Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2000-03-03
2001-09-04
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S464000, C424S468000
Reexamination Certificate
active
06284274
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to a novel dosage form for the delivery of opiate and non-opiate analgesics. The invention concerns also a dosage form comprising a composition of matter that provides for a high dose of the analgesic in the dosage form, which analgesic is delivered at a controlled rate over an extended time. The invention relates additionally to a composition of matter for use in a dosage form for delivering the analgesic to produce the analgesic effect. The invention concerns further a method of administering the dosage form for delivering the analgesic to produce an analgesic effect in a patient in need of analgesia.
BACKGROUND OF THE INVENTION
Pain is a universal experience; everyone knows what is meant by pain. To relieve pain in patients, opiate analgesics and non-opiate analgesics are administered for their therapeutic purpose. These analgesics are used to relieve pain by acting centrally to elevate pain threshold, usually without disturbing consciousness and usually without altering sensory modalities. Presently, both pharmacy and medicine administer multidoses of these analgesics for the relief of pain, as a dosage form comprising a long-term dose administered at a controlled rate over time appears to be absent in the pharmaceutical and medicinal arts.
SUMMARY OF THE INVENTION
In view of the foregoing, it is readily apparent that a serious need exists for an improvement for delivering opiate analgesics and for delivering non-opiate analgesics for their therapeutic effect. Thus, it is an immediate object of the present invention to provide a dosage form that comprises a drug analgesic composition present as a layer containing a therapeutic dose of a member selected from the group consisting of an opiate analgesic and non-opiate analgesic, which in either analgesic manufacture is administered in a preferred, essentially zero-order dose over an extended time for their therapeutic effect. Further, it is an object of the present invention to provide a novel composition of matter, manufactured as an osmotic composition in a layer, with fluid imbibing properties for expanding and pushing the opiate analgesic or non-opiate analgesic at a controlled rate over time from the dosage form.
DETAILED DESCRIPTION OF THE INVENTION
The terms “analgesic” and “analgesic drug” as used for the purpose of this invention denote an active agent that relieves pain in humans and in animals. The expression “opiate analgesic” denotes a narcotic analgesic used, for example, as an adjunct to anesthesia, to alleviate sharp pain of traumatic origin, to alleviate pain of visceral origin, in surgery, for chronic pain caused by disease and the like. The expression “non-opiate analgesic” denotes a nonnarcotic agent indicated for aches, pains of headaches and the like. Representatives of an opiate analgesic comprise a member selected from the group consisting of morphine, codeine, hydrocodone, hydromorphone, levorphanol, oxymorphone and levallorphan. The non-opiate analgesics are represented by a member selected from the group consisting of: alfentanil, buprenorphine, butorphanol, fentanyl, meperidine, methadone, propoxyphene, pentazocine, propoxyphene, sufentanil, acetaminophen, aspirin, ibuprofen and naproxen. The active analgesic can be present as the pharmaceutically acceptable salt, such as hydrobromide, hydrochloride, mucate, sulfate, acetate, phosphate, acetate trihydrate, bi(heptafluorobutyrate), bi(methylcarbamate), bi(pentafluoropropionate), maleate, bi(pyridine-3-carboxylate), bi(trifluoroacetate), bitartrate, chlorhydrate, sulfate pentahydrate, fumarate, sodium and calcium. The analgesic composition provided by this invention comprises 50 ng to 1000 mg of the opiate analgesic or the non-opiate analgesic and zero to 10 wt % (weight-percent) of a nonionic surfactant. The osmotic composition provided by this invention comprises zero to 60 wt % of an osmagent comprising a gas generating group.
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Ahlgren Nils W.
Ayer Atul D.
Hwang Paul M.
Johnson Deborah J.
Kuczynski Anthony L.
ALZA Corporation
Dhuey John A.
Jarvis William R. A.
Simboli Paul B.
Stone Steven F.
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