Controlled delay release device
First Claim
1. A controlled release device for oral administration to a human patient, the device being effective to pass through the patient'"'"'s stomach into the intestine thereby to deliver an active agent thereto, the device containing a single therapeutic dose comprising at least one active agent and a water permeable capsule coated with an enteric coating effective to prevent the ingress of liquid from the stomach into said capsule during the passage thereof through the stomach into the intestine, said capsule including a cavity suitable to receive said at least one active agent;
- an interior wall defining an orifice, said orifice being in communication with said cavity;
a closure member that is separably engageable with said capsule to close said orifice, said orifice being in communication with said cavity; and
a water sensitive material that is receivable by said cavity, wherein upon the passage of the device from the stomach into the intestine, said water sensitive material expands and causes an increasing positive pressure to be exerted on said interior wall of said capsule thereby to effect the rapid separation of said closure member from said capsule and the release of substantially all of the active agent therefrom in a single pulse.
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Accused Products
Abstract
Novel devices for the controlled release of active materials especially pharmaceuticals comprise a capsule formed from two separable pieces at least part of the capsule walls is water permeable. The capsule contains a water sensitive material which on contact with water causes the two pieces to separate. In the preferred embodiment the devices comprise a generally cylindrical tube closed at one or both ends by a water swellable plug. The devices find particular application as oral dosage forms for use in man.
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Citations
29 Claims
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1. A controlled release device for oral administration to a human patient, the device being effective to pass through the patient'"'"'s stomach into the intestine thereby to deliver an active agent thereto, the device containing a single therapeutic dose comprising at least one active agent and a water permeable capsule coated with an enteric coating effective to prevent the ingress of liquid from the stomach into said capsule during the passage thereof through the stomach into the intestine, said capsule including a cavity suitable to receive said at least one active agent;
- an interior wall defining an orifice, said orifice being in communication with said cavity;
a closure member that is separably engageable with said capsule to close said orifice, said orifice being in communication with said cavity; and
a water sensitive material that is receivable by said cavity, wherein upon the passage of the device from the stomach into the intestine, said water sensitive material expands and causes an increasing positive pressure to be exerted on said interior wall of said capsule thereby to effect the rapid separation of said closure member from said capsule and the release of substantially all of the active agent therefrom in a single pulse. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
- an interior wall defining an orifice, said orifice being in communication with said cavity;
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29. A method of preparing a controlled release device for human oral administration comprising a capsule containing an active agent, said capsule including a cavity suitable to receive said active agent;
- an interior wall defining an orifice, said orifice being in communication with said cavity;
a closure member that is separably engageable with said capsule to close said orifice; and
a water sensitive material that is receivable into said cavity, wherein upon the passage of the device from the stomach into the intestine said water sensitive material expands and causes an increasing positive pressure to be exerted on said interior wall of said capsule, thereby to effect the rapid separation of said closure member from said capsule and the release of substantially all the active agent therefrom in a single pulse, said method comprising the steps of sequentially inserting a said water-sensitive material and a said active agent respectively into said cavity defined by said capsule and said closure member; and
closing said cavity with said closure member.
- an interior wall defining an orifice, said orifice being in communication with said cavity;
Specification
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- Resources
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Current AssigneeBTG International Limited (Boston Scientific Corporation)
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Original AssigneeBTG International Limited (Boston Scientific Corporation)
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InventorsRashid, Abdul
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Primary Examiner(s)Bawa, Raj
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Application NumberUS08/356,635Time in Patent Office2,280 DaysField of Search424/453, 424/422, 424/484, 424/457, 424/463, 424/487, 424/488, 424/451US Class Current424/451CPC Class CodesA61K 9/0004 Osmotic delivery systems; S...A61K 9/4808 characterised by the form o...
