Sustained release heterodisperse hydrogel systems for insoluble drugs
AssigneeEdward Mendell Co., Inc.
InventorAnand R. Baichwal
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Abstract
A sustained release pharmaceutical formulation includes a sustained release excipient including a gelling agent, an inert pharmaceutical diluent, an optional cationic cross-linking agent, and a medicament having moderate to poor solubility is disclosed. In certain embodiments, the sustained release excipient is granulated with a solution or suspension of a hydrophobic polymer in an amount effective to slow the hydration of the gelling agent when the formulation is exposed to an environmental fluid. In another embodiment, the tablet is coated with a hydrophobic polymer.
Claims25
A sustained release oral solid dosage form for absorption of a therapeutically active medicament in the gastrointestinal tract, comprising:
- an effective amount of a medicament having a solubility of less than about 10 g/l to render a therapeutic effect;
- a sustained release excipient comprising a gelling agent comprising a heteropolysaccheride gum and a homopolysaccharide gum capable of cross-linking said heteropolysaccharide gum when exposed to an environmental fluid, the ratio of said heteropolysaccharide gum to said homopolysaccharide gum being from about 1:3 to about 3:1, an inert pharmaceutical diluent, the ratio of said inert diluent to said gelling agent being from about 1:8 to about 8:1;
- and a pharmaceutically acceptable cationic cross-linking agent capable of cross-linking with said gelling agent and increasing the gel strength when the dosage form is exposed to an environmental fluid;
- the ratio of said medicament to said gelling agent being from about 1:3 to about 1:8;
- said dosage form providing a sustained release of said medicament when exposed to an environmental fluid.
Dependencies are inferred from the claim text.