Extended release pharmaceutical formulations
AssigneeKV Pharmaceutical Company
InventorsGeorge N. Paradissis, James A. Garegnani, Roy S. Whaley
Life of this patent
Estimating the term…
Abstract
An extended release pharmaceutical formulation adapted to approach zero order release of drug over a 12 to at least 24 hour period, comprised of a mixture of 0 to aobut 50% of an immediate release particle containing a drug, inert substrate and binder, coated with talc and up to 100% of an extended release particle comprising the immediate release particle coated with a dissolution modifying system containing plasticizers and a film forming agent.
Claims29
An extended release pharmaceutical formulation for oral administration, which comprises:
- a pharmaceutical formulation which is adapted to approach zero order release of drug over a 12 to at least a 24 hour period, which formulation is comprised of a mixture of a) about 0% to about 50% of an immediate release particle containing a core comprising a therapeutically effective amount of at least one water-soluble or water-insoluble drug, about 15% to about 40% by weight inert spherical substrate particles, and about 0.5% to about 4% by weight binder, coated with about 4% to about 20% by weight talc and having a particle size of -10+60 mesh size, U.S. Standard sieve size, and b) up to 100% of an extended release particle comprising about 65% to about 95% by weight of the immediate release particle of a) additionally coated with about 5.0% to about 35% by weight of a dissolution modifying system comprising a film forming agent and plasticizer, wherein the extended release particle has a particle size of -10+60 mesh size, U.S. Standard sieve mesh size, and wherein all percentages are based on the total weight of the pharmaceutical formulation.
The extended release pharmaceutical formulation for oral administration, which comprises:
- a pharmaceutical formulation which is adapted to release a drug over a 12 to at least a 24 hour period, which formulation is comprised of a mixture of a) about 0% to about 50% of an immediate release particle containing a core comprising a therapeutically effective amount of at least one water-soluble or water-insoluble drug, about 15% to about 40% by weight inert spherical substrate particles, and about 0.5% to about 5% by weight binder, coated with about 4% to about 20% by weight talc and having a particle size of -10+60 mesh size, U.S. Standard sieve size, and b) up to 100% of an extended release particle comprising about 65% to about 95% by weight of the immediate release particle of a) additionally coated with about 5.0% to about 35% by weight of a dissolution modifying system comprising a film forming agent and plasticizer, wherein the extended release particle has a particle size of -10+60 mesh size, U.S. Standard sieve mesh size, and wherein all percentages are based on the total weight of the pharmaceutical formulation.
An extended release pharmaceutical formation for oral administration which comprises:
- a pharmaceutical formulation which is adapted to approach zero order release of drug over a 12 to at least 24 hour period, which formulation is comprised of a mixture of:
- a) 0 to about 50% of an immediate release particle containing about 15 to about 40% by weight inert spherical substrate particle about 0.5 to about 4% binder and about 4 to about 85% of at least one drug and a coating comprising about 4 to about 20% talc;
- and
- b) up to 100% of an extended release particle comprising an immediate release particle of a) coated with a dissolution modifying system comprising about 0.5 to about 25% film forming agent, about 0.01 to about 5% plasticizer and up to 25% modifying agent, all percents herein are by weight of the final product.
Dependencies are inferred from the claim text.