Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2005-03-29
2005-03-29
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S468000, C424S480000
Reexamination Certificate
active
06872407
ABSTRACT:
Disclosed is a pharmaceutical composition for extended release of an erythromycin derivative in the gastrointestinal environment. The composition comprises an erythromycin derivative and a pharmaceutically acceptable polymer so that, when ingested orally, the composition induces statistically significantly lower Cmaxin the plasma than an immediate release composition of the erythromycin derivative while maintaining bioavailability and minimum concentration substantially equivalent to that of the immediate release composition of the erythromycin derivative upon multiple dosing. The compositions of the invention have an improved taste profile and reduced gastrointestinal side effects as compared to those for the immediate release composition.
REFERENCES:
patent: 3065143 (1962-11-01), Christenson et al.
patent: 3870790 (1975-03-01), Lowey et al.
patent: 4226849 (1980-10-01), Schor
patent: 4369172 (1983-01-01), Schor et al.
patent: 4808411 (1989-02-01), Lu et al.
patent: 4842866 (1989-06-01), Horder et al.
patent: 4925675 (1990-05-01), Giannini et al.
patent: 5393765 (1995-02-01), Infeld et al.
patent: 5633006 (1997-05-01), Catania et al.
patent: 5705190 (1998-01-01), Broad et al.
patent: 5707646 (1998-01-01), Yajima et al.
patent: 6010718 (2000-01-01), Al-Razzak et al.
patent: 197 06 978 (1998-08-01), None
patent: 197 06 979 (2002-08-01), None
patent: 0 413 865 (1991-02-01), None
patent: 0293885 (1998-12-01), None
patent: 0 943 341 (1999-09-01), None
patent: 0971718 (2002-06-01), None
patent: 2584948 (1987-02-01), None
patent: 2 111 386 (1983-07-01), None
patent: 2 117 239 (1983-10-01), None
patent: 1308223 (1989-12-01), None
patent: 9317667 (1993-09-01), None
patent: 9530422 (1995-11-01), None
patent: 9716174 (1997-05-01), None
patent: 9722335 (1997-06-01), None
patent: 9811879 (1998-03-01), None
patent: 9836732 (1998-08-01), None
patent: 9846239 (1998-10-01), None
Gustavson, et al., “Pharmacokinetics of a New Extended-Release Clarithromycin Tablet at Doses of 500 and 1000 mg Daily”,Interscience Conference on Antimicrobial Agents and Chemotherapy,(1996).
Rak, J., et al., “Matrixtabletten aus Niedrigviskoser Hydropromellose”,Die Pharmazie,50(4):154-155 (1995).
Dow Chemical Co., “Methods for Formulating Controlled Release Products Outside of the Claims of Forest Laboratory Patents”,Technical Information,(1991).
Ranga Rao, K. V., et al., “Influence of Molecular Size and Water Solubility of the Solute on its Release from Swelling and Drosion Controlled Polymeric Matrices”,Journ. of Controlled Rel.,12:133-141 (1990).
Korenov et al., “Pharmaceutical Availability of a Children's Erythromycin Prodrug in Granule Form”, Antibiotics and Chemotherapy, 35 (8), 14-16, (1990)—English translation provided.
Colombo, “Swelling-Controlled Release in Hydrogel Matrices for Oral Route”, Advanced Drug Delivery Reviews, 11, 37-57 (1993).
Hogan, “Hydroxypropylmethylecellulose Sustained Release Technology”, Drug Development and Industrial Pharmacy, 15 (6&7), 975-999 (1989).
Alderman, “A Review of Cellulose Ethers in Hydrophilic Matrices for Oral Controlled-Release Dosage Forms”, Int. J. Pharm. Tech & Prod. Mfr., 5(3), 1-9, (1984).
Rao et al., “Swelling Controlled-Release Systems: Recent Developments and Applications”, International Journal of Pharmaceutics, 48, 1-13 (1988).
Vázquez et al, “Influence of Technological Variables on Release of Drugs from Hydrophilic Matrices”, Drug Development and Industrial Pharmacy, 18(11&12), 1355-1375 (1992).
Baveja et al., “Release Characteristics of Some Bronchodilators from Compressed Hydrophilic Polymeric Matrices and their Correlation with Molecular Geometry”, International Journal of Pharmaceutics, 41, 55-62 (1988).
“Formulating for Controlled Release with METHOCEL Premium cellulose ethers”, The Dow Chemical Company (1989).
“METHOCEL in Sustained Release”, Colorcon Technical Information, 1992.
Lin et al., “Biopharmaceutic Evaluation of Controlled-Release Hydrophilic-Matrix Tablets Containing Encapsulated or Unencapsulated Salbutamol Sulfate”, Current Therapeutic Research, 52(3), 486-492 (1992).
Huber et al, “Utilization of Hydrophilic Gums for the Control of Drug Release form Tablet Formulations I. Disintegration and Dissolution Behavior”, Journal of Pharmaceutical Sciences, 55(9), 974-976 (1966).
Aqualon Technical Information, “KLUCEL Hydroxypropylcellulose (HPC) Effect of Molecular Weight on Drug Release from Sustained-Release Matrix Tablets”, Bulletin VC-585 (1991).
Ford et al., “Formulation of Sustained Release Promethazine Hydrocholoride Tablets Using Hydroxypropyl-Methycellulose Matrices”, International Journal of Pharmaceutics, 24, 327-338 (1985).
Daly et al., “The Effect of Anionic Surfactants on the Release of Chlorpheniramine from a Polymer Matrix Tablet”, International Journal of Pharmaceutics, 18, 201-205 (1984).
Lapidus et al., “Some Factors Affecting the Release of a Water-Soluble Drug form a Compressed Hydrophilic Matrix”, Journal of Pharmaceutical Sciences, 55(8), 840-843 (1966).
Lapidus et al., “Drug Release from Compressed Hydrophilic Matrices”, Journal of Pharmaceutical Sciences, 57(8), 1292-1301 (1968).
Cheong et al., “Relationship Between Polymer Viscosity and Drug Release from a Matrix System”, Pharmaceutical Research, 9(11), 1510-1514 (1992).
Kees et al., “Serum and Cellular Pharmacokinetics of Clarithromycin 500 mg q.d. and 250 mg b.i.d. in Volunteers”, Infection, 23(3), 168-172 (1995).
Rote Liste, #10 270, Klacid (1996)—English translation provided.
Stamler, “Pharmacokineteics of a New Controlled-Release Formulation of Clarithromycin”, 5thWestern Pacific Congress of Chemotherapy and Infectious Disease (1996).
Chu et al., “Single- and Multiuple-dose Pharamacokinetics of Clarithromycin, a new Macrolide Antimicrobial”, J. Clin. Pharmacol., 33, 719-726 (1993).
Chu et al., “Drug-Food Interaction Potential of Clarithromycin, A New Macrolide Antimicrobial”, J. Clin. Pharmacol, 32, 32-36 (1992).
Fu Lu et al., “A Polymer Carrier System for Taste Masking of Macrolide Antibiotics”, Pharmaceutical Research, 8(6), 706-712 (1991).
Rak et al., “Matrixabletten aus niedrigwiskoser Hydropromellose”, Phamazie, 50 (2), 154-155 (1995)—English translation provided.
Opponent Sanovel's Opposition to EP-B1-0 973 527.
Opponenet Niche Generics Limited's Opposition to EP-B1-0 973 527.
Devcich Karen J.
Hom Richard C.
Notario Gerard F.
Palmer Robert N.
Semla Susan J.
Abbott Laboratories
Ghali Isis
Page Thurman K.
Poulos Nicholas A.
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