Gastric retention dosage form having multiple layers

Abstract

The present invention is directed to a multilayered dosage form which is adapted for retention in the stomach and useful for the prolonged delivery of an active agent to a fluid environment of use. The active agent dosage form is a multilayer core, often bilayer, formed of polymer matrices that swell upon contact with the fluids of the stomach. At least one layer of the multilayered dosage form includes an active agent. A portion of the polymer matrices are surrounded by a band of insoluble material that prevents the covered portion of the polymer matrices from swelling and provides a segment of the dosage form that is of sufficient rigidity to withstand the contractions of the stomach and delay expulsion of the dosage form from the stomach until substantially all of the active agent has been dispensed.

Description

FIELD OF THE INVENTION The present invention is related to the prolonged release of an active agent from a dosage form. More particularly, it relates to a multilayered active agent dosage form having a highly swellable layer and a drug layer, the dosage form being adapted for retention in the stomach for a prolonged period. BACKGROUND OF THE INVENTION Controlled release dosage forms that provide for prolonged delivery of active agent formulations to the environment of use have found application for increasing numbers of active agents. However, with respect to pharmaceutical and veterinary active agent formulations, there has been a need not only to provide for prolonged delivery of the active agent over time, but also to provide prolonged delivery of the active agent at a particular location or locations in the environment of use, such as in the stomach. Certain active agents are absorbed primarily from the small intestine. Generally, the time of passage of different particles th...

AI Technical Summary

Benefits of technology

As can be observed in the above-referenced patents and publications, devices have been described that provide for prolonged delivery of an active agent and retention in the gastric environment. Howe...

Problems solved by technology

For active agents that are not easily absorbed by the small intestine or that do not dissolve readily, the window for active agent absorption in the small intestine may be too short to provide a desired therapeutic effect.

The need for frequent dosing presents compliance problems and is often inconvenient for the user as well.

In the fed state, non-digested material is not generally able to leave the stomach.

However, it is not practical to regularly maintain the fed state over a long period of time.

While it is possible to control the dimensions of the hydrogel in the dry state, controlling the size of the glassy core within the hydrogel after administration to a subject by addition of water is not suitable for fabrication of a dosage form that can routinely and controllably be retained in the stomach of a subject over a prolonged period of time.

However, continuous oral administration requiring the interaction of the patient is not what would generally be considered suitable therapy.

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