Multi-layer tablets and bioadhesive dosage forms

Details Multi-layer tablets and bioadhesive dosage forms Multi-layer tablets and bioadhesive dosage forms

A - Human Necessities

61

K

A61K 9/28 (2006.01)

Patent

CA 2578845

Bioadhesives coatings increase the gastrointestinal retention time of orally- ingested medicaments. Certain bioadhesive coatings producing a fracture strength of at least 100 N/m2, as measured on rat intestine, when applied to at least one surface of a pharmaceutical dosage form for oral delivery of a drug, result in a gastrointestinal retention time of at least 4 hours in a fed beagle dog model, during which the drug is released from the dosage form. Multi-layer tablets, particularly those including hydrophobic excipients, are useful in administering hygroscopic and/or deliquescent drugs. In addition, varying the amount of drug in multi-layer tablets allows the release rate of the drug to be controlled.

L'invention concerne des enrobages bioadhésifs qui augmentent le temps de séjour gastro-intestinal de médicaments ingérés par voie orale. Certains enrobages bioadhésifs possèdent une résistance à la rupture d'au moins 100 N/m2, mesurée sur un intestin de rat, lorsqu'ils sont appliqués sur une surface d'une forme posologique pharmaceutique destinée à l'administration d'un médicament par voie orale. Cette caractéristique permet d'obtenir un temps de séjour gastro-intestinal d'au moins 4 jours chez un chien de race beagle qui est alimenté, période durant laquelle le médicament est libéré par la forme posologique. L'invention concerne également des comprimés multicouche, en particulier ceux contenant des excipients hydrophobes, pouvant être utilisés pour administrer des médicaments hygroscopes et/ou déliquescents. Par ailleurs, en variant la concentration de médicament dans les comprimés multicouche, on régule la vitesse de libération du médicament.

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