Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
AssigneeWatson Pharmaceuticals, Inc.
InventorsUnchalee Kositprapa, Robert I. Goldfarb, John Cardinal, Avinash Nangia
Life of this patent
Estimating the term…
Abstract
A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.
Claims31
A pharmaceutical dosage form having a first and second active drug, said dosage form comprising:
- (a) a controlled release core comprising an antihyperglycemic drug and at least one pharmaceutically acceptable excipient.
- (b) a seal coat applied to the controlled release core;
- and
- (c) an immediate release thiazolidinedione derivative containing coating applied to the seal coating.
A pharmaceutical dosage form having a first and second active drug, said dosage form comprising:
- (a) a controlled release core comprising an antihyperglycemic drug and at least one pharmaceutically acceptable excipient;
- and
- (b) an immediate release thiazolidinedione derivative containing coating applied to the controlled release core comprising:
- (i) a thiazolidinedione derivative;
- and
- (ii) a binder;
- wherein the immediate release coating is applied to the controlled release core using a solvent mixture comprising water and an organic solvent.
A pharmaceutical dosage form having a first and second active drug, said dosage form comprising:
- (a) a controlled release core comprising an antihyperglycemic drug and at least one pharmaceutically acceptable excipient;
- and
- (c) an immediate release thiazolidinedione derivative containing coating applied to the controlled release core comprising:
- (i) a thiazolidinedione derivative;
- (ii) a binder;
- (iii) a surfactant;
- and
- (iv) a pore former;
- wherein the immediate release coating is applied to the controlled release core using water, an organic solvent or a solvent mixture comprising water and an organic solvent.
A pharmaceutical dosage form having a first and second active drug, said dosage form consisting essentially of:
- (a) an osmotic tablet core wherein a osmotic tablet consists essentially of:
- (i) a core comprising:
- (I) 50-98% of metformin or a pharmaceutically acceptable salt;
- (II) 0.1-40% of a binding agent;
- and
- (III) 0-20% of an absorption enhancer;
- (ii) optionally a seal coat surrounding the core;
- and
- (iii) a semipermeable membrane comprising:
- (I) 50-99% of a polymer;
- (II) 0-40% of a flux enhancer and
- (III) 0-25% of a plasticizer, said membrane having at least one passageway formed therein for release of the metformin;
- (b) optionally a seal coat applied to the osmotic tablet core
- (c) an immediate release thiazolidinedione derivative containing coating consisting essentially of:
- (i) a thiazolidinedione derivative selected from the group consisting of troglitazone, rosiglitazone, pioglitazone, ciglitazone or pharmaceutically acceptable salts, isomers or derivatives thereof.;
- (ii) a binder;
- and
- (iii) a surfactant wherein the immediate release coating is applied to the core or sub coated core using a solvent mixture comprising water and an organic solvent and wherein the dosage form provides a Tmax of 8-12 hours for the metformin and a Tmax of 14 hours for the thiazolidinedione derivative.
Dependencies are inferred from the claim text.