Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
1994-09-16
2002-12-10
Mullis, Jeffrey (Department: 1711)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S468000, C424S473000
Reexamination Certificate
active
06491945
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to a novel therapeutic composition comprising hydrocodone. The invention concerns also a novel dosage form comprising hydrocodone. Additionally, the invention relates to a novel method of administering a dose of hydrocodone from a therapeutic composition, and to a novel method of administering a dose of hydrocodone from a dosage form that in both administrations are for producing antitussive and analgesic therapy.
BACKGROUND OF THE INVENTION
Hydrocodone is chemically 4, 5-epoxy-3-methoxy-17-methyl-morphinan-6-one. The synthesis of hydrocodone and its pharmaceutically acceptable acid addition salts are described in U.S. Pat. No. 2,715,629 issued to Pfister et al, and in the
Merck Index
, 11th Edition, page 757, entry 4708 (1989). Hydrocodone is a narcotic antitussive and analgesic. The mechanism of physiological and pharmacological actions of hydrocodone is believed that it acts directly by depressing the cough centers for its antitussive therapy. At antitussive doses, hydrocodone exerts also analgesic effects. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-dimethylation and 6-keto reduction to the corresponding 6-&bgr;-hydroxy metabolites.
The prior art administers hydrocodone in conventional tablet and syrup forms, which forms dose-dump hydrocodone thereby providing a concentration of hydrocodone followed by an absence of hydrocodone. This pharmaceodynamic variability with its fluctuation in hydrocodone availability to hydrocodone receptor sites produces uncertainty as it is unknown if a dose of hydrocodone is present for needed therapy. The prior art is deficient in providing controlled hydrocodone therapy to a patient seeking such therapy. The pharmacological properties of hydrocodone are known in
The Pharmacological Basis of Therapy
, by Gilman and Rall, 8th Edition, pg. 497, (1990); and in
Pharmaceutical Sciences
, Remington, 17th Ed., pg. 1104, (1985).
SUMMARY OF THE INVENTION
In view of the foregoing presentation, it is immediately apparent that a present and critical need exists for an improvement in the delivery of hydrocodone for its therapeutic antitussive and analgesic effects. The need exists for providing a novel therapeutic composition comprising hydrocodone, the need exists for providing a novel dosage form comprising hydrocodone, and the need exists for providing a novel method for administering hydrocodone to a patient in need of hydrocodone therapy. It is, therefore, an object of this invention to provide a therapeutic composition comprising hydrocodone with means for enhancing the administration of hydrocodone over time. It is also an object of the invention to provide a dosage form with means for controlling the delivery of hydrocodone that overcomes fluctuation in hydrocodone therapy. It is an additional object of the invention to provide a method for administering hydrocodone for better hydrocodone therapy.
DESCRIPTION OF THE INVENTION
The drug hydrocodone, as embraced by this invention, comprises a member selected from the group consisting of hydrocodone and its pharmaceutically acceptable salts. Representative of hydrocodone pharmaceutically acceptable salts comprises a member selected from the group consisting of hydrocodone bitartrate, hydrocodone bitartrate hydrate, hydrocodone hydrochloride, hydrocodone p-toluenesulfonate, hydrocodone phosphate, hydrocodone thiosemicarbazone, hydrocodone sulfate, hydrocodone trifluoroacetate, hydrocodone, hydrocodone bitartrate, dihydrocodeinone bitartrate, hydrocodone bitartrate hemipentahydrate, pentafluoropropionate, hydrocodone p-nitrophenylhydrazone, hydrocodone o-methyloxime, hydrocodone semicarbazone, hydrocodone hydrobromide, hydrocodone mucate, hydrocodone oleate, hydrocodone phosphate dibasic, hydrocodone phosphate monobasic, hydrocodone inorganic salt, hydrocodone organic salt, hydrocodone acetate trihydrate, hydrocodone bis(heptafuorobutyrate), hydrocodone bis(methylcarbamate), hydrocodone bis(pentaflu oropropionate), hydrocodone bis(pyridine carboxylate), hydrocodone bis(trifluoroacetate), hydrocodone chlorhydrate, and hydrocodone sulfate pentahydrate.
REFERENCES:
patent: 3845770 (1974-11-01), Theeuwes et al.
patent: 3916899 (1975-11-01), Theeuwes et al.
patent: 4111201 (1978-09-01), Theeuwes et al.
patent: 4111202 (1978-09-01), Theeuwes
patent: 4327725 (1982-05-01), Cortese et al.
patent: 4464378 (1984-08-01), Hussain
patent: 4576604 (1986-03-01), Guittard et al.
patent: 4612008 (1986-09-01), Wong et al.
patent: 5021053 (1991-06-01), Barclay et al.
patent: 5190765 (1993-03-01), Jao et al.
Nikitin, N.I “A General Survey of Physiochemical Properties of Cellulose” in:The Chemistry of Cellulose and Wood(Jerusalem, 1966) pp. 62-71.*
Fried, R.F in:Polymer Science and Technology(Englewood Cliffs, N.J. 07632, Prentice Hall PTR, 1995) pp 16-18 QD381.F73 1995.*
Mandelkern, L. “Structural Features and Preparation” in:An Introduction to Macromolecules, second ed. (Springer-Verlag, New York inc., 1983). pp 19-27.QD381.M37.1983.*
Hiemenz, P.C. “The Chains and Averages of Polymers” in:Polymer Chemistry The Basic Concepts(N.Y., Marcel Dekker,Inc, 1984). pp 34-43. QD381.H52 1984.
Barclay Glen E.
Childers Jerry D.
Guittard George V.
Kuczynski Anthony L.
Wong Patrick S.-L.
ALZA Corporation
Mullis Jeffrey
Neller Robert R.
LandOfFree
Hydrocodone therapy does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Hydrocodone therapy, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Hydrocodone therapy will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2961455