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US 5,472,711 AGranted
Agglomerated hydrophilic complexes with multi-phasic release characteristics
AssigneeEdward Mendell Co., Inc.
InventorAnand R. Baichwal
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Abstract
The present invention relates to a controlled release formulation which includes a therapeutically active medicament, a heterodisperse gum matrix, a pharmaceutically acceptable diluent, and an effective amount of a pharmaceutically acceptable surfactant and/or wetting agent to provide a multi-phasic controlled release of a therapeutically active medicament. The invention also relates to a method of preparing the same.
Claims24
A controlled-release oral solid dosage form for absorption of an active medicament in the gastrointestinal tract, comprising
- an effective amount of a medicament to render a therapeutic effect;
- a controlled release 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;
- and an inert pharmaceutical diluent selected from the group consisting of a monosaccharide, a disaccharide, a polyhydric alcohol, and mixtures thereof, the ratio of said inert diluent to said heterodisperse gum matrix being from about 3:7 to about 7:3;
- and from about dosage 4 to about 10 percent by weight of a multi-phasic release promoting agent to provide a multi-phasic release of said medicament when said dosage form is exposed to aqueous fluids.
1 more element
A controlled release tablet for oral administration comprising
- (i) a heterodisperse gum matrix comprising xanthan gum and locust bean gum in a ratio 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 3:7 to about 7:3;
- (iii) an affective amount of a medicament to render a therapeutic effect;
- and
- (iv) from at least 2 to about 10 percent by weight of a pharmaceutically acceptable multi-phasic release promoting agent selected from the group consisting of sodium lauryl sulfate, docusate sodium, and mixtures thereof, said medicament having a multi-phasic release of said medicament when exposed to aqueous fluid.
2 more elements
Dependencies are inferred from the claim text.