Bioadhesive tablet for non-systemic use products
AssigneeEdward Mendell Co., Inc.
InventorAnand R. Baichwal
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Abstract
The present invention relates to a controlled release bioadhesive tablet which includes a locally active agent, a heterodisperse gum matrix, and a pharmaceutically acceptable diluent. In certain preferred embodiments, the tablet further includes an additional bioadhesive agent. The final product adheres to mucous membranes and releases the locally active agent over a desired period of time. Also disclosed is a bioadhesive excipient useful in the preparation of these tablets.
Claims13
A bioadhesive controlled-release solid tablet, comprising
- a controlled release bioadhesive excipient comprising a heterodisperse gum matrix comprising a heteropolysaccharide gum and a homopolysaccharide gum capable of cross-linking said heteropolysaccharide gum in the presence of aqueous solutions, the ratio of said heteropolysaccharide gum to said homopolysaccharide gum being from about 1:3 to about 3:1;
- an inert pharmaceutical diluent selected from the group consisting of monosaccharide, a disaccharide, a polyhydric alcohol, and mixtures thereof, the ratio of said inert diluent to said heterodisperse gum matrix being from about 21:1 to 200:1;
- and
- a locally active agent in an amount effective to render a local effect when the formulation is exposed to fluid in an environment of use.
A controlled release bioadhesive tablet for administration in the oral cavity, comprising
- (i) a heterodisperse gum matrix comprising xanthan and locust bean gum in a ratio of about 1:1;
- (ii) an inert pharmaceutically acceptable diluent selected from the group consisting of a monosaccharide, a disaccharide, and mixtures thereof, the ratio of said diluent to said heterodisperse gum matrix being from about 21:1 to about 200:1;
- and
- (iii) an effective amount of a active agent to render a localized effect in the oral cavity,
- said heterodisperse gum matrix being in an amount effective to adhere to the oral mucosa while providing a controlled release of said active agent in the oral cavity when exposed to saliva.
A controlled release bioadhesive excipient, comprising
- a heterodisperse gum matrix comprising a heteropolysaccharide gum having bioadhesive properties and a homopolysaccharide gum capable of cross-linking said heteropolysaccharide gum in the presence of aqueous solutions, the ratio of said heteropolysaccharide gum to said homopolysaccharide gum being from about 1:3 to about 3:1;
- a bioadhesive agent selected from the group consisting of carbomer, poly carbophil, poly oxyethylene oxide, and mixtures of any of the foregoing, said bioadhesive agent being in an amount sufficient, in combination with said heterodisperse gum, to provide said excipient with a desired bioadhesive effect;
- and
- an inert pharmaceutical diluent selected from the group consisting of monosaccharide, a disaccharide, a polyhydric alcohol, and mixtures thereof.
Dependencies are inferred from the claim text.