Surgery – Controlled release therapeutic device or system – Osmotic or diffusion pumped device or system
Patent
1992-06-02
1998-11-24
Stright, Jr., Ronald K.
Surgery
Controlled release therapeutic device or system
Osmotic or diffusion pumped device or system
6048901, 424438, 424457, 424468, A61K 922
Patent
active
058400745
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention pertains to the provision of a loading dose in long-term agent delivery devices. More particularly, the invention relates to the provision of a beneficial agent loading dose as a part of a long-term beneficial agent delivery device having a semipermeable wall and a reservoir containing a beneficial agent formulation, an expansion means, and, optionally, a density means. Such delivery devices find use in medical and veterinary delivery of medication and nutrients to humans and animals over a prolonged period of time.
BACKGROUND OF THE INVENTION
Agent delivery systems and devices which use an expansion means can deliver a beneficial agent to an environment of use over a period of hours, days, or months. The expansion means absorbs liquid, expands, and acts to drive out beneficial agent formulation from the interior vice in a controlled manner.
Agent delivery devices which use an expansion means can be designed to deliver agent over a relatively short term, i.e., 20-25 days or less. Such devices generally comprise a highly permeable semipermeable membrane, together with a beneficial agent in a carrier which is liquid, relatively non-viscous, and easily extruded by the action of the expansion means. The agent delivery profile of such a short-term device is shown, for example, in FIG. 12 of U.S. Pat. No. 4,595,583, the disclosure of which is hereby incorporated by reference. As shown in U.S. Pat. No. 4,643,731, the disclosure of which is hereby incorporated by reference, instantaneous concentration of beneficial agent obtained from short-term devices can be achieved by providing a loading dose, i.e., an initial, immediate, short-term dose of beneficial agent, prior to the onset of the continuous delivery provided by the osmotic pump device.
Agent delivery devices can alternatively be designed to deliver agent over a longer term, i.e., 25-30 days or greater, and especially 60-120 days or greater. Such devices generally comprise a slowly permeable semipermeable membrane, together with a beneficial agent in a carrier which is viscous or paste-like and extruded by the action of the expansion means over relatively longer times than shown by the short-term devices. The startup time of the device, that is, the time during which the device does not deliver beneficial agent, depends upon the rate at which the semipermeable membrane allows hydration of the system and the rate at which the expansion means becomes hydrated sufficiently to begin extrusion of the beneficial formulation. The agent delivery curve of a device designed to deliver a given dosage for 120 days is shown, for example, in FIG. 21 of U.S. Pat. No. 4,729,793.
The teachings of the prior art pertaining to loading doses of beneficial agent regarding short-term delivery devices do not provide a solution to the problem of the startup delay in long-term devices. Due to the kinetics of the release of loading doses for short-term devices, the loading doses are active for only a short time and do not sustain the concentration of beneficial agent during the startup period demonstrated by long-term devices. Those loading doses provided within the coating of a short-term device are not appropriate for use with long-term devices having a semipermeable membrane, as such coatings can interfere with the permeability of the semipermeable membrane, and thus interfere with the operation of the device.
Ruminant animals, including cattle, sheep, goats, deer, bison, camels and giraffes, and especially domestic animals such as cattle, sheep and goats, comprise an important group of animals that require periodic administration of medicines and nutrients. The medicines and nutrients are administered for the treatment and alleviation of various conditions and for improved health. Ruminants have a complex stomach generally having three or four compartments. The largest of the stomach compartments is the rumen, which acts as an important location for receiving and passing medicines and nutrients into other compartments, including the aboma
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Ayer Atul Devdatt
Eckenhoff James B.
Kuczynski Anthony L.
Wright Jeremy C.
ALZA Corporation
Clarke Pauline A.
Rogers Christopher P.
Sabatine Paul L.
Stright Jr. Ronald K.
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