Core formulation

Details Core formulation Core formulation

2001-02-15

2003-02-25

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

C424S489000, C424S498000, C424S451000, C424S452000, C424S464000, C424S465000

Reexamination Certificate

active

06524621

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 pioglitazone, which covers at least a portion of a core comprising a biguanide, metformin (i.e., glucophage), with a modulating release polymer comprising a silicate.
2. Description of the Related Art
Metformin and pioglitazone, or 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 use 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 pioglitazone hydrochloride, which covers at least a portion of a core comprising a biguanide, e.g. metformin, one or both of which are intimately dispersed in a silicate based modulating agent.


REFERENCES:
patent: 4389330 (1983-06-01), Tice et al.
patent: 4867902 (1989-09-01), Russell
patent: 6030641 (2000-02-01), Yamashita et al.
patent: 6166043 (2000-12-01), Ikeda et al.
patent: 6296874 (2001-10-01), Cutie et al.

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