United States Patent:   6,001,386

Assignee:  University of Kentucky Research Foundation (Lexington, KY)

Filed:  April 14, 1998

A simple and implantable sustained release drug delivery device with an inner core containing an effective amount of a low solubility agent covered by a non-bioerodible polymer coating layer that is permeable to the low solubility agent is disclosed. A method for treating a mammal to obtain a desired local or systemic physiological or pharmacological effect by surgically implanting such a sustained release drug delivery device into a mammal in need of treatment is also disclosed.

DISCLOSURE OF THE INVENTION

Therefore, it is an object of this invention to provide a device suitable for the controlled and sustained release of a composition effective in obtaining a desired local or systemic physiological or pharmacological effect and which, once implanted, gives a continuous release to an affected area without requiring additional invasions into the region. Moreover, the present invention is designed to hold the low solubility agent in the correct anatomic location and to prevent disintegration of the inner core. By maintaining surface area, the present invention reduces fluctuations in release characteristics. In one embodiment, fluctuations caused by changes in the composition of the bathing fluid are also eliminated.

In one embodiment, the device includes an inner core comprising an effective amount of a low solubility agent, and a non-erodible polymer coating layer, the polymer layer being permeable to the low solubility agent, wherein the polymer coating layer partially or completely covers the inner core.

Another object of the present invention is to provide a method for treating a mammal, e.g., a human, to obtain a desired local or systemic physiological or pharmacological effect. The method includes securing the sustained release drug delivery device at an area where release of the agent is desired and allowing the agent to pass through the polymer coating layer to the desired area of treatment.

A further object of the invention is to provide an ocular device suitable for direct implantation into the eye. Such devices of the present invention are surprisingly found to provide sustained release controlled release of various compositions to treat the eye without risk of detrimental side effects.

An additional object of the present invention is to provide an ocular delivery system that could be applied to an intraocular lens to prevent inflammation or posterior capsular opacification.

Another object of the present invention is to provide a means of achieving and maintaining therapeutic levels of trans retinoic acid, cis retinoic acid and other related retinoid compounds in the eye.

The above and other objects of the invention will become readily apparent to those of skill in the relevant art from the following detailed description and figures, wherein only the preferred embodiments of the invention are shown and described, simply by way of illustration of the best mode of carrying out the invention. As is readily recognized the invention is capable of modifications within the skill of the relevant art without departing from the spirit and scope of the invention.

Claim 1 of 18 Claims

1. A sustained release drug delivery device comprising:

an inner core comprising an effective amount of an agent having a solubility less than about 10 .mu.gml; and

a polymer coating layer, the polymer layer being permeable to the agent, wherein the polymer coating layer completely covers the inner core.

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