Gastric retention system for controlled drug release

• US 5,443,843 A
• Filed: 12/24/1990
• Issued: 08/22/1995
• Est. Priority Date: 05/31/1988
• Status: Expired due to Fees

• Current Assignee: Pfizer Inc.
• Original Assignee: Pfizer Inc.
• Inventors: Curatolo, William J., Lo, Jeelin
• Primary Examiner(s): Kishore, Golladmudi S.
• Assistant Examiner(s): Benston, Jr., William E.
• Application Number:
  US07/632,877
• Time in Patent Office: 1,702 Days
• Field of Search: 604/892.1, 424/438, 424/464, 424/469
• US Class Current: 424/464
• CPC Class Codes: A61K 9/0065 Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

An oral drug delivery system having delayed gastrointestinal transit comprising a non-continuous compressible element and an attached controlled release device and which in the expanded form resists gastrointestinal transit; and a modular system for use therein comprising a non-continuous compressible element and an attached receptacle means for receiving and holding a drug-containing orally administrable controlled release device and which in the expanded form resists gastric transit.

Claims

1. A modular system for use in an oral drug delivery system in a mammal, having delayed gastrointestinal transit, which releases a drug or drugs in a controlled manner in said gastrointestinal tract and exits said gastrointestinal tract after said drug or drugs have been substantially released, said modular system comprising a receptacle means for receiving and containing an orally administrable controlled release device and one or more fibers or ribbons attached to said receptacle means, said fibers or ribbons, collectively:

(a) being restrained in a contracted configuration at the time of dosing, and

(b) uncoiling, unrolling, or unfolding after entry into the stomach, into a configuration having a circular or roughly circular cross-section having a diameter of at least about three centimeters,

said modular system capable of softening, disintegrating, dissolving or degrading in the biological environment of the stomach in order to permit the exit of the modular system therefrom.

2. A modular system according to claim 1 wherein said receptacle means is a collar which fits about and holds a controlled release device.

3. A modular system according to claim 1 wherein said receptacle means comprises an opened wall member with an internal space for receiving and holding said device.

4. A modular system according to claim 3 wherein said receptacle means is capped for closing the receptacle means holding the device, said wall and/or said capped member having a passageway to permit passage of environmental fluid into the receptacle means and passage of drug therefrom to the environment.

5. A modular system according to claim 1 wherein one end of said ribbons or fibers are attached to said receptacle.

6. A modular system according to claim 1 wherein two or more ribbons or fibers of substantially equal size are attached to the receptacle.

7. A modular system according to claim 6 wherein the ribbons or fibers are symmetrically spaced about the receptacle.

8. A modular system according to claim 7 having, in the expanded state, a size of from about 2.5 to 6.0 cm in its largest dimension.