Core formulation comprised of troglitazone and a biguanide

Details Core formulation comprised of troglitazone and a biguanide Core formulation comprised of troglitazone and a biguanide

2001-02-15

2002-09-17

Spear, James M. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S468000, C424S475000, C424S482000, C424S490000, C424S497000, C424S471000, C514S770000, C514S866000

Reexamination Certificate

active

06451342

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a core formulation, and, more particularly, to a core formulation comprising a first layer comprising troglitazone, which covers at least a portion of a core comprising a biguanide, such as for example metformin (i.e., glucophage), with a modulating release polymer comprising a silicate.
2. Description of the Related Art
Metformin and troglitazone, and their salts such as the hydrochlorides, maleates, tartrates, etc., are two active ingredients of anti-diabetic drugs that are used to treat diabetic patients, e.g. human beings. These two active agents are administered orally to patients in need thereof in protocols calling for the single administration of either ingredient. Heretofore, there has not been revealed or hinted at combining both ingredients and certainly not a physically combined core formulation comprising both ingredients. The advantage of such a core formulation is advantageous to patients and prescribers because both medicaments are synergistic to each other in the body when used in the management of blood glucose control, i.e., diabetes. Furthermore, the use of a modulating agent, like silica gel, in the preparation, controls the rate of drug release over a clinically meaningful period to enable better control of the effect of the medicinal agents in such preparation.
SUMMARY OF THE INVENTION
This invention relates to a core formulation, and, more particularly, to a core formulation comprising a first layer comprising troglitazone or a derivative thereof, e.g. troglitazone hydrochloride, which covers at least a portion of a core comprising a biguanide, one or both of which are intimately dispersed in a silicate based modulating agent.


REFERENCES:
patent: 6166042 (2000-12-01), Ikeda et al.

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