Banded prolonged release active agent dosage form

Details Banded prolonged release active agent dosage form Banded prolonged release active agent dosage form

2000-08-31

2001-11-13

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S484000, C424S486000

Reexamination Certificate

active

06316028

ABSTRACT:

FIELD OF THE INVENTION
The present invention is related to the prolonged delivery of an active agent. More particularly, it is a banded active agent dosage form useful for delivering a beneficial agent to a fluid environment of use. The invention is also directed to the method of making the banded active agent dosage form.
BACKGROUND OF THE INVENTION
Tablets, capsules, caplets and many other types of devices have been used for dispensing a beneficial agent to a fluid environment of use. Easy manufacture of a device that provides for prolonged delivery of an active agent in a controlled and predictable manner continues to be a goal, especially in the area of drug delivery.
U.S. Pat. No. 4,290,426 to Luschen et al describes a cylindrical dispenser for releasing a beneficial agent into a fluid environment at a rate that is governed by the fluid induced relaxation of a polymeric agent contained within the dispenser. The cylindrical dispenser includes an impermeable container that has within it a reservoir and a passageway from the reservoir to the exterior of the container. The reservoir contains a polymer and a beneficial agent. The polymer imbibes fluid from the environment and thereby undergoes relaxation, releasing the beneficial agent from the device. The amount of agent released is dependent on the rate of relaxation of the polymer over time.
Coated dosage forms have also been suggested for delivery of a controlled amount of a beneficial agent over a prolonged period of time. U.S. Pat. No. 5,256,440 describes a process for producing a film coated dosage form. A continuous groove is inscribed in a dosage form core. A latex film is coated onto the core, the groove defining a fixed zone and a detachable zone for the film. The detachable portion of the latex film detaches when it is exposed to the environment of use, thereby exposing a discrete portion of the dosage from core surface. The remainder of the film remains attached to the dosage form core. The exposed portion of the dosage form surface erodes and releases active agent to the environment of use.
Coated tablets for constant and prolonged drug release are described by Conte et al in
J. Controlled Release,
Vol. 26, (1993) pages 39-47. These GEOMATRIX™ Systems are swellable matrices that are coated or tableted with polymeric barrier layers. Release performances of the systems are modulated as a result of the restriction of the releasing surface by the polymeric barrier layer coatings. As the extent of coating of the system's surface is increased, the release of kinetics of the system shift toward constant release. These systems are further described in U.S. Pat. No. 4,839,177 to Colombo et al.
As can be observed in the above-referenced patents and publications, devices have been described that provide for prolonged delivery of an active agent. However, there remains a continuing need for improved systems for delivering an active agent in a reliable and reproducible manner that are easy and inexpensive to manufacture.
SUMMARY OF THE INVENTION
We have observed that devices such as those described above will provide for prolonged delivery of an active agent formulation to a fluid environment of use but that these devices may not necessarily provide for controlled and reliable release. Accordingly, the present invention is directed to a dispensing device that will release an active agent in formulation in a reliably controllable manner, and further that is easy and inexpensive to manufacture.
The invention is directed to an active agent dosage form for the prolonged delivery of an active agent to a fluid environment of use. The surface of an active agent formulation matrix contains two or more insoluble bands.
In one aspect, the invention is directed to an active agent dosage form for the prolonged delivery of an active agent to a fluid environment of use. Two or more insoluble bands surround an active agent formulation matrix. The bands drop off the matrix as it erodes, providing a decreasing path length for delivery of the drug.
In another aspect, the invention is to an active agent dosage form for the prolonged delivery of an active agent to a fluid environment of use where two or more insoluble bands are printed or otherwise securely affixed to the surface of the dosage form. The surface area of the matrix between the bands erodes delivering active agent to the fluid environment of use. The surface area not covered by the rings increases with time.
The invention is also directed to a method for preparing the active agent dosage form for prolonged delivery of an active agent. An active agent formulation matrix is prepared and insoluble material is placed or printed onto the formulation to form two or more insoluble bands on the surface of the matrix.


REFERENCES:
patent: 4290426 (1981-09-01), Luschen et al.
patent: 4327725 (1982-05-01), Cortese et al.
patent: 4503031 (1985-03-01), Glassman
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patent: 5626874 (1997-05-01), Conte et al.
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patent: 5667804 (1997-09-01), Wong et al.
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Robert Langer et al., Polymers for the Controlled Release of Macromolecules: Kinetics, Applications and External Control, AIChE Symposium Series, No. 206, vol. 77, 1981, pp. 10-20.
Dean S.T. Hsieh et al., Zero-Order Controlled-Release Polymer Matrices for Micro—and Macromolecules, Journal of Pharmaceutical Sciences, vol. 72, No. 1, Jan. 1983, pp. 17-22.
U. Conte et al., Journal of Controlled Release, 26 (1993), pp. 39-47, “Multi-Layered hydrophilic matrices as constant release devices”.
Robert H. Zimmer, M.D., Ph.D., “How to Develop Drug Products Using the Geomatrix Technology,” JAGO Pharma AG, Apr. 1997.

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