusieurs heures, ce qui permet l'absorption des ions à partir du tractus avant la formation de concentrations d'ions importantes et irritantes.

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