Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1997-08-01
1999-03-16
Brouillette, D. Gabrielle
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424479, 424480, 424489, A61K 924
Patent
active
058826823
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention pertains to both a useful and novel drug-delivery device for dispensing a drug to an environment of use. Particularly, the invention pertains to a system that releases a drug in a controlled fashion, by creating gelatinous microscopic particles of polymer gel and in so doing, generates a dispersion of drug among the microscopic particles. The dispersion then moves from the device surface into the aqueous environment of use.
The device is composed of a core containing a beneficial agent such as a medicament, a polymer which provides gelatinous microscopic particles upon hydration and if desired a hydration modulating agent. The device is completely coated with an insoluble, impermeable coating. The device is completely coated with an insoluble, impermeable coating. The coating contains apertures to expose discrete portions of the surface of the core. The delivery rate of the medicament is a function of the core composition as well as the number and size of the apertures.
In the environment of use, biological fluid contacts the exposed portions of the core surface where hydration of the polymer at the surface begins. As the particles of polymer at the exposed surface absorb water, a gelatinous microscopic dispersion of particles results. Mixed with and dispersed in these microscopic particles are the other components of the core formulation, such as a medicament.
The exposed portion of the core surface is bounded on all sides by the coating. Hydration of the polymer occurs only at the exposed surface of the core, resulting in the steady-state formulation of a gelatinous microscopic particle dispersion within which the drug is dispensed and which moves into the environment of use.
The rate of release of the beneficial agent is not dependent upon the solubility of the beneficial agent in the biological fluid. Rather, the release rate is essentially dependent upon the rate at which the gelatinous microscopic particle dispersion forms at the exposed surface of the device core and exudes from the device carrying with it the beneficial agent and any other core excipient materials that are present.
BACKGROUND OF THE INVENTION
The need for systems that can deliver any drug at a controlled rate of release to an environment of use over a specified period of time is well established.
U.S. Pat. No. 4,814,182 discloses the use of rods or slabs of pre-hydrated and swelled polyethylene oxide hydrogel. The polymer is impregnated with a biologically active agent during the hydration procedure. The hydrated polymer is then dried and partially coated with an impermeable, insoluble material. When placed in an aqueous environment, the polymer swells, but does not dissolve or disintegrate. The entrapped active ingredient is released from the polymer by diffusion. The mechanism of release is based on the ability of the soluble drug to diffuse through the rehydrated hydrogel and move into the aqueous environment.
U.S. Pat. No. 4,839,177 discloses the use of hydrogels compressed to defined geometric forms. In this device, the polymer is mixed with biologically active ingredients to form a core which is affixed to a "support platform" made of an insoluble polymeric material. When hydrated, the swellable, gellable hydrogel expands beyond the device and establishes a superstructure from which the active agent is released either by diffusion, if the active agent is soluble, or by erosion, if the active agent is insoluble. The generation and maintenance of the superstructure is vital to the proper operation of this device.
An osmotic dosage form which utilizes a semipermeable wall containing at least one "exit means" which passes through the wall surrounding a core containing an osmotic agent, a neutral and ionizable hydrogel and an active ingredient is taught in U.S. Pat. No. 4,971,790. The coating of this device is permeable to water from the environment of use. Water moves into the core through the semipermeable membrane. Once inside the device, the water solubilizes the osmotic agent, and hyd
REFERENCES:
patent: 3146169 (1964-08-01), Stephenson et al.
patent: 4220153 (1980-09-01), Dreeback
patent: 4327725 (1982-05-01), Cortese et al.
patent: 4601893 (1986-07-01), Cardinal
patent: 4743247 (1988-05-01), Wong
patent: 4783337 (1988-11-01), Wong et al.
patent: 4814182 (1989-03-01), Graham
patent: 4839177 (1989-06-01), Colombo et al.
patent: 4898733 (1990-02-01), DePrince
patent: 4915954 (1990-04-01), Ayer et al.
patent: 4971790 (1990-11-01), Magruder
patent: 4994273 (1991-02-01), Zentner
patent: 4996060 (1991-02-01), Eckenhoff et al.
patent: 5004614 (1991-04-01), Staniforth
patent: 5030452 (1991-07-01), Curatolo
patent: 5051263 (1991-09-01), Barry
patent: 5057321 (1991-10-01), Edgren et al.
patent: 5120548 (1992-06-01), McClelland
patent: 5366738 (1994-11-01), Rork et al.
F. Theeuwes, "Elementary Osmotic Pump", Journal of Pharmaceutical Sciences, vol. 64, No. 12, Dec. 1975, pp. 1987-1991.
R. Baker, "Controlled Release of Biologically Active Agents", A Wiley-Interscience Publication, pp. 169-174.
G. M. Zentner, et al., "The Controlled Porosity Osmotic Pump", Journal of Controlled Release, 1 (1985), pp. 269-282.
Pipkin James D.
Rork Gerald S.
Brouillette D. Gabrielle
Merck & Co. , Inc.
Quagliato Carol S.
Winokur Melvin
LandOfFree
Controlled release simvastatin delivery device does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Controlled release simvastatin delivery device, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Controlled release simvastatin delivery device will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-815006