Controlled release device

Details Controlled release device Controlled release device

1995-06-27

1998-05-12

Spear, James M.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Capsules

424452, 424453, 424454, 424457, 424463, A61K 948, A61K 952

Patent

active

057501432

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/GB93/02271 filed Nov. 4, 1993.


TECHNICAL FIELD

The present invention relates to a controlled release capsule construction which comprises a male member engaged within a neck portion of a female body; the capsule including a water swellable material which swells so as to disengage the female body upon exposure of the capsule to an aqueous medium. The capsule is intended to release two dosages of pharmaceutically active materials at different times.


BACKGROUND

International patent specification W090/09168 discloses a device of this type which comprises a water swellable male plug engaged within a female body. A pharmaceutically active material is contained within the device. When the capsule is exposed to water, the male hydrogel plug swells and eventually disengages itself from the female body, thereby allowing the pharmaceutically active material contained within the device to be released. It has been found that the time taken to release the pharmaceutical material is predictable and reproducible, so that the device may be used to release pharmaceutically active material within the body of a patient after a predetermined time interval (e.g. 0.5 to 12 hours). This may, for example, be useful in the treatment of medical conditions where it is desirable to administer a pharmaceutically active material to the patient sometime through the night while the patient is asleep, so as to provide a desired level of the drug in the patient in accordance with his needs, for example during the night or when he awakes. It may also be useful to allow dosing of materials at a predetermined point as the capsule passes through the gastro-intestinal tract, for example in the colon.
Patent specification W092/13521 (Alza Corporation) describes fluid-imbibing dispensing devices for delayed delivery of a pharmaceutically active agent, which include an expansion means which absorbs fluid from a surrounding environment. The dispensing device comprises a housing having first and second wall sections telescopically engaged with each other, particularly a capsule having a hollow cap and a hollow body; either the cap or the body is in the form of a male section fitted inside the open end of the other female section. The expansion means is contained within the device and expands as it absorbs fluid, forcing apart the two sections of the device. The expansion means may be a swellable polymer or an osmotic formulation which swells as it absorbs fluid. In order to allow fluid to come into contact with the expansion means contained within the device, one of the wall sections adjacent to the expansion means is fluid-permeable. After the sections are disengaged, fluid enters the device and comes into contact with the active agent contained within the device, thereby dispensing the active agent into the fluid.
Conventional hard gelatin capsules are produced and filled in large numbers using high speed automatic machinery. Very often, the cap is prefitted to the capsule body during manufacture of the capsule. During filling, the filling machine removes the cap, fills the capsule with pharmaceutical material, and then replaces the cap in a manner such that the cap is locked onto the capsule body. Patent specification U.S. Pat. No. 3,399,803 discloses a self-locking medicament capsule wherein the body has a groove near its open end and the cap has a corresponding ridge which snaps into the groove so as to lock the cap and body together. U.S. Pat. No. 4,442,941 discloses a bayonnet-type arrangement whereby a raised portion on the cap is engaged into a groove on the body. European patent specification 246504 also discloses a capsule body having a groove near its mouth for the purposes of preventing the capsule distorting from its cylindrical form, which may cause difficulty in fitting the cap onto the capsule body.


SUMMARY OF THE INVENTION

The present invention relates to a development of the capsule construction disclosed in W090/09168 to allow sequential dosing of a patient at different times with the same

REFERENCES:
patent: 3823843 (1974-07-01), Stephens et al.
patent: 4487327 (1984-12-01), Grayson
patent: 4667498 (1987-05-01), Sauter
patent: 5387421 (1995-02-01), Amidon et al.

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