Agglomerated hydrophilic complexes with multi-phasic release characteristics
AssigneeEdward Mendell Co., Inc.
InventorsAnand R. Baichwal, John N. Staniforth
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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.
Claims20
A method for preparing an oral solid dose formulation providing a multi-phasic release of a medicament when said dosage form is exposed to aqueous or gastric fluid, comprising
- mixing a heteropolysaccharide gum and a homopolysaccharide gum capable of cross-linking said heteropolysaccharide gum in the presence of aqueous solutions, such that the ratio of said heteropolysaccharide gum to said homopolysaccharide gum is from about 1:3 to about 3:1, to obtain a heterodisperse gum matrix;
- adding an inert pharmaceutical diluent selected from the group consisting of monosaccharide, a disaccharide, a polyhydric alcohol, and mixtures thereof, to said heterodisperse gum matrix such that the ratio of said inert diluent to said heterodisperse gum matrix is from about 3:7 to about 7:3;
- adding an effective amount of a medicament to render a therapeutic effect, and
- adding an effective amount of a pharmaceutically acceptable multi-phasic release promoting agent to provide a multi-phasic release of said medicament when said dosage form is exposed to aqueous fluids.
A method for preparing a tablet for oral administration comprising mixing xanthan gum and locust bean gum in a ratio of 1:1 to form a heterodisperse gum matrix;
- adding an inert pharmaceutically acceptable diluent selected from the group consisting of a monosaccharide, a disaccharide, a polyhydric alcohol, and mixtures thereof to said heterodisperse gum matrix such that the ratio of said inert diluent to said heterodisperse gum matrix is from about 3:7 to about 7:3;
- adding an effective amount of a medicament to render a therapeutic effect;
- adding from about 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;
- and
- compressing the final mixture to form a tablet, said tablet having a multi-phasic release of said medicament when exposed to aqueous fluid.
Dependencies are inferred from the claim text.